Summary of GRACE evidence profile
| Quality assessment | Patients (n) | Effect | Quality | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Intensive statin therapy | Control | Relative (95% CI) | Absolute | |
| All-cause mortality | |||||||||||
| 5 | RCT | No serious | Serious* | No serious | Serious† | Undetected | 346/4748 (7.3%) | 384/4645 (8.3%) | RR 0.85 (0.67 to 1.09) | 12 fewer per 1000 (from 27 fewer to 7 more) | ⊕⊕OO LOW |
| Stoke | |||||||||||
| 4 | RCT | No serious | No serious | No serious | No serious | Undetected | 144/4688 (3.1%) | 203/4586 (4.4%) | RR 0.69 (0.56 to 0.85) | 14 fewer per 1000 (from 7 fewer to 19 fewer) | ⊕⊕⊕⊕ HIGH |
| Myocardial infarction | |||||||||||
| 3 | RCT | No serious | Serious* | No serious | Serious† | Undetected | 118/3086 (3.8%) | 141/3081 (4.6%) | RR 0.69 (0.4 to 1.18) | 14 fewer per 1000 (from 27 fewer to 8 more) | ⊕⊕OO LOW |
| Heart failure | |||||||||||
| 3 | RCT | No serious | Serious* | No serious | Serious† | Undetected | 111/3050 (3.6%) | 151/2957 (5.1%) | RR 0.73 (0.48 to 1.13) | 14 fewer per 1000 (from 7 fewer to 19 fewer) | ⊕⊕OO LOW |
| Change of eGFR | |||||||||||
| 3 | RCT | No serious | No serious | No serious | No serious | Undetected | 2237 | 2263 | MD 1.09 higher (0.35 to 1.82 higher) | ⊕⊕⊕⊕ HIGH | |
| Any serious adverse event | |||||||||||
| 2 | RCT | No serious | No serious | No serious | No serious | Undetected | 328/1698 (19.3%) | 336/1688 (19.9%) | RR 0.97 (0.85 to 1.11) | 6 fewer per 1000 (from 30 fewer to 22 more) | ⊕⊕⊕⊕ HIGH |
| Persistent elevation of AST/ALT | |||||||||||
| 3 | RCT | No serious | Very serious‡ | No serious | Very serious§ | Undetected | 43/4209 (1.1%) | 6/3945 (0.15%) | RR 5.59 (0.40 to 77.37) | 9 more per 1000 (from 3 more to 24 more) | ⊕OOO VERY LOW |
| Myopathy | |||||||||||
| 2 | RCT | No serious | No serious | No serious | Serious† | Undetected | 3/2472 (0.1%) | 7/2440 (0.3%) | RR 0.42 (0.11 to 1.64 | 2 fewer per 1000 (from 3 fewer to 2 more) | ⊕⊕⊕O MODERATE |
| Rhabdomyolysis | |||||||||||
| 2 | RCT | No serious | Serious* | No serious | serious† | Undetected | 1/2427 | 2/2440 (0.1%) | RR 0.67 (0.11 to 4.07) | 0 fewer per 1000 (from 1 fewer to 3 more) | ⊕⊕OO LOW |
*Tests for heterogeneity, I2>50%.
†95%CI is wide.
‡I2>80%.
§95%CI is very wide.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; eGFR, estimated glomerular filtration rate; RCT, randomised controlled trial; RR, relative risk.