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Daily n-3 fatty acid supplements did not reduce CV events in high-risk patients with dysglycemia.
MedLine Citation:
PMID:  22986403     Owner:  NLM     Status:  In-Data-Review    
QUESTION In high-risk patients with dysglycemia, do n-3 fatty acid supplements reduce risk for cardiovascular (CV) events? METHODS DESIGN Randomized, 2 x 2 factorial, placebo-controlled trial (Outcome Reduction with an Initial Glargine Intervention [ORIGIN] trial). NCT00069784. ALLOCATION {Concealed}*.† BLINDING Blinded† (patients, {health care providers, data collectors}‡, and event adjudication committee). FOLLOW-UP PERIOD Median 6.2 years. SETTING 573 clinical centers in 40 countries. PATIENTS 12 611 patients ≥ 50 years of age (mean age 64 y, 65% men) who had CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes mellitus. Exclusion criteria included glycated hemoglobin (HbA 1c) level ≥ 9%, coronary artery bypass graft in the past 4 years with no subsequent CV event, severe heart failure, or cancer that could affect survival. INTERVENTION n-3 fatty acid supplement, 1 g/d in a single capsule containing eicosapentaenoic acid (EPA), 465 mg, and docosahexaenoic acid (DHA), 375 mg ( n = 6319); or placebo containing olive oil ( n = 6292). Patients were also randomized to insulin glargine or standard care. OUTCOMES Primary outcome was CV death. Other outcomes included a composite CV endpoint (CV death, nonfatal myocardial infarction, or nonfatal stroke), all-cause mortality, and death from arrhythmia. 12 500 patients were needed to detect an 18.6% relative risk reduction from 1.5% per year in CV death at ≥ 6 years of follow-up (90% power, 2-sided α = 0.05). PATIENT FOLLOW-UP 99% for the primary outcome (intention-to-treat analysis). MAIN RESULTS Daily n-3 fatty acid supplements did not reduce risk for CV death, a composite CV endpoint, all-cause mortality, or death from arrhythmia more than placebo (Table). CONCLUSION In high-risk patients with dysglycemia, daily n-3 fatty acid supplements did not reduce cardiovascular events more than placebo.n-3 fatty acid supplements vs placebo in high-risk patients with dysglycemia§Outcomesn-3 fatty acidsPlaceboAt a median 6.2 yRRR (95% CI)||NNT (CI)CV death9.1%9.3%2% (-9 to 12)Not significantAll-cause mortality15.1%15.4%2% (-6 to 10)Not significantRRI (CI)||NNH (CI)Composite CV endpoint¶16.5%16.3%1% (-6 to 9)Not significantDeath from arrhythmia4.6%4.1%10% (-7 to 29)Not significant§CV = cardiovascular; other abbreviations defined in Glossary. RRR, RRI, and CI calculated from control event rates and hazard ratios in article.||Stratified by factorial allocation, baseline diabetes status, and CV history.¶Includes CV death, myocardial infarction (5.5% vs 5.1%, P = 0.28), or stroke (5.0% vs 5.4%, P = 0.32).
Ellis Lader
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of internal medicine     Volume:  157     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-09-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  JC3-11     Citation Subset:  AIM; IM    
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