This document provides information about contraindications and adverse effects of the calcium channel blocker nifedipine. It notes that some studies have found an increased risk of myocardial infarction and death in patients taking short-acting nifedipine, especially at high doses, likely due to its hypotensive, arrhythmogenic, and proischemic effects. Common side effects of nifedipine include headaches, flushing, and lower extremity edema. Rare but serious adverse reactions include hypotension, angina, heart failure, and arrhythmias. The risks appear greater with short-acting versus long-acting nifedipine preparations.
This document describes a clinical trial that compared the effects of a fixed-dose combination of perindopril and amlodipine on target organ damage in hypertensive patients with and without ischemic heart disease. Sixty patients were treated with escalating doses of perindopril/amlodipine for 12 months. Target organ damage measures including blood pressure, arterial stiffness, cardiac parameters, and biomarkers were assessed at baseline and during treatment. Therapy effectively lowered blood pressure and regressed target organ damage in both groups, though some measures of improvement differed between patients with and without ischemic heart disease. The study demonstrates the effectiveness of perindopril/amlodipine for treating hypertension and regressing target organ damage in patients both
This study examined the prognostic significance of QRS fragmentation (fQRS) in electrocardiograms of adults with tetralogy of Fallot (TOF). The study found that the extent of fQRS strongly predicted all-cause mortality and clinical ventricular arrhythmias. Patients with more severe fQRS involving 5 or more leads had the highest mortality risk. The presence and extent of fQRS provided better prediction of outcomes than QRS duration alone. A simple risk score was created combining factors like fQRS extent, age, and prior procedures to stratify long-term mortality risk in adults with TOF.
Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients
with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal
treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from ei ther shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor
monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of
treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk
scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores
have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms
of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function
testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint
on the use of different risk stratification methods alongside clinical judgement in current clinical practice.
Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic DrugsRashiab Rashid
1) The document discusses a clinical trial that compared catheter ablation versus escalated antiarrhythmic drug therapy for patients with ischemic cardiomyopathy and an implantable cardioverter-defibrillator who experienced ventricular tachycardia despite initial drug treatment.
2) The ablation group underwent catheter ablation within 14 days, targeting all inducible ventricular tachycardias using a standardized approach, while the escalated therapy group received amiodarone or amiodarone plus mexiletine.
3) The trial found that catheter ablation significantly reduced the risk of death, ventricular tachycardia storm, or appropriate ICD shock compared to escalated drug therapy.
Sample Hypertension Protocol for Correctionsjeffk2996
This document provides guidelines for treating hypertension in jail patients. It defines normal and abnormal blood pressure readings and stages of hypertension. It recommends screening all inmates for hypertension and referring those found to have it for treatment and counseling on lifestyle changes. Treatment involves starting medications like thiazide diuretics and ACE inhibitors and adjusting or adding medications based on the patient's level of blood pressure control. It also provides guidance for treating complicated cases of resistant, urgent, or emergency hypertension.
The American Heart Association (AHA) 2012 Scientific Sessions took place in Los Angeles, CA on November 3-7, 2012. Key trials presented at the sessions include: FREEDOM, TACT, UMPIRE, PHS II, OPERA and FORWARD, ASPIRE, TRILOGY ACS/ARCTIC, MADIT-RIT, RELAX-AHF, POSEIDON / SCIPIO, PCSK9 studies, PCSK9, dal-OUTCOMES andLoDoCo.
This document describes a clinical trial that compared the effects of a fixed-dose combination of perindopril and amlodipine on target organ damage in hypertensive patients with and without ischemic heart disease. Sixty patients were treated with escalating doses of perindopril/amlodipine for 12 months. Target organ damage measures including blood pressure, arterial stiffness, cardiac parameters, and biomarkers were assessed at baseline and during treatment. Therapy effectively lowered blood pressure and regressed target organ damage in both groups, though some measures of improvement differed between patients with and without ischemic heart disease. The study demonstrates the effectiveness of perindopril/amlodipine for treating hypertension and regressing target organ damage in patients both
This study examined the prognostic significance of QRS fragmentation (fQRS) in electrocardiograms of adults with tetralogy of Fallot (TOF). The study found that the extent of fQRS strongly predicted all-cause mortality and clinical ventricular arrhythmias. Patients with more severe fQRS involving 5 or more leads had the highest mortality risk. The presence and extent of fQRS provided better prediction of outcomes than QRS duration alone. A simple risk score was created combining factors like fQRS extent, age, and prior procedures to stratify long-term mortality risk in adults with TOF.
Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients
with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal
treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from ei ther shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor
monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of
treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk
scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores
have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms
of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function
testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint
on the use of different risk stratification methods alongside clinical judgement in current clinical practice.
Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic DrugsRashiab Rashid
1) The document discusses a clinical trial that compared catheter ablation versus escalated antiarrhythmic drug therapy for patients with ischemic cardiomyopathy and an implantable cardioverter-defibrillator who experienced ventricular tachycardia despite initial drug treatment.
2) The ablation group underwent catheter ablation within 14 days, targeting all inducible ventricular tachycardias using a standardized approach, while the escalated therapy group received amiodarone or amiodarone plus mexiletine.
3) The trial found that catheter ablation significantly reduced the risk of death, ventricular tachycardia storm, or appropriate ICD shock compared to escalated drug therapy.
Sample Hypertension Protocol for Correctionsjeffk2996
This document provides guidelines for treating hypertension in jail patients. It defines normal and abnormal blood pressure readings and stages of hypertension. It recommends screening all inmates for hypertension and referring those found to have it for treatment and counseling on lifestyle changes. Treatment involves starting medications like thiazide diuretics and ACE inhibitors and adjusting or adding medications based on the patient's level of blood pressure control. It also provides guidance for treating complicated cases of resistant, urgent, or emergency hypertension.
The American Heart Association (AHA) 2012 Scientific Sessions took place in Los Angeles, CA on November 3-7, 2012. Key trials presented at the sessions include: FREEDOM, TACT, UMPIRE, PHS II, OPERA and FORWARD, ASPIRE, TRILOGY ACS/ARCTIC, MADIT-RIT, RELAX-AHF, POSEIDON / SCIPIO, PCSK9 studies, PCSK9, dal-OUTCOMES andLoDoCo.
The TWILIGHT trial compared ticagrelor monotherapy to ticagrelor plus aspirin in patients at high risk of bleeding and ischemic events after PCI. Over 7,000 patients received ticagrelor and aspirin for 3 months after PCI. Then patients were randomized to ticagrelor alone or with aspirin for 12 more months. The study found ticagrelor monotherapy was associated with a 44% lower risk of bleeding over 1 year without increasing ischemic events, suggesting it may be a safer option for high risk patients after a brief initial period of dual antiplatelet therapy.
26.09.13 how to choose your bride among three sistersRajeev Agarwala
1. The document discusses how to choose a bride among three sisters.
2. It notes that choosing a bride is a delicate matter that requires considering compatibility, personality, family background, and health of each sister.
3. The best approach is to carefully evaluate each sister individually based on these factors and choose the one who is most suitable and with whom you can have a happy marriage.
Combination Therapy In Hypertension - Dr Vivek Baliga PresentationDr Vivek Baliga
Dr Vivek Baliga of Baliga Diagnostics, Bangalore, discusses the common combination therapies used in the management of hypertension in clinical practice.
