Table 2.
Primary and secondary outcomesa,b
| Outcome | Real-world data |
PRONOUNCE trial |
||||
|---|---|---|---|---|---|---|
| Degarelix | Leuprolide | HR (95% CI)c | Degarelix | Leuprolide | HR (95% CI)c | |
| (n = 1889) | (n = 1889) | (n = 275) | (n = 269) | |||
| No. of events (%) | No. of events (%) | No. of events (%) | No. of events (%) | |||
| MACE | 73 (3.9) | 55 (2.9) | 1.35 (0.94 to 1.93) | 15 (5.5) | 11 (4.1) | 1.28 (0.59 to 2.79) |
| MACE components | ||||||
| All-cause mortality | 50 (2.6) | 35 (1.9) | 1.41 (0.90 to 2.21) | 8 (2.9) | 9 (3.3) | 0.84 (0.32 to 2.18) |
| Acute myocardial infarction | 25 (1.3) | 17 (0.9) | 1.52 (0.80 to 2.89) | 5 (1.8) | 3 (1.1) | 1.59 (0.38 to 6.67) |
| Stroke | 7 (0.4) | 6 (0.3) | 1.05 (0.35 to 3.20) | 3 (1.1) | 3 (1.1) | 0.90 (0.18 to 4.46) |
| Composite myocardial infarction and stroke | 33 (1.7) | 29 (1.5) | 1.27 (0.76 to 2.12) | — | — | — |
a
The availability of mortality information varied by database. Medicare and Clinformatics included complete information on all-cause mortality, while MarketScan only included information on in-hospital death. CI = confidence interval; HR = hazard ratio; MACE = major adverse cardiovascular event.
b
Median follow-up time to ascertain MACE events in the real-world data study was 89 days (interquartile range = 61-116), which was shorter than that of the PRONOUNCE trial.
c
Reference group is leuprolide.