Abstract

STATIN THERAPY: A PROSPECTIVE EVALUTION IN SAFETY PROFILE

A. Farsena*, Dr. C. I. Sajeeth and Dr. Anoop Gopinath

ABSTRACT

Aim and Objective: To report the adverse events (AEs) associated with statin use, their causality assessment by using Naranjo scale thereby evaluating the safety profile. Materials and Method: The study involving 212 patients were conducted as a hospital based prospective study over a period of 5 months. A total of 212 cases were included in this study. Outpatients of both gender and of age 30 years and above with statin therapy, Patients prescribed with statin for more than 45days. The details on demographic characteristics and patients were enquired about any adverse events linked to the statin therapy using questionnaire. Causality assessment for adverse events was done by using Naranjo causality assessment scale. Results: Adverse events are reported as 79% in the study population. 44% of the AEs are reported in the age group of 60-69. Majority of adverse events were reported in Atorvastatin 57%. 33% of the adverse event was Myalgia followed by Constipation(17%), Fatigue(15%), Hyperglycemia(12%), Flatulence(10%), Dizziness(6%), Weight Loss (5%), and Cognitive Problems (1%). The causality assessment of adverse events by Naranjo scale revealed that 79% of ADR was possible, 19% was probable and 1% is definite (Table 8, Fig 6). Conclusion: Myalgia and Hyperglycemia is the reported AEs which required laboratory monitoring. Rosuvastatin reported high adverse events; hence prescribing Atorvastatin can be initiated over Rosuvastatin in possible conditions. Observation of safety profile can be

Keywords: followed in clinical practice and special attention can be given in the patients belonging to definite and probable.