SAFETY EVALUATION OF STATIN IN YOGYAKARTA, INDONESIA

Background : The 3-hydroxy-3-methylglutaryl-coenzyme (HMG-Co-A) reductase inhibitors, also known as statins, are the most effective class of drugs for lowering serum Low-Density Lipoprotein cholesterol (LDL-c)concentrations. They are first-line agents for patients who require drug therapy to reduce serum LDL-c concentrations. Although these drugs have been very successful in managing the cardiovascular health of many patients, there are also potential adverse effects that have been identified. The most common adverse effects reported include muscle pain or weakness that can progress to rhabdomyolysis and mortality. If detected early, statin-related symptoms are reversible after withdrawal of the statin. Objective : This research was aimed to know the safety of statin used at Public Hospitals in Yogyakarta. Method : This research was observational study with retrospective data collected. The target population are all of diabetes mellitus, cardiovascular and stroke patients that recorded on the medical record of Public Hospitals in Yogyakarta during 2 months. Results : There were 28 patients who used simvastatin and 8 patients who used atorvastatin, experienced adverse effects of statins (n=157). Headache was the most adverse effect which was experienced by the patients. However rhabdomyolysis was not found in this reasearh. Interaction between simvastatin and nifedipine resulted more adverse effects such as headache, insomnia and abdominal pain than with other drugs. Conclusions : Simvastatin, rosuvastatin and atorvastatin were well tolerated use in Yogyakarta, Indonesia. Only 22.9% from 157 patients experienced the adverse effects of statin. Adverse effects because of the interaction between simvastatin and other drugs were experienced by 8.92% patients. The result of this study need to be confirmed with additional study with larger sample sizes and vigilant surveillance to abolish the toxicity of the statin