The SPRINT study found that treating systolic blood pressure to 120 mm Hg rather than 140 mm Hg significantly reduced mortality and cardiovascular events such as heart attack and stroke. This challenges the current JNC 8 guideline target of 140 mm Hg and below. The PATHWAY2 study found that adding spironolactone was more effective at reducing blood pressure than other drugs for patients resistant to three-drug treatment. Research also showed that ACE inhibitors resulted in poorer cardiovascular outcomes for black hypertensive patients compared to other antihypertensive drugs.
Resistant hypertension is defined as uncontrolled blood pressure despite treatment with three or more antihypertensive medications, including a diuretic. Pseudo-resistant hypertension accounts for around 50% of cases due to issues like inaccurate measurements, poor medication adherence, and inadequate treatment regimens. Ambulatory blood pressure monitoring is important for accurately diagnosing and managing resistant hypertension. Treatment involves optimizing medication regimens with medications like chlorthalidone, spiranolactone, and amiloride-hydrochlorothiazide combinations, and considering interventions for refractory cases involving more than five medications.
1) This study evaluated the efficacy and safety of levosimendan, a positive inotropic drug with vasodilator effects, in 700 patients hospitalized for acutely decompensated heart failure.
2) The study found that levosimendan provided more rapid and durable symptomatic relief compared to placebo, with fewer patients experiencing clinical worsening. However, levosimendan was also associated with more hypotension, arrhythmias, and possibly increased risk of death.
3) While levosimendan provided short-term benefits, its risks require careful consideration in the treatment of acutely decompensated heart failure.
The document compares the 2013 European Society of Cardiology (ESC) hypertension guidelines to the 2014 Eighth Joint National Committee (JNC 8) guidelines. Some key differences include: ESC defines pre-hypertension while JNC 8 does not, ESC recommends lifestyle changes for pre-hypertension while JNC 8 does not, and ESC recommends beta-blockers as first-line treatment while JNC 8 recommends thiazide diuretics, ACE inhibitors, ARBs, or CCBs as first-line based on clinical trials. Both guidelines relax blood pressure targets for elderly patients over 60 or 80 years old, respectively.
The document summarizes guidelines from various organizations on blood pressure targets from 2011-2015. It notes there has been confusion due to the multitude of guidelines from respected bodies. The JNC 8 guideline relaxed the target from 140/90 mmHg to 150/90 mmHg for those over 60, which was controversial. More recent guidelines in 2015 from the AHA/ACC/ASH set a target of <140/90 mmHg for those with CAD and <130/80 mmHg may be appropriate for some high risk groups. New hypertension guidelines are anticipated to be released in 2016 by several medical societies to update the JNC 7 guidelines from 2003.
The document discusses the rationale and history of using combination therapy to treat hypertension. It notes that combination therapy has been used since the 1950s and studies in the 1960s showed improved blood pressure control and reduced morbidity. Guidelines now recommend initial combination therapy using single pill combinations over stepwise monotherapy due to greater effectiveness in reducing blood pressure and heart disease risk. For patients still uncontrolled on dual therapy, guidelines recommend adding a third drug, often in a single pill combination, to help achieve target blood pressure goals.
Comparison of the efficacy and safety of new oral anticoagulants with warfari...Khairunnisa Zamri
This document summarizes a meta-analysis comparing the efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) to warfarin for preventing stroke in patients with atrial fibrillation. The analysis pooled data from four randomized controlled trials involving over 100,000 patients. It found that the new oral anticoagulants were as effective or more effective than warfarin at reducing strokes and systemic embolisms, with similar or lower rates of major bleeding. However, they were associated with an increased risk of gastrointestinal bleeding compared to warfarin. The analysis concluded that the new oral anticoagulants provide an improved
Management of hypertension hyperglycemia in strokeDr Pradip Mate
1. For patients with acute ischemic stroke who will receive thrombolytic therapy, antihypertensive treatment is recommended to lower blood pressure to ≤185/110 mmHg. Labetalol or nicardipine can be administered intravenously to achieve this.
2. For patients receiving reperfusion therapy, blood pressure should be maintained at ≤180/105 mmHg during and after treatment. It should be monitored frequently and medications adjusted as needed.
3. For previously untreated patients with a history of ischemic stroke or TIA, initiation of antihypertensive therapy is recommended if blood pressure remains ≥140/90 mmHg after the first few days, with a target of <140/90 mmHg
This document summarizes evidence-based approaches to diagnosing and treating acute decompensated heart failure. It discusses using BNP and NT-proBNP levels to rule in or rule out heart failure based on age. For an initial patient with NT-proBNP of 1574 and normal troponin, it recommends 40mg of IV furosemide. It also recommends starting nitroglycerin at 100 mcg/min for blood pressure control and considers alternatives to furosemide like captopril for rapid clinical improvement.
This document summarizes a presentation on treatment strategies for hospitalized heart failure patients, focusing on the drug serelaxin. It discusses two clinical trials of serelaxin (Pre-RELAX-AHF and RELAX-AHF) which found that serelaxin improved dyspnea, reduced worsening heart failure and cardiovascular mortality, shortened hospital stays, and reduced use of intravenous therapies compared to placebo. The document concludes that serelaxin has potential clinical benefits for acute heart failure based on its vasodilatory, antifibrotic and cardioprotective properties.
This document discusses guidelines and considerations for clinical trials in hypertension. It provides information on:
1. The increasing global prevalence and costs of hypertension, with an estimated 1.6 billion hypertensive patients by 2025.
2. Guidelines for classifying and treating hypertension from organizations like JNC, WHO, and ESC/ESH. The JNC 8 guideline is evidence-based and recommends treatment thresholds, goals, and medications based on randomized controlled trials.
3. Methodological considerations for designing and conducting clinical trials to evaluate antihypertensive drugs and combinations, including study populations, measures of efficacy like blood pressure and target organ damage, safety aspects, and trial durations. Long-term safety data is important
1) Serelaxin is a novel investigational therapy for acute heart failure that acts as a vasodilator, improving symptoms of dyspnea and reducing congestion.
2) In the RELAX-AHF trial, serelaxin treatment for 48 hours in over 1,100 patients hospitalized for acute heart failure resulted in greater improvement in dyspnea, reduced worsening heart failure and rehospitalization rates, and shorter hospital stays compared to placebo.
3) Serelaxin's multi-mechanistic effects include vasodilation, anti-fibrotic, anti-inflammatory, and renoprotective properties, addressing several pathophysiological processes in acute heart failure.
1) IV therapies for heart failure (HF) have not significantly improved outcomes for acute HF patients.
2) Diuretics remain the primary treatment for relieving congestion in acute HF patients, though optimal dosing strategies require further study.
3) Inotropic drugs may provide short-term hemodynamic support for patients with severe systolic dysfunction and low blood pressure, but their risks must be weighed against benefits.
Ularitide is a synthetic form of urodilatin, a natriuretic peptide. Previous trials showed ularitide reduces pulmonary capillary wedge pressure and improves dyspnea in acute heart failure patients. The TRUE-AHF trial is currently evaluating the efficacy and safety of intravenous ularitide in over 4,000 acute heart failure patients. The primary endpoint is a composite of cardiovascular death or rehospitalization for heart failure at 180 days. Secondary endpoints include change from baseline to 48 hours in dyspnea and weight. As of May 2015, over 2,150 patients had been recruited for the TRUE-AHF trial.
This document describes a clinical trial that compared the effects of a fixed-dose combination of perindopril and amlodipine on target organ damage in hypertensive patients with and without ischemic heart disease. Sixty patients were treated with escalating doses of perindopril/amlodipine for 12 months. Measurements of blood pressure, arterial stiffness, cardiac function, and other parameters were taken at baseline and during treatment. Therapy effectively lowered blood pressure and regressed target organ damage in both groups. However, some aspects of target organ damage regression differed between the groups.
