Imperial College London
Dr Ajay K Gupta

Dr Ajay K Gupta

Faculty of Medicine, National Heart & Lung Institute

Honorary Clinical Senior Lecturer
 
 
 
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Contact

 

+44 (0)20 7594 3437a.k.gupta Website

 
 
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Location

 

ICCH59/61 North Wharf RoadSt Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Gupta:2017:10.1016/S0140-6736(17)31075-9,
author = {Gupta, A and Thompson, D and Whitehouse, A and Collier, T and Dahlof, B and Poulter, N and Collins, R and Sever, P},
doi = {10.1016/S0140-6736(17)31075-9},
journal = {Lancet},
pages = {2473--2481},
title = {Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase},
url = {http://dx.doi.org/10.1016/S0140-6736(17)31075-9},
volume = {389},
year = {2017}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundIn blinded randomised controlled trials, statin therapy has been associated with few adverse events (AEs). By contrast, in observational studies, larger increases in many different AEs have been reported than in blinded trials.MethodsIn the Lipid-Lowering Arm of the Anglo-Scandinavian Cardiac Outcomes Trial, patients aged 40–79 years with hypertension, at least three other cardiovascular risk factors, and fasting total cholesterol concentrations of 6·5 mmol/L or lower, and who were not taking a statin or fibrate, had no history of myocardial infarction, and were not being treated for angina were randomly assigned to atorvastatin 10 mg daily or matching placebo in a randomised double-blind placebo-controlled phase. In a subsequent non-randomised non-blind extension phase (initiated because of early termination of the trial because efficacy of atorvastatin was shown), all patients were offered atorvastatin 10 mg daily open label. We classified AEs using the Medical Dictionary for Regulatory Activities. We blindly adjudicated all reports of four prespecified AEs of interest—muscle-related, erectile dysfunction, sleep disturbance, and cognitive impairment—and analysed all remaining AEs grouped by system organ class. Rates of AEs are given as percentages per annum.ResultsThe blinded randomised phase was done between February, 1998, and December, 2002; we included 10180 patients in this analysis (5101 [50%] in the atorvastatin group and 5079 [50%] in the placebo group), with a median follow-up of 3·3 years (IQR 2·7–3·7). The non-blinded non-randomised phase was done between December, 2002, and June, 2005; we included 9899 patients in this analysis (6409 [65%] atorvastatin users and 3490 [35%] non-users), with a median follow-up of 2·3 years (2·2–2·4). During the blinded phase, muscle-related AEs (298 [2·03% per annum] vs 283 [2·00% per annum]; hazard ratio 1·03 [
AU  - Gupta,A
AU  - Thompson,D
AU  - Whitehouse,A
AU  - Collier,T
AU  - Dahlof,B
AU  - Poulter,N
AU  - Collins,R
AU  - Sever,P
DO  - 10.1016/S0140-6736(17)31075-9
EP  - 2481
PY  - 2017///
SN  - 0140-6736
SP  - 2473
TI  - Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase
T2  - Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(17)31075-9
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000403901800026&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/50011
VL  - 389
ER  -
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