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Open Access 01-12-2022 | Duloxetine | Protocol

Tolerability of duloxetine in elderly and in non-elderly adults: a protocol of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials

Authors: Jean-Charles Roy, Chloé Rousseau, Alexis Jutel, Florian Naudet, Gabriel Robert

Published in: Systematic Reviews | Issue 1/2022

Abstract

Background

Duloxetine is an antidepressant that benefits from a wide range of approval in the elderly population, while its safety for use compared to non-elderly is not clearly assessed. This protocol outlines a systematic review and individual participant data meta-analysis comparing the tolerability of duloxetine between elderly and non-elderly.

Methods

Searches will be conducted in PubMed, ClinicalTrials.gov, Clinicaltrialsregister.eu, data sharing platforms, FDA drug approval packages, European public assessment reports and withdrawn applications from the EMA website. The review will be performed on studies available in electronic databases from their date of inception to the 31 March 2022. Only randomized controlled clinical trials, comparing duloxetine to placebo, will be included in this meta-analysis. The studies will be selected if they comprise both elderly and non-elderly adults, in conditions of use of duloxetine approved by the European Medical Agency (EMA) and the Food and Drug Administration (FDA). The primary outcome will be the rate ratio of serious adverse events under duloxetine compared to placebo, between participants at least 65 years old and non-elderly. Second, the number of any adverse events, clinical efficacy and quality of life will be compared between elderly and non-elderly under both interventions. The quality of evidence in the tolerability of duloxetine will be assessed using the GRADE system. A one or two-stage individual participant data random effect meta-analysis will be conducted depending on the availability of the data.

Discussion

This meta-analysis will investigate the tolerability safety of duloxetine in the elderly population across all conditions approved by European and American regulatory authorities. The results from this meta-analysis are intended to help prescribers to provide better care for the elderly population.

Systematic review registration

The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019130488).

Available only for authorised users

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Title: Tolerability of duloxetine in elderly and in non-elderly adults: a protocol of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials
Authors: Jean-Charles Roy
Chloé Rousseau
Alexis Jutel
Florian Naudet
Gabriel Robert
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Duloxetine
Published in: Systematic Reviews / Issue 1/2022
Electronic ISSN: 2046-4053
DOI: https://doi.org/10.1186/s13643-022-01945-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Tolerability of duloxetine in elderly and in non-elderly adults: a protocol of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials

Abstract

Background

Methods

Discussion

Systematic review registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Systematic review registration

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