Gender differences in drug responses

Franconi, Flavia; Brunelleschi, Sandra; Steardo, Luca; Cuomo, V.

doi:10.1016/j.phrs.2006.11.001

Cited by 373 publications

(313 citation statements)

References 225 publications

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“…In the second, Zhang et al (2007) demonstrated that early exposure to high doses of dextromethorphan significantly disrupted male rats' performance in a water maze but not the performance of females. Many other examples of sex differences in the effects of drugs, both quantitative and qualitative, are available (see, e.g., reviews by Franconi, Brunelleschi, Steardo, and Cuomo 2007;Schwartz 2007). The findings of these studies are sufficiently robust that the National Institute on Drug Abuse concluded in 2007 that Bstudies of drug abuse should routinely address gender issues^ (Heading 2008, p. 428) and published a 276-page reporting dealing with the topic (Volkow 2005(Volkow -2008.…”

Section: Discussionmentioning

confidence: 99%

JEAB Research Over Time: Species Used, Experimental Designs, Statistical Analyses, and Sex of Subjects

2015

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We examined the species used as subjects in every article published in the Journal of the Experimental Analysis of Behavior (JEAB) from 1958 through 2013. We also determined the sex of subjects in every article with human subjects (N=524) and in an equal number of randomly selected articles with nonhuman subjects, as well as the general type of experimental designs used. Finally, the percentage of articles reporting an inferential statistic was determined at 5-year intervals. In all, 35,317 subjects were studied in 3,084 articles; pigeons ranked first and humans second in number used. Within-subject experimental designs were more popular than between-subjects designs regardless of whether human or nonhuman subjects were studied but were used in a higher percentage of articles with nonhumans (75.4 %) than in articles with humans (68.2 %). The percentage of articles reporting an inferential statistic has increased over time, and more than half of the articles published in 2005 and 2010 reported one. Researchers who publish in JEAB frequently depart from Skinner's preferred research strategy, but it is not clear whether such departures are harmful. Finally, the sex of subjects was not reported in a sizable percentage of articles with both human and nonhuman subjects. This is an unfortunate oversight.

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Section: Discussionmentioning

confidence: 99%

JEAB Research Over Time: Species Used, Experimental Designs, Statistical Analyses, and Sex of Subjects

2015

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“…Compared to men, women in general have lower body weight, slower gastrointestinal motility, and slower glomerular filtration rates 3. These physiologic gender differences need to be considered when evaluating the PK of drugs, including AEDs.…”

Section: Discussionmentioning

confidence: 99%

Perampanel efficacy and safety by gender: Subanalysis of phase III randomized clinical studies in subjects with partial seizures

et al. 2015

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SummaryThe antiepileptic drug (AED) perampanel is approved in ≥40 countries as adjunctive therapy for drug‐resistant partial seizures in patients with epilepsy. This post hoc analysis of pooled data from three phase III, double‐blind, randomized studies of perampanel examines between‐gender differences in perampanel efficacy and safety. Of the 1,478 subjects in the pooled analysis (719 male, 759 female), 1,109 were included in the pharmacokinetic/pharmacodynamic analysis. Perampanel oral clearance was 17% lower in female than in male patients not receiving enzyme‐inducing AEDs. Pooled efficacy analysis revealed that seizure frequency was reduced with perampanel treatment regardless of gender; a greater numerical reduction in seizure frequency and increased responder rates occurred in female participants at perampanel doses of 4, 8, and 12 mg. Tolerability was similar between groups, although common adverse events such as dizziness and headache occurred more frequently in female subjects. Modest elevations in perampanel exposure in female patients may result in meaningful between‐gender differences in efficacy and safety; therefore, dosing should be individualized and clinical response monitored.

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“…In her comments Flavia Franconi ([27], see also [28,29]) pointed to sex dependent programming. She further emphasized the following issues:…”

Section: Animal Modelsmentioning

confidence: 99%

Gender perspectives in European research

Klinge

2008

Pharmacological Research

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a b s t r a c tBackground: Attention to sex and gender aspects in biomedical and health-related research has been a major initiative of the EU gender equality policy for research. The EU funded GenderBasic project (2005)(2006)(2007)(2008), conceived to stimulate this attention to sex and gender and to provide practical tools to researchers, resulted in the publication of 10 reviews by high-level scientists in a Supplement to Gender Medicine in December 2007: "Bringing Gender Expertise to Biomedical and Health-Related Research". Methods: Four commissioned reviews covered methodological aspects of addressing sex and gender in biomedical research -ranging from basic, molecular to public health research -next to six reviews that addressed sex and gender aspects relevant to selected health areas: anxiety disorders, asthma, metabolic syndrome, nutrigenomics, osteoporosis and work-related health. Results: The review articles, that were discussed at an expert meeting, attended -upon invitation -by a mixed audience of basic and clinical researchers, epidemiologists, social scientists and gender researchers, came up with excellent state of the art data, solutions to methodological and conceptual problems, practical tools and interesting questions for further research. Conclusion:The expert meeting created great enthusiasm among the participants and a real exchange took place among researchers from various backgrounds. Most life sciences researchers were familiar with the concept of sex differences but confessed that the effects of socially constructed gender until now, had received too little attention.The GenderBasic project yielded three major achievements for European research: (1) it stimulated and promoted research into sex differences; (2) it stimulated research into the workings of gender, illustrated by useful examples in particular in understanding masculinity and its effects on the health of individual men; (3) it highlighted sex-gender interaction and granted gender a prominent place on the research agenda that resulted from GenderBasic. A final conclusion of the project was that it is not differences per se that are interesting but rather how, as a result of the interaction between sex and gender, differences develop.The European Commission selected the GenderBasic project itself as an excellent example of the positive impacts EU research can achieve and the project will be featured in a catalogue of 6th Framework Success Stories.

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Gender differences in drug responses

Cited by 373 publications

References 225 publications

JEAB Research Over Time: Species Used, Experimental Designs, Statistical Analyses, and Sex of Subjects

JEAB Research Over Time: Species Used, Experimental Designs, Statistical Analyses, and Sex of Subjects

Perampanel efficacy and safety by gender: Subanalysis of phase III randomized clinical studies in subjects with partial seizures

Gender perspectives in European research

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