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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

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.

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.

FDA actions in brief

A new dosage strength of the fentanyl transdermal system (Duragesic, Alza) was approved for the management of persistent, moderate-to-severe chronic pain requiring continuous opioid administration for an extended period of time that cannot be managed by other drugs. The new patch will deliver 12 mcg of fentanyl per hour.

Despite unanimity in the belief that the COX-2 selective nonsteroidal anti-inflammatory drugs (NSAIDs) significantly increase cardiovascular risk, FDA's Arthritis and Drug Safety and Risk Management Advisory Committees have advised FDA that the risk/benefit profile of the previously approved COX-2 inhibitors support the marketing of these agents in the United States.

Evidence-based medicine is the driving philosophy for pharmacy and therapeutics (P&T) committee decision-making. When the available evidence is incomplete or unclear, the decision-making process becomes complex. Evaluation of the published literature to make sound decisions regarding appropriate medication use can be a time-consuming process. The use of expert panels or subcommittees may facilitate decision-making; however, this process is often limited by the schedules and time constraints of busy clinicians. This article describes the creation and utilization of a "virtual" panel of experts utilizing anonymous electronic communications to assist the P&T committee at a university-based teaching hospital in making medication use policy. The article includes a detailed description of the P&T committee's experience in the selection of virtual panel members, methods used, advantages, potential pitfalls, and the outcomes of a virtual committee used to evaluate the appropriateness of the off-label use of nesiritide (Natrecor, Scios).

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Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants