Atomoxetine for weight reduction in obese women: a preliminary randomised controlled trial

International Journal of Obesity (2006) 30, 11381142

& 2006 Nature Publishing Group All rights reserved 0307-0565/06 $30.00www.nature.com/ijoORIGINAL ARTICLEAtomoxetine for weight reduction in obese women:

a preliminary randomised controlled trialKM Gadde1, GM Yonish1, HR Wagner II1, MS Foust1 and DB Allison21Obesity Clinical Trials Programme, Duke University Medical Centre, Durham, NC, USA and 2Department of Biostatistics

and Clinical Nutrition Research Centre, University of Alabama at Birmingham, Birmingham, AL, USABackground and objective: Atomoxetine is a potent central norepinephrine uptake inhibitor, currently marketed for treatment

of attention-deficit/hyperactivity disorder (ADHD). With the understanding that noradrenergic agents could be useful in

assisting obese individuals to lose weight, we conducted this preliminary study to evaluate short-term efficacy and safety of

atomoxetine in obese adults.Design: At 12-week randomised, double-blind, placebo-controlled trial, conducted at Duke University Medical Centre, USA,

from May 2004 to December 2004.Participants: A total of 30 obese women (mean (s.e.) body mass index of 36.1 (0.6) kg/m2).

Interventions: Participants were randomly assigned to receive atomoxetine (n 15) or placebo (n 15). All participants were

advised to follow a balanced hypocaloric diet (500 kcal/day deficit). Atomoxetine therapy was started at 25 mg/day orally, with

gradual increase to 100 mg/day over 1 week. Placebo dosing was identical.Measurements: Body weight in kilograms was the primary outcome measure. Other measurements included waist

circumference, blood pressure and heart rate, fasting plasma glucose and lipids, and depressive symptoms.Results: Last-observation-carried-forward analysis of the available data for participants who had completed at least one

post-randomisation assessment, demonstrated that the atomoxetine group (n 12) lost more body weight over the 12-week

period than the placebo (n 14) group (mean (s.e.) 3.6 (1.0) kg (3.7% loss) vs 0.1 (0.4) kg (0.2% gain); F4,96 11.9;

Po0.0001). Three participants in the atomoxetine group and none in the placebo group lost X5% weight. Side effects

were minimal.Conclusion: Atomoxetine demonstrated modest short-term weight loss efficacy relative to placebo in this preliminary study

of obese women.International Journal of Obesity (2006) 30, 11381142. doi:10.1038/sj.ijo.0803223; published online 17 January 2006Keywords: antiobesity drugs; atomoxetine; weight loss; treatment; pharmacotherapyIntroductionModest weight loss can reduce health risks associated withobesity.1 Pharmacotherapy is a recommended treatmentoption for individuals with a body mass index (BMI) of atleast 30, or 27 kg/m2 when obesity-related illnesses or riskssuch as type 2 diabetes are present.2 Antiobesity drugs havebeen...