Table 2.
Effect of randomized treatment on outcomes according to body mass index category
| Outcome | Under/normal‐weight (n = 1348) | Overweight (n = 1722) | Obesity class I (n = 1013) | Obesity class II/III (n = 659) | P‐value for interaction | ||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 676) | Dapagliflozin (n = 672) | Placebo (n = 857) | Dapagliflozin (n = 865) | Placebo (n = 501) | Dapagliflozin (n = 512) | Placebo (n = 337) | Dapagliflozin (n = 322) | ||
| CV death or HF hospitalization/urgent HF visit | |||||||||
| No (%) | 151 (22.3) | 118 (17.6) | 169 (19.7) | 141 (16.3) | 96 (19.2) | 68 (13.3) | 86 (25.5) | 59 (18.3) | |
| Rate (95% CI) | 17.4 (14.8–20.4) | 13.0 (10.9–15.6) | 14.5 (12.5–16.9) | 11.7 (9.9–13.8) | 13.8 (11.3–16.8) | 9.3 (7.4–11.8) | 19.2 (15.5–23.7) | 13.4 (10.4–17.3) | |
| Hazard ratio a (95% CI) | 0.74 (0.58–0.94) | 0.81 (0.65–1.02) | 0.68 (0.50–0.92) | 0.71 (0.51–1.00) | 0.79 | ||||
| CV death | |||||||||
| No (%) | 88 (13.0) | 76 (11.3) | 93 (10.9) | 88 (10.2) | 52 (10.4) | 37 (7.2) | 40 (11.9) | 26 (8.1) | |
| Rate (95% CI) | 9.4 (7.7–11.6) | 8.1 (6.5–10.1) | 7.5 (6.1–9.2) | 7.0 (5.6–8.6) | 7.0 (5.4–9.2) | 4.9 (3.5–6.7) | 8.2 (6.0–11.1) | 5.5 (3.7–8.0) | |
| Hazard ratio a (95% CI) | 0.85 (0.63–1.16) | 0.94 (0.70–1.25) | 0.70 (0.46–1.07) | 0.67 (0.41–1.10) | 0.58 | ||||
| HF hospitalization/urgent HF visit | |||||||||
| No (%) | 95 (14.1) | 61 (9.1) | 106 (12.4) | 87 (10.1) | 65 (13.0) | 48 (9.4) | 60 (17.8) | 41 (12.7) | |
| Rate (95% CI) | 10.9 (8.9–13.4) | 6.7 (5.2–8.7) | 9.1 (7.5–11.0) | 7.2 (5.8–8.9) | 9.3 (7.3–11.9) | 6.6 (5.0–8.7) | 13.4 (10.4–17.2) | 9.3 (6.8–12.6) | |
| Hazard ratioa (95% CI) | 0.60 (0.44–0.83) | 0.80 (0.60–1.06) | 0.71 (0.49–1.03) | 0.72 (0.48–1.07) | 0.67 | ||||
| All‐cause death | |||||||||
| No (%) | 109 (16.1) | 89 (13.2) | 109 (12.7) | 103 (11.9) | 62 (12.4) | 48 (9.4) | 49 (14.5) | 36 (11.2) | |
| Rate (95% CI) | 11.7 (9.7–14.1) | 9.5 (7.7–11.7) | 8.8 (7.3–10.6) | 8.1 (6.7–9.9) | 8.4 (6.5–10.8) | 6.3 (4.8–8.4) | 10.0 (7.6–13.2) | 7.6 (5.5–10.5) | |
| Hazard ratioa (95% CI) | 0.81 (0.61–1.07) | 0.93 (0.71–1.21) | 0.76 (0.52–1.10) | 0.76 (0.49–1.17) | 0.77 | ||||
| Total hospitalizations for HF and CV death (recurrent events) | |||||||||
| No. events | 217 | 155 | 253 | 220 | 141 | 108 | 131 | 84 | |
| Rate (95% CI) | 23.4 (20.5–26.8) | 16.6 (14.2–19.4) | 20.5 (18.1–23.2) | 17.4 (15.3–19.9) | 19.1 (16.2–22.5) | 14.3 (11.9–17.3) | 26.8 (22.6–31.8) | 17.8 (14.3–22.0) | |
| Rate ratio a , b (95% CI) | 0.70 (0.54–0.91) | 0.86 (0.67–1.11) | 0.75 (0.53–1.06) | 0.67 (0.46–0.98) | 0.63 | ||||
| Change in KCCQ‐TSS at 8 months | |||||||||
| Change in KCCQ at 8 months (mean ± SD) | 2.5 ± 18.5 | 4.7 ± 16.9 | 3.3 ± 18.9 | 5.5 ± 18.7 | 2.9 ± 18.6 | 6.5 ± 18.9 | 5.3 ± 22.3 | 9.8 ± 20.7 | 0.40 |
| Proportion improved (≥5 points) at 8 months (%) | 50.6 (46.5–54.6) | 58.0 (54.0–62.1) | 52.2 (48.6–55.8) | 59.0 (55.6–62.4) | 51.1 (46.7–55.6) | 57.6 (53.2, 61.9) | 48.2 (42.7–53.7) | 57.9 (51.9–63.8) | |
| Odds ratio for improvement at 8 months (95% CI) | 1.16 (1.03–1.30) | 1.14 (1.03–1.26) | 1.12 (0.98–1.27) | 1.22 (1.03–1.44) | 0.81 | ||||
| Proportion deteriorated (≥5 points) at 8 months (%) | 33.8 (29.8–37.7) | 26.9 (23.3–30.5) | 31.0 (27.7–34.3) | 25.4 (22.2–28.6) | 33.2 (28.9–37.4) | 24.4 (20.6–28.2) | 35.5 (30.1–40.9) | 23.5 (18.7–28.4) | |
| Odds ratio for deterioration at 8 months (95% CI) | 0.85 (0.75–0.97) | 0.88 (0.78–0.98) | 0.82 (0.71–0.94) | 0.75 (0.63–0.89) | 0.21 | ||||
CI, confidence interval; CV, cardiovascular; HF, heart failure; KCCQ‐TSS, Kansas City Cardiomyopathy Questionnaire total symptom score; SD, standard deviation.
a
Adjusted for history of HF hospitalization (apart from all‐cause death) and stratified by diabetes status.
b
The total number of hospitalizations for HF and CV deaths was analysed by means of the semiparametric proportional‐rates model, in which the treatment effect is reported as a rate ratio.