The document summarizes trends in research and development of generic drugs in the global pharmaceutical industry. It provides an overview of historical developments in generic drug maker PLIVA dating back to 1928, and its combination with Barr Group in 2006 to form a global generic pharmaceutical company. It also discusses trends in the generic drug market, strategies for differentiation, and key factors for success in generic drug research and development, emphasizing the importance of speed, intellectual property positioning, and internal API development capabilities.
The document appears to contain sample charts, diagrams, and tables from a 2007 source. There are over 20 different chart and table examples shown with varying units of measure and data labels. Footnotes are included below some of the charts referencing the source.
500 Powerpoint diagrams templates maps graphics and shapes enargeia
The PPT Library : more than 500 fully editable diagrams, maps and graphics to be used in Powerpoint in order to enhance visual quality of your presentations and increase productivity. Used by top consulting firms and marketing professionnals
Download at www.thepptlibrary.com
- A 70 year old male presented with 10 years of dyspnea and white productive sputum without fever or other URI symptoms. Skin tests were positive for allergens.
- He has been prescribed several inhalers but was referred to determine if he has COPD or asthma.
- The document discusses the differences and similarities between the inflammation seen in COPD versus asthma. COPD typically involves neutrophilic inflammation in small airways and parenchyma while asthma usually shows eosinophilic inflammation, but there can be overlap between the conditions.
This document summarizes guidelines and information on the management of chronic obstructive pulmonary disease (COPD) and asthma. It discusses the definitions and pathophysiology of COPD and asthma. Key differences are that COPD involves irreversible airflow limitation from inflammation while asthma involves reversible airflow limitation. Treatment involves bronchodilators and inhaled corticosteroids. Spirometry is important for diagnosis and monitoring of disease severity.
This document summarizes a new drug called Umeclidinium (trade name Incruse Ellipta), which is a long-acting anticholinergic agent approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Key details include that it works by blocking acetylcholine receptors, is dosed once daily at 62.5mcg via an elliptical inhaler, and was found in clinical trials to significantly improve lung function for up to 28 hours compared to placebo. The drug was generally well tolerated with the most common side effect being headaches.
Recent advances in Asthma & COPD by Dr.Tinku JosephDr.Tinku Joseph
This document summarizes recent advances in asthma and COPD presented between January and December 2016. It describes several studies on new drug combinations that increase lung function and quality of life for COPD patients. It also discusses trials of endobronchial valves and coils that improve outcomes for selected patients with severe emphysema. New biologic drugs targeting specific inflammatory pathways in asthma are presented, along with trials of these new therapies.
The document summarizes trends in research and development of generic drugs in the global pharmaceutical industry. It provides an overview of historical developments in generic drug maker PLIVA dating back to 1928, and its combination with Barr Group in 2006 to form a global generic pharmaceutical company. It also discusses trends in the generic drug market, strategies for differentiation, and key factors for success in generic drug research and development, emphasizing the importance of speed, intellectual property positioning, and internal API development capabilities.
The document appears to contain sample charts, diagrams, and tables from a 2007 source. There are over 20 different chart and table examples shown with varying units of measure and data labels. Footnotes are included below some of the charts referencing the source.
500 Powerpoint diagrams templates maps graphics and shapes enargeia
The PPT Library : more than 500 fully editable diagrams, maps and graphics to be used in Powerpoint in order to enhance visual quality of your presentations and increase productivity. Used by top consulting firms and marketing professionnals
Download at www.thepptlibrary.com
- A 70 year old male presented with 10 years of dyspnea and white productive sputum without fever or other URI symptoms. Skin tests were positive for allergens.
- He has been prescribed several inhalers but was referred to determine if he has COPD or asthma.
- The document discusses the differences and similarities between the inflammation seen in COPD versus asthma. COPD typically involves neutrophilic inflammation in small airways and parenchyma while asthma usually shows eosinophilic inflammation, but there can be overlap between the conditions.
