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 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...
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| Format: | Article |
| Language: | English |
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BMC
2022-04-01
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| Series: | Systematic Reviews |
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| Online Access: | https://doi.org/10.1186/s13643-022-01945-0 |
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| author | Jean-Charles Roy Chloé Rousseau Alexis Jutel Florian Naudet Gabriel Robert |
| author_facet | Jean-Charles Roy Chloé Rousseau Alexis Jutel Florian Naudet Gabriel Robert |
| author_sort | Jean-Charles Roy |
| collection | DOAJ |
| description | 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, Clinicaltrialsregister.eu, data sharing platforms, FDA drug approval packages, European public assessment reports and withdrawn applications from the EMA website.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 ). |
| first_indexed | 2024-12-10T11:03:16Z |
| format | Article |
| id | doaj.art-0f8d0ce442e8499ab5c49e2d6094920f |
| institution | Directory Open Access Journal |
| issn | 2046-4053 |
| language | English |
| last_indexed | 2024-12-10T11:03:16Z |
| publishDate | 2022-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Systematic Reviews |
| spelling | doaj.art-0f8d0ce442e8499ab5c49e2d6094920f2022-12-22T01:51:38ZengBMCSystematic Reviews2046-40532022-04-011111710.1186/s13643-022-01945-0Tolerability 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 trialsJean-Charles Roy0Chloé Rousseau1Alexis Jutel2Florian Naudet3Gabriel Robert4Adult Psychiatry Department, Rennes University HospitalClinical Investigation Center INSERM 1414, Department of Clinical Pharmacology, Rennes University HospitalAdult Psychiatry Department, Rennes University HospitalAdult Psychiatry Department, Rennes University HospitalAdult Psychiatry Department, Rennes University HospitalAbstract 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 ).https://doi.org/10.1186/s13643-022-01945-0Psychiatry, GeriatricMeta-analysisDrug safetyDuloxetine hydrochloride |
| spellingShingle | Jean-Charles Roy Chloé Rousseau Alexis Jutel Florian Naudet Gabriel Robert 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 Systematic Reviews Psychiatry, Geriatric Meta-analysis Drug safety Duloxetine hydrochloride |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Psychiatry, Geriatric Meta-analysis Drug safety Duloxetine hydrochloride |
| url | https://doi.org/10.1186/s13643-022-01945-0 |
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