Anticoagulation in CKD patients with AFد.محمود نجيب
chronic kidney disease is associated with increased risk of both thrombosis and bleeding, so in CKD patients with AF it is a challenging problem whether to be anticoagulated or not
This document discusses guidelines for the treatment of hypertension. It recommends treating patients with a blood pressure consistently above 140/90 mmHg or 130/80 mmHg for those with risk factors. Lifestyle modifications like the DASH diet are encouraged first before drug treatment. The main drug classes for initial monotherapy are thiazide diuretics, calcium channel blockers, and ACE inhibitors/ARBs, with thiazides like chlorthalidone preferred. The goal is to lower blood pressure, not necessarily the specific drug, though combination treatment may provide additional benefits over monotherapy alone. Ongoing monitoring is important to detect side effects like hypokalemia.
The TWILIGHT trial compared ticagrelor monotherapy to ticagrelor plus aspirin in patients at high risk of bleeding and ischemic events after PCI. Over 7,000 patients received ticagrelor and aspirin for 3 months after PCI. Then patients were randomized to ticagrelor alone or with aspirin for 12 more months. The study found ticagrelor monotherapy was associated with a 44% lower risk of bleeding over 1 year without increasing ischemic events, suggesting it may be a safer option for high risk patients after a brief initial period of dual antiplatelet therapy.
26.09.13 how to choose your bride among three sistersRajeev Agarwala
1. The document discusses how to choose a bride among three sisters.
2. It notes that choosing a bride is a delicate matter that requires considering compatibility, personality, family background, and health of each sister.
3. The best approach is to carefully evaluate each sister individually based on these factors and choose the one who is most suitable and with whom you can have a happy marriage.
Combination Therapy In Hypertension - Dr Vivek Baliga PresentationDr Vivek Baliga
Dr Vivek Baliga of Baliga Diagnostics, Bangalore, discusses the common combination therapies used in the management of hypertension in clinical practice.
The SPRINT study found that treating systolic blood pressure to 120 mm Hg rather than 140 mm Hg significantly reduced mortality and cardiovascular events such as heart attack and stroke. This challenges the current JNC 8 guideline target of 140 mm Hg and below. The PATHWAY2 study found that adding spironolactone was more effective at reducing blood pressure than other drugs for patients resistant to three-drug treatment. Research also showed that ACE inhibitors resulted in poorer cardiovascular outcomes for black hypertensive patients compared to other antihypertensive drugs.
Resistant hypertension is defined as uncontrolled blood pressure despite treatment with three or more antihypertensive medications, including a diuretic. Pseudo-resistant hypertension accounts for around 50% of cases due to issues like inaccurate measurements, poor medication adherence, and inadequate treatment regimens. Ambulatory blood pressure monitoring is important for accurately diagnosing and managing resistant hypertension. Treatment involves optimizing medication regimens with medications like chlorthalidone, spiranolactone, and amiloride-hydrochlorothiazide combinations, and considering interventions for refractory cases involving more than five medications.
1) This study evaluated the efficacy and safety of levosimendan, a positive inotropic drug with vasodilator effects, in 700 patients hospitalized for acutely decompensated heart failure.
2) The study found that levosimendan provided more rapid and durable symptomatic relief compared to placebo, with fewer patients experiencing clinical worsening. However, levosimendan was also associated with more hypotension, arrhythmias, and possibly increased risk of death.
3) While levosimendan provided short-term benefits, its risks require careful consideration in the treatment of acutely decompensated heart failure.
The document compares the 2013 European Society of Cardiology (ESC) hypertension guidelines to the 2014 Eighth Joint National Committee (JNC 8) guidelines. Some key differences include: ESC defines pre-hypertension while JNC 8 does not, ESC recommends lifestyle changes for pre-hypertension while JNC 8 does not, and ESC recommends beta-blockers as first-line treatment while JNC 8 recommends thiazide diuretics, ACE inhibitors, ARBs, or CCBs as first-line based on clinical trials. Both guidelines relax blood pressure targets for elderly patients over 60 or 80 years old, respectively.
The document summarizes guidelines from various organizations on blood pressure targets from 2011-2015. It notes there has been confusion due to the multitude of guidelines from respected bodies. The JNC 8 guideline relaxed the target from 140/90 mmHg to 150/90 mmHg for those over 60, which was controversial. More recent guidelines in 2015 from the AHA/ACC/ASH set a target of <140/90 mmHg for those with CAD and <130/80 mmHg may be appropriate for some high risk groups. New hypertension guidelines are anticipated to be released in 2016 by several medical societies to update the JNC 7 guidelines from 2003.
The document discusses the rationale and history of using combination therapy to treat hypertension. It notes that combination therapy has been used since the 1950s and studies in the 1960s showed improved blood pressure control and reduced morbidity. Guidelines now recommend initial combination therapy using single pill combinations over stepwise monotherapy due to greater effectiveness in reducing blood pressure and heart disease risk. For patients still uncontrolled on dual therapy, guidelines recommend adding a third drug, often in a single pill combination, to help achieve target blood pressure goals.
Comparison of the efficacy and safety of new oral anticoagulants with warfari...Khairunnisa Zamri
This document summarizes a meta-analysis comparing the efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) to warfarin for preventing stroke in patients with atrial fibrillation. The analysis pooled data from four randomized controlled trials involving over 100,000 patients. It found that the new oral anticoagulants were as effective or more effective than warfarin at reducing strokes and systemic embolisms, with similar or lower rates of major bleeding. However, they were associated with an increased risk of gastrointestinal bleeding compared to warfarin. The analysis concluded that the new oral anticoagulants provide an improved
Management of hypertension hyperglycemia in strokeDr Pradip Mate
1. For patients with acute ischemic stroke who will receive thrombolytic therapy, antihypertensive treatment is recommended to lower blood pressure to ≤185/110 mmHg. Labetalol or nicardipine can be administered intravenously to achieve this.
2. For patients receiving reperfusion therapy, blood pressure should be maintained at ≤180/105 mmHg during and after treatment. It should be monitored frequently and medications adjusted as needed.
3. For previously untreated patients with a history of ischemic stroke or TIA, initiation of antihypertensive therapy is recommended if blood pressure remains ≥140/90 mmHg after the first few days, with a target of <140/90 mmHg
This document summarizes evidence-based approaches to diagnosing and treating acute decompensated heart failure. It discusses using BNP and NT-proBNP levels to rule in or rule out heart failure based on age. For an initial patient with NT-proBNP of 1574 and normal troponin, it recommends 40mg of IV furosemide. It also recommends starting nitroglycerin at 100 mcg/min for blood pressure control and considers alternatives to furosemide like captopril for rapid clinical improvement.
This document summarizes a presentation on treatment strategies for hospitalized heart failure patients, focusing on the drug serelaxin. It discusses two clinical trials of serelaxin (Pre-RELAX-AHF and RELAX-AHF) which found that serelaxin improved dyspnea, reduced worsening heart failure and cardiovascular mortality, shortened hospital stays, and reduced use of intravenous therapies compared to placebo. The document concludes that serelaxin has potential clinical benefits for acute heart failure based on its vasodilatory, antifibrotic and cardioprotective properties.
This document discusses guidelines and considerations for clinical trials in hypertension. It provides information on:
1. The increasing global prevalence and costs of hypertension, with an estimated 1.6 billion hypertensive patients by 2025.