This document summarizes guidelines and information on the management of chronic obstructive pulmonary disease (COPD) and asthma. It discusses the definitions and pathophysiology of COPD and asthma. Key differences are that COPD involves irreversible airflow limitation from inflammation while asthma involves reversible airflow limitation. Treatment involves bronchodilators and inhaled corticosteroids. Spirometry is important for diagnosis and monitoring of disease severity.
This document summarizes a new drug called Umeclidinium (trade name Incruse Ellipta), which is a long-acting anticholinergic agent approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Key details include that it works by blocking acetylcholine receptors, is dosed once daily at 62.5mcg via an elliptical inhaler, and was found in clinical trials to significantly improve lung function for up to 28 hours compared to placebo. The drug was generally well tolerated with the most common side effect being headaches.
Recent advances in Asthma & COPD by Dr.Tinku JosephDr.Tinku Joseph
This document summarizes recent advances in asthma and COPD presented between January and December 2016. It describes several studies on new drug combinations that increase lung function and quality of life for COPD patients. It also discusses trials of endobronchial valves and coils that improve outcomes for selected patients with severe emphysema. New biologic drugs targeting specific inflammatory pathways in asthma are presented, along with trials of these new therapies.
The document summarizes a study that compared the efficacy of adding formoterol or salbutamol to regular ipratropium bromide treatment in COPD patients. The study found that:
1) Treatment with a combination of formoterol and ipratropium was more effective than a combination of salbutamol and ipratropium based on improvements in morning peak expiratory flow, lung function as measured by FEV1, and symptom scores.
2) Safety profiles were comparable between the two treatment combinations.
3) For COPD patients requiring combination bronchodilator treatment, adding formoterol to regular ipratropium treatment provided better clinical benefits than adding
Chronic obstructive pulmonary disease (COPD), a complex progressive disease, is currently the third leading cause of death worldwide. One recommended treatment option is fixed-dose combination therapy of an inhaled corticosteroid (ICS)/long-acting β-agonist. Clinical trials suggest pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) show similar efficacy and safety profiles in COPD. Real-world observational studies have shown that combination therapy has significantly greater odds of achieving asthma control when delivered via pMDIs. Our aim was to compare effectiveness, in terms of moderate/severe COPD exacerbations and long-acting muscarinic antagonist (LAMA) prescriptions, for COPD patients initiating fluticasone propionate (FP)/salmeterol xinafoate (SAL) via pMDI versus DPI at two doses of FP (500 and 1,000 μg/d) using a real-life, historical matched cohort study. COPD patients with $2 years continuous practice data, $2 prescriptions for FP/SAL via pMDI/DPI, and no prescription for ICS were selected from the Optimum Patient Care Research Database. Patients were matched 1:1. Rate of moderate/severe COPD exacerbations and odds of LAMA prescription were analyzed using conditional Poisson and logistic regression, respectively. Of 472 patients on 500 µg/d, we observed fewer moderate/severe exacerbations in patients using pMDI (99 [42%]) versus DPI (115 [49%]) (adjusted rate ratio: 0.71; 95% confidence interval: 0.54, 0.93), an important result since the pMDI is not licensed for COPD in the UK, USA, or China. At 1,000 µg/d, we observed lower LAMA prescription for pMDI (adjusted odds ratio: 0.71; 95% confidence interval: 0.55, 0.91), but no difference in exacerbation rates, potentially due to higher dose of ICS overcoming low lung delivery from the DPI.
Read the full paper: https://doi.org/10.2147/COPD.S141409
1. The document discusses updates to the 2018 GOLD and GINA guidelines for chronic obstructive pulmonary disease (COPD) and asthma management.
2. New recommendations include the use of single-inhaler triple therapy and macrolide antibiotics to reduce exacerbations in COPD, as well as considering inhaled corticosteroids for mild asthma.
3. The benefits of new drug delivery methods, combinations therapies, and treatments targeting specific asthma and COPD phenotypes are summarized from recent clinical trials.
