Formulary Watch |

FDA actions in brief

Oxcarbazepine (Trileptal, Novartis) was approved as adjunctive therapy to treat partial seizures in children aged 2 years or older with epilepsy.

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Methylphenidate transdermal patch (Daytrana, Shire/Noven) to treat attention-deficit/hyperactivity disorder (ADHD)

Avelox

Moxifloxacin

Nexavar

Sorafenib tablets

Formulary policy to be shaped this year by Medicare, IT, and push for drug development

The number-one health policy issue for the new year is to find ways to keep healthcare costs under control. An aging population and more costly medical technology could increase current spending trends. These developments could have an impact on efforts to reduce the number of uninsured people in the United States and could prompt initiatives to make consumers more aware of treatment costs and options.

Chest 2005: Sitaxsentan more effective than bosentan as PAH therapy

Sitaxsentan, a highly selective endothelin-A (ET-A) receptor antagonist undergoing FDA review as an alternative to bosentan for pulmonary arterial hypertension (PAH) treatment, demonstrated improved efficacy over bosentan in a recent study.

Chest 2005: Combination drug therapies may improve efficacy, reduce side effects in PAH

Because several molecular pathways are relevant in the pathogenesis and progression of pulmonary arterial hypertension (PAH), combinations of therapies are being explored to better manage the disease.

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