Sibutramine, marketed as Meridia in the United States by Abbott, is now contraindicated in patients with a history of cardiovascular disease. According to the U.S.FDA, the drug label already warns against the use of sibutramine in patients with cardiovascular disease. "However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label," stating that sibutramine should not be used in patients with a history of cardiovascular disease, including patients with a
* History of coronary artery disease (eg, myocardial infarction, angina
* History of stroke or transient ischemic
* History of heart
* History of congestive heart
* History of peripheral arterial
* Uncontrolled hypertension (eg, >145/90 mm Hg)
The safety review was based on data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT), which enrolled more than 10,000 overweight or obese patients with diabetes or a history of coronary artery disease, peripheral vascular disease, or stroke, along with other cardiovascular risk factors.
An analysis of the trial's primary end point — a composite of myocardial infarction, stroke, resuscitated cardiac arrest, or death — found the rate to be 11.4% for patients receiving sibutramine and 10% for those receiving placebo. The current review found that the risk for cardiovascular events with sibutramine was significantly increased only in patients with a history of cardiovascular disease (P = .023).
Healthcare professionals should regularly monitor blood pressure and heart rate in patients taking sibutramine, the FDA notes."If sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued, " according to the FDA. "Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first 3 to 6 months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk."