2. Guidelines for classifying and treating hypertension from organizations like JNC, WHO, and ESC/ESH. The JNC 8 guideline is evidence-based and recommends treatment thresholds, goals, and medications based on randomized controlled trials.
3. Methodological considerations for designing and conducting clinical trials to evaluate antihypertensive drugs and combinations, including study populations, measures of efficacy like blood pressure and target organ damage, safety aspects, and trial durations. Long-term safety data is important
1) Serelaxin is a novel investigational therapy for acute heart failure that acts as a vasodilator, improving symptoms of dyspnea and reducing congestion.
2) In the RELAX-AHF trial, serelaxin treatment for 48 hours in over 1,100 patients hospitalized for acute heart failure resulted in greater improvement in dyspnea, reduced worsening heart failure and rehospitalization rates, and shorter hospital stays compared to placebo.
3) Serelaxin's multi-mechanistic effects include vasodilation, anti-fibrotic, anti-inflammatory, and renoprotective properties, addressing several pathophysiological processes in acute heart failure.
1) IV therapies for heart failure (HF) have not significantly improved outcomes for acute HF patients.
2) Diuretics remain the primary treatment for relieving congestion in acute HF patients, though optimal dosing strategies require further study.
3) Inotropic drugs may provide short-term hemodynamic support for patients with severe systolic dysfunction and low blood pressure, but their risks must be weighed against benefits.
Ularitide is a synthetic form of urodilatin, a natriuretic peptide. Previous trials showed ularitide reduces pulmonary capillary wedge pressure and improves dyspnea in acute heart failure patients. The TRUE-AHF trial is currently evaluating the efficacy and safety of intravenous ularitide in over 4,000 acute heart failure patients. The primary endpoint is a composite of cardiovascular death or rehospitalization for heart failure at 180 days. Secondary endpoints include change from baseline to 48 hours in dyspnea and weight. As of May 2015, over 2,150 patients had been recruited for the TRUE-AHF trial.
This document describes a clinical trial that compared the effects of a fixed-dose combination of perindopril and amlodipine on target organ damage in hypertensive patients with and without ischemic heart disease. Sixty patients were treated with escalating doses of perindopril/amlodipine for 12 months. Measurements of blood pressure, arterial stiffness, cardiac function, and other parameters were taken at baseline and during treatment. Therapy effectively lowered blood pressure and regressed target organ damage in both groups. However, some aspects of target organ damage regression differed between the groups.
Anticoagulation in CKD patients with AFد.محمود نجيب
chronic kidney disease is associated with increased risk of both thrombosis and bleeding, so in CKD patients with AF it is a challenging problem whether to be anticoagulated or not
This document discusses guidelines for the treatment of hypertension. It recommends treating patients with a blood pressure consistently above 140/90 mmHg or 130/80 mmHg for those with risk factors. Lifestyle modifications like the DASH diet are encouraged first before drug treatment. The main drug classes for initial monotherapy are thiazide diuretics, calcium channel blockers, and ACE inhibitors/ARBs, with thiazides like chlorthalidone preferred. The goal is to lower blood pressure, not necessarily the specific drug, though combination treatment may provide additional benefits over monotherapy alone. Ongoing monitoring is important to detect side effects like hypokalemia.
1) This study compared intravenous procainamide to intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia. 62 patients were randomized to receive either procainamide or amiodarone over 20 minutes.
2) The primary outcome was incidence of major cardiac adverse events within 40 minutes. Procainamide had a significantly lower rate of cardiac events (9% vs 41%). Secondary outcomes found procainamide more effective at terminating tachycardia episodes (67% vs 38%).
3) In conclusions, for acute treatment of wide QRS tachycardia, intravenous procainamide resulted in fewer major cardiac adverse events and was more effective at terminating tachycardia episodes compared
This study compared long-term outcomes of patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for lesions located in the proximal left anterior descending (LAD) artery versus nonproximal LAD lesions. The study analyzed data from 8,709 patients in the PROTECT trial. Results showed no significant differences in rates of death, major adverse cardiac events (MACE), or target vessel failure at 4 years between patients treated for proximal versus nonproximal LAD lesions. Treatment of lesions in the proximal LAD, which supplies a large portion of the left ventricle, did not appear to influence long-term outcomes with modern DES and medical therapy.
Anticoagulation in Valvular Heart Disease.pptxzeinabnm
Brief definition with pathology, types, risk factors, clinical manifestation and staging in Valvular heart disease.
with detailed discussion of clinical management and approaches in different situation.
necessary information about each anti-coagulation used.
In this overview, we draw inspiration from the article titled "Managing Hypertension in Primary Care“, published in the Canadian Family Physician journal (Vol 65: October 2019).
The article, edited by Khrystine Waked PharmD, Jeff Nagge PharmD, and Kelly Grindrod PharmD MSc,.
It provides valuable insights and evidence-based approaches to tackle Hypertension Management In Primary Care.
By incorporating the recommendations discussed in this article, we can enhance our ability to manage hypertension and ultimately improving patient outcomes and quality of life.
This document summarizes a study comparing long-term outcomes of clopidogrel versus aspirin monotherapy after percutaneous coronary intervention (PCI). The study included over 5,400 patients who received dual antiplatelet therapy for 6-18 months after PCI. Patients were then randomized to clopidogrel or aspirin monotherapy. After a median follow up of 5.8 years, the primary endpoint occurred in 12.8% of clopidogrel patients and 16.9% of aspirin patients, showing clopidogrel reduced risk. Secondary endpoints including thrombosis and bleeding were also lower with clopidogrel. The study concludes clopidogrel provides significant relative risk reduction compared to aspirin for long-term
Chronic coronary syndrome (CCS) is a term that defines coronary artery disease as a chronic progressive course. It has been introduced to replace the previous term ‘stable coronary artery disease’.
The TOMAHAWK trial compared outcomes of patients who experienced out-of-hospital cardiac arrest and received immediate coronary angiography versus the standard of care. The trial found that immediate angiography did not reduce all-cause mortality at 90 days compared to standard care. However, it did result in more patients being discharged from the hospital and fewer patients having severe neurological impairment.
This expert consensus document from the World Heart Federation provides recommendations for antiplatelet therapy in East Asian patients with acute coronary syndrome or undergoing percutaneous coronary intervention. While current guidelines are based primarily on large Western clinical trials, few East Asian patients were included. Additionally, East Asians have differing risk profiles and responses to antiplatelet drugs compared to white patients. This consensus aims to determine the most appropriate antiplatelet strategies for East Asians based on available evidence.
From vertigo to coma basilar artery occlusion بالاتر از سیاهی رنگی نیستramtinyoung
This document discusses standards of care for acute management of posterior circulation stroke patients. It summarizes that the patient presented with vertigo, blurred vision and other symptoms from an occlusion of the basilar artery, and received IV thrombolysis followed by a drug to promote recanalization, with improvement in symptoms. It also reviews general treatment approaches for posterior circulation strokes, including antiplatelet therapy, anticoagulation, management of blood pressure, and cautions around hemorrhagic transformation.
This document provides guidance on the management of hypertension. It begins with educational objectives and a case study example. It then reviews the magnitude of hypertension, definitions of true hypertension versus white coat hypertension, and the role of ambulatory blood pressure monitoring. Guidelines for diagnosing and staging hypertension from ACC/AHA and JNC-8 are presented. Non-pharmacologic and pharmacologic treatment options are discussed, including diuretics, ACE inhibitors, ARBs, beta blockers, calcium channel blockers, and vasodilators. Resistant hypertension, hypertensive crises, and hypertension management in specific clinical contexts like stroke are also addressed. Recommendations are provided for evaluating and managing different patient cases.
