Clinical and economic considerations of antiobesity treatment: a review of orlistat

Abstract

The objective of this study was to review the current knowledge about the use of orlistat from clinical and economic perspectives, and to assess this drug’s public health impact. Weight reduction by current antiobesity drugs, compared to placebo, is at most around 5 kg. Orlistat, the most studied antiobesity drug, is associated with the least-severe adverse effects, but compared with other drugs in its class it also delivers the most modest weight loss versus placebo (less than 3 kg). Orlistat appears to have a favorable risk/benefit profile, and cost-effectiveness ratios seem to be within a range that is generally considered acceptable. In the short-term, orlistat is related to reduced diabetes incidence and to slightly improved blood pressure and lipid profiles. Long-term clinical effects have been largely unstudied, however, and this study did not find reports that considered mortality as an endpoint. Given a very low continuation with orlistat treatment in the population and very modest and, apparently, only short-term clinical effects, orlistat is not likely to have a significant impact on the population health. Public health approaches of improving environmental and social factors to foster healthier food choices and increase physical activity remain essential for addressing the obesity epidemic.

Exercise and BMI in Overweight and Obese Children and Adolescents: A Systematic Review and Trial Sequential Meta-Analysis

“…The multiple benefits observed are in contrast to treatments such as pharmacological interventions, approaches that are usually intended to treat one outcome. In addition, orlistat, the only pharmacological intervention currently approved in the United States for the treatment of obesity in children and adolescents [ 93 ], has been shown to be less cost-effective than several nonpharmacologic interventions, including exercise [ 87 , 94 ], and has also been accompanied by side-effects such as gastrointestinal distress [ 95 ]. With respect to exercise in the current meta-analysis, four studies that did include information on side-effects reported no serious adverse events [ 74 , 77 – 79 ], defined as any intervention that results in death, a life threatening condition, hospitalization (initial or prolonged), disability, or permanent damage [ 96 ].…”

Estimating and reporting treatment effects in clinical trials for weight management: using estimands to interpret effects of intercurrent events and missing data

“…When imputing missing data only, the underlying assumption is that body weight would be unaffected by discontinuation for trial participants lost to follow up. Participants typically experience weight regain after discontinuing an effective treatment [ 33 ]; therefore, the assumption of no weight change post-discontinuation required by this version of the LOCF approach is unrealistic.…”

The effect of antiobesity drugs on waist circumference: a mixed treatment comparison

“…For the large number of patients who are not able to reduce weight by non‐pharmacological means, drug treatment offers a reasonable option to treat obesity . Orlistat (tetrahydrolipstatin) is a lipase inhibitor that blocks around one‐third of intestinal fat digestion . It is currently the only drug approved by both the European Medical Agency (EMA) and the US Food and Drug Administration (FDA) for the long‐term treatment of obesity.…”