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EASD. Still No Heart Risks With Lantus in ORIGINALE, 8,5 year, follow-up after Origin.

EASD VIENNA — Insulin glargine (Lantus) continued to carry no increased risk of cardiovascular events compared with standard care in an extension of the ORIGIN trial, researchers reported here.

In the ORIGINALE study, which continued for an additional 2.5 years beyond the 6 years of the main study, there was no significant change difference between the two groups in terms of a composite cardiovascular endpoint, Herzel Gerstein, MD, of McMaster University in Canada, and colleagues reported here at the European Association for the Study of Diabetes meeting.

”The results are exactly the same as the ORIGIN trial,” which was presented 2 years ago at the American Diabetes Association meeting and simultaneously published in the New England Journal of Medicine, Gerstein said during a press briefing.

The trial was not designed, however, to look at cancer outcomes — which the ORIGIN study found no increased risk of with insulin glargine.

ORIGIN was comprised of two studies of patients with prediabetes and diabetes considered to be at high risk for cardiovascular disease. One compared insulin with standard care, and the other looked at whether supplementation with omega-3 fatty acids could reduce cardiovascular events compared with placebo.

Both trials came up neutral, and Gerstein and colleagues wanted to assess whether those results would hold with longer follow-up.

Of the 12,537 patients originally enrolled in ORIGIN, a total of 10,535 completed the study. Of those, 5,869 enrolled in the ORIGINALE (which stands for ORIGIN And Legacy Effects) study, which followed them for an additional 2.5 years.

Just as in ORIGIN, Gerstein and colleagues saw a neutral effect of insulin on the primary composite cardiovascular endpoint (HR 1.01, 95% CI 0.94 to 1.10, P=0.72). Nor was there any effect on cardiovascular death, heart attack, or stroke individually, they reported.

Similarly, omega-3 fatty acids had no effect on cardiovascular outcomes (HR 1.00, 95% CI 0.92 to 1.08, P=0.97) or on any of the individual endpoints.

”The trial continues to show that omega-3 fatty acids are neutral,” Gerstein said during the press briefing. ”In fact, all of the evidence around the world shows that if you take omega-3 capsules, you have no difference in health outcomes than if you do not. All you do is create expensive urine.”

Although there was no significant difference in the likelihood of new diabetes with insulin versus standard care, the researchers did find a significantly lower risk of ”new and possible” diabetes with insulin (OR 0.77, 95% CI 0.63 to 0.95, P=0.014).

The ”possible” cases could not be confirmed by adjudication criteria during the ORIGIN trial, Gerstein noted.

He concluded that targeting a normal fasting plasma glucose with basal insulin glargine for more than 6 years improves long-term metabolic status and has a neutral effect on serious health outcomes.

Primary source: European Association for the Study of Diabetes
Source reference: Punthakee Z, et al ”ORIGINALE: ORIGIN and Legacy Effects, Post-ORIGIN trial follow-up” EASD 2014. 

From www.medscapetoday.com

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