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Patients Drop 6 kg on Investigational Weight Loss Drug Taranabant
Presented at ACC By Ed Susman - Avril 2008Taranabant
Funding for this study was provided by Merck Research Laboratories.
[Presentation title: A Two-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients: 52 Week Results. Abstract 1021-220]
56,5% des malades sous taranabant 2 mg/j ont perdu 5% de leur poids basal contre 27,2% sous placebo (p> 0.001).
A suivre.... pour 5% !!!!
Patients taking an experimental weight loss drug lost an average of 6.6 kg (14.5 pounds) over the course of 1 year, researchers reported here at the 57th Annual Meeting of the American College of Cardiology (ACC 2008).
"There is a critical unmet need for new weight loss options for the millions of people living with obesity," said Louis Aronne, MD, Clinical Professor of Medicine, Weill-Cornell Medical College, and Director, Comprehensive Weight Control Program, New York Presbyterian Hospital, New York, New York.
"The results of this study suggest that taranabant, an investigational therapy, has the potential to be a valuable treatment option -- if approved -- for patients suffering from obesity and its many complications," Dr. Aronne said.
Dr. Aronne, one of several investigators in the phase 3 trial, said the critical difference between taranabant and placebo is that 27.9% of overweight and obese patients on the 2-mg dose of taranabant lost more than 10% of their body weight in the year-long study compared with 8.4% of placebo patients (P < .001).
"Even losing just 5% of your body weight is important to your health," Dr. Aronne said in a presentation on March 31. "It will help you reduce your risk factors of cardiovascular disease."
In the 2,502-patient study, Dr. Aronne and colleagues assigned 417 patients to placebo and 414 patients to the 2-mg daily dose of taranabant, with the remainder receiving higher doses of taranabant.
Merck Research Laboratories, the company that makes the drug, has decided to more forward with the 2-mg dose and will not proceed with the 4- or 6-mg dose. The higher doses showed marginally better efficacy, but there was a greater incidence of adverse effects.
In the trial, patients reported their maximum weight loss after about 36 weeks and maintained that loss through week 52.
The most commonly reported adverse events were transient gastrointestinal side effects (41.8%); of subjects on taranabant who reported these adverse events, 1.7% discontinued the treatment.
More patients in the trial discontinued treatment due to patient-reported psychiatric complaints -- mainly irritability. Of the 28.3% of patients who reported these effects, 8.2% dropped out of the trial, compared with 4.1% of patients who were on placebo. There were no suicides or suicide attempts. Three patients on the 6-mg dose of taranabant reported suicide ideation.
About 56.5% of patients on 2 mg of taranabant were able to achieve at least a 5% weight loss, compared with 27.2% of patients on placebo (P < .001), Dr. Aronne said.
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