Alvimopan: A peripherally selective opioid mu receptor antagonist
June 1st 2005Post-operative ileus causes significant patient morbidity and is a major contributor to patient discomfort and increased length of hospitalization post-operatively. Alvimopan (Entereg, Adolor/GlaxoSmithKline), a peripherally selective opioid mu receptor antagonist with gastrointestinal (GI) tract-specific activity, is undergoing FDA review for the treatment of post-operative ileus.
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Medicare appeals process gets overhaul
June 1st 2005Providers may want to be aware of changes published by the Center for Medicare and Medicaid Services (CMS) that substantially overhaul the appeals process, in part, to reduce the time frames for adjudicating fee-for-service Medicare claims appeals. A process that now exceeds 1,000 days must be reduced to 300 days.
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New board to improve internal oversight, consumer communication of drug safety issues
May 1st 2005The 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.
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California HMOs required to cover all 'medically necessary' drugs
May 1st 2005New 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.
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New board to improve internal oversight, consumer communication of drug safety issues
May 1st 2005The 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.
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Warfarin underperforms in preventing stroke in the real world in patients with chronic AF
May 1st 2005Analyses 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.
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Clopidogrel beneficial during acute phase of MI; metoprolol has no overall effect
May 1st 2005Clopidogrel 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.
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Drug-eluting stent comparisons give slight edge to sirolimus-eluting sent
May 1st 2005In-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.
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Calcium antagonist has clinical advantage over beta-blocker as initial antihypertensive therapy
May 1st 2005An 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.
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Evidence supports high-dose over low-dose atorvastatin in stable coronary heart disease
May 1st 2005Atorvastatin 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.
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Secondary stroke prophylaxis: ARB bests calcium antagonist
May 1st 2005The 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.
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Ramelteon: A novel melatonin receptor agonist for the treatment of insomnia
May 1st 2005Ramelteon (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..
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