The document summarizes a budget impact analysis comparing a top-down therapy approach using Remicade (infliximab) to conventional step-up therapy for moderate to severe Crohn's disease. The analysis found that a top-down approach using infliximab improved rates of steroid-free remission and delayed time to surgery compared to step-up therapy. It also found that this approach would save a third-party payer like BC/BS MA an average of $2,641 per patient per year and $13,609 over 5 years due to lower rates of hospitalization and surgery compared to step-up therapy.
PEPTIC (Holden Young - Roseman University College of Pharmacy)HoldenYoung3
PEPTIC (Holden Young - Roseman University College of Pharmacy)
Effect of stress ulcer prophylaxis with proton pump inhibitors vs histamine-2 receptor blockers on in-hospital
mortality among ICU patients receiving invasive mechanical ventilation (PEPTIC).
JAMA . 2020; 323(7):616-626
This study investigated the effects of omega-3 fatty acids, vitamin C, and zinc supplementation individually and combined on asthma control in children. 76 children with moderate persistent asthma were randomly assigned to receive normal diet plus placebo, omega-3, zinc, vitamin C, or a combination of all three supplements over 5 phases. Asthma control was assessed using ACT scores, pulmonary function tests, and sputum inflammation markers. The combination phase showed the greatest improvement in ACT scores, lung function, and reduction of inflammatory markers compared to placebo or single supplements. This study suggests children with asthma may benefit from dietary supplementation with omega-3s, vitamin C, and zinc.
This study evaluated the use of sirolimus, an mTOR inhibitor, in 4 patients with diffuse hyperinsulinemic hypoglycemia that was unresponsive to standard treatments with diazoxide and octreotide. Patients received sirolimus with dose adjustments to achieve target serum levels. Glycemic control improved in all patients after starting sirolimus. The study suggests mTOR inhibitors may provide an alternative treatment option for severe hyperinsulinemic hypoglycemia unresponsive to other therapies, but larger and longer-term studies are still needed to fully evaluate efficacy and safety.
Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-upMohammed Shadman Shakib
VADT 15 year follow up NEJM article presentation
NEJM
June 6,2019
380:2215-2224
This article was presented in the morning session of MU-II, Dhaka Medical College Hospital.
Advances in induction in Acute Lymphocytic Leukemiaspa718
This document summarizes key findings from recent studies on improving induction therapy for acute lymphocytic leukemia (ALL). It describes trials showing that intensified chemotherapy regimens based on pediatric protocols improved outcomes for young adults compared to historical regimens. A trial incorporating the targeted therapy ponatinib into frontline therapy for Philadelphia chromosome-positive ALL achieved high rates of complete response and molecular response. Combining the epigenetic agents decitabine and vorinostat with chemotherapy showed tolerability and clinical benefit for relapsed/refractory ALL. Overall, the document discusses advances demonstrating that pediatric-inspired and targeted regimens are feasible and effective for certain adult ALL patients.
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)HoldenYoung3
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)
Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised,
controlled, multicentre, open-label, parallel-group study (NUTRIREA-2).
Lancet. 2018;391:133–43
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)HoldenYoung3
Presentation
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)
Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised,
controlled, multicentre, open-label, parallel-group study (NUTRIREA-2).
Lancet. 2018;391:133–43
This document summarizes a clinical trial that evaluated the safety and efficacy of patiromer for treating hyperkalemia in patients with chronic kidney disease receiving RAAS inhibitors. The trial had two phases - an initial 4-week treatment phase followed by an 8-week randomized withdrawal phase. Results showed that patiromer significantly reduced serum potassium levels and maintained normokalemia compared to placebo. The most common side effects were constipation and diarrhea. The authors concluded that patiromer was effective for treating hyperkalemia and allowing continued use of RAAS inhibitors in patients with chronic kidney disease.
PEPTIC (Holden Young - Roseman University College of Pharmacy)HoldenYoung3
PEPTIC (Holden Young - Roseman University College of Pharmacy)
Effect of stress ulcer prophylaxis with proton pump inhibitors vs histamine-2 receptor blockers on in-hospital
mortality among ICU patients receiving invasive mechanical ventilation (PEPTIC).
JAMA . 2020; 323(7):616-626
This study investigated the effects of omega-3 fatty acids, vitamin C, and zinc supplementation individually and combined on asthma control in children. 76 children with moderate persistent asthma were randomly assigned to receive normal diet plus placebo, omega-3, zinc, vitamin C, or a combination of all three supplements over 5 phases. Asthma control was assessed using ACT scores, pulmonary function tests, and sputum inflammation markers. The combination phase showed the greatest improvement in ACT scores, lung function, and reduction of inflammatory markers compared to placebo or single supplements. This study suggests children with asthma may benefit from dietary supplementation with omega-3s, vitamin C, and zinc.
This study evaluated the use of sirolimus, an mTOR inhibitor, in 4 patients with diffuse hyperinsulinemic hypoglycemia that was unresponsive to standard treatments with diazoxide and octreotide. Patients received sirolimus with dose adjustments to achieve target serum levels. Glycemic control improved in all patients after starting sirolimus. The study suggests mTOR inhibitors may provide an alternative treatment option for severe hyperinsulinemic hypoglycemia unresponsive to other therapies, but larger and longer-term studies are still needed to fully evaluate efficacy and safety.
Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-upMohammed Shadman Shakib
VADT 15 year follow up NEJM article presentation
NEJM
June 6,2019
380:2215-2224
This article was presented in the morning session of MU-II, Dhaka Medical College Hospital.
Advances in induction in Acute Lymphocytic Leukemiaspa718
This document summarizes key findings from recent studies on improving induction therapy for acute lymphocytic leukemia (ALL). It describes trials showing that intensified chemotherapy regimens based on pediatric protocols improved outcomes for young adults compared to historical regimens. A trial incorporating the targeted therapy ponatinib into frontline therapy for Philadelphia chromosome-positive ALL achieved high rates of complete response and molecular response. Combining the epigenetic agents decitabine and vorinostat with chemotherapy showed tolerability and clinical benefit for relapsed/refractory ALL. Overall, the document discusses advances demonstrating that pediatric-inspired and targeted regimens are feasible and effective for certain adult ALL patients.
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)HoldenYoung3
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)
Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised,
controlled, multicentre, open-label, parallel-group study (NUTRIREA-2).
Lancet. 2018;391:133–43
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)HoldenYoung3
Presentation
NUTRIREA-2 (Holden Young - Roseman University College of Pharmacy)
Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised,
controlled, multicentre, open-label, parallel-group study (NUTRIREA-2).
Lancet. 2018;391:133–43
This document summarizes a clinical trial that evaluated the safety and efficacy of patiromer for treating hyperkalemia in patients with chronic kidney disease receiving RAAS inhibitors. The trial had two phases - an initial 4-week treatment phase followed by an 8-week randomized withdrawal phase. Results showed that patiromer significantly reduced serum potassium levels and maintained normokalemia compared to placebo. The most common side effects were constipation and diarrhea. The authors concluded that patiromer was effective for treating hyperkalemia and allowing continued use of RAAS inhibitors in patients with chronic kidney disease.
The AFFIRM trial compared rate control and rhythm control strategies for treating atrial fibrillation. Over 7,000 patients with recurrent atrial fibrillation aged 65 or older were randomized to either rate or rhythm control. The primary outcome was overall mortality, with secondary outcomes including death from cardiovascular causes, stroke, bleeding, and hospitalization. The trial found no significant difference in mortality between the two groups. However, rhythm control was associated with greater need for hospitalization and higher rates of crossover to rate control. The study concluded that rate control should be the primary treatment approach for atrial fibrillation.
The document discusses the role of peroxisome proliferator activated receptor gamma (PPARγ) agonists in treating type 2 diabetes and reducing cardiovascular risk. PPARγ agonists like thiazolidinediones improve insulin sensitivity and have beneficial effects on lipids, inflammation, and vascular cell proliferation. They may reduce cardiovascular events in type 2 diabetes through these metabolic and anti-inflammatory mechanisms. However, PPARγ agonists can also cause side effects like fluid retention, weight gain, and congestive heart failure, so their risks and benefits must be carefully weighed.
This study investigated whether treatment with the proton pump inhibitor lansoprazole could reduce the frequency of common colds and exacerbations in patients with chronic obstructive pulmonary disease (COPD). The study found that patients taking lansoprazole had significantly fewer COPD exacerbations and a lower risk of frequent common colds compared to the control group. The results suggest that lansoprazole may help reduce airway inflammation and inhibit rhinovirus infection in COPD patients. However, the study was limited by a small sample size, lack of placebo control, and population that was almost entirely male and of Japanese ethnicity.
This document summarizes medication use patterns in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort. It finds that 85% of ADNI patients took 4 or more daily medications (polypharmacy), and 22% took medications from Beer's list of potentially inappropriate drugs for elderly patients. Memantine treatment was associated with more severe Alzheimer's disease, while cholinesterase inhibitors were prescribed without difference by disease severity. Treatment also differed by gender, age, and education level in both mild cognitive impairment (MCI) and Alzheimer's disease (AD) groups.
This study evaluated the efficacy and safety of lacosamide in treating diabetic neuropathic pain through an 18-week double-blind trial of 370 patients with doses of 200 mg/day, 400 mg/day, and 600 mg/day compared to a placebo. The 400 mg/day dose was found to significantly improve pain scores over the placebo and had the optimal balance of efficacy and side effects. Common side effects included dizziness, tremor and headache. While lacosamide showed potential for treating diabetic neuropathic pain, the study period was short and the 600 mg/day group had a high withdrawal rate due to adverse events.
This study investigated cardiovascular and gastrointestinal outcomes in clopidogrel users who were also taking proton pump inhibitors (PPIs) using a large cohort of patients in the Netherlands. The study found that clopidogrel users who were also taking PPIs had a 75% higher risk of cardiovascular events compared to clopidogrel-only users. However, the study had limitations such as channeling bias since PPI users had more risk factors, and residual confounding since important risk factors could not be adjusted for. While providing useful insights, the study's findings on the risks of PPI co-administration should be interpreted cautiously due to its limitations.
This document summarizes several studies presented at the 67th AAN Annual Meeting related to the use of alemtuzumab (Lemtrada) for treating relapsing-remitting multiple sclerosis (RRMS). It describes 4-year follow-up results from two clinical trials, CARE-MS I and CARE-MS II, that found alemtuzumab significantly reduced MRI lesions and brain volume loss in RRMS patients compared to interferon beta-1a. The majority of alemtuzumab-treated patients remained free of new lesions and disease activity at year 4. Switching from interferon to alemtuzumab further improved MRI outcomes.
