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Metabolic parameters in the short- and long-term treatment of schizophrenia with sertindole or risperidone

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Abstract

The presence of the metabolic syndrome is an important risk factor for cardiovascular disease and diabetes. The short- and long-term metabolic safety of sertindole was compared to that of risperidone in a subset of patients enrolled in the sertindole cohort prospective (SCoP) study, an open randomized study. In 261 randomized patients, there were moderate increases in mean weight, BMI, and waist circumference during treatment with either sertindole or risperidone; after 12 weeks, the increase in weight was 1.3 and 1.1 kg, respectively, and after 36 weeks, it was 2.2 and 2.0 kg, respectively. From baseline to last assessment (up to 60 weeks), weight gains of 1.8 and 1.7 kg for sertindole and risperidone, respectively, were observed. Similar proportions of patients (sertindole: 17% versus risperidone: 16%) had weight increases ≥7% from baseline to last assessment. The mean changes from baseline in triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, plasma glucose and blood pressure were small and not clinically relevant in both treatment groups. No patient in either of the groups developed type 2 diabetes during the study. At last assessment, the prevalence of metabolic syndrome (International Diabetes Federation) was 17% in the sertindole group and 26% in the risperidone group and the incidence of metabolic syndrome was 7% in the sertindole group and 10% in the risperidone group. Treatment with either sertindole or risperidone did not appear to be associated with an increased comparative risk of developing metabolic syndrome. In general, the metabolic effects of sertindole and risperidone were similar.

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Acknowledgments

The authors would like to thank the clinicians who collected the data and the patients who participated in the clinical trial.

Funding source

H Lundbeck A/S was the sponsor of this trial. This trial has been registered in a database available free of charge at: http://www.lundbecktrials.com/.

Clinical trial registration

Safety Study of Sertindole versus Risperidone under Normal Conditions of Use. NCT 00856583 (EudraCT 2004-000213-19) http://clinicaltrials.gov/ct2/results?term=00856583.

Conflict of interest

M. De Hert has been a consultant for, received grant/research support and honoraria from, and been on the speakers/advisory boards of Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Janssen-Cilag, Lundbeck, Pfizer, and Sanofi-Aventis. M. De Hert did not receive a financial compensation for writing the article. A. Mittoux and Y. He are employees of H. Lundbeck A/S, Copenhagen, Denmark. J Peuskens was the principle investigator of the SCoP study and has acted as a consultant and co-operated in clinical trials with AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen-Cilag, Lundbeck, Pfizer, Sanofi Synthélabo. He has also received research grants from AstraZeneca, Janssen-Cilag, Eli Lilly, Lundbeck, and Sanofi-Aventis.

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Authors and Affiliations

  1. University Psychiatric Center Catholic University Leuven, UPC KUL campus Kortenberg, Leuvensesteenweg 517, 3070, Kortenberg, Belgium

    Marc De Hert & Joseph Peuskens

  2. H. Lundbeck A/S, Ottiliavej 9, Valby, Copenhagen, Denmark

    Aurélia Mittoux & Yuan He

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  1. Marc De Hert
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  2. Aurélia Mittoux
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  3. Yuan He
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Correspondence to Marc De Hert.

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De Hert, M., Mittoux, A., He, Y. et al. Metabolic parameters in the short- and long-term treatment of schizophrenia with sertindole or risperidone. Eur Arch Psychiatry Clin Neurosci 261, 231–239 (2011). https://doi.org/10.1007/s00406-010-0142-x

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