Long-term weight control study I (weeks 0 to 34)

Abstract

To investigate the value of anorexiant medications as an adjunct to other forms of weight control therapy, we studied 121 people in a 34-week, double-blind clinical trial of 60 mg extended-release fenfluramine plus 15 mg phentermine resin versus placebo added to behavior modification, caloric restriction, and exercise. Participants weighed 130% to 180% (154% +/- 1.2%, mean +/- SEM) of ideal body weight (1983 Metropolitan Life tables) and were in good health. By week 34, participants receiving active medication lost an average of 14.2 +/- 0.9 kg, or 15.9% +/- 0.9% of initial weight (n = 58), versus a loss of 4.6 +/- 0.8 kg or 4.9% +/- 0.9% of initial weight by subjects taking placebo (n = 54; p less than 0.001). On visual analog scales, participants rated fenfluramine plus phentermine as more helpful than placebo (50.3 +/- 0.5 versus 20.3 +/- 0.3) and not bothersome (fenfluramine plus phentermine, 17.4 +/- 0.3 versus 13.5 +/- 0.2). Blood pressure decreased and pulse remained unchanged in both groups. Dry mouth was the most common adverse effect in subjects receiving fenfluramine plus phentermine; all adverse effects decreased after 4 weeks. Only nine participants left the study in the first 34 weeks. Two subjects from each group left the study as a result of adverse effects. Overall, fenfluramine plus phentermine used in conjunction with behavior modification, caloric restriction, and exercise aided weight loss and continued to be efficacious for 34 weeks.

Lifestyle Modification in the Pharmacologic Treatment of Obesity: A Pilot Investigation of a Potential Primary Care Approach

“…Thus, intensive group behavior modification, as provided in this and Weintraub's (37) study, does not appear to be necessary for successful weight loss with the fenfluramine-phentermine combination. Instead, our results strongly suggest that primary care providers could effectively treat obese individuals with a combination of medication and brief, protocolguided lifestyle modification.…”

“…Thereafter, acceptable candidates were referred to their family physicians, who completed a history and physical examination and determined if there were any contraindications to treatment. These included, in addition to major illnesses (i.e., hepatic, renal, cardiovascular, etc): essential hypertension (> 140/90 mm Hg); primary pulmonary hypertension; glaucoma; Types I or I1 diabetes; pregnancy or lactation; use of antidepressant medications; and the chronic use of nasal decongestants or any medications known to affect weight (37).…”

“…Several factors have sparked it, the first of which was Weintraub's report that patients treated by dl-fenfluramine (60 mg/day) and phentermine (15 mg/day) lost 14 kg in 34 weeks and maintained the great majority of this loss for up to three years while on medication (37,39). A second factor was the Food and Drug Administration's (FDA) recent approval of dexfenfluramine for "weight loss and the maintenance of weight loss" (30).…”

Effects of 6-Month Weight Loss New Program on Anthropometric Measurements and Biological Profile

“…Obesity is a risk factor for the chronic development diseases such as heart disease, type 2 diabetes and certain types of cancer. It has reported that dieting; exercising, pharmacotherapy and surgery are the treatments [5][6][7]. The safest treatment for obesity is weight loss [4].…”

“…Anti-obesity drugs may be taken to reduce food desire or decrease fat absorption. If diet, exercise, and medication are not stringent effect, a gastric balloon and surgery may be used to reduce weight [5][6][7].…”