A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet.
Improving the maintenance of weight loss remains a critical challenge for obesity researchers. The present 1-year, randomized, placebo-controlled trial evaluated the safety and efficacy of weight maintenance counseling combined with either placebo or the cannabinoid-1 receptor inverse agonist, taranabant, for sustaining prior weight loss achieved on a low-calorie diet (LCD). Seven hundred eighty-four individuals who had lost ≥ 6% of body weight during six initial weeks of treatment with an 800 kcal/day liquid LCD were randomly assigned to placebo or once-daily taranabant in doses of 0.5, 1, or 2 mg. All participants were provided monthly, on-site behavioral weight maintenance counseling, as well as monthly phone calls. The primary end point was change in body weight from randomization to week 52. The randomized participants lost an average of 9.6 kg (9.5% of initial weight) during the 6-week LCD. The model-adjusted mean change in body weight during the subsequent 1 year was +1.7 kg for placebo, compared with -0.1, -0.6, and -1.2 kg for the taranabant 0.5, 1, and 2 mg doses, respectively (all P values ≤ 0.007 vs. placebo). The incidences of psychiatric-related adverse events, including irritability, were higher for taranabant 1 and 2 mg vs. placebo (P ≤ 0.038). In addition to reporting data on the safety and efficacy of taranabant, this study provides a method for studying the combination of lifestyle modification and pharmacotherapy for weight maintenance after diet-induced weight loss.
Wadden
Thomas A
TA
University of Pennsylvania School of Medicine, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, Pennsylvania, USA. wadden@mail.med.upenn.edu
Fujioka
Ken
K
Toubro
Soren
S
Gantz
Ira
I
Erondu
Ngozi E
NE
Chen
Menghui
M
Suryawanshi
Shailaja
S
Carofano
Wendy
W
Johnson-Levonas
Amy O
AO
Shapiro
Deborah R
DR
Kaufman
Keith D
KD
Heymsfield
Steven B
SB
Amatruda
John M
JM
D000328:Adult; D000577:Amides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003376:Counseling; D004038:Diet, Reducing; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy / Q000628:therapy*; D011725:Pyridines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D043884:Receptor, Cannabinoid, CB1 / Q000037:antagonists & inhibitors; D015431:Weight Loss / Q000187:drug effects*
D000577:Amides; D019440:Anti-Obesity Agents; D011725:Pyridines; D043884:Receptor, Cannabinoid, CB1; C521311:N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide