March 25th 2024
J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.
Medical Crossfire®: Updates in Continuous Glucose Monitoring—Having the Important Conversations With Your Patients
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Evaluating the Recent Advancements in Chronic Kidney Disease Treatment: A Case-Based Approach to Managing CKD and Related Comorbidities
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Elevating Care for PAH: Applying Recommended Management Approaches to Maximize Outcomes
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7th Annual New York Cardio-Endo-Renal Collaborative (NY CERC)
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‘REEL’ Time Patient Counseling™: Navigating the Complex Journey of Diagnosing and Managing Fabry Disease
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Expert Illustrations & Commentaries™: Envisioning Novel Therapeutic Approaches to Managing ANCA-associated Vasculitis
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Statins may reduce prostate cancer risk
November 1st 2005Men who have used 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors to reduce their cholesterol levels may be at less risk of developing prostate cancer, according to a case-control study published in the American Journal of Epidemiology.
ACEIs, ARBs decrease new-onset type 2 diabetes in patients with hypertension, CAD, and HF
November 1st 2005ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) possess a similar and significant ability to reduce the development of new-onset type 2 diabetes among patients with hypertension, coronary artery disease, and heart failure, according to a meta-analysis study published in Diabetes Care.
Acetaminophen, NSAIDs elevate hypertension risk in women
November 1st 2005Acetaminophen at doses of more than 500 mg/d and nonsteroidal anti-inflammatory drugs (NSAIDs) at doses of more than 400 mg/d increase the risk of incident hypertension in younger and older women, according to cohort studies published in Hypertension.
Ranolazine: An update on the novel antianginal agent
October 1st 2005Ranolazine (Ranexa, CV Therapeutics) is a partial fatty acid oxidase inhibitor that increases the amount of ATP produced from glucose and increases the ability of the myocardium to retain functionality despite a reduced oxygen supply. Ranolazine is under FDA review for the treatment of chronic stable angina (CSA). Ranolazine was first reviewed in the August 2003 issue of Formulary. Since the initial review of ranolazine by FDA, additional data have emerged that merit an update in this journal. Clinical trials have demonstrated the efficacy of ranolazine as both monotherapy and combination therapy in patients with CSA. Recently published clinical trials (MARISA and CARISA) have shown an improvement in symptom-limited exercise duration. The results of the ERICA trial demonstrated a reduction in weekly anginal attacks when ranolazine was added to maximum-dose amlodipine therapy. Headache and generalized weakness were the most commonly reported adverse events in clinical trials. Prolongation of the QT interval has raised concerns; however, a lack of development of ventricular tachyarrhythmias-specifically Torsade de Pointes-remains an important safety finding. (Formulary. 2005;40:323–328.)
Formulary Decision-makers update P&T policies following COX-2 inhibitors
July 1st 2005Following the voluntary withdrawal of rofecoxib in September 2004 and the subsequent FDA-requested withdrawal of valdecoxib in April 2005, formulary decision-makers are considering options in navigating the changing pain management landscape. With one remaining COX-2 inhibitor available on the market (celecoxib [Celebrex, Pfizer]) and more cardiovascular (CV) risk data available for the class, the efficacy, adverse events, risk/benefit profiles, and costs of both COX-2-selective and nonselective NSAIDs are receiving more attention than ever.
Warfarin underperforms in preventing stroke in the real world in patients with chronic AF
May 1st 2005Analyses of 3 retrospective databases found that warfarin is much less effective at preventing strokes in the real world in patients with chronic atrial fibrillation (AF) than it is in clinical trials. The retrospective data were reported at the ASA's International Stroke Conference 2005.
Clopidogrel beneficial during acute phase of MI; metoprolol has no overall effect
May 1st 2005Clopidogrel reduces 28-day mortality in the treatment of patients with acute myocardial infarction (MI) when given on top of standard therapies, but metoprolol has no effect on in-hospital mortality when given during the acute phase of MI.
Clinical news updates from the 2004 AHA Scientific Sessions
January 1st 2005The American Heart Association (AHA) Scientific Sessions comprise the largest meeting of its kind held in the cardiovascular field, with several thousand presentations given each year. The recently concluded 2004 AHA Scientific Sessions, which took place in New Orleans, included presentations of trials that evaluated potential therapeutic compounds, as well as widely used and accepted compounds in new dosages or combinations, for the treatment of cardiovascular disorders. The compilation of clinical news that follows focuses on the cardiovascular pharmacotherapy trials of greatest interest to formulary decision-makers, including: CREATE, PEACE, A-HeFT, PROTECT, CLEAR Platelets, DIPOM, GEMINI, SHIELD, and RIO-NA.
Nebivolol: A beta antagonist with novel pharmacologic properties
November 1st 2004Nebivolol is a beta-blocker under FDA review for the treatment of hypertension. Nebivolol has unique pharmacologic properties, including high specificity for the beta-1 receptor and a nitric oxide-mediated vasodilatory effect. The agent provides significant blood pressure reduction from baseline values and as compared to placebo. Clinical trials have demonstrated that nebivolol reduces blood pressure similarly to atenolol, bisoprolol, amlodipine, nifedipine, lisinopril, and hydrochlorothiazide. The tolerability of nebivolol is similar to or better than that of these agents. If approved, nebivolol would likely be a viable alternative therapy for hypertension; however, additional studies are needed in patients with heart failure and coronary artery disease.
