Gender analysis of moxifloxacin clinical trials

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Title: Gender analysis of moxifloxacin clinical trials
Authors: Chilet Rosell, Elisa | Ruiz-Cantero, María Teresa | Pardo López, María Ángeles
Research Group/s: Salud Pública
Center, Department or Service: Universidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Ciencia
Keywords: Gender | Women | Health | Moxifloxacin | Clinical trials
Knowledge Area: Medicina Preventiva y Salud Pública
Issue Date: 1-Nov-2013
Publisher: Mary Ann Liebert
Citation: Elisa Chilet-Rosell, Ma Teresa Ruiz-Cantero, and Ma Angeles Pardo. Journal of Women's Health. Online Ahead of Print: November 1, 2013. doi:10.1089/jwh.2012.4171
Abstract: Purpose: To determine the inclusion of women and the sex-stratification of results in moxifloxacin Clinical Trials (CTs), and to establish whether these CTs considered issues that specifically affect women, such as pregnancy and use of hormonal therapies. Previous publications about women’s inclusion in CTs have not specifically studied therapeutic drugs. Although this type of drug is taken by men and women at a similar rate, adverse effects occur more frequently in the latter. Methods: We reviewed 158 published moxifloxacin trials on humans, retrieved from MedLine and the Cochrane Library (1998–2010), to determine whether they complied with the gender recommendations published by U.S. Food and Drug Administration Guideline. Results: Of a total of 80,417 subjects included in the moxifloxacin CTs, only 33.7% were women in phase I, in contrast to phase II, where women accounted for 45%, phase III, where they represented 38.3% and phase IV, where 51.3% were women. About 40.9% (n = 52) of trials were stratified by sex and 15.3% (n = 13) and 9% (n = 7) provided data by sex on efficacy and adverse effects, respectively. We found little information about the influence of issues that specifically affect women. Only 3 of the 59 journals that published the moxifloxacin CTs stated that authors should stratify their results by sex. Conclusions: Women are under-represented in the published moxifloxacin trials, and this trend is more marked in phase I, as they comprise a higher proportion in the other phases. Data by sex on efficacy and adverse effects are scarce in moxifloxacin trials. These facts, together with the lack of data on women-specific issues, suggest that the therapeutic drug moxifloxacin is only a partially evidence-based medicine.
ISSN: 1540-9996 (Print) | 1931-843X (Online)
DOI: 10.1089/jwh.2012.4171
Language: eng
Type: info:eu-repo/semantics/article
Rights: This is a copy of an article published in the Journal of Women's Health © 2013 Mary Ann Liebert, Inc.; Journal of Women's Health is available online at:
Peer Review: si
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