Sibutramine isn’t safe for adults with cardiovascular disease

Sibutramine was associated with extra heart attacks and strokes, but not deaths, in a placebo controlled trial that tested the drug in obese adults with cardiovascular disease, type 2 diabetes, or both. Sibutramine is already banned in Europe, and the Food and Drug Administration is currently considering its place on the US market⇑. In this trial, published ahead of a crucial FDA meeting on 15 September, adults who took sibutramine for a mean of 3.4 years had 28% more non-fatal heart attacks (4.1% v 3.2%; hazard ratio 1.28, 95% CI 1.04 to 1.57) and 36% more non-fatal strokes (2.6% v 1.9%; 1.36 to 1.04 to 1.77) than those who took placebo. The greatest risks were confined to those with established cardiovascular disease in subgroup analyses. Sibutramine did not seem to cause ischaemic events in people with diabetes alone. The trial was funded by Abbott, the company that makes sibutramine.

Even in the US, sibutramine is not recommended for adults with cardiovascular disease because it has sympathomimetic effects that can (and did) increase heart rate and blood pressure. People who took sibutramine in this trial lost significantly more weight than controls who took placebo (an extra 1.7 kg), but an editorial still calls for the FDA to follow Europe’s lead and take the drug off the US market (p 972). Doctors may be able to avoid prescribing sibutramine to patients with known cardiovascular disease but surely not to those whose disease has yet to show itself clinically. The benefits are modest and the risks are clear says the editorial. It is up to the FDA now.

Modest benefits from a dementia programme by occupational therapists

Non-drug treatments for dementia have had limited success in trials. The latest to be tested was an intensive intervention by occupational therapists that aimed to reduce functional dependence for adults with dementia and …