Statins are the treatment of choice for dyslipidemia, primarily lowering elevated LDL-C levels and reducing the occurrence of major cardiovascular events.
In June 2011, the FDA ( Food and Drug Administration ) issued a warning regarding the use of high-dose Simvastatin 80 mg and its risk of myopathy.
The incidence of myalgia, myopathy, and rhabdomyolysis was analyzed in a veteran population prescribed Simvastatin 80 mg.
Risk factors for myalgia were examined and compared with the results of recently published studies.
This was a retrospective medical record review of 450 patients who were prescribed Simvastatin 80 mg at the Veterans Affairs Western New York Healthcare System during the period 2006-2011.
Records were examined for evidence of myalgia, myopathy ( incipient or definite ), and rhabdomyolysis.
Variables that may have contributed to the development of myalgia were also collected and analyzed.
Myalgia was reported by 50 patients ( 11.1% ), whereas rhabdomyolysis developed in 1 patient ( 0.22% ). No patient fit the criteria for myopathy ( incipient or definite ).
Myalgia was statistically more likely to occur in younger patients, patients with a history of myalgia, and patients with low vitamin D levels.
The mean vitamin D level in patients experiencing myalgia was 26.2 versus 36.3 ng/mL.
The 25-hydroxyvitamin D level in those who reported myalgia was approximately 10 ng/mL lower compared with those who tolerated Simvastatin 80 mg ( P = 0.0003 ).
There was no statistically significant association between length of therapy and development of myalgia.
In conclusion, a lower incidence of adverse muscle events with high-dose Simvastatin 80 mg was found in patients with higher vitamin D levels, suggesting that correction of 25-hydroxyvitamin D levels before statin therapy initiation may mitigate one risk factor in the development of statin-related myalgia.
Vitamin D insufficiency appears to be a risk factor for the development of myalgia. ( Xagena )
Mergenhagen K et al, Clin Ther 2014; 36: 770-777