This document presents a case of a 59-year-old man with COPD and a history of smoking who is experiencing increased shortness of breath. After assessing the patient according to GOLD 2017 guidelines and categorizing him as GOLD stage 2B, a pharmaceutical care plan is developed that includes stopping his current COPD medications, starting new medications, smoking cessation counseling, and patient education. Newly approved COPD medications including Bevespi Aerosphere, Stiolto Respimat, and Utibron Neohaler are also briefly summarized.
This document provides an overview of newly available COPD medications, including long-acting muscarinic antagonists (LAMAs) and LAMA/long-acting beta-2 agonist (LABA) combinations. It summarizes the mechanisms of action, clinical evidence and costs of medications like Incruse Ellipta, Seebri Neohaler, Tudorza Pressair, and combinations of LAMAs and LABAs. It recommends Incruse Ellipta as the preferred new LAMA therapy based on lower cost and statistically significant improvement in lung function compared to Spiriva.
This document discusses updates to guidelines from GOLD and GINA. Some key points discussed include:
1. The GOLD guidelines now recommend LAMA/LABA combination therapy as first-line treatment for COPD based on studies showing greater improvement in quality of life compared to individual bronchodilators or placebo.
2. Studies showed the benefits of a single-inhaler triple therapy compared to ICS/LABA therapy for advanced COPD, with reductions in exacerbations.
3. The GINA guidelines now recommend considering ICS for mild asthma to reduce exacerbations based on new evidence. Anti-IL5 monoclonal antibodies like mepolizumab and benralizumab were added as add-
Controlled Trial of Budesonide–Formoterol as Needed for Mild AsthmaChing-wen Lu
This document summarizes the findings of the Novel START trial, which compared the efficacy of as-needed budesonide-formoterol to as-needed salbutamol and budesonide maintenance therapy plus as-needed salbutamol in adults with mild asthma over 52 weeks. The trial found that as-needed budesonide-formoterol was superior to as-needed salbutamol in reducing exacerbation rates and time to first exacerbation, and was comparable to budesonide maintenance therapy in reducing severe exacerbations. Budesonide maintenance therapy provided better asthma symptom control. The results extend prior evidence supporting the use of as-needed budesonide-formoterol
COPD Translating Guidelines into Clinical Pracice part 2Ashraf ElAdawy
A 68-year-old man with COPD and an FEV1 of 65% was recently discharged from the hospital after his first COPD exacerbation. According to the GOLD guidelines, this patient would be classified in Group C as they have an exacerbation history indicating higher risk. The most appropriate initial treatment for this Group C patient would be to continue his albuterol as needed and add the long-acting bronchodilator tiotropium.
Professor Riccardo Polosa - E-Cigarette Summit 2014Neil Mclaren
- Professor Riccardo Polosa is the director of the Institute of Internal Medicine and Clinical Immunology at the University of Catania. He has conducted research on e-cigarettes and has received funding from pharmaceutical companies and the e-cigarette industry.
- He presented on clinical studies that have evaluated the effects of e-cigarettes on withdrawal symptoms and cravings. Studies have found that e-cigarettes can reduce withdrawal symptoms and cravings, though the effect on cravings depends more on the ritual than nicotine.
- Larger randomized controlled trials have also found that e-cigarettes help smokers reduce or quit smoking compared to other nicotine replacement therapies or no aid. Success rates were
The REDUCE trial investigated whether a 5-day course of glucocorticoids was non-inferior to a 14-day course for the treatment of acute COPD exacerbations. The trial randomized 314 patients to receive either 5 days of steroids and 9 days of placebo or 14 days of steroids. The primary outcome of rate of re-exacerbation was not significantly different between the two groups, demonstrating non-inferiority of the shorter 5-day course. A major limitation was that the study population had more severe COPD, limiting generalizability.
This patient presents with an acute exacerbation of asthma/COPD. The document reviews guidelines on asthma and COPD, including epidemiology, pathophysiology, diagnosis and treatment approaches. It also presents two case studies, one involving a 19-year old female student with asthma symptoms and another involving a 72-year old female with multiple inhalers for COPD. Treatment strategies and inhaler techniques are discussed.
This review examines the evidence for varenicline, a smoking cessation drug approved by the FDA in 2006. Section 1 provides background on varenicline's development and approval. Section 2 describes how varenicline works as a partial nicotinic receptor agonist. Section 3 summarizes clinical trials that demonstrated varenicline's efficacy in helping smokers quit compared to placebo and other drugs. However, the FDA has issued black box warnings about possible psychiatric side effects reported in case studies, though data is limited. The conclusion re-examines varenicline's risk-benefit profile based on newer evidence.
This review examines the evidence for varenicline, a smoking cessation drug approved by the FDA in 2006. It summarizes that initial clinical trials showed varenicline was highly effective at helping smokers quit compared to placebo or other drugs. However, the FDA has since issued black box warnings for possible neuropsychiatric side effects based on case reports. Newer studies and analyses of clinical trial data do not show varenicline causes more depression or suicidality than other smoking cessation treatments. The review concludes that varenicline remains the most effective smoking cessation monotherapy, and its benefits outweigh the risks, which clinical trials indicate are mild.
Exalgo is an extended-release hydromorphone tablet manufactured by Mallinckrodt and indicated for the management of moderate to severe pain in opioid-tolerant patients. It was approved in 2010 in 8mg, 12mg and 16mg strengths and in 2012 in a 32mg strength. Clinical trials showed it was effective in reducing pain in patients with low back pain or other chronic pain conditions, though common side effects included constipation, nausea, vomiting and somnolence. Sales of Exalgo exceeded expectations, reaching $16 million by 2013, and it was seen as a promising treatment for chronic pain with the potential for higher sales upon introduction of the 32mg strength.
The document discusses drugs related to the respiratory system. It covers several classes of drugs including bronchodilators, corticosteroids, antihistamines, and cough preparations. Bronchodilators such as beta-2 agonists, antimuscarinic agents, and xanthine derivatives are used to relieve bronchospasm. Corticosteroids are used to reduce inflammation and include inhaled and systemic formulations. The document provides examples of drugs in each class, their mechanisms of action, dosages, and adverse effects.
Varenicline is the most effective medication for smoking cessation according to evidence from randomized controlled trials. It reduces withdrawal symptoms and the urge to smoke more than nicotine replacement therapy or bupropion. Common side effects include nausea and vivid dreams, but are usually mild. Recent reports have linked varenicline to psychiatric issues like depression and suicidal thoughts, but the evidence so far is limited to case reports. Close monitoring of patients is recommended when prescribing varenicline.
The document discusses future trends in COPD management, including:
1) New long-acting beta agonists (LABAs) and bifunctional bronchodilator drugs that have both beta-agonist and muscarinic receptor activity.
2) Phosphodiesterase (PDE) inhibitors, especially selective PDE3, PDE4, and PDE5 inhibitors, which could reduce inflammation and improve lung function.
3) Other developments like inhaled heparin and L-menthol which may provide relief from COPD symptoms.
Co-Chairs, Joseph K. Han, MD, and Seth J. Isaacs, MD, prepared useful Practice Aids pertaining to chronic rhinosinusitis with nasal polyps for this CME/MOC/CC/AAPA/IPCE activity titled “Biologics in CRSwNP: Putting a Paradigm Shift Into Practice.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/CC/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/3Tq6n1G. CME/MOC/CC/AAPA/IPCE credit will be available until May 6, 2025.
This document summarizes information on chronic urticaria, including its prevalence, causes, impact on quality of life, and treatment options. It notes that chronic urticaria affects approximately 1% of people with acute urticaria and has a significant negative impact on quality of life. First-line treatment includes non-sedating antihistamines, sometimes at higher off-label doses. If patients do not respond sufficiently to antihistamines alone, second-line options include doxepin, leukotriene antagonists, short-term corticosteroids, dapsone, sulfasalazine, and narrowband UVB phototherapy. The document reviews evidence on the efficacy and safety of these second-
- The patient, a 35-year-old male, presented with abdominal pain and vomiting for 2 days. On examination, he had tenderness in the right lower abdomen.
- Laboratory tests and imaging confirmed a diagnosis of appendicitis. He received IV antibiotics and underwent a laparoscopic appendectomy.
- The clinical pharmacist reviewed the patient's medications and provided recommendations to avoid potential drug interactions and maximize treatment of appendicitis.
The document summarizes a study that compared the efficacy of adding formoterol or salbutamol to regular ipratropium bromide treatment in COPD patients. The study found that:
1) Treatment with a combination of formoterol and ipratropium was more effective than a combination of salbutamol and ipratropium based on improvements in morning peak expiratory flow, lung function as measured by FEV1, and symptom scores.
2) Safety profiles were comparable between the two treatment combinations.
3) For COPD patients requiring combination bronchodilator treatment, adding formoterol to regular ipratropium treatment provided better clinical benefits than adding
Chronic obstructive pulmonary disease (COPD), a complex progressive disease, is currently the third leading cause of death worldwide. One recommended treatment option is fixed-dose combination therapy of an inhaled corticosteroid (ICS)/long-acting β-agonist. Clinical trials suggest pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) show similar efficacy and safety profiles in COPD. Real-world observational studies have shown that combination therapy has significantly greater odds of achieving asthma control when delivered via pMDIs. Our aim was to compare effectiveness, in terms of moderate/severe COPD exacerbations and long-acting muscarinic antagonist (LAMA) prescriptions, for COPD patients initiating fluticasone propionate (FP)/salmeterol xinafoate (SAL) via pMDI versus DPI at two doses of FP (500 and 1,000 μg/d) using a real-life, historical matched cohort study. COPD patients with $2 years continuous practice data, $2 prescriptions for FP/SAL via pMDI/DPI, and no prescription for ICS were selected from the Optimum Patient Care Research Database. Patients were matched 1:1. Rate of moderate/severe COPD exacerbations and odds of LAMA prescription were analyzed using conditional Poisson and logistic regression, respectively. Of 472 patients on 500 µg/d, we observed fewer moderate/severe exacerbations in patients using pMDI (99 [42%]) versus DPI (115 [49%]) (adjusted rate ratio: 0.71; 95% confidence interval: 0.54, 0.93), an important result since the pMDI is not licensed for COPD in the UK, USA, or China. At 1,000 µg/d, we observed lower LAMA prescription for pMDI (adjusted odds ratio: 0.71; 95% confidence interval: 0.55, 0.91), but no difference in exacerbation rates, potentially due to higher dose of ICS overcoming low lung delivery from the DPI.
Read the full paper: https://doi.org/10.2147/COPD.S141409
1. The document discusses updates to the 2018 GOLD and GINA guidelines for chronic obstructive pulmonary disease (COPD) and asthma management.
2. New recommendations include the use of single-inhaler triple therapy and macrolide antibiotics to reduce exacerbations in COPD, as well as considering inhaled corticosteroids for mild asthma.
3. The benefits of new drug delivery methods, combinations therapies, and treatments targeting specific asthma and COPD phenotypes are summarized from recent clinical trials.
This document presents a case of a 59-year-old man with COPD and a history of smoking who is experiencing increased shortness of breath. After assessing the patient according to GOLD 2017 guidelines and categorizing him as GOLD stage 2B, a pharmaceutical care plan is developed that includes stopping his current COPD medications, starting new medications, smoking cessation counseling, and patient education. Newly approved COPD medications including Bevespi Aerosphere, Stiolto Respimat, and Utibron Neohaler are also briefly summarized.
This document provides an overview of newly available COPD medications, including long-acting muscarinic antagonists (LAMAs) and LAMA/long-acting beta-2 agonist (LABA) combinations. It summarizes the mechanisms of action, clinical evidence and costs of medications like Incruse Ellipta, Seebri Neohaler, Tudorza Pressair, and combinations of LAMAs and LABAs. It recommends Incruse Ellipta as the preferred new LAMA therapy based on lower cost and statistically significant improvement in lung function compared to Spiriva.
This document discusses updates to guidelines from GOLD and GINA. Some key points discussed include:
1. The GOLD guidelines now recommend LAMA/LABA combination therapy as first-line treatment for COPD based on studies showing greater improvement in quality of life compared to individual bronchodilators or placebo.
