ADVERSE DRUG REACTION MONITORING OF ATORVASTATIN IN A TERTIARY CARE HOSPITAL.

Abstract

OBJECTIVE To study the incidence and pattern of adverse effects of Atorvastatin. To assess the severity of  adverse effects of Atorvastatin. METHODOLOGY This study included 100 patients with hyperlipidemia who were taking only Atorvastatin drug. Patients who were willing to participate in the study were given a questionnaire containing  demographic data and adverse drug profile of Atorvastatin. The adverse drug reaction was documented. The causality   assessment was done by WHO assessment scale and   severity assessment by using modified Hartwig seigel severity assessment scale. RESULTS In Our study, most of the  patients belong to 41-50 years age group. Among the 100   patients who were on Atorvastatin, 73 developed adverse drug reaction. Percentage of ADRs reported was more in patients with increased doses (more than 10mg) of atorvastatin. The most common adverse drug effects documented in our study was CNS disturbances(40) followed by GI disturbances(33), myopathy(23) and increased serum   transaminases(4). Most of the ADRs come under possible category using causality assessment scale. Severity assessment showed most of the ADRs come under moderate category. CONCLUSION Most of the patients who were   taking Atorvastatin had atleast one adverse drug reaction. The ADRs mostly belong to possible category and were moderate in severity. Early identification of these adverse             effects and proper dose adjustment will make the treatment safe and more effective.