Table 3.
Effect of Dapagliflozin on Clinical Outcomes in Patients Enrolled in Asia and Outside Asia
| Patients Enrolled in Asia (n = 1,096) |
Patients Not Enrolled in Asia (n = 3,648) |
Interaction P Value | |||
|---|---|---|---|---|---|
| Dapagliflozin | Placebo | Dapagliflozin | Placebo | ||
| Primary composite outcomea | |||||
| Number of events | 77/543 (14.2) | 114/553 (20.6) | 309/1830 (16.9) | 388/1818 (21.3) | |
| Rate (95% CI) | 11.0 (8.8-13.7) | 16.8 (14.0-20.2) | 11.7 (10.5-13.1) | 15.2 (13.8-16.8) | |
| HR (95% CI) | 0.65 (0.49-0.87) | 0.77 (0.66-0.89) | 0.32 | ||
| Cardiovascular death | |||||
| Number of events | 44/543 (8.1) | 54/553 (9.8) | 183/1830 (10.0) | 219/1818 (12.0) | |
| Rate (95% CI) | 6.1 (4.5-8.2) | 7.4 (5.6-9.6) | 6.6 (5.7-7.7) | 8.1 (7.1-9.2) | |
| HR (95% CI) | 0.83 (0.56-1.23) | 0.82 (0.67-1.00) | 0.97 | ||
| Worsening heart failure eventa | |||||
| Number of events | 42/543 (7.7) | 76/553 (13.7) | 195/1830 (10.7) | 250/1818 (13.8) | |
| Rate (95% CI) | 6.0 (4.4-8.1) | 11.2 (9.0-14.1) | 7.4 (6.4-8.5) | 9.8 (8.7-11.1) | |
| HR (95% CI) | 0.53 (0.37-0.78) | 0.75 (0.62-0.91) | 0.11 | ||
| All-cause death | |||||
| Number of events | 49/543 (9.0) | 62/553 (11.2) | 227/1830 (12.4) | 267/1818 (14.7) | |
| Rate (95% CI) | 6.8 (5.1-8.9) | 8.4 (6.6-10.8) | 8.2 (7.2-9.3) | 9.8 (8.7-11.1) | |
| HR (95% CI) | 0.80 (0.55-1.17) | 0.83 (0.70-1.00) | 0.85 | ||
| First and recurrent heart failure hospitalization and cardiovascular death | |||||
| Number of events | 105 | 162 | 462 | 580 | |
| Rate (95% CI) | 15.6 (12.0-17.6) | 22.4 (19.2-26.1) | 16.8 (15.3-18.4) | 21.4 (19.7-23.2) | |
| Rate ratio (95% CI) | 0.65 (0.47-0.90) | 0.78 (0.66-0.93) | 0.32 | ||
| KCCQ-TSS | |||||
| Mean change in score at 8 mo (95% CI) | 4.7 (3.1-6.4) | 1.1 (-0.6-2.7) | 6.5 (5.5-7.4) | 4.0 (3.0-5.0) | 0.36 |
| Patients with ≥5-point improvement at 8 mo | 59.7 (55.3-64.2) | 50.4 (45.9-54.8) | 57.8 (55.4-60.3) | 51.1 (48.7-53.4) | |
| OR (95% CI) | 1.20 (1.05-1.37) | 1.14 (1.06-1.22) | 0.47 | ||
| Patients with ≥5-point deterioration at 8 mo | 27.5 (23.4-31.6) | 34.8 (30.5-39.1) | 24.7 (22.6-26.7) | 32.3 (30.0-34.6) | |
| OR (95% CI) | 0.85 (0.74-0.98) | 0.83 (0.77-0.90) | 0.81 | ||
Values are n/N (%), unless otherwise indicated. Event rates presented per 100 patient-years. HRs and 95% CIs were estimated with the use of Cox regression models, stratified according to diabetes status, with a history of hospitalization for heart failure and treatment group assignment as explanatory variables (for all-cause mortality history of hospitalization for heart failure was not included in the model).
KCCQ-TSS = Kansas City Cardiomyopathy Questionnaire total symptom score
The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or death from cardiovascular causes.