Conference Coverage

ORIGIN: Glargine Doesn't Cut Cardiac Events

Publish date: June 14, 2012

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‘This Won’t Change Clinical Practice’

I think the findings definitively show that cardiovascular risk is not reduced by early insulin treatment. So this will not change the guidelines in any way. Also, insulin glargine did not appear to increase cancer risk. I think this will finally put to bed the insulin and cancer story. The hazard ratio was as close to unity as possible. It will certainly provide reassurance in many people’s minds.



Dr. Naveed Sattar

Whether early insulin use prevents diabetes is slightly interesting, but it’s not going to change anything in clinical practice. By 100 days, the difference in diabetes was less. People are wondering whether early insulin protects the pancreas, and I don’t think these data definitively confirm or refute that. From what we now know, the risks of early insulin – hypoglycemia and weight gain – are greater among those who don’t yet have diabetes.

The fish oil side is interesting. We would have liked to see a benefit in reducing cardiovascular death, which is what most people might have predicted. But the reality is that if you treat people with statins and ACE inhibitors, reduce their risk by those mechanisms, fish oil will provide no benefits above and beyond those things.

Dr. Naveed Sattar is professor of metabolic medicine at the University of Glasgow. He is on the advisory panel for AstraZeneca, Eli Lilly, Merck Sharp & Dohme, and Sanofi-Aventis.


 

FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION

The incidence of a first episode of severe hypoglycemia was 1.0 per 100 person-years in the glargine group versus 0.3 in the standard-care group (P less than .001). Rates of nonsevere hypoglycemia were 16.7 versus 5.2 per 100 person-years. The proportion of each group that experienced no symptomatic hypoglycemia was 43% with glargine versus 75% with standard care.

Participants in the glargine group gained a median weight of 1.6 kg, while those in the standard-care group lost a median of 0.5 kg.

In the n–3 fatty acid study arm, the incidence of the primary outcome, cardiovascular death, was 9.1% for those receiving the capsules versus 9.3% for those taking placebo at a median 6.2-year follow-up. Use of the supplements also had no impact on the rates of major cardiovascular events (16.5% vs. 16.3%, respectively), death from any cause (15.1% vs. 15.4%), or death from arrhythmia (4.6% vs. 4.1%).

However, use of n–3 fatty acids was associated with a greater reduction in triglyceride levels, 23.5 mg/dL, versus 9.0 mg/dL with placebo.

Several possibilities might account for the difference between these findings and those of previous large trials that have found a benefit of fish oil supplements. At least two of those trials used subjects with more severe cardiovascular disease. Also, ORIGIN participants were taking more concomitant medications for lowering cholesterol and blood pressure, noted Dr. Aldo P. Maggioni, director of the Research Centre, Italian Association of Hospital Cardiologists, Florence.

At least three other large trials are currently assessing the use of n–3 fatty acids to prevent cardiovascular disease in low-risk participants, Dr. Maggioni said.

According to Dr. Riddle, "Ninety years after insulin was first used to treat diabetes, we now know its long-term effect on important health outcomes. We believe the ORIGIN trial has added significantly to this understanding."

The ORIGIN study subjects will continue to be observed passively in an extension study called ORIGINALE (Outcome Reduction With an Initial Glargine Intervention and Legacy Effect).

The study was funded by Sanofi. Dr. Riddle is an adviser, consultant, or speaker for, and/or has received research support from, Amylin Pharmaceuticals, Eli Lilly, and Sanofi-Aventis. Dr. Gerstein has those same disclosures for Abbott Diabetes Care, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck, Novo Nordisk, Roche Pharmaceuticals, Sanofi-Aventis, and Janssen Biotech. Dr. Maggioni is a board member of Sanofi-Aventis and has received research support from Boehringer Ingelheim.

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