October 8th, 2010
Abbott Withdraws Sibutramine from U.S. Market
Larry Husten, PHD
Abbott has pulled its weight-loss drug sibutramine (Meridia) from the U.S. market. A safety communication from the FDA said the “drug may pose unnecessary cardiovascular risks to patients.” Earlier this year the drug was withdrawn in Europe. Sibutramine was approved by the FDA in 1997. The FDA recommendation is based upon a recent analysis of data […]
October 8th, 2010
Analysis of ADVANCE Explores Role of Hypoglycemia
Larry Husten, PHD
A new analysis of the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation) trial sheds light on the role of hypoglycemia in recent trials of glucose control. In a paper in the New England Journal of Medicine, the ADVANCE investigators report that 2.1% of 11,140 patients with type 2 diabetes […]
October 7th, 2010
Genome Studies Pool Data to Gain Power
Larry Husten, PHD
Leaders of several genome-wide association studies have agreed to collaborate and combine their data in the hope that by dramatically raising the sample size of their studies, they will “contribute to our understanding of the role of common genetic variation on risk for CAD and MI.” In an article in Circulation: Cardiovascular Genetics, Michael Preuss and […]
October 4th, 2010
Study Finds Deep Ties Between Sleep and Weight Loss
Larry Husten, PHD
A good night’s sleep might be a key to losing weight. In a crossover study among 10 overweight people, Arlet Nedeltcheva and colleagues compared the effects of 2 weeks of dieting with 8.5 or 5.5 hours of sleep each night. They found that during the sleep curtailment period, weight loss came more from lean body […]
October 4th, 2010
Consensus Statement Highlights Urgency of Treating Hypertension in Blacks
Larry Husten, PHD
Hypertension in blacks should be treated earlier and more aggressively, according to an update of the International Society on Hypertension in Blacks (ISHB) consensus statement published in Hypertension. The update lowers the threshold for treatment and recommends that: Lifestyle changes be initiated in African-Americans when blood pressure is at or above 115/75 mm Hg. Drug therapy be […]
October 1st, 2010
Chronic Kidney Disease and Cardiovascular Risk
Larry Husten, PHD
People with early-stage chronic kidney disease are at elevated risk for cardiovascular disease, according to a new study published in BMJ. Researchers from the U.K. and Iceland followed 17,000 adults in Reykjavik for a median of 24 years and found that people with chronic kidney disease at baseline had significantly elevated risk for cardiovascular events, […]
September 29th, 2010
How Are You Managing Co-Morbid Conditions?
Joseph S. Ross, MD, MHS
Some of you may remember a 2005 paper in JAMA, in which relevant clinical practice guidelines were applied to a hypothetical 79-year-old woman. This woman had multiple co-morbid conditions, otherwise known as multimorbidity, including COPD, type 2 diabetes, osteoporosis, hypertension, and osteoarthritis. The authors surmised that, if guideline-directed care were followed, this hypothetical patient would be […]
September 23rd, 2010
FDA and EMA Split on Fate of Avandia
Larry Husten, PHD
The FDA and the European Medicines Agency announced separate and divergent decisions on the fate of rosiglitazone (Avandia) today. On the one hand, the FDA announced that it would allow rosiglitazone to remain on the market, though only with severe restrictions on its use. Additionally, the FDA said it would require the drug’s manufacturer “to convene […]
September 23rd, 2010
Fondaparinux Effective in Superficial-Vein Thrombosis
Larry Husten, PHD
In the randomized, double-blind CALISTO (Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis with Placebo) trial, 3002 patients with acute, symptomatic superficial-vein thrombosis in the legs, but without DVT or symptomatic PE, received either fondaparinux (2.5 mg) or placebo for 45 days. The primary efficacy endpoint ─ a composite of all-cause death, symptomatic PE […]
September 20th, 2010
FDA Panel Unanimously Recommends Approval for Dabigatran
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw […]