Sibutramine, an appetite suppressant, and topiramate, an anticonvulsant that can reduce food cravings, have been used individually to support weight loss. In some clinical settings, physicians have prescribed them together, but evidence regarding their combined safety and efficacy has been sparse. The SIBAMATE retrospective cohort study, led by Dr. Cintia Cercato and colleagues from the University of São Paulo Medical School Hospital, aimed to address this gap.
The team reviewed records of 246 adults treated between 2012 and 2022 at the hospital’s Obesity Unit. Eligible participants were at least 18 years old and either had a body mass index (BMI) over 30 kg/m² or a BMI above 27 kg/m² with a related condition such as type 2 diabetes, high blood pressure, or abnormal lipid levels. Women made up the majority of the group (86.2%), with an average age of 42.8 years. At baseline, the mean BMI was 39.7 and the average weight was 104.2 kg. Most patients also received guidance on a calorie-restricted diet and regular exercise, supported by a multidisciplinary team of endocrinologists and nutritionists.
Patients were prescribed daily doses averaging 11 mg of sibutramine and about 120 mg of topiramate. After three months, the results were striking:
- 61.8% of participants lost at least 5% of their starting weight.
- 29.4% achieved more than 10% weight loss.
- 10.9% shed over 15% of their initial weight.
- At 36 months, 64% maintained at least a 5% weight loss.
- 40.6% maintained a loss of 10% or more.
- 26.5% continued to exceed 15% weight loss.
- Reported side effects included tingling sensations, memory issues, slowed thinking, and elevated blood pressure.
- No major safety concerns were identified during an average follow-up of just over two years.
- Approximately one-quarter of participants discontinued treatment.
The investigators concluded that this drug combination can provide meaningful, lasting weight reduction in a real-world setting, particularly in regions where affordability is crucial. They suggested that a daily regimen of roughly 10 mg of sibutramine and 100 mg of topiramate was most common in their clinic.
However, the authors cautioned that their single-center, retrospective design limits broader generalization, especially since most participants were relatively young women and the study lacked a control group. Despite these limitations, the findings highlight a practical therapeutic option for carefully selected patients while newer obesity treatments continue to emerge.
Reference:
Cercato, C., Stumpf, M.A.M., da Cunha Freire, G.N. et al. Combination of sibutramine and topiramate for the treatment of obesity: the SIBAMATE retrospective cohort study. Diabetol Metab Syndr 17, 289 (2025). https://doi.org/10.1186/s13098-025-01842-1
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