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Evidence Summary
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Key messages from scientific research that's ready to be acted on
Got It, Hide thisStatins 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*
| Outcomes | 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) | 5.8% | 8.0% | About 22 fewer people out of 1,000 had a heart attack |
|
| 8 trials (37,002 people without CVD) | 2.0% | 3.0% | About 10 fewer people out of 1,000 had a heart attack |
| Stroke | 7 trials ( 27,610 people with CVD) | 3.4% | 4.1% | About 7 fewer people out of 1,000 had a stroke |
|
| 8 trials ( 37,002 people without CVD) | 0.7% | 1.1% | About 4 fewer people out of 1,000 had a stroke |
| Death | 14 trials (39,080 people with CVD) | 13% | 14% | About 10 fewer people out of 1,000 died |
|
| 10 trials (43,124 people without CVD) | 3.1% | 3.6% | About 5 fewer people out of 1,000 died |
| Serious side-effects† | 5 trials (14,993 people with CVD) | 8.3% | 11% | No difference in effect‡ |
|
| 9 trials (38,257 people without CVD) | 14.8% | 14.9% | No difference in effect |
| Diabetes | 2 trials (20,640 without CVD) | 2.7% | 2.2% | About 5 more people out of 1,000 got diabetes |
Related Topics
Glossary
A fat-like substance with a soft, waxy texture.
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.
Studies where people are assigned to one of the treatments purely by chance.
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.
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