Statins are a class of drugs used for reducing high cholesterol levels, typically prescribed to people at a high risk of heart disease or stroke. However, one complaint among users is the triggered muscle pains and related issues, with the statin side effects sometimes so severe that the patient stops taking it altogether.

Now, a new study analyzing about 500 individuals confirmed the muscle-related side effects of statins.

The trial, discussed at the 65th Annual Scientific Session of the American College of Cardiology, demonstrated that PCSK9 inhibitors, a new injectable class of drug, can effectively help manage cholesterol, serving as a viable option for patients who couldn’t tolerate statins.

According to the findings, 209 out of 491 subjects with previously reported muscle pain after taking at least two different statin drugs saw their muscle symptoms recur when they took statin, unlike when they were given a placebo.

“These findings provide unique insights into the challenging clinical problem of muscle symptoms in statin treated patients,” says Dr. Steven Nissen, trial lead author and chair of Cleveland Clinic's cardiovascular medicine.

The trial participants had extremely high LDL cholesterol levels averaging more than 210 mg/dL. While statins showed to be most effective, some patients said they had muscle weakness or pain while on statin therapy.

Controversy surrounds statins’ muscle-related side effects, as large randomized trials documented low symptom rates while observational research suggested that up to 20 percent of statin users experienced symptoms.

Nissen adds that statin intolerance continues to be puzzling, frustrating both cardiologists and patients since there are hardly any good, affordable alternative to the treatment.

The first phase of the trial involved a statin challenge, where subjects were administered 20 milligrams of atorvastatin or a placebo every day for a 10-week period. They were then switched over to take what they had not received in the first cycle – statin drug or placebo – for another 10 weeks.

About 42.6 percent of the patients reported muscle-related side effects during statin use, but not with placebo. However, 26.5 percent experienced muscle pain while taking the placebo – something not attributable to statin intake.

After this phase, those with confirmed statin intolerance were recruited in the second phase comparing PCSK9 inhibitor evolocumab – administered via self-injection – and ezetimibe, which decreased the absorption of cholesterol in the small intestine.

After six months, the researchers saw a 50 percent reduction in cholesterol level in the evolocumab group versus the 17 percent in the ezetimibe group, with both newer medications causing muscle symptoms in only up to 30 percent of participants.

The researchers concluded that those who suffer muscle-related symptoms while on statin therapy may benefit from evolocumab as an alternative treatment to continue lowering their LDL or “bad” cholesterol.

The findings were published in the journal JAMA.

In the United Kingdom, the National Health Service did not recommend taking evolocumab if other cholesterol-lowering treatments are available. The final version of its draft guidance, however, may say something different sometime this year.

The U.S. Preventive Services Task Force (USPSTF), on the other hand, released new draft recommendations early this year that back low to moderate doses of statins for preventing first-time heart attack or stroke in high-risk adults.

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