Orlistat 60 mg Reduces Visceral Adipose Tissue: A 24‐Week Randomized, Placebo‐Controlled, Multicenter Trial

Abstract

It is well established that abdominal obesity or upper body fat distribution is associated with increased risk of metabolic and cardiovascular disease. The purpose of the present study was to determine if a 24 week weight loss program with orlistat 60 mg in overweight subjects would produce a greater change in visceral adipose tissue (VAT) as measured by computed tomography (CT) scan, compared to placebo. The effects of orlistat 60 mg on changes in total fat mass (EchoMRI‐AH and BIA), ectopic fat (CT) and glycemic variables were assessed. One‐hundred thirty‐one subjects were randomized into a multicenter, double‐blind placebo controlled study in which 123 subjects received at least one post baseline efficacy measurement (intent‐to‐treat population). Both orlistat‐and placebo‐treated subjects significantly decreased their VAT at 24 weeks with a significantly greater loss of VAT by orlistat treated subjects (−15.7% vs. −9.4%, P < 0.05). In addition, orlistat‐treated subjects had significantly greater weight loss (−5.93 kg vs. −3.94 kg, P < 0.05), total fat mass loss (−4.65 kg vs. −3.01 kg, P < 0.05) and trended to a greater loss of intermuscular adipose tissue and content of liver fat compared with placebo‐treated subjects. This is the first study to demonstrate that orlistat 60 mg significantly reduces VAT in addition to total body fat compared to placebo treated subjects after a 24 week weight loss program. These results suggest that orlistat 60 mg may be an effective weight loss tool to reduce metabolic risk factors associated with abdominal obesity.

Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity

“…There are some clinical studies with orlistat at 60 mg and 120 mg against placebo [3, 12–14] in subjects undergoing caloric restriction for a period of treatment ranging between 14 and 104 weeks. These trials show that in general, an approximate weight reduction of about 2 kg can be added to weight loss induced by caloric restriction alone.…”

Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis

“…51,55 The remaining 12 studies (2 studies were single-group pre-post designs, 1 study had a more active comparison group, and 9 studies reported outcomes at < 12 mo) were only included in analyses of adverse events. 24,29,57,63,[75][76][77][78][79][80][81]83 High within-group heterogeneity was common; however, the direction of treatment effect was consistent across most studies, and the confidence intervals overlapped. This statistical heterogeneity is likely due to small versus large treatment effects observed across studies.…”

“…20,27,57,59,61,66,67,[70][71][72][73]77,79,84 Gastrointestinal events were reported only in studies that used drug interventions and in the 23 studies with data that could be pooled; those taking active medications were more likely to report these events than control participants. 57,59,[61][62][63][64][65][66][67][68][69][71][72][73][74][75][76][77]79,[81][82][83][84] Likewise, participants in 25 pharmacologic studies were more likely to withdraw from their study because of adverse events compared with control participants (Table 5). 46,56,[58][59][60][61][62][63][64][65]…”

“…57,59,[61][62][63][64][65][66][67][68][69][71][72][73][74][75][76][77]79,[81][82][83][84] Likewise, participants in 25 pharmacologic studies were more likely to withdraw from their study because of adverse events compared with control participants (Table 5). 46,56,[58][59][60][61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76][77]79,81,82 …”

Obesity and the Cardiorenal Metabolic Syndrome: Therapeutic Modalities and Their Efficacy in Improving Cardiovascular and Renal Risk Factors

“…In the Swedish Multimorbidity Study, the authors concluded that treatment with orlistat in addition to dietary modifications produced significantly greater mean weight loss (5.9% in non-diabetics and 4.6% in diabetics) and CVD risk factor reduction than treatment with dietary modifications alone [44]. Weight loss with orlistat has been associated with improvement in comorbidities of obesity [45,46,47]. …”