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Statins do not increase risk of serious or minor symptomatic side-effects

Finegold JA, Manisty CH, Goldacre B, et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol. 2014;21:464-74.

Review question

Do statins have side-effects that cause symptoms?

Background

Cardiovascular disease is a major cause of death throughout the world. It includes diseases of the heart or blood vessels, such as coronary heart disease, high blood pressure, or deep vein thrombosis (blood clots in veins of the leg). Some cardiovascular disease is caused by an excess of some types of fat (cholesterol) in the blood.

People who have, or are at risk of, cardiovascular disease are often prescribed statins. These medications lower cholesterol levels in the blood and reduce risk of cardiovascular events such as heart attacks or strokes. Statins may also have side-effects that cause symptoms.

How the review was done

The researchers did a systematic review, searching for studies up to December 2012.

They found 29 randomized controlled trials with 83,880 people (average age 55 to 75 years).

The key features of the trials were:

• people had cardiovascular disease or were at risk of cardiovascular disease (e.g., people with diabetes or high cholesterol levels);
• people having kidney dialysis or who had an organ transplant were excluded;
• treatment was statins, including rosuvastatin (Crestor®), lovastatin (Altocor®, Altoprev®, Mevacor®), pravastatin (Pravachol®), atorvastatin (Lipitor®), fluvastatin (Lescol®) or simvastatin (Zocor®);
• treatment was compared with a placebo; and
• people in the trials did not know whether they were getting a statin or placebo during treatment.

What the researchers found

Compared with placebo:

• statins reduced heart attacks, strokes and death in people with or without prior cardiovascular disease;
• statins increased risk of diabetes; and
• statins did not increase risk of serious side-effects (i.e., those that were life-threatening, led to hospitalization, needed treatment, or resulted in death) or specific symptomatic side-effects including suicide, kidney disorders, cancer, muscle aches, back pain, headaches, insomnia, fatigue, nausea or gastrointestinal symptoms.

Conclusion

Statins reduce heart attacks, strokes and death and do not increase serious or minor symptomatic side-effects; they do slightly increase the risk of diabetes.

Statins vs placebo*

*CVD = cardiovascular disease (e.g., coronary heart disease, high blood pressure, blood clots in the leg).

†Effects that were life-threatening, led to hospitalization, needed treatment, or resulted in death.

‡Although the rates for the 2 groups look a little different, the differences were not statistically significant. This means that the differences could simply be due to chance rather than due to the different treatments.