Statin intolerance is real, researchers find

Statin intolerance is real, researchers find. Another (more costly) drug may get around the problem. – The Washington Post

Not everyone can take them, though; a significant number of people complain of muscle pain, weakness and cramping so severe that they discontinue the therapy even at the risk of a heart attack or stroke.

Their resistance to the medication has been controversial, because in most cases there are no biomarkers for the muscle problems individuals describe.

Some researchers have speculated that the problem is psychological, the “nocebo” effect of blaming the medication for the pain.

This blaming of any negative symptoms on  “psychological factors” has become a common response and it must stop.  

Researchers found that 42.6 percent of people who had complained of muscle pain while taking at least two different statins experienced the same symptoms when given a statin during the study but had no ill effects when administered a placebo

They were then able to reduce their LDL cholesterol levels by more than half when given a PCSK9 inhibitor, evolocumab, for 24 weeks, compared with just a 16.7 percent reduction on ezetimibe, another medication.

In addition to requiring FDA approval, the drugs are much more expensive — from $10,000 to $15,000 a year.

And because evidence of statin intolerance is largely subjective, insurance companies may balk until there are ways to more conclusively prove that patients are unable to take the cheaper drugs.

Just like with pain, our medical system seems to be rejecting the validity of any symptom that can’t be seen and measured.

The vast majority of painful symptoms are much more complex and subtle than can be determined by taking measurements.

In Nissen’s study, 491 people who were unable to tolerate various kinds or doses of statins were given atorvastatin (Lipitor) or a placebo at 53 research sites around the world. Their ages ranged from 18 to 80, and they had heart disease, high LDL cholesterol or other risk factors for cardiovascular problems. Overall, 209 suffered side effects from the statins and were put on either evolocumab or ezetemibe (Zetia).

The PCSK9 inhibitor works by blocking a substance that hinders the liver’s ability to remove cholesterol from the blood.

Ezetemibe, by contrast, decreases cholesterol absorption in the small intestine.

The monthly injections of the PCSK9 inhibitor proved far more effective after 24 weeks, cutting patients’ LDL cholesterol by an average of 52.8 percent, compared with 16.7 percent for the other drug.

In another study released Sunday morning, researchers showed that a drug that raises HDL cholesterol, often called good cholesterol, and lowers LDL cholesterol does not help high-risk heart patients.

In fact, the study of more than 12,000 people was cut short after the results revealed that the drug, evacetrapib, did not prolong the time until death, heart attack, stroke, coronary artery bypass surgery or hospitalization for chest pain due to restricted cardiac blood flow.

It was the third failure for drugs in a class known as cholesteryl ester transferprotein (CETP) inhibitors, which disrupt the process by which HDL cholesterol is converted to LDL cholesterol, the ACC said in a release.

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