Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity.
OBJECTIVE
The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity.


METHODS
This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice.


METHODS
A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2).


METHODS
The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects.


RESULTS
Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%).


CONCLUSIONS
Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated.
Smith
I G
IG
Synexus LTD, Chorley, United Kingdom. ian.smith@synexus.co.uk
Goulder
M A
MA
D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000494:pharmacology / Q000627:therapeutic use*; D001521:Behavior Therapy; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D003131:Combined Modality Therapy; D003503:Cyclobutanes / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009747:Nutritional Physiological Phenomena; D009765:Obesity / Q000145:classification / Q000175:diagnosis / Q000188:drug therapy*; D010919:Placebos; D011320:Primary Health Care; D017367:Selective Serotonin Reuptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
D001067:Appetite Depressants; D003503:Cyclobutanes; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; C058254:sibutramine