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PCSK9 Inhibitor Drug Evolocumab Offers Option To Reduce LDL Cholesterol In Statin Intolerant Patients

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Statin has revolutionized cardiovascular care providing patients with an effective and inexpensive means to reduce levels of LDL cholesterol, the so-called "bad cholesterol," in their bloodstream.

Not everyone can take statins, though. About one in five people who take the drug has to stop using it because of side effects such as muscle pain or weakness.

For those who are unable to take statins, however, findings of a new study reveal another alternative for the cholesterol-reducing drug that can be just as effective.

In the study published in JAMA, Steven Nissen, from the Cleveland Clinic, and colleagues have shown that a new injectable class of drug called PCSK9 inhibitors can effectively help people lower their LDL cholesterol. The treatment may possibly be more effective than currently available non-statin options.

Statin intolerance has been controversial because of the absence of biomarkers for the muscle problems that patients describe. Some speculate that the problem is psychological. The findings of the study, which was released on April 3, however, showed that statin intolerance is real.

The researchers involved more than 500 adults who have suffered from muscle problems when using statins in the past and confirmed their intolerance when they were given either a common statin or placebo.

The study found that about 200 of these patients had muscle problems only when they take statin and did not suffer from ill effects when they were given a placebo.

"This rigorously designed trial clearly shows that in carefully selected patients, statin intolerance withstands the placebo-controlled test," said Erik Stroes, from the Academic Medical Center (AMC) in Amsterdam. "These often high-risk patients truly experience muscle-related side effects while on statin therapy and may therefore benefit from an alternative treatment like evolocumab to lower their LDL cholesterol."

The researchers divided the study participants into two groups. Those in the first group were given the new PCSK9 inhibitor drug evolocumab while those in the other group were given the non-statin option ezetimibe.

After six months, those who received evolocumab showed about 50 percent drop in cholesterol level while those on ezetimibe only saw a reduction of 17 percent. The newer medications also only caused muscle symptoms in between 20 and 30 percent of the subjects.

"Among patients with statin intolerance related to muscle-related adverse effects, the use of evolocumab compared with ezetimibe resulted in a significantly greater reduction in LDL-C levels after 24 weeks," the researchers wrote. "Further studies are needed to assess long-term efficacy and safety."

The Food and Drug Administration (FDA) gave the green light to PCSK9 inhibitors last year, but only for those who have inherited a disease that dramatically increases bad cholesterol levels.

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