Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population.
OBJECTIVE
To evaluate the safety and efficacy of sibutramine 15 mg by mouth once per day in obese patients over a period of 6 months.


METHODS
A monocenter, double-blind, placebo controlled, parallel, prospective clinical trial was carried out. Sixty-nine male and female obese patients (body mass index [BMI] > 30 kg/m2) aged 16 to 65 years entered the trial.


RESULTS
22 of 35 patients in the sibutramine group and 9 of 34 patients in the placebo group completed the trial. The high dropout rate in the sibutramine group was due to adverse events in 3 cases, lack of efficacy (as judged by patients) in 7, loss to follow-up in 2, and an orthopedic device being worn in 1; in the placebo group the dropouts were ascribed to lack of efficacy (as judged by patients) in 17 cases and to loss to follow-up in 8 cases. Using the method of last observation carried forward, the weight loss in the sibutramine group was 10.27 kg (95% confidence intervals [95% CI] 7.66; 13.07) and 1.26 kg (95% CI 0.3; 2.23) in the placebo group. The BMI loss was 4.17 kg/m2 (95% CI 3.11; 5.22) in the sibutramine group and 0.53 kg/m2 (95% CI 0.13; 0.92) in the placebo group. The waist circumference reduction was 12.51 cm (95% CI 9.25; 15.77) in the sibutramine group and 3.26 cm (95% CI 1.38; 5.14) in the control group (p<0.05 by paired Student's t test for all the intragroup comparisons). Twenty-three sibutramine patients had 34 adverse events, the most frequent adverse events in the sibutramine group were upper respiratory tract infections (n = 6) and constipation (n = 6); 16 placebo patients had 21 adverse events. Three sibutramine patients withdrew their informed consent when they had adverse events.


CONCLUSIONS
The results show that sibutramine induces significant loss of body weight and waist circumference. Cardiovascular function was not significantly affected by sibutramine. Sibutramine was well tolerated by most of the patients.
Cuellar
G E
GE
Módulo de diabetes del Hospital Psiquiátrico con Unidad de Medicina Familiar No. 10 Dr. Guillermo Dávilla García IMSS Delegación 04 del DF, Mexico City.
Ruiz
A M
AM
Monsalve
M C
MC
Berber
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000008:administration & dosage / Q000627:therapeutic use*; D001824:Body Constitution; D015992:Body Mass Index; D002319:Cardiovascular System / Q000503:physiopathology; D003503:Cyclobutanes / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000503:physiopathology; D010919:Placebos; D011446:Prospective Studies; D015431:Weight Loss
D001067:Appetite Depressants; D003503:Cyclobutanes; D010919:Placebos; C058254:sibutramine