2. Studies showed the benefits of a single-inhaler triple therapy compared to ICS/LABA therapy for advanced COPD, with reductions in exacerbations.
3. The GINA guidelines now recommend considering ICS for mild asthma to reduce exacerbations based on new evidence. Anti-IL5 monoclonal antibodies like mepolizumab and benralizumab were added as add-
Controlled Trial of Budesonide–Formoterol as Needed for Mild AsthmaChing-wen Lu
This document summarizes the findings of the Novel START trial, which compared the efficacy of as-needed budesonide-formoterol to as-needed salbutamol and budesonide maintenance therapy plus as-needed salbutamol in adults with mild asthma over 52 weeks. The trial found that as-needed budesonide-formoterol was superior to as-needed salbutamol in reducing exacerbation rates and time to first exacerbation, and was comparable to budesonide maintenance therapy in reducing severe exacerbations. Budesonide maintenance therapy provided better asthma symptom control. The results extend prior evidence supporting the use of as-needed budesonide-formoterol
COPD Translating Guidelines into Clinical Pracice part 2Ashraf ElAdawy
A 68-year-old man with COPD and an FEV1 of 65% was recently discharged from the hospital after his first COPD exacerbation. According to the GOLD guidelines, this patient would be classified in Group C as they have an exacerbation history indicating higher risk. The most appropriate initial treatment for this Group C patient would be to continue his albuterol as needed and add the long-acting bronchodilator tiotropium.
Professor Riccardo Polosa - E-Cigarette Summit 2014Neil Mclaren
- Professor Riccardo Polosa is the director of the Institute of Internal Medicine and Clinical Immunology at the University of Catania. He has conducted research on e-cigarettes and has received funding from pharmaceutical companies and the e-cigarette industry.
- He presented on clinical studies that have evaluated the effects of e-cigarettes on withdrawal symptoms and cravings. Studies have found that e-cigarettes can reduce withdrawal symptoms and cravings, though the effect on cravings depends more on the ritual than nicotine.
- Larger randomized controlled trials have also found that e-cigarettes help smokers reduce or quit smoking compared to other nicotine replacement therapies or no aid. Success rates were
The REDUCE trial investigated whether a 5-day course of glucocorticoids was non-inferior to a 14-day course for the treatment of acute COPD exacerbations. The trial randomized 314 patients to receive either 5 days of steroids and 9 days of placebo or 14 days of steroids. The primary outcome of rate of re-exacerbation was not significantly different between the two groups, demonstrating non-inferiority of the shorter 5-day course. A major limitation was that the study population had more severe COPD, limiting generalizability.
This patient presents with an acute exacerbation of asthma/COPD. The document reviews guidelines on asthma and COPD, including epidemiology, pathophysiology, diagnosis and treatment approaches. It also presents two case studies, one involving a 19-year old female student with asthma symptoms and another involving a 72-year old female with multiple inhalers for COPD. Treatment strategies and inhaler techniques are discussed.
This review examines the evidence for varenicline, a smoking cessation drug approved by the FDA in 2006. Section 1 provides background on varenicline's development and approval. Section 2 describes how varenicline works as a partial nicotinic receptor agonist. Section 3 summarizes clinical trials that demonstrated varenicline's efficacy in helping smokers quit compared to placebo and other drugs. However, the FDA has issued black box warnings about possible psychiatric side effects reported in case studies, though data is limited. The conclusion re-examines varenicline's risk-benefit profile based on newer evidence.
This review examines the evidence for varenicline, a smoking cessation drug approved by the FDA in 2006. It summarizes that initial clinical trials showed varenicline was highly effective at helping smokers quit compared to placebo or other drugs. However, the FDA has since issued black box warnings for possible neuropsychiatric side effects based on case reports. Newer studies and analyses of clinical trial data do not show varenicline causes more depression or suicidality than other smoking cessation treatments. The review concludes that varenicline remains the most effective smoking cessation monotherapy, and its benefits outweigh the risks, which clinical trials indicate are mild.