Outcomes in Long-term Opioid Tapering and Buprenorphine Transition: A Retrosp...Paul Coelho, MD
This study analyzed outcomes for 240 patients with chronic pain who were prescribed long-term opioid therapy above 90 mg morphine-equivalent daily doses. Patients were offered an outpatient opioid taper or transition to buprenorphine if taper was not tolerated. 44.6% successfully tapered, 18.8% transitioned to buprenorphine, and 36.6% dropped out of treatment. Higher initial opioid doses predicted needing buprenorphine, and benzodiazepine/z-drug use predicted greater dropout. Pain intensity changes after treatment were mixed, with over half of tapered patients reporting increased pain and about half of transitioned patients reporting decreased pain.
Basal bolus insulin therapy resulted in improved glycemic control compared to sliding scale insulin therapy for hospitalized patients with type 2 diabetes, according to the RABBIT 2 trial. The mean daily blood glucose was 27 mg/dL lower in patients receiving basal glargine plus prandial glulisine compared to those receiving sliding scale regular insulin. Both regimens resulted in a similar rate of hypoglycemia and length of hospital stay. Basal bolus insulin provided better glycemic control and achieved target blood glucose levels under 140 mg/dL in more patients than sliding scale insulin alone.
This document summarizes the results of a study that evaluated the health care resource utilization and costs of patients with symptomatic multiple myeloma in the United Kingdom. The study found that the average total cost per treatment line was £34,296, with most costs attributed to anti-tumor drugs. The average cost per month of active treatment was £5,168. For patients receiving best supportive care after discontinuing active treatment, the average total cost was £1,444 if they progressed or £2,480 if they did not progress before death.
This document contains abstracts from multiple studies related to alemtuzumab treatment for relapsing-remitting multiple sclerosis (RRMS). Key findings from the studies include:
1) Alemtuzumab improved quality of life measures in RRMS patients with an inadequate response to prior therapies, and these benefits were maintained at 4-year follow up.
2) Administering alemtuzumab over non-consecutive days did not impact lymphocyte depletion, infusion reactions, or efficacy compared to consecutive day administration.
3) Alemtuzumab treatment resulted in durable disability improvement in treatment-naive RRMS patients, with mean disability scores remaining below pretreatment levels at 4-year follow up.
This study examined the association between statin and beta-blocker (BB) use and outcomes in 130 patients diagnosed with both head and neck cancer and diabetes mellitus. The results showed that use of lipophilic statins and selective BBs was associated with improved overall survival and disease-free survival. However, the small sample sizes of patients using hydrophilic statins and non-selective BBs may have biased these results. The study was limited by its inability to determine medication duration but suggests longer use prior to cancer diagnosis.
Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment.
This multicenter study evaluated the efficacy and safety of rituximab treatment in 57 patients with difficult-to-treat nephrotic syndrome, including 24 with steroid-dependent nephrotic syndrome (SDNS) and 33 with steroid-resistant nephrotic syndrome (SRNS). At a mean follow-up of 16-21 months, rituximab led to sustained remission in 83% of SDNS patients and 48.5% of SRNS patients. It also significantly reduced relapse rates in SDNS patients. The treatment was generally well-tolerated with few minor infusion-related reactions reported. Larger controlled trials are still needed to confirm rituximab's benefits in nephrotic
The DANISH trial investigated whether implanting an ICD in patients with non-ischemic heart failure reduced mortality. Over 67 months of follow-up:
1) ICD implantation did not provide an overall survival benefit compared to usual care.
2) The risk of sudden cardiac death was halved with an ICD.
3) Younger patients and those receiving CRT may benefit more from an ICD.
4) ICDs were associated with device-related complications but reduced inappropriate shocks compared to earlier studies. The trial adds to understanding ICD benefits in non-ischemic heart failure.
Comparative evaluation of 2g single dose versus conventional dose azithromycin in uncomplicated skin and skin structure infections. Indian Journal Of Pharmacology. August 2015;Vol. 47; Issue 4
Erectile Dysfunction and Risk Factors in Male Peruvian Hemodialysis Patientsasclepiuspdfs
Introduction: Erectile dysfunction (ED) is a common condition in patients with renal disease, but little is known about the prevalence of ED in some specific groups of patients such as Peruvian hemodialysis (HD) patients. Materials and Methods: A cross‑sectional study was conducted to determine the frequency of ED in HD patients (n = 390) in Lima, Peru. The prevalence and severity of ED were assessed using the International Index of Erectile Function with the validated Peruvian version. The dependence of ED on independent variables was evaluated by logistic regression. P ≤ 0.05 was regarded as statistically significant.
This study compared outcomes of patients with MDR/XDR Acinetobactor baumannii pneumonia treated with tigecycline or colistin. 70 patients received either tigecycline (n=30) or colistin (n=40). There were no significant differences in clinical outcomes between the two groups except nephrotoxicity, which only occurred in the colistin group. While the study indicates comparable efficacy, limitations include its small size, retrospective design, and exclusions. Further large randomized studies are still needed to properly evaluate tigecycline and optimal treatment combinations for MDR infections.
Proton Pump Inhibitors and Risk of Acute and Chronic Kidney Disease: A Retros...KhalafAlGhamdi
This document summarizes a study presented at a nephrology journal club that examined the association between proton pump inhibitor (PPI) use and the risk of acute kidney injury (AKI) and chronic kidney disease (CKD) using a large health insurance database. The study found that PPI use was associated with a 4-fold higher risk of AKI and a 20% higher risk of CKD compared to non-users. While the results strengthen evidence of this association, limitations include potential residual confounding and inability to account for over-the-counter medication use. The conclusion calls for provider education and deprescribing initiatives to reduce PPI overuse and potential kidney risks.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
The AFFIRM trial compared rate control and rhythm control strategies for treating atrial fibrillation. Over 7,000 patients with recurrent atrial fibrillation aged 65 or older were randomized to either rate or rhythm control. The primary outcome was overall mortality, with secondary outcomes including death from cardiovascular causes, stroke, bleeding, and hospitalization. The trial found no significant difference in mortality between the two groups. However, rhythm control was associated with greater need for hospitalization and higher rates of crossover to rate control. The study concluded that rate control should be the primary treatment approach for atrial fibrillation.
The document discusses the role of peroxisome proliferator activated receptor gamma (PPARγ) agonists in treating type 2 diabetes and reducing cardiovascular risk. PPARγ agonists like thiazolidinediones improve insulin sensitivity and have beneficial effects on lipids, inflammation, and vascular cell proliferation. They may reduce cardiovascular events in type 2 diabetes through these metabolic and anti-inflammatory mechanisms. However, PPARγ agonists can also cause side effects like fluid retention, weight gain, and congestive heart failure, so their risks and benefits must be carefully weighed.
This study investigated whether treatment with the proton pump inhibitor lansoprazole could reduce the frequency of common colds and exacerbations in patients with chronic obstructive pulmonary disease (COPD). The study found that patients taking lansoprazole had significantly fewer COPD exacerbations and a lower risk of frequent common colds compared to the control group. The results suggest that lansoprazole may help reduce airway inflammation and inhibit rhinovirus infection in COPD patients. However, the study was limited by a small sample size, lack of placebo control, and population that was almost entirely male and of Japanese ethnicity.
This document summarizes medication use patterns in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort. It finds that 85% of ADNI patients took 4 or more daily medications (polypharmacy), and 22% took medications from Beer's list of potentially inappropriate drugs for elderly patients. Memantine treatment was associated with more severe Alzheimer's disease, while cholinesterase inhibitors were prescribed without difference by disease severity. Treatment also differed by gender, age, and education level in both mild cognitive impairment (MCI) and Alzheimer's disease (AD) groups.
This study evaluated the efficacy and safety of lacosamide in treating diabetic neuropathic pain through an 18-week double-blind trial of 370 patients with doses of 200 mg/day, 400 mg/day, and 600 mg/day compared to a placebo. The 400 mg/day dose was found to significantly improve pain scores over the placebo and had the optimal balance of efficacy and side effects. Common side effects included dizziness, tremor and headache. While lacosamide showed potential for treating diabetic neuropathic pain, the study period was short and the 600 mg/day group had a high withdrawal rate due to adverse events.
This study investigated cardiovascular and gastrointestinal outcomes in clopidogrel users who were also taking proton pump inhibitors (PPIs) using a large cohort of patients in the Netherlands. The study found that clopidogrel users who were also taking PPIs had a 75% higher risk of cardiovascular events compared to clopidogrel-only users. However, the study had limitations such as channeling bias since PPI users had more risk factors, and residual confounding since important risk factors could not be adjusted for. While providing useful insights, the study's findings on the risks of PPI co-administration should be interpreted cautiously due to its limitations.
This document summarizes several studies presented at the 67th AAN Annual Meeting related to the use of alemtuzumab (Lemtrada) for treating relapsing-remitting multiple sclerosis (RRMS). It describes 4-year follow-up results from two clinical trials, CARE-MS I and CARE-MS II, that found alemtuzumab significantly reduced MRI lesions and brain volume loss in RRMS patients compared to interferon beta-1a. The majority of alemtuzumab-treated patients remained free of new lesions and disease activity at year 4. Switching from interferon to alemtuzumab further improved MRI outcomes.
Outcomes in Long-term Opioid Tapering and Buprenorphine Transition: A Retrosp...Paul Coelho, MD
This study analyzed outcomes for 240 patients with chronic pain who were prescribed long-term opioid therapy above 90 mg morphine-equivalent daily doses. Patients were offered an outpatient opioid taper or transition to buprenorphine if taper was not tolerated. 44.6% successfully tapered, 18.8% transitioned to buprenorphine, and 36.6% dropped out of treatment. Higher initial opioid doses predicted needing buprenorphine, and benzodiazepine/z-drug use predicted greater dropout. Pain intensity changes after treatment were mixed, with over half of tapered patients reporting increased pain and about half of transitioned patients reporting decreased pain.
Basal bolus insulin therapy resulted in improved glycemic control compared to sliding scale insulin therapy for hospitalized patients with type 2 diabetes, according to the RABBIT 2 trial. The mean daily blood glucose was 27 mg/dL lower in patients receiving basal glargine plus prandial glulisine compared to those receiving sliding scale regular insulin. Both regimens resulted in a similar rate of hypoglycemia and length of hospital stay. Basal bolus insulin provided better glycemic control and achieved target blood glucose levels under 140 mg/dL in more patients than sliding scale insulin alone.
