Saturday, May 18, 2013

ORIGIN – A Major Diabetes Study that Failed

By Dr. Bill Quick, Health Pro Thursday, June 14, 2012

 

The graphs showing these outcomes were shown on huge screens in the meeting room, and were spectacular, and it’s a bit of a shame that they can’t be reproduced here. (They are available at the NEJM website, at

http://www.nejm.org/action/showImage?doi=10.1056%2FNEJMoa1203858&iid=f02 for insulin and

http://www.nejm.org/action/showImage?doi=10.1056%2FNEJMoa1203859&iid=f02 for O3FA.)

 

Result by result, the curves showing the outcomes for Lantus or for O3FA were superimposed on the curves for the outcomes with standard care: no differences!

 

Although not the main reason for doing the study, the results did show that insulin glargine delayed progression from pre-diabetes to type 2 diabetes, and there was no association between insulin glargine use and increased risk of any cancer. No new unexpected side effects of Lantus were uncovered. But there was a cost. The risk of severe hypoglycemia was 0.7% higher in the Lantus group (1% versus 0.3% per year), and one death attributed to hypoglycemia occurred in a participant taking Lantus. And patients on Lantus gained a median of 1.6 kg, while those in the standard-care group lost a median of 0.5 kg.

 

The title of the press release that the ADA put out about ORIGIN (“Study Finds No Increased Heart, Cancer Risk from Daily Insulin Glargine Use”) was lipstick on a pig. Strictly speaking, that title was true, but clearly was not the reason the manufacturer was willing to part with millions of dollars to underwrite the study: they were hoping to find that early use of Lantus would decrease cardiovascular risk. It didn’t. The press release title should have been “Huge Diabetes Study Shows Insulin Glargine is Ineffective at Lowering Cardiovascular Risk When Given to People with Early T2DM or Prediabetes.”

By Dr. Bill Quick, Health Pro— Last Modified: 06/16/12, First Published: 06/14/12