Table 4.
Adverse events from selected statin trials.
| Study | Intervention | Run-in period, weeks; (drug) | Mean duration of follow-up, y | Adverse effect (cut-off) | Group 1, % | Group 2, % | Comments |
|---|---|---|---|---|---|---|---|
| PROSPER | Pravastatin 40 mg vs placebo | 4 (placebo) | 3.2 | (At 3 months) | Pravastatin 40 mg | Placebo | New cancerc diagnoses were increased with pravastatin |
| AST/ALT (>3x ULN) | 0.03 | 0.03 | |||||
| CK (>10x ULN) | 0 | 0 | |||||
| Rhabdomyolysis | 0 | 0 | |||||
| SAGE | Atorvastatin 80 mg vs pravastatin 40 mg | None | 1 | (Transient) | Atorvastatin 80 mg | Pravastatin 40 mg | P |
| AST/ALT (>3x ULN) | 4.3 | 0.2 | <0.001 | ||||
| CK (>10x ULN) | 0 | 0.2 | NS | ||||
| Rhabdomyolysis | 0 | 0 | NS | ||||
| ASCOT-LLA | Atorvastatin 10 mg vs placebo | 4 (NR) | 3.3b | Atorvastatin 10 mg | Placebo | ||
| AST/ALT (NR) | Similar in both groups | Actual numbers for AST/ALT NR in original manuscript | |||||
| CK (NR) | NR | NR | |||||
| Rhabdomyolysis | 0.02 | 0 | |||||
| CARDS, Elderly | Atorvastatin 10 mg vs placebo | 6 (placebo) | 3.9b | (Persistent) | Atorvastatin 10 mg | Placebo | |
| AST/ALT (>3x ULN) | 0.3 | 0 | Overall safety profile was similar between age-groups | ||||
| CK (>10x ULN) | 0 | 0 | |||||
| Rhabdomyolysis | 0 | 0 | |||||
| IDEAL | Atorvastatin 80 mg vs simvastatin 20 mg | None | 4.8b | (Persistent) | Atorvastatin 80 mg | Simvastatin 20 mg | p |
| AST/ALT (>3x ULN) | 0.41/0.97 | 0.04/0.11 | <0.001 NS | ||||
| CK (>10x ULN with muscle symptoms) | 0 | 0 | |||||
| Study (Ref) | Intervention | Duration of run-in period prior to randomization, weeks | Mean duration of follow-up, y | Adverse effect | Group 1 | Group 2 | Comments |
| TNT, Elderly | Atorvastatin 80 mg vs atorvastatin 10 mg | 8 (Atorvastatin 10 mg) | 4.9b | (Persistent) | Atorvastatin 80 mg | Atorvastatin 10 mg | Similar AST/ALT elevations were seen in patients >65 years (1.3 vs 0.3%, respectively) |
| AST/ALT (>3x ULN) | 1.3 | 0.1 | |||||
| CK (>10x ULN) Rhabdomyolysisa (age unknown) | 0 | 0.1 | |||||
| Rhabdomyolysisa (age unknown) | 0.04 | 0.06 | |||||
| PROVE-IT, Elderly | Atorvastatin 80 mg vs pravastatin 40 mg | None | 2 | (Transient) | Atorvastatin 80 mg | Pravastatin 40 mg | |
| ALT (>3x ULN) | 4.8 | 0 | p < 0.0001 | ||||
| CK (>3x ULN) | 1.1 | 1.1 | p = 0.9 | ||||
| Rhabdomyolysisz | 0 | 0 | Overall, rates of ALT and CK elevation were similar among older and younger patients | ||||
Data from parent study, includes subjects < and ≥65 years.
Median.
Among all major statin trials that reported incidence of new cancer diagnosis, PROSPER and LIPID (elderly subanalysis) were the only ones that reported increased new cancers with statin use.
Abbreviations: AST, aspartate transaminase; ALT, alanine transaminase; CK, creatine kinase; NR, not reported; NS, not significant; CARDS, Collaborative Atorvastatin Diabetes Study; PROSPER, Prospective Study of Pravastatin in the Elderly at Risk; ASCOT-LLA, Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm; PROVE-IT, Pravastatin or Atorvastatin Evaluation and Infection Therapy; TNT, Treating to New Targets; SAGE, Study Assessing Goals in the Elderly.