Table 2.
Primary and secondary outcomes at three years in adults assigned to receive rosuvastatin or atorvastatin.* Values are number (percentage) unless stated otherwise
| Outcome | Rosuvastatin group (n=2204) | Atorvastatin group (n=2196) | Absolute difference (95% CI) | Hazard ratio (95% CI) | P value† |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Death, myocardial infarction, stroke, or any coronary revascularisation | 189 (8.7) | 178 (8.2) | 0.5 (−1.2 to 2.1) | 1.06 (0.86 to 1.30) | 0.58 |
| Components of primary outcome | |||||
| Death: | 57 (2.6) | 51 (2.3) | 0.3 (−0.7 to 1.2) | 1.12 (0.77 to 1.63) | 0.57 |
| Cardiac death (No) | 14 | 15 | |||
| Myocardial infarction | 34 (1.5) | 26 (1.2) | 0.3 (−0.4 to 1.0) | 1.27 (0.76 to 2.12) | 0.37 |
| Stroke: | 24 (1.1) | 20 (0.9) | 0.2 (−0.4 to 0.8) | 1.20 (0.66 to 2.17) | 0.55 |
| Ischaemic (No) | 16 | 16 | |||
| Haemorrhagic (No) | 8 | 4 | |||
| Coronary revascularisation‡ | 115 (5.3) | 111 (5.2) | 0.2 (−1.2 to 1.5) | 1.03 (0.80 to 1.34) | 0.81 |
| Secondary outcomes | |||||
| New onset diabetes mellitus | 152 (7.1) | 119 (5.5) | 1.5 (0.1 to 3.0) | 1.29 (1.01 to 1.63) | 0.04 |
| New onset diabetes mellitus among participants without diabetes mellitus at baseline § | 152/1479 (10.4) | 119/1453 (8.4) | 2.1 (−0.0 to 4.2) | 1.26 (0.99 to 1.60) | 0.06 |
| Initiation of antidiabetics among participants without diabetes mellitus at baseline § | 104/1479 (7.2) | 74/1453 (5.3) | 2.0 (0.2 to 3.7) | 1.39 (1.03 to 1.87) | 0.03 |
| Hospital admission due to heart failure | 12 (0.6) | 8 (0.4) | 0.2 (−0.2 to 0.6) | 1.50 (0.61 to 3.66) | 0.37 |
| Deep vein thrombosis or pulmonary embolism: | 7 (0.3) | 2 (0.1) | 0.2 (−0.0 to 0.5) | 3.50 (0.73 to 16.84) | 0.10 |
| Deep vein thrombosis (No) | 5 | 2 | |||
| Pulmonary embolism (No) | 3 | 0 | |||
| Peripheral artery revascularisation | 12 (0.5) | 17 (0.8) | −0.3 (−0.8 to 0.2) | 0.65 (0.30 to 1.38) | 0.25 |
| Aortic intervention or surgery: | 3 (0.1) | 2 (0.1) | 0.0 (−0.2 to 0.3) | 1.50 (0.25 to 8.94) | 0.66 |
| Endovascular treatment (No) | 3 | 0 | |||
| Surgical treatment (No) | 0 | 2 | |||
| End stage kidney disease | 9 (0.4) | 4 (0.2) | 0.2 (−0.1 to 0.6) | 2.25 (0.69 to 7.30) | 0.17 |
| Discontinuation of statin treatment | 40 (1.8) | 37 (1.7) | 0.1 (−0.7 to 0.9) | 1.08 (0.69 to 1.69) | 0.74 |
| Cataract surgery | 53 (2.5) | 32 (1.5) | 1.0 (1.4 to 1.8) | 1.66 (1.07 to 2.58) | 0.02 |
| Composite of laboratory detected abnormalities¶: | 26 (1.2) | 22 (1.0) | 0.2 (−0.4 to 0.8) | 1.24 (0.70 to 2.20) | 0.47 |
| Increase in aminotransferase (No) | 10 | 10 | |||
| Increase in creatine kinase (No) | 5 | 6 | |||
| Increase in creatinine (No) | 11 | 7 |
CI=confidence interval.
Primary and secondary outcomes were evaluated in the intention-to-treat population three years after randomisation. The listed percentages were estimated using the Kaplan-Meier method, so values might not calculate mathematically.
Calculated using log rank test.
All coronary revascularisations were clinically indicated by a diameter stenosis ≥50% on invasive coronary angiography with ischaemic symptoms or signs or ≥70% even in the absence of symptoms or signs.
Data are number of patients/total number of patients (%).
An increase in aminotransferase level was defined as more than baseline level and >3 times the upper reference limit; an increase in creatine kinase level was defined as more than baseline level and >5 times the upper reference limit; and an increase in creatinine level was defined as >50% increase from baseline and greater than the upper reference limit.