Effect of Colestimide on Reduction of Body Weight and Waist Circumference in Metabolic Syndrome Patients with Cardiovascular Risk Factors

Background and objective: Insulin resistance is thought to be central to the pathogenesis of abdominal obesity- linked metabolic syndrome (MetS). Colestimide, a 2-methylimidazole-epichlorohydrin polymer, is a new bile-acid- sequestering resin used to lower LDL cholesterol. In recent reports, bile acid-controlled signaling pathways have shown promise as novel drug targets to treat metabolic disorders, such as obesity, type 2 diabetes, hyperlipidemia, and athero- sclerosis. The aim of this study was to evaluate the efficacy of colestimide on weight loss in MetS patients. Methods: Sixty-one patients with MetS who had cardiovascular risk factors were randomized to receive lifestyle counsel- ing with or without colestimide treatment. The primary endpoint was achieved when the reduction in body weight is � 5%. Additionally, differences in the waist circumference and metabolic-associated profiles between the colestimide group and the control group, which received lifestyle modifications alone, were analyzed. Results: The numbers of participants who achieved � 5% weight loss significantly favored the colestimide group over the non-colestimide group (71.4% vs. 33.3%; p < 0.01). The mean reduction in waist circumference during the study period (average 22 weeks) was greater with colestimide than without it (10.1 � 5.4 vs. 7.1 � 5.2 cm, p < 0.05). Conclusions: The colestimide treatment together with lifestyle intervention was associated with reduction in body weight and waist circumference over a relatively short term in obese subjects. The combination of colestimide and lifestyle inter- vention may be useful for weight management in MetS patients with cardiovascular risk factors.