In patients with PAD, smoking should be stopped and hypertension, dyslipidemia, and diabetes mellitus treated. Patients with PAD should be treated with atorvastatin 40 mg to 80 mg daily or rosuvastatin 20 to 40 mg daily.
ntiplatelet drugs such as aspirin or clopidogrel and angiotensin-converting enzyme inhibitors should be given .Beta blockers should be given if coronary artery disease, especially prior myocardial infarction, s present unless contraindicated. Cilostazol improves exercise time until intermittent claudication. Exercise rehabilitation programs should be used. Indications for lower extremity percutaneous transluminal angioplasty or bypass surgery are 1) incapacitating claudication in patients interfering with work or lifestyle; 2) limb salvage in patientss with limb-threatening ischemia as manifested by rest pain, nonhealing ulcers, and/or infection or gangrene; and 3) vasculogenic impotence.
http://www.scireslit.com/
Nifedipine is the active ingredient in PROCARDIA XL, which is an extended release tablet used to treat hypertension and chest pain called angina. It works by blocking calcium channels and relaxing blood vessels. PROCARDIA XL tablets have an osmotic pump system that slowly releases nifedipine over 24 hours for continuous effect. Common side effects include headache, dizziness, and ankle swelling. It can be used alone or combined with other blood pressure medications and is generally started at a low dose that is increased gradually based on the patient's response.
DISCHARGE SUMMARY PCI IN THE ELDERLY PATIENT1DISCHARGE SUMMAAlyciaGold776
DISCHARGE SUMMARY: PCI IN THE ELDERLY PATIENT 1
DISCHARGE SUMMARY: PCI IN THE ELDERLY PATIENT
DISCHARGE SUMMARY: PCI IN THE ELDERLY PATIENT 6
DISCHARGE SUMMARY: PCI in the Elderly Patient
Professor: XXXX
Student Name
Grand Canyon University-ANP 654
Date
DISCHARGE SUMMARY
Discharge Summary
Date
XXXX-ANP 654
Patient Name: H.W.
MRN: 123456
Sex: Male
Date of Birth: 12/12/1933
Provider: C.H. APRN/MILLENIUM PHYSICIAN GROUP
Primary Care Provider: Dr. S.B.
Admission Date: xx/xx/xxxx
Discharge Date: xx/xx/xxxx
Admitting Diagnoses:
I25.1 Atherosclerotic heart disease of native coronary artery
R00.1 Bradycardia, unspecified (permanent pacemaker placed by Dr. R 12/28/2019)
I10 Renovascular hypertension
N18.6 End stage renal disease (on peritoneal dialysis)
Discharge Diagnosis:
I25.1 Atherosclerotic heart disease of native coronary artery-elective cardiac catheterization on this admission
R00.1 Bradycardia, unspecified
I10 Renovascular hypertension controlled
I70.1 Atherosclerosis of renal artery
N18.6 End stage renal disease (peritoneal dialysis 1/14/20 prior to discharge)
Admission Procedure:
01/13/20- Cardiac catheterization under moderate sedation with use of IVP contrast for coronary angiography
Impression: Non-dominant RCA without significant obstructive disease <60%. OM with an 80% proximal lesion, Circumflex with mid 90% lesion, LAD is without disease, large diagonals without disease. LV function is normal, EF 50%, no wall motion abnormalities. PCI to the OM and Circumflex were performed with good results.
Consultations:
Dr. R Interventional Cardiologist- performed elective cardiac catheterization 1/13/20
Course of Treatment:
This is an 86 year-old male patient with a complex cardiac history. The patient had a permanent pacemaker placed on 12/28/2019 for severe symptomatic bradycardia. After pacemaker placement, the patient underwent a Lexiscan showing ischemia. A planned cardiac catheterization was scheduled for 1/13/20. Dr. R. performed PCI and placed BM stents to the patient’s OM and Circumflex arteries. His RCA was assessed and was deemed not severe enough for intervention and was a non-dominant vessel. The patient was admitted for further observation overnight post procedure. He had no complaints of chest pain, no shortness of breath, no nausea or vomiting, no dizziness, and no numbness or tingling in his bilateral lower extremities. No hematoma, redness or swelling noted at his right groin catheterization site. Overall, the patient is stable for discharge this evening after his peritoneal dialysis treatment.
Admission Home Medications:
Auryxia 210mg, 2 tabs, po three times daily
Entresto 24/26mg, 1 tab, po twice daily
Thiamine 100mg po daily
Docusate sodium 100mg po twice daily
Discharge Medication:
Auryxia 210mg, 2 tabs, po three times daily
Entresto 24/26mg, 1 tab, po twice daily
Thiamine 100mg po daily
Docusate sodium 100mg po twice daily
New:
Nitroglycerine 0.4mg, one tablet SL ...
This document provides guidelines for the inpatient management of hyponatremia (sodium <130 mmol/L) at Norfolk and Norwich University Hospital. It was authored by several doctors and approved by medical committees. The guidelines outline procedures for assessing patients, determining the cause of hyponatremia, and prescribing appropriate treatment depending on whether patients present with euvolaemic, hypovolemic, or hypervolemic hyponatremia. The objectives are to safely and effectively treat hyponatremia while avoiding risks like overly rapid sodium correction.
This document discusses drug-induced bradycardia. It defines different types of bradycardia including drug-induced, drug-provoked, and drug-associated bradycardia. It provides examples of drugs that can cause clinically significant bradycardia such as beta-blockers, calcium channel blockers, and antiarrhythmic drugs. The document also presents a case study of a 74-year-old female patient who presented with low heart rate. Her bradycardia was assessed as being drug-induced due to her medications for heart conditions, hypertension, hypothyroidism and diabetes. Her treatment plan involved holding two cardiac medications and administering atropine.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Cell Therapy Expansion and Challenges in Autoimmune Disease
Di request fom 10
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CONTRAINDICATION OF NIFEDIPINE
Response to inquiry
While serious adverse reactions requiring discontinuance of nifedipine therapy or dosage
adjustments are uncommon,Ref126284307342 concerns about safety and efficacy of
calcium-channel blocking agents (mainly conventional [short-acting] preparations of
dihydropyridine derivatives) have been raised by findings of several
studies.Ref24024124224324424524624724824925025125225325425525625725825926026
1262263264266344345346347348 Results of a case-control study indicate dose-dependent
increases in the risk of myocardial infarction (by about 60%) in hypertensive patients (with
or without diagnosed cardiovascular disease, but excluding myocardial infarction or heart
failure) receiving a short-acting calcium-channel blocking agent (e.g., nifedipine, diltiazem,
verapamil) compared with those receiving a diuretic or a β-adrenergic blocking
agent.Ref242243244245246247252253254258259261263 In addition, findings of several
pooled analyses of studies indicate an increased risk of mortality (by about 16%) and
reinfarction (by about 19%) in patients who have had a myocardial infarction or in those
with stable or unstable angina who were receiving dihydropyridine-derivative calcium-
2. channel blocking agents (mainly conventional [short-acting] preparations of nifedipine)
compared with those receiving placebo.Ref240242248255266 Results of a pooled analysis of
16 studies indicate that the nifedipine-associated mortality may be dose dependent,
especially in patients receiving short-acting nifedipine dosages of 80 mg or more daily when
compared with those receiving placebo.Ref241242243248249250251254
The National Heart, Lung, and Blood Institute (NHLBI) concluded from the apparent
concordance of findings from observational studies in hypertensive patients and from
randomized studies principally in acute myocardial infarction and unstable angina patients
that it seems prudent and consistent with current evidence to recommend that short-acting
nifedipine, especially at high doses, be used in the management of hypertension, angina, or
myocardial infarction with great caution, if at all.Ref242 In arriving at this conclusion, the
NHLBI recognized the potential biases of observational studies.Ref242 The NHLBI and some
clinicians also state that while other calcium-channel blocking agents (e.g., diltiazem,
verapamil) also were associated with increased risk of myocardial infarction in the described
case-control study, results of previous well-designed clinical studies indicate that the use of
calcium-channel blocking agents was not associated with an increased risk of death;
therefore, the adverse effects associated with short-acting nifedipine may not necessarily
apply to other calcium-channel blocking agents, including other short-acting
dihydropyridines (e.g., isradipine), or to long-acting preparations of
nifedipine.Ref241242243249354 Recent findings of the Antihypertensive and Lipid-Lowering
Treatment to Prevent Heart Attack Trial (ALLHAT), which compared long-term therapy with
an ACE inhibitor (lisinopril) or dihydropyridine-derivative calcium-channel blocker
(amlodipine) revealed no difference in the primary outcome of combined fatal coronary
heart disease or nonfatal myocardial infarction among these therapies.Ref381382415416
The increased risk of myocardial infarction and death in patients receiving short-acting
calcium-channel blocking agents may be associated with the arrhythmogenic, proischemic,
negative inotropic, and/or prohemorrhagic effects of these agents; proischemic effects may
result from reflex increases in sympathetic activity or from a reduction of coronary perfusion
pressure induced by short-acting calcium-channel blocking agents.Ref242248262352
However, some clinicians state that while current evidence indicates an increased relative
risk of myocardial infarction associated with calcium-channel blocking agents, the actual
increased risk for an individual patient may be low.Ref244252258259261 Therefore, patients
should not discontinue such therapy independently,Ref244249253261 but instead should
consult their clinician about possible alternatives based on full evaluation of their medical
condition,Ref244258 since the known risks of uncontrolled hypertension may be far greater
than the postulated but unproven hazards associated with calcium-channel blocking
agents.Ref247258
Cardiovascular Effects
Serious adverse reactions requiring discontinuance of nifedipine therapy or dosage
adjustment are relatively rare.Ref284 An increase in the frequency, intensity, and duration
of angina, possibly resulting from hypotension, has occurred rarely during initiation of
nifedipine therapy.Ref284 Additional serious adverse effects including myocardial infarction,
3. congestive heart failure or pulmonary edema, and ventricular arrhythmia or conduction
defects have reportedly occurred in 4%, 2%, and less than 0.5% of patients receiving
conventional nifedipine capsules, respectively, but these have not been directly attributed to
the drug.Ref284 For additional information on potential serious cardiovascular effects
associated with nifedipine, see the introductory discussion in Cautions and see also
Cautions: Precautions and Contraindications.
Chest pain (nonspecific) has been reported in less than 3% of patients receiving extendedrelease nifedipine tablets in clinical trials.Ref126 Adverse cardiovascular effects reported in
up to 1% of patients receiving extended-release nifedipine tablets include substernal chest
pain,Ref342 arrhythmia,Ref126 atrial fibrillation,Ref342 bradycardia,Ref342
tachycardia,Ref126342 cardiac arrest,Ref342 extrasystole,Ref342 hypotension,Ref126342
postural hypotension,Ref342 syncope,Ref126 increased angina,Ref126 phlebitis,Ref342 and
cutaneous angiectases.Ref342
Most of the common adverse reactions to nifedipine result from its vasodilating action on
vascular smooth muscle and include dizziness, lightheadedness, giddiness, flushing or heat
sensation, and headache, reportedly occurring in up to 25% of patients, and less frequently,
hypotension (usually mild to moderate and well tolerated), weakness, peripheral edema,
and palpitation.Ref284 The incidence and severity of syncope, peripheral (ankle) edema, and
hypotension generally are dose related and occasionally may be obviated by a reduction in
dosage.Ref284 In patients receiving conventional liquid-filled (short-acting) nifedipine
capsules, transient hypotension occurred in about 2% of patients receiving less than 60 mg
daily and in about 5% of patients receiving 120 mg or more daily.Ref284 Nifedipine-induced
peripheral edema of the lower extremities usually responds to diuretic therapy.Ref284 The
relatively common adverse effects reported with conventional liquid-filled (short-acting)
nifedipine capsules are similar in nature to those reported with extended-release tablets of
the drug.Ref126 However, some evidence indicates that the risk of certain adverse effects
may be increased with short-acting preparations of the drug, particularly at high
doses.Ref240241242243244245246247248249250251252253254255256257258259260261
262263264266(See the introductory discussion in Cautions.)
Although the hypotensive effect of nifedipine is modest and well tolerated in most patients
receiving the drug for angina, excessive and poorly tolerated hypotension occurs
occasionally in such patients.Ref126284286307 Such excessive hypotension usually occurs
during initial dosage titration or subsequent upward titration of dosage, and may be more
likely in patients receiving a β-adrenergic blocking agent
concomitantly.Ref126129284286307 Severe hypotension and/or increased fluid
requirements also have been reported in patients who were receiving these drugs
concomitantly and underwent coronary artery bypass surgery involving high-dose fentanyl
anesthesia.Ref126129284307342(See Drug Interactions: Fentanyl.) Several cases of
profound hypotension, cerebrovascular ischemia or stroke, myocardial ischemia or
infarction, and/or death have been reported when conventional short-acting preparations of
nifedipine were used for the management of hypertensive
crises,Ref119283284288295300302303304307308 and therefore, the manufacturers
currently warn that short-acting preparations should not be used for acute reduction in
4. blood pressure.Ref284307(See Hypertensive Crises under Uses: Hypertension.) However,
profound hypotension, myocardial ischemia or infarction, and/or death also have been
reported occasionally in patients receiving conventional short-acting preparations of the
drug for other uses (e.g., angina, pulmonary hypertension).Ref283286287310 The
manufacturers also warn that short-acting preparations of nifedipine should not be used for
the chronic management of hypertension.Ref284307
The frequency of nifedipine-induced peripheral edema appears to be dose related and
reportedly occurs in 10–30% of patients receiving the drug.Ref126 The edema is localized
and probably occurs secondary to vasodilation of dependent arterioles and small blood
vessels rather than to left ventricular dysfunction or generalized fluid
retention.Ref126284307342 Intolerable adverse effects associated with nifedipine-induced
vasodilation (e.g., headache, flushing, orthostatic hypotension) may limit the usefulness of
nifedipine in some patients receiving the drug for Raynaud’s
phenomenon.Ref144146147148151158160297305306 The extended-release preparations
of nifedipine appear to be tolerated better than the short-acting preparation in patients with
this condition.Ref297305306 The principal troublesome adverse effect during long-term
therapy in these patients appears to be peripheral (ankle) edema.Ref297
Erythromelalgia has been reported in about 0.5% of patients receiving
nifedipine.Ref284307331 Characteristic manifestations of erythromelalgia include burning
pain, increased skin temperature, and erythema of the extremities, usually the feet and
lower legs, and less commonly, the hands.Ref331 Manifestations resolve following
discontinuance of the drug.Ref331
Nervous System Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, weakness
was reported in 12% of patients, while tremor, nervousness, and mood changes occurred in
about 7–8% of patients; fever and chills were reported in up to 2% of patients, and
shakiness, jitteriness, disturbed sleep, and difficulty with postural balance occurred
occasionally; mental depression and paranoid syndrome were reported rarely. Ref284 In
patients receiving extended-release nifedipine tablets, fatigue and asthenia were reported in
about 4–6% of patients,Ref126342 pain occurred in less than 3% of patients,Ref126342 and
paresthesia, vertigo, asthenia, insomnia, nervousness, and somnolence were reported in up
to 3% of patients, while migraine,Ref126342 anxiety,Ref126342 confusion,Ref342
ataxia,Ref126 depression,Ref126342 hypertonia,Ref126342 hypoesthesia,Ref126342
paroniria,Ref126 fever,Ref126342 and tremorRef126 were reported in up to 1% of
patients.Ref126342 Chills occurred in less than 1% of patients.Ref342For nervous system
effects associated with the vasodilating effect of nifedipine, see Cautions: Cardiovascular
Effects.
