2.b. Pharmacotherapy Trials
Rationale: The effects of pharmacological therapy on weight loss and subsequent changes in total serum cholesterol levels were evaluated by examining eight RCTs (386, 390-393, 395, 407, 408) (Table III-3). The four trials of dexfenfluramine showed no consistent effects on total cholesterol; three trials showed decreases in triglycerides ranging from 14 to 40 percent and two trials showed increases in HDL-cholesterol of 8 percent in women to 27 percent in men. One trial of phentermine plus fenfluramine showed a 24 percent decrease in triglycerides and a slight change in HDL-cholesterol (395). The trial of orlistat showed a decrease in total cholesterol and an increase in triglycerides, while the trial of fluoxetine showed the opposite (407, 408). Other RCTs using orlistat have shown a modest improvement in lipids with weight loss (388).
In a combined summary of data presented at the FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting (held in Bethesda, Maryland, in September 1996), use of sibutramine, which resulted in a greater net weight loss of 2.4 kg (5.3 lb) at 4 months, also resulted in modestly lower levels of total cholesterol, LDL-cholesterol, and triglycerides, along with slightly higher HDL-cholesterol levels, compared to placebos (389).
TC=Total Cholesterol TG=Triglycerides BMI=Body Mass Index