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Statins: Risk of side effects is low, say experts

For most people who take statins to lower cholesterol, the risk of side effects is low compared to the benefits, according to a recent scientific statement.
pills and stethoscope against a pink and blue background
New research suggests that the benefits of statins outweigh the risks.

The American Heart Association (AHA) statement applies to those who — according to current guidelines — are at risk of heart attack and ischemic strokes, which are strokes arising from blood clots.

Statins are drugs that reduce low-density lipoprotein (LDL) cholesterol by blocking an enzyme in the liver.

Around a quarter of adults over the age of 40 years old in the United States use statins to reduce their risk of heart attack, ischemic stroke, and other conditions that can develop when plaque builds up in arteries.

However, up to 1 in 10 of individuals taking statins stop using them because they assume that the drug is responsible for symptoms that they experience, although that may not be the case.

"Stopping a statin," says Dr. Mark Creager, who is director of the Heart and Vascular Center at Dartmouth-Hitchcock Medical Center in Lebanon, NH, and former president of the AHA, "can significantly increase the risk of a heart attack or stroke caused by a blocked artery."

The journal Arteriosclerosis, Thrombosis, and Vascular Biology carries a full report on the research that went into the statement.

Within guidelines, 'benefits outweigh risks'

The statement's authors say that trials have proved that statins have had a major effect on reducing heart attacks, strokes, other cardiovascular diseases, and associated deaths.

Further to this, they reviewed a large number of studies and clinical trials that have evaluated the safety and potential adverse effects of statins.

"Over 30 years of clinical investigation," the authors write, "have shown that statins exhibit few serious adverse effects."

They point out that, apart from a few exceptions, it is possible to reverse the adverse effects of statin use. This should be compared, they argue, with the fact that heart attacks and stroke damage the heart or brain permanently, and they can kill.

They list the exceptions as "hemorrhagic stroke and the possible exception of newly diagnosed diabetes mellitus and some cases of autoimmune necrotizing myositis."

"Thus," they conclude, "in the patient population in whom statins are recommended by current guidelines, the benefit of reducing cardiovascular risk with statin therapy far outweighs any safety concerns."

According to the AHA, the current guidelines recommend the use of statins for the following groups:

Those who have experienced heart attack, stroke, transient ischemic attacks, or who have a history of cardiovascular conditions such as angina and peripheral artery disease. Adults aged 40–75 years old whose LDL cholesterol is in the 70–189 milligrams per deciliter (mg/dl) range and whose risk of having a heart attack or stroke in the next 10 years is 7.5 percent or above. Adults aged 40–75 years of age who have diabetes and whose LDL cholesterol is in the range 70–89 mg/dl. Anyone aged 21 years and older with a very high LDL cholesterol level of 190 mg/dl and above.
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'Muscle aches and pains'

People using statins who report side effects most often mention "muscle aches and pains."

However, the research that the statement's authors reviewed reveals that fewer than 1 percent of people who use statins "develop muscle symptoms that are likely caused by statin drugs."

Uncertainty about the causes of any aches and pains, coupled with the fact that they are taking statins, may prompt people to make a link where none exists.

The AHA say that if individuals stop taking their statins for this reason, they may be doing more harm than good by raising their risk of a cardiovascular event.

They urge healthcare providers to "pay close attention to their patients' concerns and help them assess likely causes." They could, for instance, check for blood markers of muscle damage. If they are normal, this could reassure their patients.

Another option is to check vitamin D levels, as insufficiency amounts can also cause muscle aches and pains.

Risk of diabetes and hemorrhagic stroke

There is a slight chance that statins might raise the risk of diabetes, especially in those at higher risk. These include individuals with obesity or whose lifestyle is largely sedentary.

The statement suggests that the absolute risk of being diagnosed with diabetes as a result of using statins is around 0.2 percent per year.

For those who already have diabetes, there could be a slight increase in the amount of glucose in the blood, as their HbA1c measure may reflect.

However, the increase is very small and should not prevent the use of statins, note the AHA.

The research that the statement reviewed did not find that statins increase the risk of a first hemorrhagic stroke, which is a type of stroke that occurs when a blood vessel ruptures.

People with a history of hemorrhagic stroke, on the other hand, may have a slightly higher risk of a further one if they use statins. However, this risk is very small and the overall benefits of statin use in reducing strokes and "other vascular events" outweighs it.

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Risk of other side effects

The statement's authors also looked at evidence that statin use might increase the risk of other conditions. These included damage to peripheral nerves, other neurological effects, damage to the liver, cataracts, and ruptures to a tendon.

They found, however, "little evidence" to support the idea that using statins raised the risk of these conditions.

In rare instances, there could be a side effect called rhabdomyolysis, which is a type of muscle injury that can lead to acute kidney failure. A sign of this can be passing dark urine, so if this happens people should stop taking their statins and see their doctor, say the AHA.

From the reviewed evidence, the statement suggests that rhabdomyolysis is a side effect in less than 0.1 percent of people taking statins.

"In most cases, you should not stop taking your statin medication if you think you are having side effects from the drug — instead, talk to your healthcare provider about your concerns."

Dr. Mark Creager

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