Table 4.

Recommendations for Future Cardiovascular Trials in Women

Include equal representation of women and men unless adequately justified

Limit exclusion criteria and remove upper age limit to improve the generalizability of results and the projection of effectiveness in clinical practice

Women-only trials should be limited to the study of conditions unique to or predominate in women

Cardiovascular end points should include the scope of outcomes significant for women, including all acute coronary syndromes, fatal coronary heart disease, stroke (thromboembolic and hemorrhagic), and heart failure

Quality-of-life measures should be part of outcomes evaluated by gender

Gender-specific analyses should be conducted and published for both efficacy and safety

Reasons for nonadherence to interventions should be documented according to gender

Cost-effectiveness analysis should be conducted and gender-specific data published

Gender-specific power calculations should be conducted and published

Dissemination of results should include communication regarding any significant gender differences in efficacy and adverse effects