Statin Induced Myopathy and Myalgia: Time Trend Analysis and Comparison of Risk Associated with Statin Class from 1991–2006

Abstract

BackgroundStatins are widely used as a cholesterol lowering medication, reduce cardiovascular mortality and morbidity in high risk patients; and only rarely cause serious adverse drug reactions (ADRs). UK primary care databases of morbidity and prescription data, which now cover several million people, have potential for more powerful analytical approaches to study ADRs including adjusting for confounders and examining temporal effects.MethodsCase-crossover design in detecting statin associated myopathy ADR in 93, 831 patients, using two independent primary care databases (1991–2006). We analysed risk by drug class, by disease code and cumulative year, exploring different cut-off exposure times and confounding by temporality.ResultsUsing a 12 and 26 week exposure period, large risk ratios (RR) are associated with all classes of statins and fibrates for myopathy: RR 10.6 (9.8–11.4) and 19.9 (17.6–22.6) respectively. At 26 weeks, the largest risks are with fluvastatin RR 33.3 (95% CI 16.8–66.0) and ciprofibrate (with previous statin use) RR 40.5 (95% CI 13.4–122.0). AT 12 weeks the differences between cerivastatin and atorvastatin RR for myopathy were found to be significant, RR 2.05 (95% CI 1.2–3.5), and for rosuvastatin and fluvastatin RR 3.0 (95% CI 1.6–5.7). After 12 months of statin initiation, the relative risk for myopathy for all statins and fibrates increased to 25.7 (95% CI 21.8–30.3). Furthermore, this signal was detected within 2 years of first events being recorded. Our data suggests an annual incidence of statin induced myopathy or myalgia of around 11.4 for 16, 591 patients or 689 per million per year.ConclusionThere may be differential risks associated with some classes of statin and fibrate. Myopathy related to statin or fibrate use may persist after a long exposure time (12 months or more). These methods could be applied for early detection of harmful drug side effects, using similar primary care diagnostic and prescribing data.

An Unusual Case of Statin-Induced Myopathy: Anti-HMGCoA Necrotizing Autoimmune Myopathy

“…Different statins have varied propensities for causing self-limited myopathy, with atorvastatin and simvastatin associated with higher rates of myopathy than rosuvastatin; however, there is no established association between specific statins and the occurrence of statin-associated necrotizing autoimmune myopathy. 17,18 Interestingly, our patient was on simvastatin with a normal CK for 10 years and only developed symptoms when transitioned to atorvastatin. In one series of 25 patients, 21 were taking atorvastatin at the time of the development of proximal muscle weakness, though this was likely a representation of prescribing practices and not necessarily indicative of an association between atorvastatin and increased risk of NAM.…”

Improving Adherence to Lipid-Lowering Therapy in a Community Pharmacy Intervention Program: A Cost-Effectiveness Analysis

“…33 Myopathy was more common, with an incidence rate of 0.69 per 1,000 patient-years, based on 4,002 cases in 5.8 million patient-years of statin use. 34 Myopathy was not assumed to be fatal, but both myopathy and nonfatal rhabdomyolysis were associated with a loss in quality of life as will be described. Noncardiovascular mortality rates were based on Dutch overall population data and were age and sex specific.…”

Hypolipidemic Effect of a Blue-Green Alga (Nostoc commune) Is Attributed to Its Nonlipid Fraction by Decreasing Intestinal Cholesterol Absorption in C57BL/6J Mice

“…[2][3][4] Although the drugs are effective in lowering plasma lipids, undesirable side effects are commonly observed with administration of the drugs. 5,6 Natural products, such as omega three fatty acids, dietary fibers, and polyphenols, have been shown to lower plasma LDL cholesterol and TG. [7][8][9][10] Blue-green algae (BGA) are photosynthetic microorganisms found in the aquatic ecosystem and have been consumed by humans as food and medicine for centuries.…”