Exalgo is an extended-release hydromorphone tablet manufactured by Mallinckrodt and indicated for the management of moderate to severe pain in opioid-tolerant patients. It was approved in 2010 in 8mg, 12mg and 16mg strengths and in 2012 in a 32mg strength. Clinical trials showed it was effective in reducing pain in patients with low back pain or other chronic pain conditions, though common side effects included constipation, nausea, vomiting and somnolence. Sales of Exalgo exceeded expectations, reaching $16 million by 2013, and it was seen as a promising treatment for chronic pain with the potential for higher sales upon introduction of the 32mg strength.
The document discusses drugs related to the respiratory system. It covers several classes of drugs including bronchodilators, corticosteroids, antihistamines, and cough preparations. Bronchodilators such as beta-2 agonists, antimuscarinic agents, and xanthine derivatives are used to relieve bronchospasm. Corticosteroids are used to reduce inflammation and include inhaled and systemic formulations. The document provides examples of drugs in each class, their mechanisms of action, dosages, and adverse effects.
Varenicline is the most effective medication for smoking cessation according to evidence from randomized controlled trials. It reduces withdrawal symptoms and the urge to smoke more than nicotine replacement therapy or bupropion. Common side effects include nausea and vivid dreams, but are usually mild. Recent reports have linked varenicline to psychiatric issues like depression and suicidal thoughts, but the evidence so far is limited to case reports. Close monitoring of patients is recommended when prescribing varenicline.
The document discusses future trends in COPD management, including:
1) New long-acting beta agonists (LABAs) and bifunctional bronchodilator drugs that have both beta-agonist and muscarinic receptor activity.
2) Phosphodiesterase (PDE) inhibitors, especially selective PDE3, PDE4, and PDE5 inhibitors, which could reduce inflammation and improve lung function.
3) Other developments like inhaled heparin and L-menthol which may provide relief from COPD symptoms.
Co-Chairs, Joseph K. Han, MD, and Seth J. Isaacs, MD, prepared useful Practice Aids pertaining to chronic rhinosinusitis with nasal polyps for this CME/MOC/CC/AAPA/IPCE activity titled “Biologics in CRSwNP: Putting a Paradigm Shift Into Practice.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/CC/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/3Tq6n1G. CME/MOC/CC/AAPA/IPCE credit will be available until May 6, 2025.
This document summarizes information on chronic urticaria, including its prevalence, causes, impact on quality of life, and treatment options. It notes that chronic urticaria affects approximately 1% of people with acute urticaria and has a significant negative impact on quality of life. First-line treatment includes non-sedating antihistamines, sometimes at higher off-label doses. If patients do not respond sufficiently to antihistamines alone, second-line options include doxepin, leukotriene antagonists, short-term corticosteroids, dapsone, sulfasalazine, and narrowband UVB phototherapy. The document reviews evidence on the efficacy and safety of these second-
- The patient, a 35-year-old male, presented with abdominal pain and vomiting for 2 days. On examination, he had tenderness in the right lower abdomen.
- Laboratory tests and imaging confirmed a diagnosis of appendicitis. He received IV antibiotics and underwent a laparoscopic appendectomy.
- The clinical pharmacist reviewed the patient's medications and provided recommendations to avoid potential drug interactions and maximize treatment of appendicitis.
Similar to Tudorza Pressair® (Aclidinium Bromide) (20)
1. Tudorza Pressair®
(aclidinium bromide)
By Katrina Korn
3rd-Year Professional Pharmacy Student
kkorn@purdue.edu
2. Learning Objectives
State the mechanism of action for
Tudorza Pressair® (aclidinium bromide)
Provide information on indication, dosing
and side effects for aclidinium to patients
and professionals
Discuss advantages and disadvantages
of aclidinium with reference to clinical
trials results
Formulate an opinion regarding this
drug’s impact on clinical practice.
List important patient counseling points
for aclidinium
3. Background1,2
Dry-powder inhaler
Marketed by Forrest Labs, Inc.
