Systematic Review of Gender Bias in the Clinical Trials of New Long-Acting Antipsychotic Drugs
| Autor: | María Santos-Casado, Adela García-Avello |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty medicine.drug_class medicine.medical_treatment Sexism Population Aripiprazole Atypical antipsychotic Paliperidone Palmitate medicine Humans Pharmacology (medical) Paliperidone Psychiatry education Antipsychotic Clinical Trials as Topic education.field_of_study Risperidone business.industry Clinical trial Psychiatry and Mental health Delayed-Action Preparations Inclusion and exclusion criteria Schizophrenia Female business Antipsychotic Agents medicine.drug |
| Zdroj: | Journal of Clinical Psychopharmacology. 39:264-272 |
| ISSN: | 1533-712X 0271-0749 |
| Popis: | Purpose/background This article evaluates gender bias in the published clinical trials of new long-acting antipsychotics. Methods/procedures We conducted a review of controlled clinical trials of the new prolonged-release antipsychotics (aripiprazole, risperidone, or paliperidone) for the treatment of schizophrenia published in MEDLINE over the last 10 years and available in full text in English. The study followed the corresponding international recommendations. Results We identified 132 trials, and of these, 40 met the inclusion and exclusion criteria. We found that only 36.41% of the total patients were women. The separate analysis of the main variable between the subpopulations of men and women was carried out in only 6 of the 40 works included. In contrast, in 15 trials, this analysis was performed on secondary variables, generally related to safety. Only 3 of the 40 trials discussed the results separately according to sex. Conclusions The clinical trials of long-acting atypical antipsychotic drugs show a far-from-negligible gender bias. Women are underrepresented, and the main and secondary variables are not analyzed separately according to gender. This is despite international recommendations establishing these criteria as part of a package of minimum requirements for meeting scientific validity and making results apt to extrapolate to the general population of patients. |
| Databáze: | OpenAIRE |
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