Sibutramine Saga: Not as safe in CVD
This news has again led us into another cul de sac in managing our obese patients. Not so long after Sanofi’s Rimonabant withdrawn from the market as result of psychiatric adverse events, now the previously declared safe Sibutramine has been found to be not as safe in patients with preexisting CVD
This follows a postmarketing study (post SCOUT) that was conducted in some 10,000 obese patients with stable heart disease or type 2 diabetes plus another risk factor. Preliminary findings show more cardiovascular events occurred in patients who took sibutramine compared with placebo (11.4% vs. 10.0%).
Following this, the FDA has issued warning of contraindication in the use of Sibutramine in the following group of patients:
* History of coronary artery disease (e.g., heart attack, angina)
* History of stroke or transient ischemic attack (TIA)
* History of heart arrhythmias
* History of congestive heart failure
* History of peripheral arterial disease
* Uncontrolled hypertension (e.g., > 145/90 mmHg)
Jan 23 2010