Prevention & lipidsMeta-analysis

Female participation, and sex-specific reporting practices, in polypill randomized controlled trials in the prevention of atherosclerotic cardiovascular disease: a secondary analysis of a systematic review

Eur J Prev CardiolPublished

  • Secondary analysis of a systematic review

Authors' conclusion

The participation of females in cardiovascular polypill trials is substantially higher in primary prevention trials as compared with trials conducted in mixed or exclusively secondary prevention populations. The use of sex-specific eligibility criteria was not linked to lower female participation. Sex-specific reporting is sparsely conducted, although most frequent in larger trials.

Study context

Population
Polypill RCTs for prevention of atherosclerotic cardiovascular disease (CVD)
Participants
26 trials
Comparison
Primary prevention trials vs Mixed or secondary prevention trials
  • Primary prevention trialsn = 18
  • Mixed or secondary prevention trialsn = 8
Outcome
Female participation and sex-specific analyses and reporting

Pooled result

As reported in the abstract

Proportion of female participants
Overall female participants
42%
Female participation range across trials
10% to 73%

Further pooled results

Female participation by sex-specific exclusion criteria

Trials trials that excluded groups of females 12 · trials without explicit exclusion criteria 13

Sex-stratified analyses reported

Trials reporting sex-stratified analyses (9 of 26)
35%
Share of all participants in those trials
70%
Trials finding some evidence of possible sex differences (larger BP effects in females)
2
Trials with sex considerations in the discussion
4

Original publication

Female participation, and sex-specific reporting practices, in polypill randomized controlled trials in the prevention of atherosclerotic cardiovascular disease: a secondary analysis of a systematic review. Eur J Prev Cardiol. Published 20 September 2024. doi:10.1093/eurjpc/zwae307

Summarised from the published abstract; every number is checked against it