Atorvastatin in factorial with omega-3 EE90 risk reduction in diabetes (AFORRD): A randomised controlled trial

Holman, R. R., Paul, S., Farmer, A., Tucker, L., Stratton, I. M., Neil, H. A. W. and on behalf of the AFORRD study group (2009) Atorvastatin in factorial with omega-3 EE90 risk reduction in diabetes (AFORRD): A randomised controlled trial. Diabetologia, 52 1: 50-59. doi:10.1007/s00125-008-1179-5


Author Holman, R. R.
Paul, S.
Farmer, A.
Tucker, L.
Stratton, I. M.
Neil, H. A. W.
on behalf of the AFORRD study group
Title Atorvastatin in factorial with omega-3 EE90 risk reduction in diabetes (AFORRD): A randomised controlled trial
Journal name Diabetologia   Check publisher's open access policy
ISSN 0012-186X
1432-0428
Publication date 2009-01-01
Sub-type Article (original research)
DOI 10.1007/s00125-008-1179-5
Volume 52
Issue 1
Start page 50
End page 59
Total pages 10
Place of publication Heidelberg, Germany
Publisher Springer
Language eng
Subject 1117 Public Health and Health Services
Formatted abstract
Aims/hypothesis
The aim of the study was to examine the impact of statin or omega-3-acid ethyl esters 90 (omega-3 EE90; omega-3-acid ethyl esters 90 refers to a mixture of ethyl esters of n-3 fatty acids) on estimated cardiovascular disease (CVD) risk in community-based people with type 2 diabetes but without known CVD and not taking lipid-lowering therapy.

Methods

A central computer randomised 800 patients in 59 UK general practices to atorvastatin (n = 401, 20 mg/day) or placebo (n = 399) and omega-3 EE90 (n = 397, 2 g/day) or placebo (n  = 403) in a concealed factorial manner. Participants with LDL-cholesterol <2.6 mmol/l, triacylglycerol <1.5 mmol/l and estimated 10-year CVD risk <20% were compared at 4 months.

Results

Mean (SD) age was 63.5 (11.7) years, HbA1c 6.9 (1.1) % and known diabetes duration (median [interquartile range]) was 4 (2–8) years. Fifty-seven per cent were men, 90% white and 74% had an estimated 10-year CVD risk ≥20%. Of 732 patients with 4-month data, more allocated atorvastatin (n = 371) compared with placebo (n = 361) achieved LDL-cholesterol <2.6 mmol/l (91% vs 24%, p < 0.001) and had estimated 10-year CVD risks <20% (38% vs 26%, p < 0.001). No differences were seen between those allocated omega-3 EE90 (n = 371) compared with placebo (n = 361) for participants achieving triacylglycerol <1.5 mmol/l (65% vs 60%, p = 0.18) or estimated 10-year CVD risks <20% (34% vs 30%, p = 0.18). There were no side effects of note.

Conclusions/interpretation

Many community-based diabetic patients without known CVD remain at high CVD risk despite statin treatment and require additional risk-reduction strategies. The impact of omega-3 EE90 on CVD risk will remain uncertain until clinical endpoint trial results are available.

Keyword Atorvastatin
Cardiovascular risk
Omega-3 EE90
Primary care
n-3 polyunsaturated fatty acids
Type 2 diabetes
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Public Health Publications
 
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Created: Thu, 07 Jan 2010, 21:30:39 EST by Ms Lynette Adams on behalf of School of Public Health