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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?


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.


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*


Number of trials and people

Rate of events with statins

Rate of events with placebo

Absolute effect of statins

Heart attack

11 trials (31,193 people with CVD)



About 22 fewer people out of 1,000 had a heart attack


8 trials (37,002 people without CVD)



About 10 fewer people out of 1,000 had a heart attack


7 trials ( 27,610 people with CVD)



About 7 fewer people out of 1,000 had a stroke


8 trials ( 37,002 people without CVD)



About 4 fewer people out of 1,000 had a stroke


14 trials (39,080 people with CVD)



About 10 fewer people out of 1,000 died


10 trials (43,124 people without CVD)



About 5 fewer people out of 1,000 died

Serious side-effects†

5 trials (14,993 people with CVD)



No difference in effect‡


9 trials (38,257 people without CVD)



No difference in effect


2 trials (20,640 without CVD)



About 5 more people out of 1,000 got diabetes

*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.


Coronary heart disease
Also known as coronary artery disease (CAD), is a narrowing of the blood vessels (coronary arteries) that supply oxygen and blood to the heart.
Related to the stomach and the intestines (bowels).
A harmless, inactive, and simulated treatment.
Randomized controlled trials
Studies where people are assigned to one of the treatments purely by chance.
Systematic review
A comprehensive evaluation of the available research evidence on a particular topic.
The body's network of blood vessels. It includes the arteries, veins, and capillaries that carry blood to and from the heart.

Related Web Resources

  • Coronary artery disease risk screening

    Health Link B.C.
    Men over 40 and women past menopause or over 50 should get screened for coronary artery disease (CAD) every 1 to 3 years. Your risk is higher if you have diabetes, high blood pressure, abdominal obesity, kidney disease, family history of CAD or if you smoke.
  • High cholesterol: Does reducing the amount of fat in your diet help?

    Informed Health Online
    Eat less saturated fats in your diet to help prevent heart disease. Eat less meat, butter, cheese and cream to improve your health long-term.
  • Statins: Should I Take Them to Prevent a Heart Attack or Stroke?

    This patient decision aid helps people considering taking medicines called statins to lower their risk of heart attack and stroke by comparing the benefits, risks, and side effects of both options. It also includes alternative treatment options to taking statins such as trying to lower risk with lifestyle changes.
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