Table 1. Signal detection for statin-associated muscular adverse events.
Statins | N | PRR (kai2) | ROR (95% CI) | IC (95% CI) | EBGM (95% CI) | |
Myalgia | Pravastatin | 518 | 3.047 (704.853)* | 3.062 (2.807, 3.316)* | 1.591 (1.465, 1.716)* | 3.000 (2.789)* |
Simvastatin | 1980 | 3.453 (3437.911)* | 3.524 (3.369, 3.678)* | 1.774 (1.710, 1.839)* | 3.418 (3.293)* | |
Atorvastatin | 2456 | 3.503 (4383.844)* | 3.593 (3.450, 3.735)* | 1.795 (1.737, 1.853)* | 3.468 (3.354)* | |
Rosuvastatin | 1693 | 9.439 (12420.824)* | 9.646 (9.185, 10.107)* | 3.193 (3.122, 3.263)* | 9.186 (8.825)* | |
Rhabdomyolysis | Pravastatin | 212 | 2.246 (145.068)* | 2.253 (1.968, 2.538)* | 1.152 (0.958, 1.347)* | 2.205 (1.967) |
Simvastatin | 2278 | 7.210 (12122.472)* | 7.594 (7.278, 7.911)* | 2.830 (2.769, 2.891)* | 7.129 (6.887)* | |
Atorvastatin | 1114 | 2.861 (1353.202)* | 2.915 (2.746, 3.084)* | 1.509 (1.423, 1.595)* | 2.840 (2.703)* | |
Rosuvastatin | 605 | 5.994 (2492.472)* | 6.073 (5.602, 6.544)* | 2.558 (2.442, 2.674)* | 5.933 (5.546)* | |
Increase of CPK | Pravastatin | 206 | 2.461 (177.003)* | 2.470 (2.153, 2.787)* | 1.283 (1.085, 1.480)* | 2.410 (2.147)* |
Simvastatin | 1036 | 3.673 (2017.111)* | 3.755 (3.529, 3.981)* | 1.866 (1.777, 1.956)* | 3.641 (3.458)* | |
Atorvastatin | 997 | 2.886 (1233.942)* | 2.942 (2.762, 3.122)* | 1.522 (1.431, 1.613)* | 2.865 (2.719)* | |
Rosuvastatin | 505 | 5.634 (1908.004)* | 5.702 (5.220, 6.184)* | 2.469 (2.342, 2.596)* | 5.581 (5.182)* |
N: the number of co-occurrences.
PRR: the proportional reporting ratio [19], ROR: the reporting odds ratio [20], IC: the information component [21], EBGM: the empirical Bayes geometric mean [22].
CI: the confidence interval; two-sided for ROR and IC, and one-sided for EBGM.
*: signal detected, see “Methods” for the criteria of detection.
Myalgia, rhabdomyolysis and increase of creatine phosphokinase (CPK) level were coded as PT10028411, PT10039020 and PT10005470, respectively.