Women's health and gender-based clinical trials on etoricoxib: methodological gender bias.
BACKGROUND
The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics.


METHODS
The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007).


RESULTS
Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors.
Chilet-Rosell
E
E
Preventive Medicine and Public Health Unit, University of Alicante, 03080 Alicante, Spain. elisa.chilet@ua.es
Ruiz-Cantero
M T
MT
Horga
J F
JF
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D017321:Clinical Trials, Phase I as Topic; D003270:Contraceptive Agents; D000075202:Contraindications; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004347:Drug Interactions; D000077613:Etoricoxib; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D020249:Hormone Replacement Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011725:Pyridines / Q000627:therapeutic use*; D012727:Sex Characteristics; D017678:Sex Distribution; D013450:Sulfones / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health; D055815:Young Adult
D003270:Contraceptive Agents; D052246:Cyclooxygenase 2 Inhibitors; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib