Table 2. Signal detection for statin-associated renal adverse events.
Statins | N | PRR (kai2) | ROR (95% CI) | IC (95% CI) | EBGM (95% CI) | |
Acute renal failure | Pravastatin | 338 | 1.424 (42.101) | 1.426 (1.281, 1.570)* | 0.503 (0.349, 0.658)* | 1.414 (1.292) |
Simvastatin | 1371 | 1.713 (406.242) | 1.723 (1.633, 1.813)* | 0.771 (0.693, 0.848)* | 1.704 (1.630) | |
Atorvastatin | 1112 | 1.133 (17.315) | 1.135 (1.069, 1.200)* | 0.179 (0.093, 0.264)* | 1.131 (1.077) | |
Rosuvastatin | 340 | 1.330 (27.468) | 1.332 (1.197, 1.466)* | 0.406 (0.252, 0.560)* | 1.322 (1.209) | |
Non-acute renal failure | Pravastatin | 237 | 1.160 (5.056) | 1.160 (1.021, 1.300)* | 0.209 (0.025, 0.393)* | 1.153 (1.036) |
Simvastatin | 817 | 1.184 (23.316) | 1.186 (1.107, 1.265)* | 0.242 (0.142, 0.341)* | 1.182 (1.115) | |
Atorvastatin | Not detected | |||||
Rosuvastatin | 299 | 1.361 (28.138) | 1.362 (1.215, 1.509)* | 0.438 (0.274, 0.602)* | 1.351 (1.228) | |
Increase of CR | Pravastatin | 242 | 1.635 (58.964) | 1.638 (1.443, 1.833)* | 0.700 (0.518, 0.883)* | 1.618 (1.454) |
Simvastatin | 629 | 1.257 (33.035) | 1.260 (1.165, 1.355)* | 0.328 (0.214, 0.441)* | 1.254 (1.174) | |
Atorvastatin | Not detected | |||||
Rosuvastatin | 196 | 1.229 (8.134) | 1.230 (1.069, 1.391)* | 0.291 (0.089, 0.494)* | 1.220 (1.084) |
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.
Acute renal failure, non-acute renal failure and increase of blood creatinine (CR) level were coded as PT10038436, PT10038435 and PT10005483, respectively.