Risk of high-dose simvastatin
April 17, 2012
Seattle, WA - Statins were responsible for rhabdomyolysis in 7.5% of patients diagnosed with the skeletal muscle condition, according to a review of International Classification of Disease, Ninth Edition (ICD-9) codes from a large nonprofit healthcare system in Seattle, WA.
Publishing their findings as a letter to the editor in the Journal of the American Medical Association, Dr James Floyd (University of Washington, Seattle) and colleagues also confirmed a significantly higher risk of rhabdomyolysis in patients treated with high doses of simvastatin.
Incidence rates of statin-related rhabdomyolysis
| Statin | Person-years of use | Validated rhabdomyolysis cases, n | Incidence rates per 100 000 person-years |
| Simvastatin <20 mg/d | 21 832 | 0 | 0 |
| Simvastatin 20-39 mg/d | 75 082 | 4 | 5.3 |
| Simvastatin 40-79 mg/d | 56 703 | 8 | 14.1 |
| Simvastatin >80 mg/d | 16 876 | 1 | 64.8 |
| All doses | 170 605 | 23 | 13.5 |
| Other statins | 116 54 | 6 | 5.2 |
| All statins | 286 756 | 29 | 10.1 |
In total, 22 cases of statin-related rhabdomyolysis were validated among 292 statin users with an ICD-9 code for rhabdomyolysis (positive predictive value 7.5%). Seven other patients were confirmed as having statin-related rhabdomyolysis using other criteria. Overall, the risk of rhabdomyolysis was significantly elevated among patients treated with simvastatin. The incidence rate ratio (IRR) for simvastatin compared with other statins was 2.61 (95% 1.03-7.84) using all validated cases of rhabdomyolysis.
"These results confirm in a community setting findings from a recent clinical trial that prompted the US Food and Drug Administration to issue a warning about the use of high-dose simvastatin," write the researchers.
Source
- Floyd JS, Keckbert SR, Weiss SR, Carrel DS, Psaty BM. Use of administrative data to estimate the incidence of statin-related rhabdomyolysis. JAMA 2012; 307:1580-1583.
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