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Meridia & Dexfenfluramine Weight Loss Pills Trial
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Diet Pills Trial - A Comparison of Meridia/Sibutramine and Dexfenfluramine in the Treatment of Obesity

Aim of Diet Pills Trial
Because long-term weight reduction is often unsuccessful with dietary restriction alone, pharmacological agents have been used to promote weight loss. We have compared the novel (multiple monoamine neurotransmitter reuptake inhibitor) antiobesity drug Meridia/Sibutramine (10 mg once daily) with the extensively studied serotonin-releasing antiobesity agent dexfenfluramine (15 mg twice daily).

226 healthy outpatients (aged 18 to 65 years; body mass index > or =27 kg/m2) were included in a 12-week, randomized, double-blind, parallel group study. The main outcome measures were changes in weight, body mass index, waist and hip circumference and ratio, and safety profiles.

Mean absolute weight loss was 4.5 +/- 0.4 kg in the Meridia/Sibutramine group (n = 112) and 3.2 +/- 0.3 kg in the dexfenfluramine group (n = 112); 4.7 +/- 0.4 kg in the sibutramine group (n = 101); and 3.6 +/- 0.3 kg in the dexfenfluramine group (n = 94). Comparing the two treatments under the conventional null hypothesis of equality as a secondary analysis, weight loss at endpoint in patients receiving sibutramine was significantly greater than that achieved with dexfenfluramine. Both drugs had similar adverse events profiles: 174 patients (77 percent) experienced adverse events; 17 patients withdrew due to adverse events (sibutramine, n = 6; dexfenfluramine, n = 11). Pulse rate increased significantly in sibutramine-treated patients, but decreased in dexfenfluramine-treated patients.

Conclusion of Diet Pills Trial
Meridia/Sibutramine (10 mg once daily) is at least as effective as dexfenfluramine (15 mg twice daily) in achieving weight loss in patients with obesity.

Source: Hanotin C, Thomas F, Jones SP, Leutenegger E, Drouin P. Medical Direction,Laboratoires Knoll France-BASF Pharma.

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