Formulary Watch |

Chest 2005: Heparin antibodies, independent of HIT, common in patients undergoing cardiac surgery

The presence of antibodies to heparin is an independent risk factor for potentially serious complications following cardiac surgery, even in patients who do not develop heparin-induced thrombocytopenia (HIT), said David Kress, MD, at the 71st international scientific assembly of the American College of Chest Physicians in Montreal, Quebec, Canada.

Monoclonal antibody demonstrates efficacy in postmenopausal osteoporosis

A pivotal phase 3 trial of a fully human monoclonal antibody, denosumab, that prevents bone destruction is under way and includes 7,800 postmenopausal, osteoporotic women aged 60 to 90 years. The primary endpoint is new vertebral fractures versus placebo and secondary end points are safety and tolerability of the new agent. Phase 2 clinical trials have demonstrated that denosumab is superior to aldendronate in preserving bone mineral density (BMD), reported researchers during the American College of Rheumatology Annual Scientific Meeting in San Diego, Calif.

Study diminshes value of beta blockers in treatment of hypertension

Beta 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

Early 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.

Retrospective analysis demontrates that switching statins hinders treatment compliance, persistence

Patients who have switched statins should receive special care as they are substantially less likely to be compliant and remain on the treatment long enough to obtain its full benefits, researchers reported in the American Journal of Managed Care.

Lower incidence of CHD, other vascular events observed with absolute reductions in LDD-C

Utilizing statin therapy, researchers have provided further evidence that absolute reductions in LDL-C reduce the incidence of coronary heart disease (CHD) and other major vascular events.

2005 AHA Scientific Sessions: EURIDES/ADONIS

Dronedarone, 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

The 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

Drugs 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

In 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: Varenicline efficacy trial

A nicotinic acetylcholine receptor partial agonist is an effective smoking cessation aid, said Serena Tonstad, MD, PhD, professor of nutrition at the Ulleval University Hospital, Oslo, Norway.

2005 AHA Scientific Sessions: ERICA trial

The 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: PROactive

An exploratory analysis of PROactive (Prospective Pioglitazone Clinical Trial In Macrovascular Events Study) demonstrated a significant reduction in the risk of a second coronary event in patients with type 2 diabetes who took pioglitazone.

2005 AHA Scientific Sessions: ACTIVE-W

Oral 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.

2005 AHA Scientific Sessions: FIELD trial

The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease.

FDA seeks more information about potential CV mortality risk related to short-term clarithrycin use

Short-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).

Drug Watch: Agents in late-stage development for the treatment of selected dermatologic disorders (December 2005) (PDF)

Review of agents in late-stage development for the treatment of selected dermatologic disorders (December 2005).

Pharmacologic options for the management of diabetic peripheral neuropathy

Diabetic peripheral neuropathy, one of the most common late complications of diabetes, is associated with decreased quality of life and increased morbidity. The pathophysiology of diabetic neuropathy (DN) is multifactorial, contributing to ischemic and painful events and neuronal damage.

Focus On: Exubera An Orally inhaled insulin

Safety Labeling updates and new warnings

The labeling for darbepoetin alfa (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen and Procrit, Ortho Biotech) was revised to include information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with the agents. This has been reported predominantly in patients with chronic renal failure receiving these products by subcutaneous administration.

Contraindicated metformin fares well in heart failure patients with diabetes

In an observational study of patients with type 2 diabetes being treated for heart failure, researchers found that metformin—whether used alone in vulnerable patients or in combination—is associated with lower mortality, less morbidity, and fewer hospitalizations compared with sulfonylurea monotherapy. The study, conducted in Canada, was published in Diabetes Care.

Effexor HR

This dual-acting antidepressant is believed to exert its effect through the inhibition of neuronal serotonin and norepinephrine reuptake. Venlafaxine was approved on November 18, 2005, for the treatment of panic disorder, with or without agoraphobia, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).

FDA actions in brief

The injectable antibiotic ertapenem (Invanz, Merck) was approved by FDA to treat moderate-to-severe complicated foot infections due to indicated pathogens in patients who have diabetes without osteomyelitis

Pipeline Preview

Thalidomide (Thalomid, Celgene) as a treatment for multiple myeloma

Tarceva

The epidermal growth factor receptor (EGFR) is expressed on the surface of normal cells and cancer cells, and erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with EGFR.

Drug Watch: Agents in late-stage development for the treatment of asthma (November 2005) (PDF)

Review of agents in late-stage development for the treatment of asthma (November 2005).

Rapid Response Team to focus on countering potential threat of pandemic flu in the United States

In response to the emerging threat of pandemic (avian) influenza, FDA has announced the formation of a Rapid Response Team to ensure that antiviral drugs are available to citizens in the United States if they are needed. While avian flu has not emerged in this country, the team will help ensure an adequate supply of treatments, such as oseltamivir (Tamiflu, Roche) and other anti-influenza drugs, for stockpiling in the event there is an outbreak in the United States.

Prescription drug label information goes electronic

In an effort to meet the administration's goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow healthcare providers and consumers to more easily access the product information found in package inserts for all approved medications in the United States.

Uncertainty continues at FDA while the agency addresses drug safety; Medicare drug benefit rolls out

The future leadership of FDA remains highly uncertain following the unexpected resignation of commissioner Lester M. Crawford, DVM, PhD, in September. Andrew C. von Eschenbach, MD, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), was named acting FDA commissioner, but conflict arose initially because Dr von Eschenbach wanted to retain a leadership role at NCI while also taking the helm of FDA. Although he handed over day-to-day leadership of NCI to a deputy, that move failed to fully appease critics concerned about conflicts of interest in advocating for speedy access to new cancer treatments while overseeing the safety and effectiveness of those therapies. Department of Health & Human Services (HHS) secretary Michael Leavitt has indicated that Dr von Eschenbach is not likely to get the top job at FDA on a permanent basis.

Statins may reduce prostate cancer risk

Men 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.