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Tolerability and Safety of the New Anti-Obesity Medications

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Abstract

Worldwide obesity prevalence has nearly doubled since 1980. Due to numerous co-morbidities, obesity represents a serious health and socioeconomic problem worldwide. Pharmacotherapy should be an integral part of comprehensive obesity management. Drug therapy can assist in weight loss and its maintenance in those individuals who do not achieve appropriate weight loss through lifestyle interventions alone. After the withdrawal of sibutramine from the market in 2010, orlistat, a lipase inhibitor, was the only remaining prescription drug approved for the long-term treatment of obesity. In 2012, phentermine/topiramate extended-release (PHEN/TPM ER) combination and lorcaserin were approved by the US FDA as novel medications for long-term weight management. Three major phase III trials conducted with each drug confirmed their efficacy in terms of weight loss/maintenance and improvement of cardiometabolic risks. No head-to-head studies between the two new anti-obesity drugs have been carried out. However, in the existing studies PHEN/TPM ER had a superior weight loss profile to lorcaserin but the incidence of adverse effects was lower with lorcaserin. Both drugs were well-tolerated, and adverse events were modest in intensity, dose dependent, rather rare, and tended to decrease with the duration of treatment. Major safety concerns regarding PHEN/TPM ER include elevations in resting pulse rate, teratogenicity, mild metabolic acidosis, and psychiatric and cognitive adverse events. Valvulopathy, cognitive impairment, psychiatric disorders, and hypoglycemia represent major safety concerns for lorcaserin. Although existing trials have not demonstrated any significant issues with PHEN/TPM ER-induced heart rate elevation and lorcaserin-induced valvulopathy, all safety concerns should be seriously taken into account in patients treated with either of these novel anti-obesity medications.

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Acknowledgments

The manuscript was supported by the project of the Ministry of Health (Czech Republic) for conceptual development of research organization 00023761 (Institute of Endocrinology, Prague, Czech Republic) and by the program of the Charles University in Prague PRVOUK P31.

Conflict of interest

Vojtech Hainer and Irena Aldhoon Hainerová have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Obesity Management Center, Institute of Endocrinology, Národní 8, 116 94, Prague 1, Czech Republic

    Vojtech Hainer & Irena Aldhoon-Hainerová

  2. Department of Pediatrics and Center for Research of Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic

    Irena Aldhoon-Hainerová

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  1. Vojtech Hainer
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  2. Irena Aldhoon-Hainerová
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Correspondence to Vojtech Hainer.

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Hainer, V., Aldhoon-Hainerová, I. Tolerability and Safety of the New Anti-Obesity Medications. Drug Saf 37, 693–702 (2014). https://doi.org/10.1007/s40264-014-0206-3

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