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Risk of Depressive Episodes with Rimonabant

A Before and After Modified Prescription Event Monitoring Study Conducted in England

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Abstract

Background: Marketing authorization for rimonabant was withdrawn in October 2008, mainly because the psychiatric adverse effects could not be addressed by further risk minimization.

Objective: The aim of the study was to compare the risk of major and minor depressive episodes in the 6 months prior to and the 6 months after starting treatment with rimonabant.

Methods: We conducted a before and after study using the observational cohort technique of Modified Prescription Event Monitoring to compare the risk of major and minor depressive episodes in new users of rimonabant reported in the 6 months before to the 6 months after starting treatment with rimonabant. Patients were identified from dispensed prescriptions issued by primary care physicians from June 2006 to October 2008. Patient demographics and information on depressive episodes were requested 6 months after the date of the first prescription for each patient. Risk ratios (RR) were calculated by comparing before and after events using a matched analysis.

Results: The cohort comprised 10011 patients. The number of patients who had major depressive episodes before and after starting treatment were 147 and 168, respectively (RR 1.14; 95% CI 0.94, 1.39) and the number of patients who had minor depressive episodes were 825 and 829, respectively (RR 1.00; 95% CI 0.93, 1.10). For patients who had a previous history of psychiatric illness (n= 1132), 91 and 73, respectively, experienced major depressive episodes (RR 0.80; 95% CI 0.62,1.03), and 367 and 220, respectively, experienced minor depressive episodes (RR 0.59; 95% CI 0.53, 0.68). For patients without a previous history of psychiatric illness (n = 8879), 56 and 95, respectively, experienced major depressive episodes (RR 1.7; 95% CI 1.2,2.3), and 458 and 609, respectively, experienced minor depressive episodes (RR 1.33; 95% CI 1.20, 1.48).

Conclusions: When comparing all patients in the cohort, there was no increased risk of developing a depressive episode whilst taking rimonabant. However, when considering subsets of patients with and without a previous history of psychiatric illness, the risk profiles were different. In patients without a previous history of psychiatric illness, there were more depressive episodes in the 6 months after starting treatment compared with the 6 months before starting treatment with rimonabant.

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Acknowledgements

The DSRU is an independent charity (No. 327206) and is an Associate Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth. It receives unconditional donations from pharmaceutical companies. The companies have no control on the conduct or publication of the studies conducted by the DSRU. The DSRU has received such funds from the manufacturer of rimonabant. Victoria Cornelius and Saad Shakir have received consultancy fees for work unrelated to this project. The other authors have no potential conflicts of interest to declare that are directly relevant to this study.

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Authors and Affiliations

  1. Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, UK

    Yvonne Buggy (Senior Research Fellow), Victoria Cornelius, Lynda Wilton & Saad A.W. Shakir

  2. School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK

    Yvonne Buggy (Senior Research Fellow), Victoria Cornelius, Lynda Wilton & Saad A.W. Shakir

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  1. Yvonne Buggy
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  2. Victoria Cornelius
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  4. Saad A.W. Shakir
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Correspondence to Yvonne Buggy.

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Buggy, Y., Cornelius, V., Wilton, L. et al. Risk of Depressive Episodes with Rimonabant. Drug-Safety 34, 501–509 (2011). https://doi.org/10.2165/11588510-000000000-00000

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