Fluoxetine: a randomized clinical trial in the maintenance of weight loss.
Because current weight-reduction treatments have considerable recidivism, a therapy that could help patients maintain weight loss would be of benefit. A six-center, randomized, double-blind trial compared the effects of the specific serotonin uptake inhibitor, fluoxetine hydrochloride, and placebo on maintenance of weight loss. Obese outpatients who had lost > or = 3.6 kg after 8 weeks of single-blind fluoxetine 60 mg/day in the qualification phase (N=317 [70.4% of patients entered]; mean +/- standard deviation [SD] weight loss, 6.8 +/- 2.8 kg) were randomly assigned to fluoxetine 20 mg/day (N=104), fluoxetine 60 mg/day (N=106), or placebo (N=107) for 40 weeks (maintenance phase). Patients received minimal nutrition/dietary counseling. Qualification phase clinic visits were biweekly; maintenance phase visits were monthly for 4 months, then bimonthly for 6 months. Patients treated with fluoxetine 60 mg/day continued to lose weight for 8 additional weeks (16 weeks total; maximum mean +/- SD weight loss, 7.2 +/- 4.6 kg); those treated with fluoxetine 20 mg/day or placebo began to regain weight. Mean weights remained below baseline values at week 48 (all groups); treatment differences were not statistically significant. Study completion rates were comparable (fluoxetine 20 mg/day, 67.3%; fluoxetine 60 mg/day, 56.6%; placebo, 67.3%; p = 0.175). Among commonly reported adverse events (> 10% incidence), only asthenia was reported statistically significantly (p < 0.050) more frequently with fluoxetine than with placebo. Few patients discontinued for any single adverse event. Fluoxetine 60 mg/day was effective for a longer period than fluoxetine 20 mg/day or placebo in maintaining weight loss. Overall, fluoxetine was safe and well tolerated.
Goldstein
D J
DJ
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
Rampey
A H
AH
Dornseif
B E
BE
Levine
L R
LR
Potvin
J H
JH
Fludzinski
L A
LA
D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D002241:Carbohydrates; D002784:Cholesterol / Q000378:metabolism; D008078:Cholesterol, LDL / Q000378:metabolism; D003404:Creatinine / Q000378:metabolism; D004311:Double-Blind Method; D004912:Erythrocytes / Q000378:metabolism; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008214:Lymphocytes / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D009765:Obesity / Q000188:drug therapy*; D010919:Placebos; D012306:Risk; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D015430:Weight Gain; D015431:Weight Loss / Q000187:drug effects*
D002241:Carbohydrates; D002784:Cholesterol; D008078:Cholesterol, LDL; D003404:Creatinine; D005473:Fluoxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors