Meal replacement therapy followed by treatment with topiramate did not result in significant changes in BMI among adolescents with severe obesity, according to results from a pilot study presented at ObesityWeek 2016.
Muna Sunni, MBBCh, MS, and colleagues conducted a double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for BMI reduction in adolescents with severe obesity (BMI ≥ 35 kg/m2).
Study participants (n=30; mean age: 15.2±1.7 years; mean BMI 40.3±4.6 kg/m2; 63% girls) completed 4 weeks of meal replacement therapy, consuming 1400 kcal/day, and were randomly assigned 1:1 to receive either 24 weeks of topiramate 75 mg/d or placebo. All participants underwent lifestyle modification therapy throughout the course of the study. Twenty-one of the 30 participants completed the study.
Researchers found no statistically significant difference in mean percent change in BMI between the topiramate and placebo groups (–1.9% [95% CI, -5.2%-1.5%]; P =.29), but found a significant improvement in visceral fat and VLDL cholesterol in the topiramate group (–165 g [95% CI, –310 to –20]; P =.03 and –9.4 mg/dL [95% CI, -17.8, -1.0]; P =.04, respectively).
While there were no changes of concern in motor speed, memory, attention, or executive function, 31% of participants in the topiramate group reported experiencing paresthesia.
“In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared to meal replacement therapy alone did not result in a statistically significant BMI reduction,” the researchers concluded. “Since higher doses of topiramate have been associated with better weight loss in adults, studies using higher doses for adolescents with severe obesity may be warranted.”
- Kelly A, Fox C, Kaizer A, et al. Meal-replacement therapy followed by topiramate for BMI reduction in adolescents with severe obesity: a pilot randomized placebo-controlled trial. Abstract T-OR-2084. Presented at: ObesityWeek 2016; October 31-November 4, 2016; New Orleans, LA.