Sibutramine (Meridia) is a very expensive ($240/month) brandname weight loss medication with stimulant properties.  It causes only a mild weight loss the first year and must be continued indefinitely or the weight returns.  There is no evidence that it improves health.  In fact, it causes an increase in blood pressure and heart rate.  The FDA in November, 2004, U.S. Senate hearings mentioned it as one of five medications on the market that are potentially dangerous.  Yale's Medical Letter consultants recommend against using it (12/6/04; 46:issue 1197).  

Orlistat (Xenical) and Sibutramine (Meridia) Small Benefit at High Price: Eleven orlistat weight loss studies (four of which reported a second year ) and five sibutramine studies (three weight loss and two second year) were included in a meta-analysis. Dropouts averaged 33% during the weight loss phase for orlistat and 43% for sibutramine. All received lifestyle modification. Compared to placebo, orlistat-treated patients lost 6 pound or 2.9% more weight than placebo and those on sibutramine lost 9 pound or 4.6%. The numbers achieving 10% or greater weight loss were 12% higher with orlistat and 15% higher with sibutramine. Weight loss maintenance results were similar. Orlistat caused gastrointestinal side effects and sibutramine caused small increases in blood pressure and pulse rate. Both were modestly effective, but with high dropout rates. Long-term health effects are unknown. Long-term pharmacotherapy for obesity and overweight. Padwal R, Li S, Lau D. Toronto, Ontario. Cochrane Database Syst Rev. 2004;3:CD004. Ed: The costs of these medicines are $1700 and $3000 per year. Since patients regain most of the weight shortly after stopping the medications, these medicines compare poorly with surgery. 

Sibutramin (Meridia) Patients Gradually Regain Their Lost Weight: In an 18-month DB PC study of 189 obese adults who had first lost at least 10% of their body weight by means of a 3-month Very Low Calorie Diet, of those who were randomized to sibutramine 10 mg/day (n=94) in addition to a recommended diet and exercise program, 70% at 6 months, 51% at 12 months and 30% at 18 months maintained more than 80% of the weight loss achieved during the VLCD phase. This compared to 48, 31 and 20% of placebo-treated patients. The differences between the treatment groups were significant (P</=0.03) at all time points. Long-term maintenance of weight loss with sibutramine in a GP setting following a specialist guided very-low-calorie diet: a double-blind, placebo-controlled, parallel group study. Mathus-Vliegen EM. University of Amsterdam, The Netherlands. European Journal of Clinical Nutrition (2005) 59, Suppl 1, S31-S39. Ed: While the authors stress the benefits, after 18 months of continuous medication, only 10% of the Meridia patients were maintaining their weight loss better than placebo patients. 

Sibutramine (Meridia) Helps Lose Only 6.6 Pounds More than Placebo: Sibutramine is an expensive selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. In a DB PC 54-week study of 362 obese patients with BMIs between 30 and 40, mean weight loss in the sibutramine 15 mg/day (S) group was 8.1 kg vs. 5.1 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis).  In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05). Weight reduction by sibutramine in obese subjects in primary care medicine: the s. A. T. Study. Hauner H, Meier M, Wendland G, Kurscheid T, Lauterbach K, Study Group SA. German Diabetes Research Institute, Dusseldorf, Germany. Exp Clin Endocrinol Diabetes. 2004 Apr;112(4):201-7. Ed: Meridia costs $240 per month.  The only long-term study found that 57% of patients regained some weight in the second year, despite staying on medication. I have not been impressed by Meridia research and prefer using metformin.  

Sibutramine Helps Lose 8 Pounds in Year, But Heart Rate Up: In a random assigned 12-month, 588-patient study, mean weight loss at 6 months was 6.8 kg in the drug group vs 3.1 kg in the nondrug group. Weight loss was maintained at 12 months. There were no significant changes in laboratory values or blood pressure. Patients taking sibutramine experienced a significant increase in heart rate (1.7 beats/min vs. -0.4 beats/min; P <.004). The Long-term Outcomes of Sibutramine Effectiveness on Weight (LOSE Weight) study: evaluating the role of drug therapy within a weight management program in a group-model health maintenance organization. Porter JA, Raebel MA, Conner DA, Lanty FA, Vogel EA, Gay EC, Merenich JA. Aventis Pharmaceuticals. Am J Manag Care. 2004 Jun;10(6):369-76

Sibutramine & Slim Fast Helped in Small Study: Twenty-nine patients with type 2 diabetes were assigned to a control group that was given standard treatment, which included education, counseling and individualized exercise and diet prescriptions. Thirty other patients got the same treatment plus sibutramine daily and meal replacement products for 1 week every 2 months. The Slim Fast Foods Company provided meal replacement products and snack bars. At 1 year, the combination-treatment group lost significantly more weight (average 7.3 kilograms, about 16 pounds) than the control group (0.8 kg). Redmond, U Minn. Diabetes Care, September 2003

Sibutramine a Little Better than Metformin or Orlistat in Brief Turkish Study: A 6-month Turkish study of 150 obese patients given sibutramine 10 mg twice a day, metformin 850 mg twice a day, or orlistat 120 mg three times a day found somewhat greater weight loss with sibutramine of 13.5% of BMI vs. 9.9% for metformine and 9.0% for orlistat. All decreased insulin resistance. Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity. Gokcel A, Gumurdulu Y, Karakose H, Melek Ertorer E, Tanaci N, BascilTutuncu N, Guvener N. Diabetes Obes Metab. 2002 Jan;4(1):49-55

Sibutramine Helped Obesity a Little, but Lots of Backsliding: A DB PC study treated obese patients who lost 5% of their weight in the first six months for another 18 months or gave them a placebo. Only 43% maintained weight loss, although placebo did even worse with 18% maintaining weight loss. Also reduced triglyceride concentrations, increased high density lipoprotein (HDL) cholesterol concentrations, reduced cholesterol:HDL cholesterol ratio (an important index to predict the risk of coronary heart disease), reduced insulinaemia and C peptide levels, and decreased uric acid concentrations. BMJ 2001;322:1379-1380 ( 9 June )

Thomas E. Radecki, M.D., J.D.

modern-psychiatry.com

Email: [email protected]