Table 2. Effects of Dapagliflozin Compared With Placebo on Clinical Events According to Sex.
| Outcome | Women (n = 1109) | Men (n = 3635) | P value for interaction | ||
|---|---|---|---|---|---|
| Placebo (n = 545) | Dapagliflozin (n = 564) | Placebo (n = 1826) | Dapagliflozin (n = 1809) | ||
| Worsening HF event or cardiovascular death | |||||
| No. (%) | 96 (17.6) | 79 (14.0) | 406 (22.2) | 307 (17.0) | .67 |
| Event rate per 100 person-years (95% CI) | 12.5 (10.2 to 15.3) | 9.7 (7.8 to 12.1) | 16.5 (15.0 to 18.2) | 12.2 (10.9 to 13.6) | |
| HR (95% CI) | 0.79 (0.59 to 1.06) | 0.73 (0.63 to 0.85) | |||
| HF hospitalization or cardiovascular death | |||||
| No. (%) | 95 (17.4) | 79 (14.0) | 400 (21.9) | 303 (16.7) | .64 |
| Event rate per 100 person-years (95% CI) | 12.4 (10.1 to 15.1) | 9.7 (7.8 to 12.1) | 16.2 (14.7 to 17.9) | 12.0 (10.7 to 13.4) | |
| HR (95% CI) | 0.80 (0.59 to 1.08) | 0.73 (0.63 to 0.85) | |||
| HF hospitalization | |||||
| No. (%) | 66 (12.1) | 50 (8.9) | 252 (13.8) | 181 (10.0) | .83 |
| Event rate per 100 person-years (95% CI) | 8.6 (6.8 to 10.9) | 6.1 (4.7 to 8.1) | 10.2 (9.0 to 11.6) | 7.2 (6.2 to 8.3) | |
| HR (95% CI) | 0.73 (0.51 to 1.06) | 0.69 (0.57 to 0.84) | |||
| Cardiovascular death | |||||
| No. (%) | 49 (9.0) | 38 (6.7) | 224 (12.3) | 189 (10.4) | .68 |
| Event rate per 100 person-years (95% CI) | 6.0 (4.5 to 7.9) | 4.5 (3.3 to 6.2) | 8.5 (7.5 to 9.7) | 7.2 (6.2 to 8.3) | |
| HR (95% CI) | 0.76 (0.49 to 1.16) | 0.84 (0.69 to 1.02) | |||
| Recurrent HF hospitalization or cardiovascular death | |||||
| No. of events | 149 | 104 | 593 | 463 | .54 |
| Event rate per 100 person-years (95% CI) | 18.3 (15.6 to 21.5) | 12.3 (10.1 to 14.9) | 22.6 (20.9 to 24.5) | 17.6 (16.1 to 19.3) | |
| RR (95% CI) | 0.69 (0.49 to 0.96) | 0.77 (0.65 to 0.91) | |||
| Expanded composite outcomea | |||||
| No. (%) | 134 (24.6) | 118 (20.9) | 550 (30.1) | 409 (22.6) | .25 |
| Event rate per 100 person-years (95% CI) | 18.5 (15.6 to 21.9) | 15.3 (12.7 to 18.3) | 23.8 (21.9 to 25.9) | 16.9 (15.3 to 18.6) | |
| HR (95% CI) | 0.83 (0.65 to 1.07) | 0.70 (0.62 to 0.80) | |||
| All-cause death | |||||
| No. (%) | 58 (10.6) | 51 (9.0) | 271 (14.8) | 225 (12.4) | .84 |
| Event rate per 100 person-years (95% CI) | 7.1 (5.5 to 9.2) | 6.0 (4.6 to 7.9) | 10.3 (9.1 to 11.6) | 8.5 (7.5 to 9.7) | |
| HR (95% CI) | 0.85 (0.58 to 1.24) | 0.82 (0.69 to 0.98) | |||
| KCCQ-TSS | |||||
| Mean change in KCCQ-TSS at 8 mo | |||||
| Mean change (95% CI) | 6.0 (4.1 to 7.8) | 6.1 (4.2 to 8.0) | 2.5 (1.6 to 3.5) | 6.1 (5.2 to 7.0) | .046 |
| Difference in mean change (95% CI) | 0.2 (−2.5 to 2.8) | 3.6 (2.2 to 4.9) | |||
| ≥5-Point improvement in KCCQ-TSS at 8 mo | |||||
| Proportion of patients, % | 54 | 57 | 50 | 59 | .14 |
| OR (95% CI) | 1.06 (0.92 to 1.22) | 1.18 (1.11 to 1.27) | |||
| ≥5-Point decrease in KCCQ-TSS at 8 mo | |||||
| Proportion of patients, % | 31 | 27 | 34 | 25 | .15 |
| OR (95% CI) | 0.92 (0.79 to 1.06) | 0.81 (0.75 to 0.88) | |||
| KCCQ-CSS | |||||
| Mean change in KCCQ-CSS at 8 mo | |||||
| Mean change (95% CI) | 5.1 (3.5 to 6.8) | 6.1 (4.3 to 7.8) | 2.3 (1.4 to 3.2) | 5.3 (4.5 to 6.2) | .22 |
| Difference in mean change (95% CI) | 0.9 (−1.5 to 3.3) | 3.1 (1.8 to 4.3) | |||
| ≥5-Point improvement in KCCQ-CSS at 8 mo | |||||
| Proportion of patients, % | 49 | 54 | 44 | 53 | .26 |
| OR (95% CI) | 1.10 (0.96 to 1.27) | 1.20 (1.12 to 1.29) | |||
| ≥5-Point decrease in KCCQ-CSS at 8 mo | |||||
| Proportion of patients, % | 29 | 27 | 32 | 25 | .12 |
| OR (95% CI) | 0.95 (0.82 to 1.11) | 0.84 (0.77 to 0.90) | |||
| KCCQ-OSS | |||||
| Mean change in KCCQ-OSS at 8 mo | |||||
| Mean change (95% CI) | 5.8 (4.2 to 7.5) | 7.0 (5.3 to 8.7) | 3.3 (2.4 to 4.2) | 5.9 (5.1 to 6.7) | .34 |
| Difference in mean change (95% CI) | 1.2 (−1.1 to 3.5) | 2.6 (1.4 to 3.8) | |||
| ≥5-Point improvement in KCCQ-OSS at 8 mo | |||||
| Proportion of patients, % | 50 | 56 | 45 | 53 | .64 |
| OR (95% CI) | 1.10 (0.97 to 1.25) | 1.14 (1.07 to 1.23) | |||
| ≥5-Point decrease in KCCQ-OSS at 8 mo | |||||
| Proportion of patients, % | 27 | 24 | 32 | 25 | .17 |
| OR (95% CI) | 0.94 (0.81 to 1.08) | 0.83 (0.77 to 0.90) | |||
Abbreviations: CSS, clinical summary score; HF, heart failure; HR, hazard ratio; KCCQ, Kansas City Cardiomyopathy Questionnaire; OR, odds ratio; OSS, overall summary score; RR, rate ratio; TSS, total symptom score.
a
A composite of the primary end point plus worsening heart failure symptoms/signs leading to the initiation of new oral therapy or augmentation of existing oral treatment.