FREQUENCY OF ADVERSE EVENTS ASSOCIATED WITH STATIN USE IN ROUTINE CLINICAL PRACTICE IN PAKISTANI POPULATION

Objective: To evaluate the frequency of adverse events associated with statins use in routine clinical practice in Pakistani population. Methodology: This cross sectional study was conducted at PNS SHIFA a tertiary care hospital in Karachi, Pakistan from January 2015 to December 2015. Male and female patients aged between 20-80 years who were taking statin for more than 3 months and were willing to participate in the study were included. Demographic data like age, gender, medical morbidities e.g. diabetes mellitus, hypertension, ischemic heart disease, cerebrovasculr accident, type and dose of statin and outcome variables like hepatitis, myalgia, myositis and rhabdomyolysis were recorded in a performa. Sample size was calculated using open Epi software. Data was entered and analyzed using SPSS version 21.0. P < 0.05 was taken as significant. Results: A total of 1350 patients aged between 20-80 years of age(Mean age 55.7 +/- 10.2 years) were included in the study. There were 53.1 % male patients. Majority of patients (56.9%) were between 41-60 years of age group. About 58.2 % patients had diabetes mellitus.41.9% had hypertension,26 % patients had dyslipidimia, 88 % patients were with ischemic heart disease and 9.41 % patients had CVA. Rosuvastatin were prescribed to 56.3% patients, atorvastatin to 33% and simvastatin to 10.7% patients. Regarding the adverse effects, myalgias were most frequently reported in 6.7 % patients; myositis was noted in 0.8 % patients, while rhabdomyolysis was not reported in any patient. Statin induced hepatitis was noted in 2.9%. Conclusion: There is overall a low frequency of adverse events associated with the use of commonly prescribed statins in routine clinical practice. Further large scale studies are needed to validate our findings.