Formulary Watch |

New board to improve internal oversight, consumer communication of drug safety issues

The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.

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

A review of agents in late-stage development for the treatment of hepatitis (May 2005).

California HMOs required to cover all 'medically necessary' drugs

New regulations proposed by the California state Department of Managed Health Care (DMHC) that are expected to be implemented by the end of this year would require HMOs in California to cover all medically necessary prescription drugs, even if they are excluded from a plan's formulary.

New board to improve internal oversight, consumer communication of drug safety issues

The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.

Type 2 diabetes therapies may increase HF risk

The use of any pharmacological therapy for type 2 diabetes appears to be associated with an increased risk of heart failure (HF). However, the risk does not extend beyond the first year after diagnosis and does not appear to differ among the types of drug therapy, according to researchers who assessed 25,680 patients in the UK General Practice Research Database between 1988 and 1999. The researchers categorized person-time drug exposures to monotherapies in insulin, sulfonylureas (SUs), metformins, and other oral hypoglycemic agents (OHA), and combination therapy including insulin, combination therapy without insulin, and triple combination therapy with or without insulin.

Warfarin underperforms in preventing stroke in the real world in patients with chronic AF

Analyses 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.

Pipeline Preview

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed (Tdap) (Boostrix, GlaxoSmithKline) for vaccination against tetanus, diptheria, and pertussis

FDA actions in brief

A new once-weekly formulation of alendronate in combination with 2,800 IU of vitamin D3 (Fosamax Plus D, Merck) was approved by FDA. The combination is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.

Xibrom

Twice-daily ophthalmic NSAID approved to reduce inflammation after cataract surgery

Baraclude

Oral therapy approved for hepatitis B infection

Clopidogrel beneficial during acute phase of MI; metoprolol has no overall effect

Clopidogrel 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.

Drug-eluting stent comparisons give slight edge to sirolimus-eluting sent

In-lesion restenosis is similar between the sirolimus-eluting stent (Cypher) and the paclitaxel-eluting stent (Taxus) when used for the treatment of routine coronary artery stenoses, but the sirolimus-eluting stent may offer an advantage in patients with diabetes, according to a study reported at the ACC Annual Scientific Session 2005.

Calcium antagonist has clinical advantage over beta-blocker as initial antihypertensive therapy

An antihypertensive therapeutic strategy that starts with the calcium antagonist amlodipine is superior to one starting with the beta-blocker atenolol in preventing coronary heart disease (CHD) events, Peter S. Sever, MD, reported at the ACC Annual Scientific Session 2005.

Evidence supports high-dose over low-dose atorvastatin in stable coronary heart disease

Atorvastatin 80 mg/d is associated with better cardiovascular outcomes than atorvastatin 10 mg/d in patients with stable coronary heart disease (CHD), according to John LaRosa, MD, who presented the results of the Treating to New Targets (TNT) study at the ACC Annual Scientific Session 2005.

Secondary stroke prophylaxis: ARB bests calcium antagonist

The angiotensin receptor blocker (ARB) eprosartan is superior to the calcium antagonist nitrendipine in secondary stroke prophylaxis in patients with hypertension, Hans-Christian Diener, MD, reported at the ASA's International Stroke Conference 2005.

Ramelteon: A novel melatonin receptor agonist for the treatment of insomnia

Ramelteon (Takeda Pharmaceuticals) is a selective melatonin receptor agonist awaiting FDA approval for the treatment of insomnia. Unlike the currently prescribed hypnotic agents that work by targeting gamma-aminobutyric acid (GABA) receptors, ramelteon offers a novel mechanism of action, specifically targeting the MT1 and MT2 receptors in the brain, which are thought to play a role in regulating sedation and circadian rhythms. Ramelteon is characterized by undergoing extensive first-pass metabolism along with having high oral bioavailability. Results of phase 2 clinical trials have demonstrated that ramelteon-treated patients had significantly shorter sleep onset latencies and longer total sleep times than placebo-treated patients. Furthermore, ramelteon therapy did not appear to impair patient cognition, memory recall, levels of alertness, or ability to concentrate. Data from animal studies suggest that ramelteon is not likely to cause abuse or physical dependence. Unlike the current FDA-approved..

First-time generic approvals

Anti-sense compound (LR3001, Genta) for the treatment of chronic myelocytic leukemia

Hyzaar

Combination indicated to reduce risk of stroke in hypertensive patients with LVH

Boniva

First once-monthly therapy approved for treatment and prevention of osteoporosis

Drug Watch: Agents in late-stage development for the treatment of HIV/AIDS (April 2005) (PDF)

A review of agents in late-stage development for the treatment of HIV/AIDS (April 2005).

Drug Watch: Agents in late-stage development for the treatment of HIV/AIDS (April 2005) (PDF)

A review of agents in late-stage development for the treatment of HIV/AIDS (April 2005).

Aspirin plus esomeprazole superior to clopidogrel for prevention of recurrent ulcer bleeding

Among patients with a history of aspirin-induced ulcer bleeding, aspirin plus esomeprazole was shown to be superior to clopidogrel for the prevention of recurrent bleeding. The results of a 12-month, prospective, randomized, double-blind trial do not support current American College of Cardiology/American Heart Association guidelines recommending that clopidogrel be used as an alternative antiplatelet agent in patients who have a major gastrointestinal intolerance to aspirin, according to the authors of the study.

Tipranavir

If approved, tipranavir (Boehringer Ingelheim) will be the ninth protease inhibitor (PI) available and the first nonpeptidic PI available in the United States. Designed by structure-based analysis, tipranavir is more flexible at the binding site, allowing for a potent and durable antiretroviral response. The tipranavir (TPV) and ritonavir (RTV) PI regimen (TPV/r) studied in clinical trials had a moderate pill burden, requiring 4 pills to be taken twice daily (2 RTV 100 mg and 2 TPV 250 mg).

FDA actions in brief

Peginterferon alfa-2a (Pegasys, Roche) and ribavirin (Copegus, Roche) were approved in combination for the treatment of chronic hepatitis C in patients coinfected with HIV who have clinically stable HIV disease.

A timely transition to insulin: Identifying type 2 diabetes patients failing oral therapy

Although oral antidiabetic medications initially may be effective for controlling hyperglycemia, these agents often fail to maintain adequate glycemic control as the disease progresses, and insulin eventually is required in most patients. This review explores strategies for identifying patients with type 2 diabetes who are failing to maintain glycemic control on oral agents and for transitioning these patients to insulin. Based on available data, patients are not reaching recommended glycemic goals due to delays in and reluctance towards intensification of therapy, resulting in an increased risk of complications.

Symlin

This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-?-D-glucan, an essential component of fungal cell walls.

Mycamine

This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.

CME images

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Ziprasidone and risperidone equally efficacious for treatment of acute exacerbation of schizophrenia or schizoaffective disorder

Ziprasidone (Geodon, Pfizer) and risperidone (Risperdal, Janssen) are equally efficacious in the treatment of patients with acute exacerbation of schizophrenia and schizoaffective disorder, with ziprasidone demonstrating a lower movement disorder burden and less effect on prolactin concentrations and weight than risperidone.

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

A review of agents in late-stage development for the treatment of osteoporosis (March 2005)