This document summarizes the results of a study that evaluated the health care resource utilization and costs of patients with symptomatic multiple myeloma in the United Kingdom. The study found that the average total cost per treatment line was £34,296, with most costs attributed to anti-tumor drugs. The average cost per month of active treatment was £5,168. For patients receiving best supportive care after discontinuing active treatment, the average total cost was £1,444 if they progressed or £2,480 if they did not progress before death.
This document contains abstracts from multiple studies related to alemtuzumab treatment for relapsing-remitting multiple sclerosis (RRMS). Key findings from the studies include:
1) Alemtuzumab improved quality of life measures in RRMS patients with an inadequate response to prior therapies, and these benefits were maintained at 4-year follow up.
2) Administering alemtuzumab over non-consecutive days did not impact lymphocyte depletion, infusion reactions, or efficacy compared to consecutive day administration.
3) Alemtuzumab treatment resulted in durable disability improvement in treatment-naive RRMS patients, with mean disability scores remaining below pretreatment levels at 4-year follow up.
This study examined the association between statin and beta-blocker (BB) use and outcomes in 130 patients diagnosed with both head and neck cancer and diabetes mellitus. The results showed that use of lipophilic statins and selective BBs was associated with improved overall survival and disease-free survival. However, the small sample sizes of patients using hydrophilic statins and non-selective BBs may have biased these results. The study was limited by its inability to determine medication duration but suggests longer use prior to cancer diagnosis.
Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment.
This multicenter study evaluated the efficacy and safety of rituximab treatment in 57 patients with difficult-to-treat nephrotic syndrome, including 24 with steroid-dependent nephrotic syndrome (SDNS) and 33 with steroid-resistant nephrotic syndrome (SRNS). At a mean follow-up of 16-21 months, rituximab led to sustained remission in 83% of SDNS patients and 48.5% of SRNS patients. It also significantly reduced relapse rates in SDNS patients. The treatment was generally well-tolerated with few minor infusion-related reactions reported. Larger controlled trials are still needed to confirm rituximab's benefits in nephrotic
The DANISH trial investigated whether implanting an ICD in patients with non-ischemic heart failure reduced mortality. Over 67 months of follow-up:
1) ICD implantation did not provide an overall survival benefit compared to usual care.
2) The risk of sudden cardiac death was halved with an ICD.
3) Younger patients and those receiving CRT may benefit more from an ICD.
4) ICDs were associated with device-related complications but reduced inappropriate shocks compared to earlier studies. The trial adds to understanding ICD benefits in non-ischemic heart failure.
Comparative evaluation of 2g single dose versus conventional dose azithromycin in uncomplicated skin and skin structure infections. Indian Journal Of Pharmacology. August 2015;Vol. 47; Issue 4
Erectile Dysfunction and Risk Factors in Male Peruvian Hemodialysis Patientsasclepiuspdfs
Introduction: Erectile dysfunction (ED) is a common condition in patients with renal disease, but little is known about the prevalence of ED in some specific groups of patients such as Peruvian hemodialysis (HD) patients. Materials and Methods: A cross‑sectional study was conducted to determine the frequency of ED in HD patients (n = 390) in Lima, Peru. The prevalence and severity of ED were assessed using the International Index of Erectile Function with the validated Peruvian version. The dependence of ED on independent variables was evaluated by logistic regression. P ≤ 0.05 was regarded as statistically significant.
This study compared outcomes of patients with MDR/XDR Acinetobactor baumannii pneumonia treated with tigecycline or colistin. 70 patients received either tigecycline (n=30) or colistin (n=40). There were no significant differences in clinical outcomes between the two groups except nephrotoxicity, which only occurred in the colistin group. While the study indicates comparable efficacy, limitations include its small size, retrospective design, and exclusions. Further large randomized studies are still needed to properly evaluate tigecycline and optimal treatment combinations for MDR infections.
Proton Pump Inhibitors and Risk of Acute and Chronic Kidney Disease: A Retros...KhalafAlGhamdi
This document summarizes a study presented at a nephrology journal club that examined the association between proton pump inhibitor (PPI) use and the risk of acute kidney injury (AKI) and chronic kidney disease (CKD) using a large health insurance database. The study found that PPI use was associated with a 4-fold higher risk of AKI and a 20% higher risk of CKD compared to non-users. While the results strengthen evidence of this association, limitations include potential residual confounding and inability to account for over-the-counter medication use. The conclusion calls for provider education and deprescribing initiatives to reduce PPI overuse and potential kidney risks.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
This document contains summaries of multiple studies related to value-based healthcare for inflammatory bowel diseases. The first study found that a coordinated care program for IBD patients led to less corticosteroid use, more immunomodulator and biologic use, fewer hospitalizations and ER visits, and more biomarker testing compared to matched controls. The second study quantified patients' preferences for disease control, quality of life, and productivity outcomes using a choice-based survey. The third study evaluated a value-based healthcare program for IBD and found less corticosteroid use and trends toward more appropriate medication use and decreased utilization compared to matched controls.
1) The non-profit health organization Clalit Health Services in Israel will fund the Oncotype DX test for breast cancer patients to determine who would benefit from chemotherapy and who could avoid it.
2) Oncotype DX testing changed the treatment recommendation in 40% of cases, avoiding chemotherapy in 84% deemed at low risk of recurrence by the test.
3) The added cost of Oncotype DX testing was partially offset by savings from avoiding chemotherapy and resulted in a cost-effectiveness ratio of $10,770 per quality-adjusted life year gained.
