Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients.

OBJECTIVE: Our objective was to assess the efficacy and safety of sibutramine with a low-calorie diet (LCD) and commercial meal-replacement product in achieving weight loss and weight-loss maintenance in obese patients. RESEARCH METHODS AND PROCEDURES: Eight U.S. centers recruited 148 obese patients for a 3-month comprehensive weight-loss therapy (Phase I) comprising daily sibutramine 10 mg + LCD (two Slim-Fast meal-replacement shakes, one low-calorie meal; total kcal/d = 1200-1500). Patients (N = 113) who lost > or =5% of initial body weight during Phase I were randomized for a 9-month period (Phase II) to daily sibutramine 15 mg + LCD (one meal-replacement shake; two low-calorie meals: total kcal/d approximately 1200-1500) or daily placebo + three low-calorie meals (total kcal/d approximately 1200-1500). Both phases included behavior modification. Efficacy was assessed by body weight change during each phase and by the number of patients at endpoint maintaining > or =80% of the weight they had lost by the end of Phase I. Other outcomes included changes in cardiovascular and metabolic risk factors, adverse events, and vital signs. RESULTS: Mean body weight change during Phase I was -8.3 kg (p < 0.001). Patients randomized to sibutramine in Phase II had an additional -2.5 kg mean weight loss vs. a 2.8-kg increase in the placebo group (p < 0.001). More sibutramine patients maintained > or =80% of their Phase I weight loss at the end of Phase II (85.5% vs. placebo 36.7%, p < 0.001). Most adverse events were mild or moderate in severity, and all serious adverse events were unrelated to sibutramine. DISCUSSION: Sibutramine plus LCD with meal replacements and behavior modification is a safe and effective strategy for achieving and sustaining weight loss in obese patients.

Predictors of attrition in a large clinic-based weight-loss program.

OBJECTIVE: Identifying client factors that predict dropout is critical for the development of effective weight-loss programs. Although demographic predictors are studied, there are few consistent findings. The purpose of this study was to identify predictors of dropout in a large clinic-based weight-loss program using readily attainable demographic variables. RESEARCH METHODS AND PROCEDURES: All 866 weight-loss patients in a clinic-based weight-loss program enrolled during 1998 to 1999 were followed. Attrition and retention rates were measured at 8 and 16 weeks. Six variables (sex, race, marital status, age, BMI, and treatment protocol) were evaluated using bivariate and multivariable statistics for relative association with dropout. RESULTS: The overall attrition rate for the 16-week program was 31%. The retention rate was 69%. Significant risk for dropout, measured as bivariate relative risk (95% confidence interval), was found among patients who were: females, 1.32 (1.01 to 1.73); divorced, 1.54 (1.13 to 2.09); African Americans, 1.68 (1.26 to 2.23); age < 40, 1.66 (1.27 to 2.18); and ages 40 to 50, 1.33 (1.01 to 1.76). There were no significant differences in retention rates by BMI group or program protocol. After logistic regression analysis to control for all variables, young age < 50 years had the only significant association with dropout [odds ratio = 1.39 (1.02 to 1.90)]. DISCUSSION: Multivariable modeling was helpful for prioritizing risk factors for program dropout. These findings have important implications for improving weight-loss program effectiveness and reducing attrition. By knowing the groups at risk for dropout, we can improve or target program treatments to these populations.