Table 6.

Adverse effects of statins in primary prevention

ADVERSE EFFECTCLINICAL SIGNIFICANCENNH FOR WOMEN (MEN)*
MyopathyPain unrelated to CPK levels69
Rhabdomyolysis is rare
Rare autoimmune myopathy can occur70
39 (91) over 5 y*
Elevated transaminase levelsHepatic damage or failure is extremely rare71136 (142) over 5 y*
Withdrawal effectsMortality and morbidity following ACS72 or stroke73 are increased if statins are discontinued at event onset4 at 30 d for ACS72
4 at 3 mo for stroke73
Drug or food interactionsLevels increased with some drugs (eg, amiodarone, protease inhibitors, gemfibrozil) and with grapefruit juiceNA
DiabetesStatins 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 exerciseMyalgia might interfere with ability to exercise76,77
Symptomatic myopathy more common with changes in exercise intensity78
No data
Cognitive functionDementia and postoperative delirium have been studied
Conclusions are inconsistent
No consistent data
Renal diseaseSmall 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.