Table 2.
Analysis schemea | Exposure | n of patients | N outcomes | N person years | Median follow-up (IQR), days | Incidence rate (95% CI)/1000 person years |
---|---|---|---|---|---|---|
Analysis 1 | PDE5 inhibitors | 2888 | 55 | 3065 | 168 (37, 530) | 17.9 (13.5–23.4) |
ERA | 2888 | 59 | 3136 | 151 (47, 508) | 18.8 (14.3–24.3) | |
Analysis 2 | PDE5 inhibitors | 1706 | 62 | 3125 | 693 (320, 1095) | 19.8 (15.2–25.4) |
ERA | 1706 | 63 | 3168 | 720 (328, 1095) | 19.9 (15.3–25.4) | |
Analysis 3 | PDE5 inhibitors | 1292 | 31 | 2060 | 382 (150, 794) | 15.1 (10.2–21.4) |
ERA | 1292 | 46 | 2037 | 358 (124, 810) | 22.6 (16.5–30.1) | |
Analysis 4 | PDE5 inhibitors | 2888 | 16 | 3099 | 169 (38, 533) | 5.2 (3–8.4) |
ERA | 2888 | 15 | 3167 | 151 (47, 517) | 4.7 (2.7–7.8) |
Analysis 1: ‘As-treated’ follow-up approach; Analysis 2: ‘As-started’ follow-up approach incorporating a 6-month induction period; Analysis 3: Incorporating a 6-month ‘symptom to diagnosis’ period’ and Analysis 4: Alternate outcome definition (See Methods for additional description of analytic approach). ERAs, endothelin receptor antagonists, IQR, interquartile range, PDE, phosphodiesterase.