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Real-world safety evaluation of topical corticosteroid use: A community pharmacy-based, prospective, observational study

 Young‐Mi Ah  ;  Sunghee Hwang  ;  Kwanghee Jun  ;  Soo An Choi  ;  Yun Mi Yu  ;  EunYoung Kim  ;  Do Young Kim  ;  Wan Gyoon Shin  ;  Ju‐Yeun Lee 
 Basic & Clinical Pharmacology & Toxicology, Vol.125(4) : 405-413, 2019 
Journal Title
 Basic & Clinical Pharmacology & Toxicology 
Issue Date
adverse drug event ; observational study ; prospective ; safety evaluation ; topical corticosteroid ; utility pattern
Considering the concerns about topical corticosteroid (TC) phobia that prevents necessary use of patients from using the necessary TCs, estimating the incidence and characteristics of adverse drug events (ADEs) related to TCs in the real world is warranted. However, limited study investigated them. This prospective observational study aimed to assess the utility patterns and safety data related to TC use and predisposing factors among community-dwelling population. We included and prospectively observed the TC users through nationwide multi-centre observational cohort based on community pharmacies and dermatologic clinic. Among the enrolled 1175 over-the-counter and prescription TC users, a total of 1103 participants were included for the analysis. Inappropriate TC use was observed in 6.3%. The cumulative incidence and prevalence of overall ADE for 6 months were 3.5% and 7.2%, respectively, and the incidence rate was 0.3 cases per 1000 person-days of TC use. Most ADEs were local reactions, mainly skin atrophy and hyperpigmentation. Exposure to TCs for >12 weeks (adjusted odds ratio [aOR] 4.38, 95% confidence interval [CI] 2.23-8.63) and past experience of ADE (aOR 36.70, 95% CI 16.74-80.44) were identified as significant predictors of TC-related ADEs. The ADE incidence related to TCs was relatively low, and the real-world safety of using TCs in the general population might not be greatly concerning. However, some populations who are highly at a risk of ADEs should be closely monitored and made aware regarding the risk.
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1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영) ORCID logo https://orcid.org/0000-0002-0194-9854
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