BIRMINGHAM, AL — David B. Allison, Ph.D., distinguished professor and associate dean for science in the School of Public Health and lead investigator for the study, helped design and analyze the results of the 56-week, randomized, controlled trial. Allison, along with W. Timothy Garvey, M.D., chair of the UAB Department of Nutrition Sciences, evaluated the safety and efficacy of the controlled-release of topiramate and phentermine for weight-loss and metabolic improvements. The results were published online Nov. 3, 2011, by the journal Obesity.
“We found that in terms of total efficacy, this combination gives better results than have been reported for any drug on the market right now. There are currently two FDA-approved, weight-loss drugs, and this combination is far more effective than those have been reported to be,” explains Allison.
The study enrolled 1,267 severely obese men and women whose initial body mass index put them in the category of class II and class III obesity, as defined by the International Classifications according to BMI.
Participants were given two different amounts of the drug combination or placebo. Those given the higher dose lost 14.4 percent of initial body weight and experienced improvements in blood pressure and cholesterol levels.
The most common adverse effects were tingling on the skin, dry mouth, constipation, a change in taste and insomnia. Study limits included an overrepresentation of women (83 percent), with the authors noting further studies with larger groups of men may be more informative.
Allison has served as a paid consultant for the drug manufacturer of the phentermine and topiramate combination, VIVUS, Inc. Garvey received research support from VIVUS, has served on advisory boards for VIVUS and also holds stock in VIVUS.