A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity.
OBJECTIVE
To evaluate the safety and efficacy of Sibutramine 10 mg per os, once a day in obese patients over a period of 6 months.


METHODS
A monocenter, double-blind, placebo-controlled, parallel, prospective clinical trial.


METHODS
109 male and female obese patients (BMI>30 kg/m2) from 16 to 65 y entered the trial.


METHODS
Body weight, body mass index (BMI), waist and waist/hip ratio, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECG.


RESULTS
40 out of 55 patients in the Sibutramine group and 44 out of 54 patients in the placebo group completed the trial. Using the method of last observation carried forward (LOCF), the weight loss in the Sibutramine group was 7.52 kg (95% confidence intervals (95% CI) 6.15; 8.9) and that in the placebo group was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kg/m2 (95% CI 2.58; 3.69) in the Sibutramine group and 1.46 kg/m2 (95% CI 0.99; 1.93) in the placebo group. The waist 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 placebo group (P<0.05 by paired Student's t-test for all the intragroup comparisons). 32 Sibutramine patients had 45 adverse events, the most frequent adverse events in the Sibutramine group being dry mouth (n=19), increase in blood pressure (n=5), constipation (n=5) and tachycardia (n=5); 23 placebo patients had 29 adverse events, mainly increase in blood pressure (n=11) and dry mouth (n=10). Two Sibutramine patients withdrew from the trial due to adverse events.


CONCLUSIONS
Sibutramine induces significant loss of body weight, BMI and waist, but does not significantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.
Fanghänel
G
G
Servicio de Endocrinologia del Hospital General de México, Organo Descentralizado, Mexico City, Mexico.
Cortinas
L
L
Sánchez-Reyes
L
L
Berber
A
A
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001824:Body Constitution; D015992:Body Mass Index; D001835:Body Weight; D018592:Cross-Over Studies; D003503:Cyclobutanes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine