Weight loss drug safely used in high-risk patients

By Will Boggs, MD

NEW YORK (Reuters Health) - Sibutramine, which is marketed under the trade names Meridia and Reductil, appears safe and possibly effective for weight management in patients at a high risk for heart attack and stroke -- for whom the drug is usually not recommended -- according to a report in the European Heart Journal.

"Sibutramine could very well be safe for high-risk patients with overweight," Dr. Christian Torp-Pedersen from Bispebjerg University Hospital, Copenhagen, told Reuters Health.

In the Sibutramine Cardiovascular Outcomes (SCOUT) trial, Torp-Pedersen and associates measured blood pressure and heart rates to gauge how safe the drug would be in 10,742 overweight and obese patients at high risk for cardiovascular events, such as heart attack and stroke. In this preliminary analysis, the subjects were treated with sibutramine for 6 weeks in addition to standard care for weight management.

"Only 1,171 (11 percent) of subjects failed to lose weight or gained weight" during the study, the authors report.

Fewer than 5 percent of the patients experienced two consecutive increases in blood pressure of any possible significance, the report indicates, and overall blood pressure declined slightly.

Heart rates increased by just 1.0 to 1.5 beats per minute during the course of the study.

Diastolic blood pressure, the bottom number on a standard blood pressure reading, declined in patients with high blood pressure at study entry who lost at least 5 percent of their body weight; whereas diastolic blood pressure increased slightly in patients with normal blood pressures at entry and lost a similar amount of weight. The pattern was the same among patients who lost less than 5 percent of their body weight.

Changes were comparable for men, women and patients who were treated with beta-blockers, a class of standard blood pressure drugs, and those who were not treated with these drugs, the researchers note.

"Treatment with sibutramine at the currently accepted therapeutic dose of 10 milligrams once daily was tolerated well in these obese and overweight subjects with a high risk of cardiovascular events," the investigators conclude.

"Sibutramine might be beneficial judging from the encouraging findings during the start of the study," Torp-Pedersen said, "but this conclusion must await the final results."

SOURCE: European Heart Journal, December 2007.