Cancer Clinical Trials_ USA Scenario and Study Designs.pdfProRelix Research
Clinical trials in oncology are vital for the advancement of cancer treatments and
care. The US is at the forefront of these clinical trials, with many different study
designs being used to assess the efficacy and safety of new treatments. This article
will explore the current state of oncology clinical trial services in the US, as well as
discuss different types of study designs that are commonly used. It will provide
insight into how these trials are conducted, what data is collected, and how this
information can be used to improve patient care.
The United States Food and Drug Administration (FDA) has released
several guidance documents over the years through the Oncology Center
of Excellence to support the development of oncologic treatments and
diagnoses. Furthermore, information on the clinical trials for the treatment
of different types of cancer or specific interventions can be found on the
National Cancer Institute (NCI) website and Clinical Trials. Currently,
ClinicalTrials.gov, a website maintained by the National Library of
Medicine (NLM) and the National Institutes of Health (NIH) contains
listings of publicly and privately sponsored trials and includes information
on 91,937 studies related to cancer indicating the high volume of
research being conducted in this field.According to the World Health Organization (WHO), cancer is the leading
cause of death worldwide, with a death rate of one in six in 2020 (1).
Aside from the high mortality rate and morbidity associated with cancer, it
also negatively impacts the quality of life and poses a significant financial
burden on patients and payers making it imperative to develop effective
treatments for the disease. According to Global Cancer Observatory
(GLOBACAN), the United States accounted for 13.3% of all estimated
new cases of cancer in 2020 (2). In 2020, the single leading type of
cancer in the United States was breast cancer (11.1%) followed by lung
cancer (10%), prostrate (9,2%), colorectum (6.8%), and melanoma of the
skin (4.2%). Despite the significant prevalence of cancer and numerous
clinical trials conducted for oncology treatments, data have shown an
almost 95% attrition rate for anticancer drugs from Phase I trials until
marketing authorization. Various factors such as inaccurate preclinical
models, lack of suitable biomarkers in clinical trials, and a disconnect
between industry, academia, and regulators are responsible for the high
attrition rate (3). Therefore, it is vital to develop suitable study designs
and protocols for candidate molecules such that they obtain regulatory
approval and can be marketed. In addition to these challenges, the
development of anti-cancer agents comes at a monumental cost of an
estimated $2.8 billion. Several factors such as the choice of relevant
endpoints, the choice of appropriate biomarkers that are guided by tumor
biology, and careful patient selection are expected to improve the overall
fate of oncologic agents in the clinical trial phase
This document contains summaries of multiple studies and presentations related to inflammatory bowel disease (IBD). The summaries are:
1) A study that used a choice-based conjoint analysis to quantify IBD patients' preferences for different outcome metrics like disease control, quality of life, and productivity. It found that quality of life was most important on average.
2) A study comparing practice patterns of academic vs. non-academic gastroenterologists, finding differences in medication use, testing, and procedures between the groups.
3) A study evaluating the impact of a coordinated IBD care program, finding reductions in steroid use, imaging, and healthcare utilization compared to matched controls.
How to achieve deep remission in treatment of inflammatory bowel disease.Younis I Munshi
The document discusses methods for achieving deep remission in treatment of inflammatory bowel disease (IBD). Deep remission means achieving both symptomatic and mucosal remission. Optimization of conventional therapy, early treatment, use of the Lemann score to assess damage, performance of double-balloon endoscopy, treatment using Traditional Chinese Medicine, and good communication between physicians and patients are needed to attain deep remission. Using these methods can help change the course of the disease, improve patient prognoses, and increase quality of life by minimizing complications and bowel damage.
When Is Critical Care Medicine Cost-Effective?shivabirdi
When is critical care medicine cost-effective? A literature review examines cost-effectiveness analyses (CEAs) of critical care interventions published between 1993-2003. The review identified 19 original CEA studies, most from the US. CEAs evaluated treatments for severe sepsis, respiratory failure requiring mechanical ventilation, and other interventions. Cost-effectiveness ratios varied widely depending on the intervention and patient risk level, from $12,570 to $575,054 per life year saved. Defining cost-effectiveness requires judging a society's willingness to pay for health benefits.
A cohort study evaluated the effect of combination Vitamin D, Magnesium and Vitamin B12 (DMB) on older COVID-19 patients. 17 patients received DMB and 26 did not. Significantly fewer DMB patients required oxygen therapy (17.6% vs 61.5%). DMB exposure was associated with reduced odds of oxygen therapy need and intensive care support. The study supports larger trials to determine if DMB can ameliorate COVID-19 severity through immunomodulation.
The Challenges Associated with Evaluating the Cost Benefit of Gene Therapies ...Covance
Despite the growing availability of approved gene therapies, decision-makers face significant challenges when evaluating pricing and reimbursement of these novel therapeutics. From determining cost-benefit ratios, setting out patient access criteria and designing reimbursement plans, this white paper explores some of the complex aspects of value assessment for gene therapies, and discusses results from a survey of key decision-makers across Germany, Sweden and the UK responsible for making pricing and reimbursement decisions.
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1. Comparing a top-down therapy approach with Remicade (infliximab) to conventional
step-up therapy in moderate to severe Crohn’s disease: a budget impact analysis
Amirana S, Chen L, Gandhi P, Ofokansi R, Salamo K, Seagren R
1 School of Pharmacy, Bouvé College of Health Sciences, Northeastern University, Boston, MA
PHMD 6270: Economic Evaluation of Pharmaceuticals and Pharmacy Practice Final Project, April 2014
Introduction to Crohn’s Disease
Definition:
An autoimmune, inflammatory bowel disease (IBD) resulting in chronic inflammation
potentially involving any location of the gastrointestinal (GI) tract, which can interfere with
the digestion of food, absorption of nutrients, and elimination of waste. Patients will go
through phases of acute flares and periods of remission.
Complications:
Fistulas, strictures leading to intestinal blockage, perforation, perirectal abscesses,
pseudopolyps, anal fissures, toxic megacolon, colon cancer, and psychological
complications (such as anxiety, stress, and depression).
Disease Burden:
• Approximately 1.4 million Americans currently have inflammatory bowel disease. IBD
is a term that encompasses Crohn’s disease (CD) and ulcerative colitis (UC)
• CD affects an average of 200 out of 100,000 people in the US according to the
National Institute of Health
• Complications in the GI tract occur in 33% of patients at the time of diagnosis, and
then in at least 50% of patients within 20 years of diagnosis
• IBD accounts for on average:
• > 700,000 physician visits
• 100,000 hospitalizations
• 119,000 disabilities annually
Treatment:
Results Discussion
Our findings show, in terms of clinical efficacy, a top-down approach using infliximab
therapy compared to step-up therapy improved rates of steroid-free clinical remission,
improved mucosal healing, and delayed time to surgery. When using a top-down therapy
approach, infliximab has been proven to be cost-effective compared to step-up therapy.
The budget impact analysis showed that BC/BS MA will save on average $2,641 per
patient per year with diagnosed CD and an average of $13,609 over the next 5 years.
Although the estimated cost of one year of infliximab therapy is much higher than the
estimated cost of standard step-up therapy ($33,280 for infliximab compared to $13,348
with 6 relapses for step-up), the rates of surgery and hospitalizations were much greater
in patients using a step-up therapy approach.
Additional complications of the disease such as renal disease, liver disease,
cholelithiasis, joint complications, and skin and eye complications, were not taken into
account in the BIA. If infliximab prevents disease progression, then it is very likely that it
will prevent or delay these complications. Running a sensitivity analysis showed that
these complications can cost up to $1.77M annually, not taking into account surgeries or
hospitalizations related to these complications. Although infliximab has come with its
own set of serious complications, such as malignancies and infusion-related reactions,
these complications are very rare and are seen more frequently in doses greater than
10mg/kg, which is not FDA approved in CD.
Weaknesses we have identified with our BIA are primarily a result of the usual course of
the disease. Each patient requires individualized therapy based on symptom severity
and possible disease complications. There were many assumptions when considering
top-down compared to step-up therapy such as the weight of the patient, the number of
clinical relapses, and other comorbid conditions. However, what is unique about our
analysis is that it is the first to evaluate the clinical and economic impact of top-down
therapy with infliximab in moderate-severe CD patients in a real-world clinical setting.
Step-Up Therapy Top-Down Therapy
• Acute: Steroids (prednisone 40-60mg
daily) until resolution of symptoms
• Maintenance:
• Azathioprine (AZA)
• 6-mercaptopurine (6-MP)
• Methotrexate (MTX)
• May take up to 4 months to be
effective and up to 50% of patients
will become “steroid dependent”
• Biologic therapy only considered in
refractory patients
• Biologic therapy: tumor necrosis factor-
alpha inhibitor (anti-TNF! agent)
• Remicade (infliximab)
• Humira (adalimumab)
• Cimzia (certolizumab)
• Treatment with infliximab has shown to
be more effective in maintaining steroid-
free clinical remission than AZA in
moderate-severe Crohn’s disease
Objectives
1. Identify and analyze conclusions drawn from clinical literature about clinical efficacy of
top-down therapy in Crohn’s disease
2. Identify and analyze conclusions drawn from economic literature about cost-
effectiveness and budget impact analysis of top-down therapy in Crohn’s disease
3. Implement a budget impact analysis from a 3rd party payer perspective of top-down
therapy in Crohn’s disease patients
Methods
Economic Impact
Overall, examining all the cost-effectiveness
articles with a good or fair evidence grade,
infliximab fell below the incremental cost-
effective ratio (ICER) threshold assigned in
the studies proving to be cost-effective. The
studies primarily focused on adult patients at
an average weight with moderate to severe
luminal or fistulizing CD while a few included
pediatric patients as well. Varying from a
one-year to a five-year time horizon, the trials
extrapolated and performed various one-way
sensitivity analyses based on the time
horizon, patient weight and age, and all-cause
mortality. Even these sensitivity analyses
indicated that infliximab and other biologics
are generally more cost-effective as
compared to standard therapy.
Clinical Efficacy
Overall, results of primary randomized, double-
blind trials such as the ACCENT-I trial and the
SONIC trial showed that infliximab was more
effective in providing longer steroid-free clinical
remission with a decreased need for surgery. The
ACCENT-I trial showed that infliximab as
maintenance therapy was superior to placebo when
given as a 5mg/kg infusion every 8 weeks in terms
of clinical remission and steroid discontinuation. The
SONIC trial showed that therapies with infliximab
(whether as monotherapy or in combination with
AZA) were superior to AZA monotherapy in the
duration of steroid-free clinical remission and
mucosal healing. Other retrospective studies
showed that a top-down therapy approach with anti-
TNF agents reduced the risk of CD-related surgery
when compared to conventional step-up therapy.
Conclusions
In conclusion, 3rd party payers should consider a top-down therapy approach in patients with
moderate to severe CD, which, not only saves costs for the payers, but also benefits the patients in
terms of improved quality of life. From the overall analysis, we recommend that every patient’s
treatment be individualized based on past experience, treatment preference, and potential side
effects as some patients may not respond to infliximab therapy or may have side effects resulting in
nonadherence. However, this statement remains true for a step-up approach as well. Overall, the
BIA shows that the benefits for using infliximab outweigh the risks, and from our results, top-down
therapy with infliximab exhibits cost savings and improvements in quality of life when compared to
step-up therapy from a 3rd party payer perspective.
Acknowledgements
We would like to thank Steven Pizer, PhD and Mark Douglass, PharmD for their guidance with this analysis.
Search Strategy:
• Sources: PubMed, Medline
• Search terms: infliximab, Crohn’s disease, clinical
efficacy, top-down, budget impact, cost effectiveness,
United States
• Findings: We found a total of 36 articles for clinical
efficacy and 30 articles for economic impact. We
eliminated articles from analysis if infliximab was not
considered as a biologic agent of choice. We also
considered moderate to severe CD as a CDAI of 220 – 450
Budget Impact Analysis:
• Cost calculator approach using a one-way sensitivity analysis
• Assumptions: 0.2% prevalence rate equal between male and female, AZA therapy will require a minimum of 1 treatment course of prednisone per year, dosing
based on 60kg patient, costs inflated to 2012 pricing, and discount rate of 3%
Analytic Framework:
Patients with
diagnosed
moderate-severe
Crohn’s disease
(CDAI 220-450)
Treat-
ment
Treatment Approach:
! Top-down therapy
with infliximab 5mg/kg
IV infusion at weeks
0, 2, 6, and then
every 8 weeks
thereafter
! Step-up therapy with
steroids and/or AZA,
6-MP, MTX
! Surgery
Outcomes:
! Duration of
steroid-free
clinical
remission
! Mucosal
healing
! Surgery
prevention
KQ1 KQ2 KQ3
0
50
100
150
200
250
300
Average Low High
Cost(inmillions)
Budget Impact (Per Budget Holder)
over a 5-Year Time Horizon
Step-Up Therapy Infliximab Budget Impact
Our budget impact analysis was a 5 year duration starting in
2012 from the perspective of a 3rd party payer, specifically, Blue
Cross / Blue Shield HMO of Massachusetts (BC/BS MA). As
shown from the graph, costs of step-up therapy are much
higher than infliximab, due to a higher rate of hospitalizations
and required surgeries in this cohort.
BC/BS MA spent $12.8 billion dollars in 2012. Choosing a top-
down therapy approach for their patients with moderate-severe
CD would save them on average $79 million over a 5 year
period. These costs include the costs of diagnostics, surgeries
due to CD, and hospitalizations due to CD. This is consistent
with the findings of the economic impact research that is
currently available for a top-down therapy approach in
moderate-severe CD patients.
For our sensitivity analysis, an estimated 1.5% was used for
inflation costs and a compounded 3% per year discount rate was
applied over the 5 year duration. Hospitalizations and surgery
rates of step-up therapy compared to top-down therapy with
infliximab were the primary inputs. As noted from the tables, there
was an average savings of $1.96M from hospitalizations and a
$14.3M savings from surgeries if a top-down therapy approach
with infliximab was utilized. Even when different patient weights
were considered, average savings were still $16.3M per year with
infliximab therapy.
Average Rate of
Hospitalizations
Average Cost of
Hospitalizations
Low Rate of
Hospitalizations
Low Cost of
Hospitalizations
High Rate of
Hospitalizations
High Cost of
Hospitalizations Average
Step-Up 26.00% $16.8M 24.15% $15.5M 27.85% $18M Savings
Infliximab 23.00% $14.8M 21.08% $13.5M 24.92% $16.1M
Difference $2M $2M $1.9M $1.96M
Average Rate of
Surgeries
Average Cost of
Surgeries
Low Rate of
Surgeries
Low Cost of
Surgeries
High Rate of
Surgeries
High Rate of
Surgeries Average
Step-Up 16.53% $26.1M 14.45% $22.8M 18.61% $29.4M Savings
Infliximab 7.44% $11.8M 5.13% $8.1M 9.75% $15.4M
Difference $14.3M $14.7 $14M $14.3M
Annual Hospitalization Rates
Annual Surgery Rates
Weight Dose Yearly
Cost of
Treatment Savings
40kg $2.6K $23.7K $36.55M $16.28M
60kg $3.7K $33.3K $36.56M $16.27M
80kg $4.8K $42.8K $36.57M $16.26M
100kg $5.8K $52.4K $36.58M $16.25M
120kg $6.9K $61.9K $36.59M $16.24M
Average $16.3M
Patient Weight
Low Cost of Step-Up $48.4M
High Cost of Infliximab $41.5M
Total Savings $6.9M
Best Case for Step-Up Therapy
Even when analyzing the “best case scenario” for step-up
therapy, infliximab costs were still lower, which saved the 3rd
party payer an average of $6.9M per year. Therefore, it can
be said that even when rates of surgery and hospitalizations
are higher than anticipated in a top-down approach, this is
still a more cost effective option.