Expression of concern—Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial

Abstract

In 2008, The Lancet published a phase 2 study of tesofensine as an adjunct to a hypocaloric diet in the treatment of obesity. 1 Astrup A Madsbad S 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: 1906-1913 Summary Full Text Full Text PDF PubMed Scopus (150) Google Scholar The study was also published in Ugeskrift for Læger.2 Nielsen AL Larsen TM Madsbad S et al. The effect of tesofensine on body weight and body composition in obese subjects—secondary publication [Article in Danish]. Ugeskr Laeger. 2009; 171: 2974-2977 PubMed Google Scholar In 2011, The Danish Health and Medicines Authority decided to inspect completed trials at random. This study was among those selected and was inspected in November of that year. Concerns were expressed about two of the five sites where the trial was undertaken, and were brought to the attention of The Lancet in 2012 by the Article's corresponding author. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trialOur results suggest that tesofensine 0·5 mg might have the potential to produce a weight loss twice that of currently approved drugs. However, these findings of efficacy and safety need confirmation in phase III trials. Full-Text PDF Under-reporting of adverse effects of tesofensineThe Lancet Editors (April 6, p 1167)1 recently expressed concern regarding issues raised by the Danish Health and Medicines Authority (DHMA) audit2 of two of the five clinical sites and the sponsor of our study reported in The Lancet.3 We appreciate this opportunity to clarify the issues. Full-Text PDF