Most patients who report statin intolerance can actually tolerate drugs on subsequent trials

Most patients who report statin intolerance, including muscle aches and other side effects from the cholesterol-lowering drugs, can actually tolerate drugs from this class on subsequent trials, according to research from Cleveland Clinic recently released online and forthcoming in the September issue of the American Heart Journal. The study is the largest ever to examine the effects of re-challenging statin-intolerant patients.

Statins are among the most prescribed drugs in the world and are a first-line, highly effective therapy for patients with high cholesterol, which is a major risk factor in the development of cardiovascular disease. Statins have been shown to reduce cholesterol levels by as much as 20 to 40 percent at the lowest dose level. However, in clinical trials, about 5 to 10 percent of patients have been reported as suffering from statin-related side effects like muscle pain and liver enzyme abnormalities, making them statin intolerant. In observational studies - which often incorporate patients not typically selected for clinical trials, including older patients, more women, and those with comorbidities - the rate of statin intolerance is as high as 20 percent.

In these patients, physicians often try intermittent dosing of statins, instructing patients to take the medication every other day, for instance, instead of daily, to reduce side effects.

Researchers, led by Leslie Cho, M.D., Section Head of Preventative Cardiology and Rehabilitation in the Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic, analyzed the electronic medical records of 1,605 patients who were referred to Cleveland Clinic for statin intolerance between January 1995 and March 2010.

Dr. Cho and her colleagues found that 72.5 percent of patients who were previously reported to be intolerant to two or more statins were able to take drugs from the class on subsequent trials when they were overseen in Cleveland Clinic's preventative cardiology clinic and had their statin regimen carefully restarted. Further, 63.2 percent of previously statin-intolerant patients were able to tolerate a daily statin regimen, with only 9.3 percent going on intermittent statin therapy. While those patients who remained on a daily dose of statin saw their cholesterol lowered to a greater extent than those on intermittent statin dosing, Dr. Cho and her colleagues found that the intermittent group did benefit significantly from the statin therapy.

"Our study shows that patients who have experienced statin intolerance should, under the close care of their physician, continue to try other drugs in this class because there is a very good chance that they will eventually be able to tolerate long-term use of a statin and benefit from its cholesterol-lowering effects," said Dr, Cho. "Even if patients cannot tolerate a daily dose of a statin, it's possible to see a significant reduction in cholesterol levels from taking the drug less often, even as infrequently as once a week."

Still, Dr. Cho points out that, given how widely statins are prescribed, it's important to note that almost 30 percent of the patients in the study remained statin intolerant and required alternative therapies to treat their high cholesterol.