December 11, 2012
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STOMP: Statin use increases muscle complaints

Data from the STOMP trial reveal that treatment with high-dose atorvastatin for 6 months did not decrease average muscle strength or exercise performance in healthy, statin-naïve individuals. However, results confirm that stain usage is associated with increased complaints of muscle pain and mild injury.

The blinded, controlled STOMP trial assessed symptoms and measures of creatine kinase, exercise capacity and muscle strength before and after treatment with atorvastatin 80 mg (Lipitor, Pfizer) or placebo for 6 months. The trial enrolled 420 healthy, statin naïve individuals who were recruited over 4 years.

Researchers found no significant changes in measures of muscle strength or exercise capacity after treatment with atorvastatin. Myalgia developed in more patients who used atorvastatin compared with placebo (19 vs. 10; P=.05). Fourteen variables were used to measure muscle strength. Patients with myalgia taking atorvastatin experienced decreased muscle strength in five variables and patients taking placebo experienced decreases in four variables (P=.69).

Twenty-three patients taking atorvastatin and 14 patients taking placebo reported new, unexplained muscle pain. Among all patients with myalgia, scores of pain severity and pain interference with daily life averaged 0.7 and 0.3 at baseline (out of a possible score of 10) and increased to 2.4 and 2 with treatment (P=.001); there was no difference between the atorvastatin and placebo groups (P=.37). Baseline pain severity and pain interference with daily life were similar for patients without myalgia taking both atorvastatin and placebo, and did not change with treatment.

The most common muscle complaints by patients with myalgia taking atorvastatin were leg symptoms, including hip flexor, quadriceps, hamstring and/or calf aches or fatigue. The most common complains by patients with myalgia taking placebo were whole body fatigue, worsening pain from previous injuries, groin pain and foot cramping.“STOMP is, to our knowledge, the first randomly assigned, double blind study designed to examine the effects of statins on muscular complaints, muscle strength and exercise performance,” Beth A. Parker, MD, of the division of cardiology, Henry Low Heart Center, Hartford Hospital, Conn., and colleagues wrote. “These results should prompt additional studies examining muscular performance with long term statin treatment in both healthy patients as well as those with confirmed statin-associated myalgia.”

For more information:

Parker BA. Circulation. 2012;doi:10.1161/​CIRCULATIONAHA.112.136101.

Disclosure:See the full study for a list of the researchers’ relevant financial disclosures.