Predictors of the Common Adverse Drug Reactions of Statins

Abstract

Statins are common lipid lowering agents to reduce elevation of cholesterol or as prophylaxis against other cardiac diseases. It estimated that 62.5% to 91.7% of dyslipidemic patients in United State of America are using statins1 These agents widely used among cardiovascular patients in Malaysia2. In other countries, for example in UK, it has found that most patients who use statins are older than 35 years old and more of them are males (56%)3. In Canada, about 90% of cardiac patients are using statin, while in US, at least one third of all cardiac patients are using statins4. About 60% of American patients who older than 60 years old are using statin5. Thus, high number of users contributed to increase the risk of adverse drug reactions (ADRs). The Food and Drug Administration (FDA) has determined that common statin-associated ADRs are fatigue, muscle pain, joints pain, back pain, visual disturbance and insomnia6,7. Previous studies have examined the incidence of these ADRs, and their results showed that more than half of the reported cases of muscle pain were related to statin use8,9. Clearfield et al found that fatigue, muscle pain, and bone pain were common and frequent ADRs in UK, and related to atorvastatin and rosuvastatin use10. Other studies exploring ADRs in patients using atorvastatin and lovastatin in the US found that muscle pain and fatigue were the most common statin-related ADRs11. The UK Committee on Safety of Medicines, as well as other studies, have reported that these symptoms should consider as early signs for more serious ADRs8,12-15. However, from our knowledge, no data available on the common ADRs statin-related and their predictors for Asian patients. Only a few studies (not related with Asian patients) have found out the predictors of the statin-related ADRs8,9,10,16,17. As health care professional, they should find methods to ensure patients not only receive effective medication but also feel comfortable with the therapy. Thus, the objectives of this study was to determine the common statin-related ADRs and their predictors in one of the referral hospital in Malaysia (one of country in South East Asia).