ADVERSE EFFECT | CLINICAL SIGNIFICANCE | NNH FOR WOMEN (MEN)* |
---|---|---|
Myopathy | Pain unrelated to CPK levels69 Rhabdomyolysis is rare Rare autoimmune myopathy can occur70 | 39 (91) over 5 y* |
Elevated transaminase levels | Hepatic damage or failure is extremely rare71 | 136 (142) over 5 y* |
Withdrawal effects | Mortality and morbidity following ACS72 or stroke73 are increased if statins are discontinued at event onset | 4 at 30 d for ACS72 4 at 3 mo for stroke73 |
Drug or food interactions | Levels increased with some drugs (eg, amiodarone, protease inhibitors, gemfibrozil) and with grapefruit juice | NA |
Diabetes | Statins increase risk of diabetes in primary prevention trials74 High-dose statins increase risk compared with moderate dosages75 | 255 in primary prevention trials at 4 y74 498 high dose vs moderate dose at 1 y75 |
Interference with exercise | Myalgia might interfere with ability to exercise76,77 Symptomatic myopathy more common with changes in exercise intensity78 | No data |
Cognitive function | Dementia and postoperative delirium have been studied Conclusions are inconsistent | No consistent data |
Renal disease | Small association with increased renal failure in a large prospective cohort study High-dose statins associated with increased acute renal injury vs low doses in patients with kidney disease79 | 434 (346) over 5 y* 1700 high dose vs low dose at 3 mo79 |
ACS—acute coronary syndrome, CPK—creatine phosphokinase, NA—not applicable, NNH—number needed to harm, NNT—number needed to treat.
↵* Data from Hippisley-Cox and Coupland80; NNTs for benefit over 5 y range from 24 to 64.