Table 6.
Occurrence of Cardio‐ and Cerebrovascular as Well as Other Events During the Longitudinal Follow‐Up in the 2 ROADMAP Treatment Groups
| Placebo (n=877) | Olmesartan (n=881) | Odds Ratio (95%‐CI) | P Value | |
|---|---|---|---|---|
| Cardio‐/cerebrovascular morbidity and mortality, n (%) | 86 (9.8) | 73 (8.3) | 0.845 (0.604; 1.182) | 0.325 |
| Cardio‐/cerebrovascular morbidity, n (%) | 86 (9.8) | 73 (8.3) | 0.845 (0.604; 1.182) | 0.325 |
| Cardiovascular morbidity, n (%) | 71 (8.1) | 60 (6.8) | 0.829 (0.574; 1.196) | 0.316 |
| Acute coronary syndrome | 23 (2.6) | 24 (2.7) | 1.025 (0.566; 1.854) | 0.936 |
| Coronary revascularisation | 22 (2.5) | 20 (2.3) | 0.895 (0.476; 1.683) | 0.731 |
| Silent myocardial infarction | 2 (0.2) | 2 (0.2) | 0.772 (0.101; 5.903) | 0.803 |
| Congestive heart failure* | 12 (1.4) | 3 (0.3) | 0.231 (0.063; 0.846) | 0.027 |
| New onset of atrial fibrillation | 24 (2.7) | 17 (1.9) | 0.675 (0.355; 1.281) | 0.229 |
| Peripheral vascular disease* | 6 (0.7) | 10 (1.1) | 1.840 (0.645; 5.249) | 0.254 |
| Cerebrovascular morbidity, n (%) | 22 (2.5) | 14 (1.6) | 0.668 (0.334; 1.336) | 0.254 |
| Non fatal stroke | 18 (2.1) | 7 (0.8) | 0.436 (0.178; 1.067) | 0.069 |
| Transient ischemic attack | 5 (0.6) | 7 (0.8) | 1.244 (0.377; 4.105) | 0.720 |
| Cardio‐/cerebrovascular mortality*, n (%) | 2 (0.2) | 0 (0.0) | ||
| Congestive heart failure | 1 (0.1) | 0 (0.0) | n.a. | n.a. |
| Fatal stroke | 1 (0.1) | 0 (0.0) | ||
| Non‐CV related mortality, n (%) | 5 (0.6) | 3 (0.3) | 0.476 (0.108; 2.109) | 0.329 |
| Not CV related death | 3 (0.3) | 2 (0.2) | 0.554 (0.087; 3.515) | 0.531 |
| Death of unknown cause | 2 (0.2) | 1 (0.1) | 0.369 (0.030; 4.567) | 0.437 |
| Total mortality, n (%) | 7 (0.8) | 3 (0.3) | 0.374 (0.093; 1.505) | 0.166 |
| Other endpoints, n (%) | ||||
| End stage renal disease | 1 (0.1) | 1 (0.1) | 1.245 (0.060; 26.006) | 0.888 |
| New onset diabetic retinopathy | 23 (2.6) | 8 (0.9) | 0.342 (0.149; 0.782) | 0.011 |
CV indicates cardio‐/cerebrovascular events; n.a., not applicable; ROADMAP, Randomized Olmesartan and Diabetes Microalbuminuria Prevention.
Requiring hospital treatment.
No death due to sudden cardiac death, myocardial infarction or during cardiovascular surgery was reported.