Obesity treatment with a progressive clinical tri-therapy combining sibutramine and a supervised diet--exercise intervention.
OBJECTIVE
: Sibutramine favors a negative energy balance and also has the potential to increase heart rate and blood pressure. We investigated if a progressive supervised sibutramine--diet--exercise clinical intervention could increase the body weight loss previously reported while minimizing the potential cardiostimulatory effects of this drug.


METHODS
: The tri-therapy intervention was divided into two phases of 6 weeks each in which sibutramine (10 mg) was taken once daily by eight obese men (body mass index (BMI) between 30 and 40 kg/m(2)). Part A consisted of a dietary follow-up with an energy restriction, whereas in part B an aerobic exercise program combined with a low-fat diet was introduced. Systolic (SBP) and diastolic (DBP) blood pressure, resting heart rate (RHR) and body weight were measured every 2 weeks while body density, resting metabolic rate (RMR) and respiratory quotient (RQ) were determined before and after the intervention.


RESULTS
: This clinical intervention produced a substantial body weight loss (-10.7 kg, P<0.01) which was about twice as much as other 12-week studies. In part A, both RHR (+4 beats/min) and DBP (+5 mmHg, P<0.01) were increased. However, after part B, RHR (-8 beats/min, P=0.02) and DBP (-3 mmHg, P<0.01) were significantly decreased. RMR was decreased at the end of the program but this effect did not persist after adjustments for fat-free mass. RQ was also reduced (-0.05, P<0.01) following the clinical tri-therapy.


CONCLUSIONS
: In conclusion, these observations suggest that this clinical tri-therapy favored a satisfactory benefit--risk profile since it enhanced weight loss without inducing increases in heart rate and blood pressure or detrimental changes in RMR and substrate oxidation.
Bérubé-Parent
S
S
Division of Kinesiology, Laval University, Ste-Foy, Québec, Canada.
Prud'homme
D
D
St-Pierre
S
S
Doucet
E
E
Tremblay
A
A
D000328:Adult; D001481:Basal Metabolism / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003503:Cyclobutanes / Q000009:adverse effects* / Q000627:therapeutic use*; D004038:Diet, Reducing; D004734:Energy Metabolism; D015444:Exercise; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D009765:Obesity / Q000628:therapy*; D010101:Oxygen Consumption; D018570:Risk Assessment
D003503:Cyclobutanes; C058254:sibutramine