Table 1: Women’s Benefit in Randomised Controlled Trials Dedicated to Prevention for Different Class of Drugs.
| Trial | Total Population, Women Enrolled, n (%) | Primary Endpoint | CV Death | Selected Major Secondary Outcome Benefit |
|---|---|---|---|---|
| SGLT2is | ||||
| EMPA-REG OUTCOME[3] | Total 7,020 Women 2,004 (28.5%) | CV death + non-fatal MI + non-fatal stroke HR 0.86; 95% CI [0.74–0.99]; p=0.04 for superiority RRR 14% | HR 0.62; 95% CI [0.49–0.77]; p<0.001 RRR 38% | HHF HR 0.65; 95% CI [0.50–0.85]; p=0.002 RRR 35% |
| CANVAS[4] | Total 10,142 Women 3,633 (35.8%) | CV death + non-fatal MI + non-fatal stroke: HR 0.86; 95% CI [0.75–0.97]; p=0.02 for superiority RRR 14% | HR 0.87; 95% CI [0.72–1.06]; p=not significant | HHF HR 0.67; 95% CI [0.52–0.87] RRR 23% |
| DECLARE-TIMI 58[5] | Total 17,160 Women 6,422 (37.4%) | CV death or HHF HR 0.83; 95% CI [0.73–0.85]; p=0.005 RRR 17% Co-primary efficacy endpoint: CV death + MI + ischaemic stroke HR 0.76; 95% CI [0.84–1.03]; p=0.17 (not significant) |
HR 0.98; 95% CI [0.82-1.17] p=not significant | HHF HR 0.73; 95% CI [0.61–0.88] RRR 27% |
| SCORED[9] | Total 10,584 Women 4,754 (44.9%) | CV death + HHF + urgent visit for HF HR 0.74; 95% CI [0.63–0.88]; p=0.0004 RRR 26% Co-primary endpoint: CV death + MI + stroke HR 0.84; 95% CI [0.72–0.99]; p=0.035 RRR 16% |
HR 0.90; 95% CI [0.73–1.12]; p=not significant | Total HHF + urgent visit for HF HR 0.67; 95% CI [0.55–0.82]; p<0.001 RRR 33% |
| GLP1-RA | ||||
| LEADER[12] | Total 9,340 Women 3,337 (35.7%) | CV death + non-fatal MI + non-fatal stroke HR 0.87; 95% CI [0.78–0.97]; p=0.01 for superiority RRR 13% | HR 0.78; 95% CI [0.66–0.93]; p=0.007 RRR 22% | MI HR: 0.86; 95% CI [0.73–1.00]; p=0.046 RRR 14% |
| REWIND[14] | Total 9,901 Women 4,589 (46.3%) | CV death + non-fatal MI + non-fatal stroke HR 0.88; 95% CI [0.79-0.99]; p=0.026 RRR 12% | HR 0.91; 95% CI [0.78–1.06]; p=not significant | MI HR 0.88; 95% CI [0.79–0.99]; p=0.026 RRR 12% |
| SUSTAIN-6[15] | Total 3,297 Women 1,215 (36.8%) | CV death + non-fatal MI + non-fatal stroke HR 0.74; 95% CI [0.58–0.95]; p<0.001 for non-inferiority RRR 26% | HR 0.98; 95% CI [0.65–1.48]; p=not significant | MI HR 0.74; 95% CI [0.51–1.08]; p= not significant RRR 26% |
| PCSK9i | ||||
| FOURIER[18] | Total 27,564 Women 6,769 (24.6%) | CV death + MI + stroke + hospitalisation for UA + coronary revascularisation HR 0.85; 95% CI [0.79–0.92]; p<0.001 RRR 15% | HR 1.05; 95% CI [0.88–1.25]; p=not significant | MI HR 0.73; 95% CI [0.65–0.82]; p<0.001 RRR 27% |
| ODYSSEY-OUTCOME[19] | Total 18,924 Women 4,762 (25.2%) | Coronary heart disease-death, non-fatal MI + ischaemic stroke + hospitalisation for UA HR 0.85; 95% CI [0.78–0.93]; p<0.001 RRR 15% | HR 0.88; 95% CI [0.74–1.05]; p=not significant | MI HR 0.86; 95% CI [0.77–0.96] RRR 14% |
| ORION 10 and 11[22] | Total 3,178 Women 935 (29.4%) | LDL cholesterol decrease HR 0.50; p<0.01 for superiority RRR 49.9 % | NA* | NA* |
| Icosapent Ethyl | ||||
| REDUCE-IT[23] | Total 8,179 Women 2,357 (28.8%) | CV death + non-fatal MI + non-fatal stroke + UA + coronary revascularisation HR 0.75; 95% CI [0.68–0.83]; p<0.001 RRR 25% | HR 0.80; 95% CI [0.66–0.98]; p=0.03 RRR 20% | MI HR 0.69; 95% CI [0.58–0.81]; p<0.001 RRR 31% |
| Bempedoic Acid | ||||
| CLEAR HARMONY[26] | Total 2,230 Women 602 (27%) | Any adverse event HR 0.95; p=0.91 RRR 5% | NA* | NA* |
*Trials designed for safety and lipid level reduction. CV = cardiovascular; GLP-1 RA = glucagon-like peptide-1 receptor agonists; HF = heart failure; HHF = hospitalisation for heart failure; NA = not available; PCSK9i = proprotein convertase subtilisin/kexin type 9; RRR = relative risk reduction; SGLT2i = sodium-glucose co-transporter type 2 inhibitors; UA = unstable angina.