CHICAGO — Individuals taking atorvastatin were twice as likely to report symptoms of myalgia as compared with individuals taking placebo, according to study findings presented at the American College of Cardiology’s 61st Scientific Sessions.
Researchers for the blinded, controlled Effect of Statins On Skeletal Muscle Function and Performance (STOMP) study administered daily atorvastatin 80 mg (n=203) or placebo (n=217) to statin-naïve adults for 6 months or until they met the study criteria for myalgia. Half of the participants were women, and most were middle-aged and relatively healthy, Beth A. Parker, MD, of the department of preventive cardiology at Hartford Hospital, said during an oral session.
“We had a rigorous definition of myalgia for this cohort,” Parker said. “If patients reported new or increased muscle aches that were unassociated with recent exercise or physical activity and the symptoms persisted for at least 2 weeks, we entered them into the myalgia tree. They were then classified as [having] myalgia if the symptoms stopped within 2 weeks of stopping the study drug and then reoccurred after starting up again, thereby confirming myalgia through drug de-challenge and re-challenge.”
Twenty-three patients assigned to atorvastatin developed muscle symptoms, 19 of whom experienced symptoms after stopping treatment and then starting treatment again. Ten instances of myalgia were reported in the placebo group (P=.05 for comparison).
“In the atorvastatin group, the time to onset of symptoms was about 30 days,” Parker said. For placebo, the time to onset of symptoms was double that, around 60 days.”
The researchers found no significant changes in muscle strength or aerobic performance with atorvastatin vs. placebo.
“It is worth noting that, regarding myalgic outcomes, we saw significant decreases in many strength variables in the myalgic patients in the atorvastatin group. However, how specific this is to myalgia and statins remains unclear,” Parker said.
Other results showed a significant mean reduction in LDL of 59.1 mg/dL in the atorvastatin group, but no change in the placebo group (P<.01). Mild elevations in creatine kinase (mean, 20.8 U/L) and alanine aminotransferase (mean, 3.2 U/L) were reported in patients taking atorvastatin, but not in patients taking placebo (P<.01 for both). Compliance to drug therapy did not differ between the two groups (P=.44).
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Disclosure: Dr. Parker reports no relevant financial disclosures.