Study summary · research use only
Tesofensine--a novel potent weight loss medicine. Evaluation of: Astrup A, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:1906-13
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This is a human clinical-trial evaluation article commenting on a phase II trial of tesofensine in obese subjects. The authors note that obesity incidence is increasing and is associated with several comorbidities. The abstract reports that, after 26 weeks, tesofensine caused a significant weight loss and may have a higher maximal ability to reduce weight than presently available anti-obesity agents, while also increasing blood pressure and heart rate and possibly increasing psychiatric disorders. The authors state that tesofensine 0.5 mg may cause almost double the weight loss observed with sibutramine or rimonabant, suggest a head-to-head comparison with sibutramine, and note that at 0.5 mg it increases heart rate and adverse effects such as nausea and insomnia, requiring further evaluation in phase III trials.
Abstract
The incidence of obesity is increasing; this is of major concern, as obesity is associated with cardiovascular disease, stroke, type 2 diabetes, respiratory tract disease, and cancer. This evaluation is of a Phase II clinical trial with tesofensine in obese subjects. After 26 weeks, tesofensine caused a significant weight loss, and may have a higher maximal ability to reduce weight than the presently available anti-obesity agents. However, tesofensine also increased blood pressure and heart rate, and may increase psychiatric disorders. It is encouraging that tesofensine 0.5 mg may cause almost double the weight loss observed with sibutramine or rimonabant. As tesofensine and sibutramine have similar pharmacological profiles, it would be of interest to compare the weight loss with tesofensine in a head-to-head clinical trial with sibutramine, to properly assess their comparative potency. Also, as teso fensine 0.5 mg increases heart rate, as well as increasing the incidence of adverse effects such as nausea, drug mouth, flatulence, insomnia, and depressed mode, its tolerability needs to be further evaluated in large Phase III clinical trials.
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