September 25, 2013
Largest Study Yet: Most Can Tolerate Statins Despite
Initial Side Effects

Cleveland—In the largest study to date examining rechallenge in statin intolerance, Cleveland Clinic researchers found that most patients reporting side effects, including muscle aches, can do okay with that class of cholesterol-lowering drugs when they try again.

Background in the study, published online by the American Heart Journal, points out that about 5% to 10% of patients are statin intolerant and suffer adverse effects, such as muscle pain and liver enzyme abnormalities. The rate of statin intolerance can be as high as 20% in some observational studies, which often include older participants, women and those with comorbidities, the report notes.

One way prescribers respond to those concerns is by trying intermittent dosing of statins, such as every other day, according to the authors.

For the study, researchers analyzed the electronic medical records of 1,605 patients who were referred to Cleveland Clinic for statin intolerance between January 1995 and March 2010. They found that with oversight and careful resumption of statin treatment, 72.5% of patients who were previously reported to be intolerant to two or more statins were able to take drugs from the class.

Of those, 63.2% were able to tolerate a daily statin regimen, while just 9.3% required intermittent statin therapy to minimize side effects.

Patients on a daily dose of statin experienced greater lowering of cholesterol levels, but the intermittent group also benefited significantly from 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 Leslie Cho, MD, section head of Preventative Cardiology and Rehabilitation at Cleveland Clinic. “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.”

The 149 patients on intermittent statin dosing had significantly lower LDL reductions compared with the 1,014 patients in the daily-dosing group (21.3% ± 4.0% vs. 27.7% ± 1.4%, P < .04). Compared with the 442 participants in the statin-discontinued group, however, their LDL levels were substantially decreased (21.3% ± 4.0% vs. 8.3 ± 2.2%, P < .001), with higher percentages reaching their LDL-C Adult Treatment Panel III goal (61% vs. 44%, P < .05).

Furthermore, researchers found a trend toward a decrease in all-cause mortality at 8 years for patients on daily and intermittent statin dosing, compared with those who discontinued statins (P = .08).

While rechallenging with statins is effective for most patients, the authors caution that nearly 30% of the patients in the study remained statin-intolerant and required alternative therapies to treat their high cholesterol.

U.S. Pharmacist Social Connect