Table 5.
Amputations in patients randomized to dapagliflozin or placebo according to a history of PAD, overall and according to diuretic use at baseline and Type 2 diabetes
| No PAD | PAD | P-value for interaction | |||
|---|---|---|---|---|---|
| Placebo | Dapagliflozin | Placebo | Dapagliflozin | ||
| Full population | 1.00 | ||||
| No. of events (%) | 20 (0.39) | 18 (0.35) | 18 (4.22) | 14 (3.67) | |
| Event rate per 100 person-years (95% CI) | 0.23 (0.15–0.35) | 0.20 (0.12–0.31) | 2.62 (1.65–4.16) | 2.23 (1.32–3.76) | |
| HR (95% CI)a | 0.87 (0.46–1.64) | 0.87 (0.43–1.75) | |||
| No diuretics | N/A | ||||
| No. of events (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Event rate per 100 person-years (95% CI) | N/A | N/A | N/A | N/A | |
| HR (95% CI)a | N/A | N/A | |||
| Diuretics | 0.98 | ||||
| No. of events (%) | 20 (0.41) | 18 (0.37) | 18 (4.37) | 14 (3.83) | |
| Event rate per 100 person-years (95% CI) | 0.24 (0.15–0.37) | 0.20 (0.13–0.32) | 2.70 (1.70–4.29) | 2.31 (1.37–3.91) | |
| HR (95% CI)a | 0.86 (0.46–1.63) | 0.86 (0.43–1.73) | |||
| No Type 2 diabetes | 0.60 | ||||
| No. of events (%) | 3 (0.10) | 3 (0.10) | 4 (2.13) | 2 (1.14) | |
| Event rate per 100 person-years (95% CI) | 0.06 (0.02–0.18) | 0.06 (0.02–0.18) | 1.28 (0.48–3.42) | 0.69 (0.17–2.76) | |
| HR (95% CI)a | 0.96 (0.19–4.77) | 0.52 (0.09–2.83) | |||
| Type 2 diabetes | 0.81 | ||||
| No. of events (%) | 17 (0.79) | 15 (0.69) | 14 (5.86) | 12 (5.85) | |
| Event rate per 100 person-years (95% CI) | 0.46 (0.29–0.74) | 0.39 (0.23–0.64) | 3.73 (2.21–6.29) | 3.55 (2.01–6.24) | |
| HR (95% CI)a | 0.85 (0.42–1.69) | 0.97 (0.45–2.11) | |||
CI, confidence interval; HR, hazard ratio; N/A, not applicable.
A total of 18 randomized patients were excluded from the safety analysis, as these were performed in patients who had undergone randomization and received at least one dose of dapagliflozin or placebo.
Models were stratified by Type 2 diabetes status (except in the subgroup analysis of patients with and without Type 2 diabetes) and trial.