GI Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, nausea and
heartburn occurred in 11% of patients, while diarrhea, constipation, cramps, and flatulence
were reported occasionally, and gingival hyperplasia occurred rarely.Ref284 In patients
5. receiving extended-release nifedipine tablets, nausea and constipation were reported in
about 2–3 and about 1–3%, respectively, while abdominal pain, diarrhea, dry mouth,
dyspepsia, and flatulence occurred in less than 3% of patients,Ref126342 and
dysphagia,Ref342 eructation,Ref126342 gastroesophageal reflux,Ref126 esophagitis,Ref342
vomiting,Ref126342 melena,Ref126 GI hemorrhage,Ref342 gum hemorrhage,Ref342 gum
hyperplasia,Ref126 gum disorder,Ref342 unspecified GI disorder,Ref342 and taste
perversionRef126 were reported in up to 1% of patients. GI irritation and GI bleeding have
been reported in less than 1% of patients receiving Procardia XL® extended-release
nifedipine tablets in open-label trials and during post-marketing experience, although a
causal relationship to the drug has not been established.Ref126
Symptoms of GI obstruction have occurred in several patients with a history of GI strictures
who were receiving extended-release tablets of the drug.Ref126(See Cautions: Precautions
and Contraindications.) GI obstruction also has occurred in at least one patient with no
preexisting abnormality who was receiving conventional capsules of the drug concomitantly
with diltiazem; it was suggested that obstruction in this patient may have resulted from a
pharmacologic effect on intestinal smooth muscle.Ref235
Dermatologic and Sensitivity Reactions
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, dermatitis,
pruritus, urticaria, and sweating have been reported occasionally, Ref284 while angioedema
(principally oropharyngeal edema and occasionally breathing difficulty) occurred in less than
0.5% of patients.Ref284307 Exfoliative dermatitis, exfoliative or bullous skin reactions
(including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal
necrolysis), and photosensitivity reactions have been reported rarely.Ref284
In patients receiving extended-release nifedipine tablets, rash and pruritus have been
reported in up to 3% of patients,Ref126342 while angioedema,Ref342 allergic
reaction,Ref342 cellulitis,Ref342 facial edema,Ref126342 periorbital edema,Ref126
alopecia,Ref126342 sweating,Ref126342 urticaria,Ref126 photosensitivity reactions,Ref342
and petechial rashRef342 were reported in up to 1% of patients.
Anaphylactic reactions have been reported rarely in patients receiving nifedipine.Ref342
Respiratory Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, dyspnea,
cough, wheezing, nasal congestion, and sore throat occurred in 6% of of patients,
whileRef284 chest congestion and shortness of breath have been reported in up to 2% of
patients.Ref284
In patients receiving extended-release nifedipine tablets, dyspnea, epistaxis, and rhinitis
were reported in up to 3% of patients, Ref126342 while cough,Ref126342
pharyngitis,Ref342 sinusitis,Ref126 upper respiratory tract infection,Ref126 respiratory
disorder,Ref126 rales,Ref342 and stridorRef342 were reported in up to 1% of patients.
Musculoskeletal Effects
6. In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, muscle
cramps occurred in 8% of patients, while musculoskeletal complaints of inflammation and
joint stiffness have been reported occasionally, and myalgia and arthritis with increased
antinuclear antibodies (ANA) have been reported rarely.Ref284
In patients receiving extended-release nifedipine tablets, arthralgia,Ref126342 leg
pain,Ref342 and leg crampsRef126342 occurred in up to 3% of patients, while
myalgia,Ref126342 arthritis,Ref342 joint disorder,Ref342 myasthenia,Ref342 back
pain,Ref126 neck pain,Ref342 and goutRef126 occurred in up to 1% of patients.
Genitourinary Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, sexual
difficulty has been reported occasionally, while gynecomastia, nocturia, and polyuria have
been reported rarely.Ref284
In patients receiving extended-release nifedipine tablets, impotence,Ref126342
polyuria,Ref126342 and urinary frequencyRef342 have been reported in up to 3% of
patients, while decreased libido,Ref126342 breast pain,Ref126 pelvic pain,Ref342
dysuria,Ref126342 hematuria,Ref126 and nocturiaRef126342 occurred in up to 1% of
patients, and renal calculi, urogenital disorder, and breast engorgement were reported in
less than 1% of patients.Ref342 Gynecomastia has been reported in less than 1% of patients
receiving Procardia XL® extended-release nifedipine tablets in open-label trials and during
postmarketing experience, although a causal relationship to the drug has not been
established.Ref126
Hepatic Effects
Abnormal laboratory test results including mild to moderately increased serum
concentrations of alkaline phosphatase, LDH, creatine kinase (CK, creatine phosphokinase,
CPK), AST (SGOT), and ALT (SGPT) have been reported rarely in patients receiving
nifedipine.Ref126284342 Although a definite causal relationship of these laboratory test
results to the drug has not been established, the relationship has been considered probable
in several cases. Ref126284342 In most cases, the laboratory test abnormalities were not
associated with clinical symptoms; however, cholestasis (with or without jaundice) has been
reported.Ref126284342 Small increases (about 5%) in mean alkaline phosphatase
concentrations have been reported in patients receiving extended-release nifedipine tablets;
however, these increases were clinically asymptomatic, isolated incidents that rarely
resulted in values outside the normal range.Ref126342 Increased γ-glutamyltransferase
(GGT, γ-glutamyltranspeptidase, GGTP) concentrations have been reported in less than 1%
of patients receiving Adalat® CC extended-release nifedipine tablets.Ref342 Allergic hepatitis
has occurred rarely.Ref126284342
Renal Effects
In patients with preexisting chronic renal insufficiency receiving nifedipine, reversible
increases in blood urea nitrogen (BUN) and serum creatinine concentrations have been
reported rarely.Ref126284342 Although a definite causal relationship of these laboratory
7. test results to the drug has not been established, the relationship has been considered
probable in several cases.Ref126284342
Ocular and Otic Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, blurred
vision has been reported occasionally,Ref284 while transient blindness at peak serum
nifedipine concentrations and transient unilateral loss of vision have been reported
rarely.Ref284
In patients receiving extended-release nifedipine tablets, abnormal lacrimationRef126 and
vision abnormalitiesRef126342 have been reported in up to 1% of patients, while amblyopia,
conjunctivitis, diplopia, eye disorder, and ocular hemorrhage have been reported in less
than 1% of patients.Ref342
Tinnitus has been reported in up to 1% of patients receiving nifedipine.Ref342
Hematologic Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules,
thrombocytopenia, anemia, leukopenia, and purpura have been reported rarely.Ref284 In
patients receiving extended-release nifedipine tablets, purpura occurred in up to 1% of
patients,Ref126342 and eosinophilia and lymphadenopathy occurred in less than 1% of
patients.Ref342 Positive antiglobulin (Coombs’) test results, with or without hemolytic
anemia, have been reported in patients receiving nifedipine, but a causal relationship to the
drug has not been established.Ref126284307342
Like other calcium-channel blocking agents, nifedipine decreases platelet aggregation in
vitro.Ref126284342 A moderate decrease in platelet aggregation and increases in bleeding
time, believed to be related to inhibition of calcium transport across the platelet membrane,
have been reported in patients receiving nifedipine in a limited number of clinical studies;
however, these findings were not considered to be clinically important.Ref126284342
Metabolic Effects
Weight gain has been reported in up to 1% of patients receiving Procardia XL® extendedrelease nifedipine tablets,Ref126 while weight loss has been reported in less than 1% of
patients receiving Adalat® CC extended-release nifedipine tablets.Ref342
Other Adverse Effects
In patients receiving extended-release nifedipine tablets, hot flushes (flashes),Ref126
rigors,Ref126 and malaiseRef126342 were reported in up to 1% of patients in clinical trials.
Precautions and Contraindications
Some findings concerning possible risks of calcium-channel blocking agents have raised
concerns about the safety and efficacy of these agents (mainly conventional [short-acting]
preparations of
8. nifedipine).Ref24024124224324424524624724824925025125225325425525625725825926
0261262263264266352 However, recent findings with amlodipine in the ALLHAT study have
shown a beneficial effect of dihydropyridine-derivative calcium-channel blockers on fatal
coronary heart disease and nonfatal myocardial infarction in patients treated with the drug
for hypertension.Ref381382415416 In addition, post hoc analysis of the ALLHAT study
directly comparing patients receiving a calcium-channel blocking agent (amlodipine) or an
ACE inhibitor (lisinopril) has shown that patients receiving the ACE inhibitor experienced
higher risks of stroke, combined cardiovascular disease, GI bleeding, and angioedema, while
the risk of developing heart failure was higher in those receiving the calcium-channel
blocking agent.Ref417418
Whether the adverse cardiovascular and mortality effects associated with short-acting
nifedipine apply to other calcium-channel blocking agents, including other short-acting
dihydropyridine derivatives (e.g., isradipine), or to extended-release preparations or innately
slow-acting blockers remains to be established.Ref242352 For additional information on
possible risks, see the introductory discussion in Cautions and also the section on
Cardiovascular Effects as well as Uses: Other Uses.
Nifedipine shares the toxic potentials of the calcium-channel blocking agents, and the usual
precautions of these agents should be observed.
Because nifedipine decreases peripheral vascular resistance and occasionally causes
excessive and poorly tolerated hypotension, blood pressure should be monitored carefully,
especially during initiation of therapy and titration or upward adjustment of dosage. In
addition, the manufacturers warn that the frequency, duration, and severity of angina may
increase during initiation of therapy or upward adjustment of dosage.
Nifedipine should be used with caution in patients with congestive heart failure or aortic
stenosis, especially in those receiving concomitant β-adrenergic blocking agents, because
nifedipine may precipitate or worsen heart failure in these patients. Peripheral edema
occurring during the course of nifedipine therapy should be investigated, especially in
patients with congestive heart failure, since it may indicate deterioration in left ventricular
function induced by the drug.
When nifedipine therapy is initiated in patients with angina, they should be warned that the
drug may cause increased angina, especially if β-adrenergic blocker therapy is withdrawn
abruptly when nifedipine therapy is being initiated. (See Drug Interactions: β-Adrenergic
Blocking Agents.)
As with other nondeformable material, extended-release nifedipine tablets should be used
with caution in patients with underlying severe GI narrowing (pathologic or iatrogenic) since
obstruction may occur.Ref126
Nifedipine is contraindicated in patients with known hypersensitivity to the
drug.Ref126284342
Pediatric Precautions
9. Although safety and efficacy remain to be fully established in children younger than 18 years
of age,Ref126284 some experts have recommended pediatric dosages for hypertension
based on currently limited clinical experience.Ref395For information on overall principles for
treatment of hypertension and overall expert recommendations for such disease in pediatric
patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement
40:28.20.
Geriatric Precautions
Although a prolonged elimination half-life and an increase in peak plasma concentration and
area under the plasma concentration-time curve (AUC) have been observed in
pharmacokinetic studies in small numbers of patients (see Pharmacokinetics: Elimination),
clinical studies of nifedipine did not include sufficient numbers of patients 65 years of age
and older to determine whether geriatric patients respond differently than younger
adults.Ref284342 While other clinical experience generally has not revealed age-related
differences in response or tolerance, drug dosage generally should be titrated carefully in
geriatric patients, usually initiating therapy at the low end of the dosage range and adjusting
dosage as necessary based on patient response.Ref284342 The greater frequency of
decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug
therapy observed in the elderly also should be considered.Ref284342
Mutagenicity and Carcinogenicity
In vivo studies using nifedipine have not revealed evidence of mutagenicity.Ref126284342
No evidence of carcinogenicity was observed in rats receiving oral nifedipine for 2
years.Ref126284342
Pregnancy, Fertility, and Lactation
Pregnancy
Nifedipine has been shown to be teratogenic in rats and rabbits.Ref126284 Digital anomalies
similar to those reported with phenytoin also have been reported in the offspring of animals
receiving nifedipine or other dihydropyridines; these anomalies may occur secondary to
compromised uterine blood flow.Ref126284307 Nifedipine administration in rats, mice,
rabbits, and monkeys also has been associated with a variety of other embryotoxic,
placentotoxic, and fetotoxic effects, including stunted fetuses (rats, mice, and rabbits), rib
deformities (mice), cleft palate (mice), small placentas and underdeveloped chorionic villi
(monkeys), embryonic and fetal deaths (rats, mice, and rabbits), and prolonged
pregnancy/decreased neonatal survival (rats; not evaluated in other
species).Ref126284307342 The dosages (on a mg/kg basis) of nifedipine associated with
teratogenic, embryotoxic, or fetotoxic effects in animals were higher (3.5–42 times) than the
maximum recommended human dosage (120 mg daily);Ref126284 however, such dosages
were within one order of magnitude of the maximum recommended human
dosage.Ref126284342 The dosages of nifedipine associated with placentotoxic effects in
monkeys were equivalent to or lower than the maximum recommended human dosage on a
mg/m2 basis.Ref126284 There are no adequate and well-controlled studies using nifedipine
10. in pregnant women, and the drug should be used during pregnancy only when the potential
benefits justify the possible risks to the fetus.Ref126284342
Fertility
Nifedipine caused decreased fertility when given to rats prior to mating at a dosage
approximately 30 times the maximum recommended human dosage.Ref126284342 A
reversible reduction in the ability of human sperm to bind to and fertilize an ovum in vitro
has been reported in a limited number of infertile men who were receiving usual dosages of
nifedipine when the sperm was obtained.Ref126284307342
Lactation
Nifedipine is distributed into milk.Ref165342 In one lactating woman who received 10, 20,
and 30 mg of the drug every 8 hours as conventional capsules, peak milk concentrations of
nifedipine occurred within 1 hour after a dose and ranged from about 13–53 ng/mL; the
drug generally was not detectable during the hour prior to a dose.Ref165 Because of the
potential for serious adverse reactions to nifedipine in nursing infants, a decision should be
made whether to discontinue nursing or the drug, taking into account the importance of the
drug to the woman.Ref
References:
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