Table 2. Clinical Events and Treatment Effect by Timing of Most Recent Heart Failure (HF) Hospitalization Relative to Trial Enrollmenta.
| Most recent HF hospitalization | Events, No. | Patients, No. | Placebo arm | Dapagliflozin arm incidence rate per 100 patient-years (95% CI) | Treatment effect hazard ratio (95% CI)b | ||
|---|---|---|---|---|---|---|---|
| Incidence rate per 100 patient-years (95% CI) | Unadjusted hazard ratio (95% CI) | Adjusted hazard ratio (95% CI) | |||||
| Primary efficacy end point | |||||||
| Never | 414 | 2493 | 13.1 (11.5-15.0) | 1 [Reference] | 1 [Reference] | 11.0 (9.5-12.7) | 0.84 (0.69-1.01) |
| >12 mo | 173 | 950 | 15.2 (12.5-18.6) | 1.07 (0.89-1.27) | 1.08 (0.90-1.29) | 11.0 (8.8-13.8) | 0.73 (0.54-0.99) |
| ≤12 mo | 301 | 1301 | 21.6 (11.6-25.0) | 1.45 (1.25-1.68) | 1.30 (1.12-1.51) | 13.8 (11.6-16.6) | 0.64 (0.51-0.80) |
| Worsening HF episodec | |||||||
| Never | 241 | 2493 | 8.2 (6.9-9.7) | 1 [Reference] | 1 [Reference] | 5.9 (4.8-7.1) | 0.72 (0.56-0.93) |
| >12 mo | 112 | 950 | 9.4 (7.3-12.1) | 1.18 (0.95-1.48) | 1.19 (0.95-1.49) | 6.9 (5.8-9.9) | 0.80 (0.55-1.16) |
| ≤12 mo | 210 | 1301 | 15.0 (12.6-17.9) | 1.73 (1.44-2.08) | 1.56 (1.29-1.88) | 9.6 (7.8-12.0) | 0.64 (0.48-0.84) |
| Cardiovascular death | |||||||
| Never | 253 | 2493 | 7.4 (6.2-8.7) | 1 [Reference] | 1 [Reference] | 6.7 (5.6-8.0) | 0.91 (0.71-1.16) |
| >12 mo | 97 | 950 | 8.1 (6.2-10.6) | 0.98 (0.77-1.23) | 1.01 (0.80-1.29) | 5.9 (4.3-7.9) | 0.74 (0.49-1.11) |
| ≤12 mo | 150 | 1301 | 9.2 (7.4-11.4) | 1.14 (0.93-1.40) | 0.98 (0.80-1.21) | 7.0 (5.5-8.9) | 0.76 (0.55-1.05) |
a
Both models include randomized treatment as a factor and are stratified by baseline diabetes status. Adjusted hazard ratios are adjusted for age, sex, race, left ventricular ejection fraction, baseline N-terminal pro-B-type natriuretic peptide concentration, and New York Heart Association class.
b
Dapagliflozin vs placebo.
c
Hospitalization for HF or an urgent HF visit.