High-dose simvastatin fails to achieve primary end point in trial of ACS
October 1st 2004Initiating high-dose simvastatin (Zocor, Merck) early after an acute coronary syndrome (ACS) event does not result in significantly superior clinical outcomes compared to delayed initiation of low-dose simvastatin.This major finding of phase Z of the A to Z Trial is in contrast to the results of 2 previous clinical trials in which aggressive therapy with atorvastatin (Lipitor, Pfizer) was found to be superior to less aggressive statin therapy in reducing the risk of adverse clinical events in ACS patients.
Higher-dose rofecoxib linked to 3x greater risk of acute cardiac events compared to other NSAIDs
September 1st 2004A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.
Higher-dose rofecoxib linked to 3x greater risk of acute cardiac events compared to other NSAIDs
September 1st 2004A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.
Drug-eluting stents: A pharmacy management perspective
September 1st 2004Current treatment options for acute coronary syndromes as well as chronic stable angina often include the use of percutaneous coronary intervention (PCI) with routine stenting. The clear benefits of stents have lead to their routine use for prevention of restenosis. However, the benefits of stenting demonstrated on some aspects of restenosis are compromised by the induction of restenosis by neointimal hyperplasia that is stimulated by standard bare metal stents. FDA has approved 2 drug-eluting stents (DES). DES create a local delivery system at the vascular site to reduce restenosis by neointimal hyperplasia. Multiple clinical trials have demonstrated the safety and efficacy of the use of DES. This article reviews the use of PCI in coronary artery disease, the evolution and pathophysiology of restenosis, and multiple aspects of DES technology. While DES may not be a direct pharmacy and therapeutics committee responsibility, committee members are being called upon to provide insights into pathway processes for medical technology review committees evaluating DES since these products contain a key pharmacologic component. There are also important adjunctive antiplatelet therapy protocols that need to be developed and adhered to in conjunction with DES in order to ensure optimal outcomes.
New NCEP cholesterol management guidelines recommend lower LDL treatment goals
August 1st 2004A newly released update to the National Cholesterol Education Program's (NCEP) guidelines on cholesterol management recommend that clinicians consider more intensive treatment options for patients at high and moderately high risk for heart attack. These evidence-based recommendations include setting lower treatment goals for low-density lipoprotein cholesterol (LDL-C) and initiating cholesterol-lowering drug therapy at lower LDL thresholds.
Rofecoxib use increases congestive heart failure risk compared to celecoxib and nonselective NSAIDs
July 1st 2004A study was conducted to assess hospital admission rates for congestive heart failure in patients dispensed cyclooxygenase-2 (COX-2) inhibitors or nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Researchers at the Institute for Clinical Evaluative Sciences in Toronto, Ontario, Canada, studied patients taking rofecoxib (Vioxx, Merck), celecoxib (Celebrex, Pfizer), and nonselective NSAIDs, with a control group consisting of non-NSAID users who were not given any study drugs. Study findings indicate that, relative to non-NSAID users, patients receiving rofecoxib and nonselective NSAIDs had an increased risk of admission for congestive heart failure than patients taking celecoxib.
CEE alone increases stroke risk in post-menopausal women
June 1st 2004Findings from a newly released Women's Health Initiative (WHI) study suggest that conjugated equine estrogen (CEE) alone should not be used for chronic disease prevention, specifically coronary heart disease (CHD), in postmenopausal women. The study, published in the Journal of the American Medical Association, found that CEE increased the risk of stroke by 39% and offered no protection against heart disease.
Clopidogrel combined with aspirin lowers risk of CEA-induced cerebral emboli
June 1st 2004Combination use of clopidogrel and aspirin the night before undergoing carotid endarterectomy (CEA) may significantly reduce the risk of cerebral emboli, according to a study published in the journal Circulation.
Adjusted-dose warfarin lowers stroke risk in AF patients vs aspirin
June 1st 2004Adjusted-dose warfarin compared to aspirin more effectively reduces the high risk of secondary stroke in atrial fibrillation (AF) patients who have a history of transient ischemic attack (TIA), according to a study published in the journal Stroke.
New class may help smokers quit, curb post-cessation weight gain
May 4th 2004In phase 3 trials, the first agent in a novel class known as the selective cannabinoid type 1 receptor blockers doubled the odds of quitting smoking while reducing post-cessation weight gain compared with placebo. The agent, rimonabant, also improved several features of the metabolic syndrome in patients with abdominal obesity, reported researchers at the 53rd Annual Scientific Session of the American College of Cardiology (ACC).
Enoxaparin clinically equivalent to UFH in the treatment of high-risk ACS
May 4th 2004>Enoxaparin is an effective and safe alternative to unfractionated heparin (UFH) in the early and invasive management of high-risk patients with non-ST-elevation acute coronary syndromes (ACS), said Robert Califf, MD, at the 53rd Annual Scientific Session of the American College of Cardiology (ACC).
Clinical news updates from the 2003 AHA Scientific Sessions
January 1st 2004The American Heart Association (AHA) Scientific Sessions comprise the largest meeting of its kind held in the cardiovascular field, with several thousand presentations given each year. The recently concluded 2003 AHA Scientific Sessions included presentations of trials that evaluated potential therapeutic compounds, as well as widely used and accepted compounds in new dosages or combinations, for the treatment of cardiovascular disorders. The compilation of clinical news reviewed focuses on the cardiovascular pharmacotherapy trials of greatest interest to formulary decision-makers, including: VALIANT, REVERSAL, SPORTIF V, PAPABEAR, PRIMO-CABG, and CREST.
Statins linked to reduced risk of cancer
September 1st 2003Users of statins were 20% less likely to have cancer (adjusted odds ratio, 0.80; 95% CI, 0.660.96) in a case-control study from the Academic Medical Centre, University of Amsterdam, Netherlands, that was presented at the 39th Annual Meeting of the American Society of Clinical Oncology