Researchers Performed Blinded Tests To Prove That Statin Intolerance Exists

While statins such as Lipitor and other generics are effective and inexpensive cardiovascular care to reduce LDL or bad cholesterol in the bloodstream, some patients are suffering from statin intolerance that causes several side effects.

Cleveland Clinic researchers did a blinded trial to confirm the presence of muscle-related symptoms in patients with statin intolerance through atorvastatin and a placebo. The test is also to see if evolocumab, a PCSK9 inhibitor is more effective than ezetimibe to lower the LDL cholesterol level,  EurekAlert reports.

The double-blinded, placebo-controlled clinical research has two phases:

Phase A has two groups of patients that were given atorvastatin or placebo for 10 weeks, and then moved to an alternative therapy for another 10 weeks. They were then asked to report any pain or weakness on the muscle.

The Phase B was where the patients from Phase A moved after reporting statin intolerance symptoms. These patients were given two alternative non-statin therapies, evolocumab and ezetimibe for 24 weeks.

"Statin intolerance has been a very challenging clinical problem," said Steven Nissen, M.D., chair of Cardiovascular Medicine at Cleveland Clinic. "The study showed that PCSK9 inhibitors can significantly lower cholesterol in patients with documented statin intolerance, providing an effective treatment for these difficult to manage patients."

The researchers found that 42.6 percent of the patients who reported the symptoms after taking the atorvastatin did not suffer any muscle pain after taking the placebo. This proves that the statin intolerance does really exist.

The PCSK9 inhibitor blocks a substance in the liver that hinders its ability to remove the LDL cholesterol from the blood. Ezetimibe, on the other hand, decreases the LDL cholesterol absorption in the small intestine, according to Washington Post.

The PCSK9 inhibitor's monthly injections decreased the patient's LDL cholesterol by half within 24 weeks. Ezetimibe reduced the LDL cholesterol by only 16.7 percent.