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Analysis of National Pharmacovigilance Data Associated with Statin Use in Korea
Author(s) -
Kim Hyunah,
Kim Namhyo,
Lee Da Hee,
Kim HunSung
Publication year - 2017
Publication title -
basic and clinical pharmacology and toxicology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.805
H-Index - 90
eISSN - 1742-7843
pISSN - 1742-7835
DOI - 10.1111/bcpt.12808
Subject(s) - myalgia , medicine , pharmacovigilance , rosuvastatin , adverse effect , statin , drug reaction , atorvastatin , pediatrics , drug , pharmacology
Abstract The aim of this study was to evaluate clinical manifestations, age distribution and risk factors of adverse drug reactions ( ADR s) of statins. Korean Adverse Event Reporting System ( KAERS ) database records (July 2009–June 2014) on statin‐treated adults were used. ADR s classified as ‘certain’, ‘probable’ and ‘possible’ based on the WHO ‐Uppsala Monitoring Centre criteria were analysed. The frequency of ADR s was compared between adults (18–64 years) and older people (age ≥65 years) groups. In total, 2161 ADR s from 1690 patients (579, 34.3% older people) were included for analysis. Mean patient age and ADR s per patient were 60.46 ± 12.72 years and 1.28, respectively. ADR s were reported with atorvastatin (48.4%), rosuvastatin (23.0%), pitavastatin (10.4%) and simvastatin (9.1%). The frequent ADR s were gastrointestinal (421 events, 19.5%), musculoskeletal (331, 15.3%), skin (312, 14.4%) and hepatobiliary disorders (286, 13.2%). Skin disorders were significantly more frequent in adults compared to those in older patients (16.3% versus 12.4%, p = 0.021). Common clinical symptoms were myalgia (263 events, 12.2%), dyspepsia (133, 6.2%) and pruritus (103, 4.8%). Myalgia was more frequently reported in adults (12.7% versus 9.5%, p = 0.039) and dizziness was more frequent in older people (3.4% versus 5.8%, p = 0.015). According to KAERS data, leading statin ADR s were gastrointestinal and musculoskeletal disorders. Myalgia and dyspepsia were the common clinical symptoms.