Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity. Results from the European multi-centre STORM trial

Abstract

BACKGROUND:In this report we assess pre-treatment determinants of weight loss and maintenance outcome in The Sibutramine Trial of Obesity Reduction and Maintenance (STORM), a 2 y randomized, double-blind, placebo-controlled, European multicenter study examining the effect of sibutramine (Sib) on inducing and maintaining weight loss in obese subjects. MATERIAL: A total of 605 obese patients (BMI: 30 ± 45 kgam 2 ) of both gender were included from eight European centers and treated for 24 months. The patients were treated for the initial 6 months by Sib (10 mgaday) and a low-fat low-energy, individualized diet (600 kcaladay de®cit). The 467 patients who achieved b 5% weight loss after 6 months were randomized 3 : 1 to Sib (10 mgaday) (SibaSib) and placebo (SibaPla) for weight maintenance over a further 18 months. MAIN OUTCOME AND ANALYSES: Pre-treatment individual characteristics were assessed as predictors of 6 months weight loss (kg) and 24 months weight maintenance using simple and multivariate correlation and regression analyses. RESULTS: In univariate analyses, the 6 month weight loss (n 505) was positively associated with pre-treatment body weight (r 0.27), height (r 0.18), fat-free mass (r 0.21) (all P`0.001), fat mass (r 0.13, P`0.03), and resting metabolic rate (r 0.13, P`0.003). However, no relation was found with age, gender, smoking status, age at onset of obesity, or number of previous slimming attempts. The same predictors were found for weight change to endpoint in the SibaSib group (n 350), while no predictors were identi®ed in the SibaPla (n 114). In the multivariate regression analysis only pre-treatment body weight predicted weight loss at 6 months (P`0.001). Weight change (kg) to 24 month was predicted by: 4.34 0.07Ãbody weight (kg) 7 4Ãtreatment (Sib 1, Pla 0) 7 0.06Ãage (y), (r 2 8%, P`0.001). CONCLUSION: Only pre-treatment body weight seems to be an important independent predictor of 6 months weight loss and 24 month weight maintenance in this study on diet and Sib. As only 8% of the variation in 24 months weight change could be explained by the predictors, the clinical value of this information is limited.

Psychobehavioral and nutritional predictors of weight loss in obese women treated with sibutramine

“…At 3 months, energy intake was reduced by 186 kcal and weight change associated with topiramate treatment correlated with lower baseline energy intake, energy intake reduction as well as with higher baseline leptin and rT 3 levels. As in our study and in the STORM trial 19 with sibutramine, baseline BMI significantly predicted weight loss maintenance in topiramate treated patients; baseline BMI remained the only factor correlating with weight loss after 1 y treatment with topiramate.…”

“…Baseline body weight, mode of treatment and age explained only 9% of the variation in 24-month weight change in the STORM study. 19 Body weight or BMI at baseline predicted weight loss in several other studies on weight management. 10,12 In the STORM study, 19 baseline body weight, sex, age, resting metabolic rate, smoking history, previous attempts to lose weight and age of onset of obesity were included as predictors of weight change but psychobehavioral and nutritional parameters were not taken into account.…”

Impact of the menstrual cycle on determinants of energy balance: a putative role in weight loss attempts

“…Pretreatment body weight is an important independent predictor of weight loss and slightly overweight women may not respond as well to a weight management program as women who are obese. 115 Nor do all women experience changes in cravings and in food intake related to the menstrual cycle. This review addresses whether hormonal changes affect different components of energy balance, such as food intake, but food intake can also affect hormones.…”

Comparison of combinations of drugs for treatment of obesity: body weight and echocardiographic status

“…There have been numerous studies conducted with all of the obesity drugs on the market, and the weight losses average about 5-10% of initial body weight at 6 months to 1 year. An exception was the Sibutramine Trial of Obesity Reduction and Maintenance (STORM) trial with sibutramine, 48 carried on in multiple sites in Europe, which achieved a loss of about 13% of initial body weight, and a study by Wadden et al 49 that demonstrated a weight loss of 16.5% at 1 year with sibutramine, rigid diet and lifestyle modification. However, the study by Wadden et al 49 and most of the sites in the STORM trial used very low-calorie diets to achieve a large initial weight loss, so the data are not comparable to those of other trials.…”