September 16th 2023
Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
COX-2 inhibitors, nonselective NSAID use increases risk of death, reinfarction in acute MI patients
August 1st 2006A meta-analysis of data from national hospital records in Denmark and from the country's national prescription registry showed that the use of selective cyclooxygenase-2 (COX-2) inhibitors in all doses and nonselective non-steroidal anti-inflammatory drugs (NSAIDs) in high doses raised the risk of death in patients who experienced first-time acute myocardial infarction (MI).
Use of ACE inhibitors in first trimester raises risk of fetal cardiovascular, CNS malformation
July 1st 2006An observational cohort study found that the risk of major congenital malformations for infants who were exposed to angiotensin-converting enzyme (ACE) inhibitors during their first trimester increased by a factor of more than 2, while exposure to other antihypertensive medications did not demonstrate an increased risk.
NSAID use among elderly increases risk of first-time hospitalization for heart failure
July 1st 2006A cohort study with a nested case-control analysis of first hospitalizations for heart failure (HF) associated the use of non-steroidal anti-inflammatory drugs (NSAIDs) with a 30% increase in the target end point among patients aged 60 to 84 years.
Nebivolol demonstrates efficacy and favorable safety profile in treatment of hypertension
July 1st 2006Phase 3 clinical trials demonstrated that the once-daily, highly selective beta blocker nebivolol lowers blood pressure in a dose-dependent manner and is well tolerated at all doses, according to presenters at the 21st annual scientific meeting of the American Society of Hypertension (ASH), in New York, NY.
ACE inhibitors versus ARBs: comparison of practice guidelines and treatment selection considerations
June 1st 2006Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) play a role in the treatment of hypertension (HTN) and heart failure (HF). The literature shows that in patients with HTN with comorbidities, such as HF, myocardial infarction (MI), diabetes mellitus, chronic kidney disease, and stroke, ACE inhibitors and ARBs appear to provide added benefit beyond solely lowering blood pressure. In addition, clinical trials have also demonstrated that ACE inhibitors and ARBs may be beneficial in the prevention of diabetes, atrial fibrillation (AF), and recurrent stroke. This review evaluates the practice guidelines and current literature to assess the implications for the use of ACE inhibitors or ARBs in HTN and HF.
Aspirin resistance: a growing concern
April 1st 2006Aspirin is the cornerstone of therapy in the treatment and prevention of cardiovascular disease. The potential benefit of aspirin therapy may be significantly reduced in patients with aspirin resistance, creating a clinical and economic burden on the healthcare system. The purpose of this article is to clarify the term "aspirin resistance," describe the proposed mechanisms, review the clinical outcome studies with associated resistance testing, and discuss the potential pharmacologic management of this problem. Literature searches were performed using MEDLINE (January 1966 to January 2006) for review articles on aspirin resistance and antiplatelet activity. Aspirin's primary mechanism of action is to irreversibly inhibit cyclooxygenase-1 (COX-1); however, there are reports of alternative biochemical pathways producing platelet aggregation. The addition of thienopyridines to aspirin should be considered for the management of aspirin-resistant patients. (Formulary. 2006;41:192–201.)
Topiramate safely decreases body mass hypertension
March 1st 2006Topiramate safely decreases body mass, hypertension. Topiramate reduces body weight and blood pressure with generally mild-to-moderate adverse effects, according to a randomized, placebo-controlled trial involving obese subjects with hypertension.
Meta-analysis concludes statins have no effect on cancer risk
March 1st 2006A recent meta-analysis published in the Journal of the American Medical Association (JAMA) found that statins have no effect on cancer risk. The finding is in contrast with at least 7 retrospective analyses that suggest that statins reduce the risk of developing cancer.
Aprotinin may increase risk in cardiac surgery; FDA issues alert
March 1st 2006The serine protease inhibitor aprotinin (Trasylol, Bayer) may increase the risk of renal failure, myocardial infarction, heart failure, stroke, and encephalopathy among patients undergoing coronary artery bypass graft (CABG) surgery, according to an observational study in the New England Journal of Medicine (NEJM).
Study diminshes value of beta blockers in treatment of hypertension
January 1st 2006Beta blockers, touted for 3 decades as first-line drugs in the treatment of hypertension, are less than optimum in comparison to other antihypertensive drugs and raise the risk of stroke, according to a meta-analysis published online by The Lancet.
Early invasive stategy no better than selectively invasive approach for acute coronary syndromes
January 1st 2006Early invasive strategy, recommended by the current guidelines in the treatment of patients with acute coronary syndromes (ACS), did not excel when compared with its more conservative alternative in a randomized study published in the New England Journal of Medicine.
2005 AHA Scientific Sessions: EURIDES/ADONIS
January 1st 2006Dronedarone, a class III multichannel blocker developed for maintenance of sinus rhythm and ventricular rate control, reduces the risk of all-cause hospitalizations and death in patients with atrial fibrillation/flutter (AF/AFl), according to a post-hoc analysis of 2 randomized, placebo-controlled clinical trials.
2005 AHA Scientific Sessions: REVIVE II/SURVIVE trials
January 1st 2006The calcium sensitizer levosimendan was associated with an improvement in the clinical course of patients compared with placebo when used for the treatment of acute decompensated heart failure (ADHF), but the drug failed to reduce 6-month mortality when compared with dobutamine in a similar set of patients.
2005 AHA Scientific Sessions: CAF? trial
January 1st 2006Drugs that reduce brachial blood pressure similarly can have different effects on central blood pressure. This finding may explain differences in clinical end points between antihypertensive drugs that lower blood pressure similarly, said Bryan Williams, MD, lead investigator of the Conduit Artery Function Evaluation (CAF?) trial, a substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT).
2005 AHA Scientific Sessions: IDEAl trial
January 1st 2006In a trial comparing high-dose atorvastatin with moderate-dose simvastatin in patients with stable coronary heart disease (CHD), the aggressive LDL-lowering strategy offered no significant advantage over the less aggressive strategy in reducing the number of coronary events, said Terje R. Pedersen, MD.
2005 AHA Scientific Sessions: ERICA trial
January 1st 2006The anti-anginal agent ranolazine, in phase 3 clinical trials, reduced anginal frequency in patients experiencing 3 or more anginal attacks per week despite daily treatment with amlodipine 10 mg/d said Peter Stone, MD, lead investigator of the Evaluation of Ranolazine in Chronic Angina (ERICA) trial.
2005 AHA Scientific Sessions: ACTIVE-W
January 1st 2006Oral anticoagulant therapy proved superior to the combination of clopidogrel and aspirin in preventing adverse vascular outcomes in patients with atrial fibrillation (AF). This outcome was observed in a large, multicenter trial at the 2005 AHA meeting in Dallas, comparing warfarin therapy with combination antiplatelet therapy in patients with AF.
FDA seeks more information about potential CV mortality risk related to short-term clarithrycin use
January 1st 2006Short-term treatment with the macrolide clarithromycin may cause significantly higher cardiovascular mortality in patients with stable coronary heart disease, according to a randomized, placebo-controlled multicenter study that took place in Denmark and was published in the British Medical Journal (BMJ).
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.)