Statins do not cause most side effects listed on package inserts.

A pooled analysis of more than 154,000 people across 23 randomized trials found no significant increase for 62 of 66 side effects listed on statin labels, with only small absolute rises observed for a few measures such as abnormal liver blood tests.

Researchers pooled data from over 154,000 participants in 23 randomized trials that lasted at least two years to examine side effects reported for statin drugs. Nineteen trials compared commonly used statins with placebo and four compared more intensive versus less intensive statin therapy. The team reported that most listed adverse effects did not occur more often with statins than with placebo. Known rare harms such as myopathy were confirmed to be uncommon, and small increases in blood sugar were observed. Key findings: - The analysis combined data from more than 154,000 participants in 23 randomized trials of at least two years' duration. - Only 4 of 66 side effects listed on product labels showed slightly higher odds with statins; for 62 listed effects there was no significant difference between statin and placebo groups. - Myopathy (a muscle disorder) was estimated at about 1 in 10,000 patients per year, mostly in the first year, and small increases in blood sugar were noted. - Small absolute increases were reported for some laboratory measures: about 0.1% for abnormal liver blood tests, about 0.3% for certain urine changes, and about 0.07% for edema. - Representatives from Oxford and the British Heart Foundation said the findings could reassure patients and clinicians, and some called on regulators to review package inserts. Summary: The analysis indicates that for most people the benefits of statins in reducing heart attack and stroke risk outweigh small or unproven harms for many listed side effects. Authors and health groups said the evidence may reassure patients and clinicians and could prompt regulators to review package inserts. Regulatory action is possible but undetermined at this time.