Open AccessSafety of atorvastatin in Asian patients within clinical trials
Author(s) -
Chan Juliana C. N.,
Kong Alice P. S.,
Bao Weihang,
Fayyad Rana,
Laskey Rachel
Publication year - 2016
Publication title -
cardiovascular therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.818
H-Index - 46
eISSN - 1755-5922
pISSN - 1755-5914
DOI - 10.1111/1755-5922.12214
Subject(s) - atorvastatin , medicine , incidence (geometry) , adverse effect , placebo , clinical trial , myalgia , rhabdomyolysis , pathology , physics , alternative medicine , optics
Summary Introduction Data on statin safety in Asian patients are limited compared with evidence from Western populations. Aim This study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials. Methods Data from 52 short‐term trials (median exposure 4–72 weeks) and six long‐term cardiovascular outcomes trials (median exposure 3.1–4.9 years) conducted across the atorvastatin 10–80‐mg dose range were analyzed retrospectively to assess the incidence of safety endpoints. Results A total of 77 952 patients were identified (49 974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short‐term trials, the incidence of all‐causality adverse events ( AE s) and serious AE s ( SAE s) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment‐related AE s/ SAE s were infrequent (2.0% across all doses). These observations were confirmed in the long‐term trials. Treatment‐related SAE s were rare (n = 4) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin‐treated Asian patients, and the incidence of myalgia was 1.8% in the short‐term studies and 6.7% in the long‐term trials. Elevations (>3× the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal AE s occurred in <2%. Conclusion The incidence of AE s/ SAE s with atorvastatin 10–40‐mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80‐mg is required owing to the limited number of Asian patients (n = 281; 11.2%) who received this dose.