Tolerability aspects in duloxetine-treated patients with depression: should one use a lower starting dose in clinical practice?

Abstract

Objective: This study questions whether a lower starting dose of duloxetine (DLX) could be beneficial for patients with depression, in terms of tolerability and safety in routine clinical care.

Research design and methods: Post-hoc analyses of a multicenter, prospective, non-interventional, 6-month study in adult outpatients with a depressive episode was undertaken.

Main outcome measures: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), discontinuations due to TEAEs and hospitalizations due to depression, were all documented at 2 weeks, 4 weeks, 3 months and 6 months after treatment initiation/switch to DLX.

Results: Of 4517 patients enrolled, 4313 were included for TEAE evaluation. TEAEs occurred in 17.2% of patients, and SAEs occurred in 0.79% of patients, including one case of suicidal ideation. 1404 patients discontinued within 6 months (TEAEs: n = 119). Starting treatment with 30 mg/day DLX (72.7%) was favored in females, or after inadequate efficacy of previous antidepressant treatment; 60 mg/day DLX was favored in more severe depression and patients receiving concomitant pain medication.

Conclusion: Initiating treatment with 60 mg/day DLX was not associated with poorer tolerability in this study. Physicians may be guided by their clinical experience to carefully consider the individual benefit/risk ratio and TEAE susceptibility when deciding to start treatment with a higher or a lower dose of DLX.

Keywords::

• depression
• dosing
• duloxetine
• non-interventional study
• safety
• tolerability

Acknowledgements

This project was based on data from the PADRE study (Painful Physical Symptoms in Depressed Patients: Relation to Treatment Outcomes in Clinical Practice) which was supported by Lilly Deutschland GmbH, Germany and Boehringer Ingelheim Pharma GmbH & Co. KG, Germany. We would like to thank all investigators and patients who participated in this study. The sponsor was involved in study design, in the collection, analysis, and interpretation of data, in the writing of the manuscript and in the decision to submit the paper for publication. Previous data presentation: Wilhelm S, Hegerl U, Linden M, et al. Tolerability and safety of Duloxetine in a population of depressed patients with painful physical symptoms: Results of a 6-month naturalistic study [abstract no. 179]. Pharmacopsychiatry 2009 Oct;42 Suppl. 247. Poster presented at the 26^nd Congress of the “Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP)”; 2009 October 07–10; Munich.

Notes

This box summarises key points contained in the article.