PMID- 27520479
OWN - NLM
STAT- MEDLINE
DCOM- 20170206
LR  - 20221207
IS  - 1755-5922 (Electronic)
IS  - 1755-5914 (Print)
IS  - 1755-5914 (Linking)
VI  - 34
IP  - 6
DP  - 2016 Dec
TI  - Safety of atorvastatin in Asian patients within clinical trials.
PG  - 431-440
LID - 10.1111/1755-5922.12214 [doi]
AB  - 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 (AEs) and serious AEs (SAEs) 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 AEs/SAEs were infrequent 
      (2.0% across all doses). These observations were confirmed in the long-term 
      trials. Treatment-related SAEs 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 (>3x the upper limit of normal) in 
      liver transaminases were observed in ~2% of Asian patients receiving 
      atorvastatin; renal AEs occurred in <2%. CONCLUSION: The incidence of AEs/SAEs 
      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.
CI  - (c) 2016 The Authors Cardiovascular Therapeutics Published by John Wiley & Sons 
      Ltd.
FAU - Chan, Juliana C N
AU  - Chan JC
AD  - Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and 
      Obesity, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin 
      NT, Hong Kong SAR, China.
FAU - Kong, Alice P S
AU  - Kong AP
AD  - Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and 
      Obesity, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin 
      NT, Hong Kong SAR, China.
FAU - Bao, Weihang
AU  - Bao W
AD  - Pfizer Inc, New York, NY, USA.
FAU - Fayyad, Rana
AU  - Fayyad R
AD  - Pfizer Inc, New York, NY, USA.
FAU - Laskey, Rachel
AU  - Laskey R
AD  - Pfizer Inc, New York, NY, USA.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Cardiovasc Ther
JT  - Cardiovascular therapeutics
JID - 101319630
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - A0JWA85V8F (Atorvastatin)
SB  - IM
MH  - Aged
MH  - Asia
MH  - *Asian People
MH  - Atorvastatin/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Drug-Related Side Effects and Adverse Reactions/ethnology
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage/adverse 
      effects
MH  - Male
MH  - Middle Aged
MH  - Patient Safety
MH  - *Patient Selection
MH  - Randomized Controlled Trials as Topic/*methods
MH  - *Research Subjects
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5129583
OTO - NOTNLM
OT  - Adverse event
OT  - Asian
OT  - Atorvastatin
OT  - Cardiovascular disease
OT  - Data pooling
OT  - Hyperlipidemia
EDAT- 2016/08/16 06:00
MHDA- 2017/02/07 06:00
PMCR- 2016/11/30
CRDT- 2016/08/14 06:00
PHST- 2016/08/16 06:00 [pubmed]
PHST- 2017/02/07 06:00 [medline]
PHST- 2016/08/14 06:00 [entrez]
PHST- 2016/11/30 00:00 [pmc-release]
AID - CDR12214 [pii]
AID - 10.1111/1755-5922.12214 [doi]
PST - ppublish
SO  - Cardiovasc Ther. 2016 Dec;34(6):431-440. doi: 10.1111/1755-5922.12214.