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.
BACKGROUND
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.


OBJECTIVE
This evaluation is of a Phase II clinical trial with tesofensine in obese subjects.


RESULTS
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.


CONCLUSIONS
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.
Doggrell
Sheila A
SA
Queensland University of Technology, School of Life Sciences, GPO Box 2334, QLD 4001, Australia. sheila.doggrell@qut.edu.au
D000293:Adolescent; D000328:Adult; D000368:Aged; D001823:Body Composition / Q000187:drug effects* / Q000502:physiology; D015992:Body Mass Index; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000494:pharmacology / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D015431:Weight Loss / Q000187:drug effects* / Q000502:physiology; D055815:Young Adult
D019086:Bridged Bicyclo Compounds, Heterocyclic; C518479:Tesofensine