Table 4.
Monitored adverse events, measured laboratory values, and other reported events during follow-up in JUPITER
| Women | Men | |||||
|---|---|---|---|---|---|---|
| Rosuvastatin N=3,426 |
Placebo N=3,375 |
P | Rosuvastatin N=5,475 |
Placebo N=5,526 |
P | |
| Monitored adverse events | ||||||
| Any serious adverse event | 503 (7.7) | 481 (7.4) | 0.61 | 849 (7.6) | 896 (7.9) | 0.31 |
| Muscular weakness, stiffness, or pain | 552 (8.9) | 509 (8.3) | 0.24 | 869 (8.1) | 866 (7.9) | 0.77 |
| Myopathy | 5 (0.07) | 4 (0.06) | 0.76 | 5 (0.04) | 5 (0.04) | 0.99 |
| Rhabdomyolysis | 0 | 0 | – | 1 (0.01) | 0 | 0.32 |
| Newly diagnosed cancer | 100 (1.4) | 94 (1.4) | 0.74 | 198 (1.7) | 220 (1.8) | 0.32 |
| Death from cancer | 12 (0.2) | 17 (0.2) | 0.33 | 23 (0.2) | 41 (0.3) | 0.03 |
| Gastrointestinal disorder | 724 (12.0) | 734 (12.5) | 0.54 | 1,029 (9.8) | 977 (9.0) | 0.13 |
| Renal disorder | 166 (2.4) | 135 (2.0) | 0.09 | 369 (3.2) | 345 (2.9) | 0.29 |
| Bleeding | 99 (1.4) | 106 (1.5) | 0.54 | 159 (1.3) | 169 (1.4) | 0.63 |
| Hepatic disorder | 57 (0.8) | 63 (0.9) | 0.53 | 159 (1.3) | 123 (1.0) | 0.02 |
| Laboratory values | ||||||
| Creatinine, >100% increase from baseline | 6 (0.09) | 6 (0.09) | 0.98 | 10 (0.08) | 4 (0.03) | 0.10 |
| Glomerular filtration rate at 12 mo, ml/min/1.73 m2 | 64.1 (56.1–71.6) | 64.2 (56.6–70.9) | 0.66 | 71.0 (63.6–79.7) | 70.5 (62.7–79.4) | 0.006 |
| Alanine aminotransferase >3x ULN on consecutive visits | 3 (0.04) | 5 (0.07) | 0.47 | 20 (0.16) | 12 (0.10) | 0.15 |
| HbA1c at 24 mo, % | 5.9 (5.7–6.2) | 5.9 (5.6–6.1) | <0.0001 | 5.9 (5.6–6.1) | 5.8 (5.6–6.0) | <0.0001 |
| Glucose at 24 mo, mg/dL | 96 (89–104) | 95 (88–104) | 0.37 | 99 (92–107) | 99 (91–108) | 0.18 |
| Other events | ||||||
| Newly diagnosed diabetes (physician-reported) | 108 (1.5) | 71 (1.0) | 0.008 | 162 (1.4) | 145 (1.2) | 0.29 |
| Hemorrhagic stroke | 3 (0.04) | 3 (0.04) | 0.99 | 3 (0.02) | 6 (0.05) | 0.32 |
Values are number of events (rates per 100 person-years) or median (25th–75th percentile)