Indication: FDA-approved in July 2012
for maintenance treatment of COPD
bronchospasms
4. Mechanism of Action1,2
Reversible, long-acting muscarinic
antagonist (anticholinergic)
Blocks M3 receptors in bronchiolar
smooth muscle
Leads to enhanced bronchodilation
Decreased bronchospasms
5. Dosing1
400 mcg twice daily via oral inhalation
Each puff delivers 400 mcg of
medicine
7. ACCORD COPD 13
Phase III, 12-week, double-
blind, randomized multicenter clinical trial
Compared twice-daily 200 mcg
aclidinium, daily 400 mcg aclidinium, and
placebo
Outcomes: change from baseline in
trough FEV1, COPD symptoms
Results: both active groups showed
improvement in FEV1, similar adverse
events compared to placebo
Comments: mean age 64 years, smoking
status unknown, longer studies needed
8. ATTAIN4
24-week, double-blind, placebo-controlled
trial
Compared twice-daily 200 mcg aclidinium vs.
twice-daily 400 mcg aclidinium vs. placebo
Outcomes: mean change in trough
FEV1, COPD symptoms
Significant improvement in FEV1 and
symptoms compared to placebo
SE were low and similar to placebo for both
groups
Comments: Smoking status unknown, not
comparative
9. Clinical trial comparing Spiriva®
(tiotropium) to aclidinium5
Phase IIa randomized, double-blind, double-
dummy crossover trial
Tiotropium 18 mcg vs. aclidinium 400 mcg vs.
placebo
15-day trial
Outcomes included change in peak FEV1 and
change in FEV1 AUC
Showed greater improvement in FEV1 AUC
values for aclidinium over tiotropium
COPD symptom scores improved with
aclidinium but not tiotropium
Comments: short, small study, symptom
scoring system unknown, FEV1 AUC not
standard
10. Clinical trial comparing
Spiriva® to aclidinium2,3,4,5
aclidinium Spiriva® ipratropium
Advantages Improved FEV1 more studies, Cost, well-
over Spiriva, currently first- studied and
lower line long-acting characterized,
incidence of cholinergic available in
Anticholinergic antagonist for combination with
side effects COPD, once albuterol
compared to daily dosing
both
Disadvantage cost ($261 for more anticholinergic
s one device), anticholinergic side effects, four
twice daily side effects times daily
dosing, 400 compared to dosing
mcg twice daily aclidinium
vs. 18 mcg
once daily for
11. Impact on Practice
Currently would argue against
formulary so it is not used as first-line
agent
Consider using in patients who are on
combo therapy including
corticosteroids who are not
experiencing relief
Consider using in patients who cannot
tolerate anticholinergic side effects
High cost, generic a possibility
12. Patient Counseling1
Inhalation technique – dry-powder
inhaler
Dose counter decreases by ten
Not a rescue inhaler – use twice every
day
Smoking cessation
Difficult urination, blurry vision,
bronchospasm
Discard after 45 days
Pregnancy category C
13. References
1. CenterWatch. Drug Information. Available at:
http://www.centerwatch.com/drug-information/fda-approvals/drug-
details.aspx?DrugID=1211. Accessed September 13, 2012.
2. TUDORZA PRESSAIR®. [package insert]. St. Louis, MO: Forrest Labs, Inc. ;
2012.
3. Kerwin EM, D’Urzo AD, Gelb AF, et al. Efficacy and safety of a twelve-week
treatment with twice-daily aclidinium bromide in COPD patients. (ACCORD
COPD 1). [abstract]. COPD 2012 Apr;9(2):90-101.
<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed/2232014>.
Accessed September 15, 2012. PMID:22320148.
4. Jones PW, Singh D, Bateman ED, et al. Efficacy and safety of twice-daily
aclidinium bromide in COPD patients: The ATTAIN study. [abstract]. Eur Respir J
2012 Mar 22. [Epub ahead of print].
<http://www.ncbi.nlm.nih.gov.ezproxy.lib.purdue.edu/pubmed?term=efficacy%20
of%20aclidinium%20bromide%2024-week>. Accessed September 15, 2012.
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