MD Conference Express EASD 2012 - (Page 12)
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ORIGIN Trial: Insulin Glargine and n-3 Fatty Acids Neither Reduces CV Events Nor Increases Cancers in Diabetic Patients
Written by Rita Buckley
Insulin glargine used to target normal fasting glucose for more than 6 years had a neutral effect on cardiovascular (CV) outcomes and cancers in high-risk patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or early diabetes. Although it reduced new onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight in the Outcome Reduction with Initial Glargine Intervention Trial [ORIGIN Trial Investigators. N Engl J Med 2012]. In the same trial, daily supplementation with n-3 fatty acids did not reduce CV events. Hertzel C. Gerstein, MD, MSc, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada, reported the main results from the study. The international double-blind trial with a 2x2 factorial design included 12,537 patients with diabetes (88%) or with IFG and/or IGT but no diabetes (12%) randomized to receive insulin glargine (with a target fasting blood glucose level of ≤95 mg/dL) or standard care. Participants also received a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily. The coprimary outcomes of the insulin glargine versus standard care arm were nonfatal myocardial infarction, nonfatal stroke, or death from CV causes, and these events plus revascularization or hospitalization for heart failure. Microvascular outcomes, incident diabetes, hypoglycemia, weight gain, and cancers were also compared between the two groups. The primary outcome in the n-3 fatty acids arm was death from CV causes. The median follow-up was 6.2 years. Rates of incident CV outcomes were similar in the glargine and the standard care groups: 2.94 and 2.85 per 100 person-years, respectively, for the first coprimary outcome (MI, stroke, or CV death; HR, 1.02; 95% CI, 0.94 to 1.11; p=0.63) and 5.52 and 5.28 per 100 person-years, respectively, for the second coprimary outcome (MI, stroke, CV death, revascularization, heart failure; HR, 1.04; 95% CI, 0.97 to 1.11; p=0.27). Differences in the incidence of any cancer were not significant (HR, 1.00; 95% CI, 0.88 to 1.13; p=0.97). Among patients receiving n-3 fatty acids versus placebo, the incidence of primary outcome was not significantly decreased (574 patients [19.1%] vs 581 patients [9.3%]; HR, 0.98; 95% CI, 0.87 to 1.10; p=0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients vs 1017 patients; HR, 1.01; 95% CI, 0.93 to 1.10; p=0.81), death from any cause (951 vs 964; HR, 0.98; 95% CI, 0.89 to 1.07; p=0.63), or death from arrhythmia (288 vs 259; HR, 1.10; 95% CI, 0.93 to 1.30; p=0.26; Figure 1). Triglyceride levels were reduced by 14.5 mg/dL more among patients receiving n-3 fatty acids versus placebo (p<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups [ORIGIN Trial Investigators. N Engl J Med 2012].
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November 2012
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Table of Contents for the Digital Edition of MD Conference Express EASD 2012
MD Conference Express EASD 2012
Contents
Understanding Incretin Hormone Action and the Treatment of Diabetes
New ADA/EASD Guidelines Focus on Patient-Centered Care
ORIGIN Trial: Insulin Glargine and n-3 Fatty Acids Fail to Reduce CV Events in Diabetic Patients
Exenatide Once Weekly Sustained Improvement in Glycemic Control with Weight Loss Through 4 Years
DiaPep277® Shows Promise as a Therapeutic Strategy for T1DM
Linagliptin Proves Safe and Effective as Add-on Therapy to Basal Insulin
12-Week Treatment with LY2409021 Significantly Lowers HbA1C and Is Well Tolerated in Patients with T2DM
Insulin Degludec Is Superior to Sitagliptin in Improving Glycemic Control in Uncontrolled Patients with Type 2 Diabetes on Oral Agents
Dapagliflozin Does Not Impact Renal Function in Patients with T2DM
Population-Based Screening for T2DM:The ADDITION-Cambridge Trial
The Challenges of Pharmaceutical Management of Painful Diabetic Peripheral Neuropathy
Enterovirus Infection
Novel Oral Agents
GLP-1
Genetics
Renal Denervation
Hypertension and Renal Function Are Risk Factors for CAD in T1DM
MD Conference Express EASD 2012
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