Thursday, December 19, 2013

Points: Origin Hypoglycemia Subanalysis


1. 12,537 patients with known CV disease recruited into prospective study from 573 centers from around the world. Randomized to standard care vs glargine. With glargine titrated to fasting glucose <=95 by self-measurement. Study powered to detect 18% and 16% relative risk reduction in primary outcome and secondary outcome. All patients self-monitored and logged glucose levels. Median follow up 6.2 yrs. 99% outcome status known. Primary outcome: composite non-fatal MI, non-fatal CVA, or death from CV cause. Secondary outcome: any of primary events, a revascularization procedure, or hospitalization for heart failure. Points in favor of the Origin study are the power of study, prospective, randomized and using patients who had known CV disease and therefore at higher risk for an event. The subanalysis included all patients and data from the original study.

2. From table 2: Significant elevated hazard score in severe hypoglycemia for each endpoint shown: CV death or non-fatal MI or stroke 1.77, Total mortality 2.05, CV death 2.02, Arrhythmic death 2.14. Unadjusted hazard for severe nocturnal hypoglycemia was also significantly elevated in all 4 categories.  The unadjusted hazard for non-severe mortality was also significantly elevated at 1.21.

3. From table 3: Incidence of hypoglycemia both non-severe and severe is higher in insulin glargine group versus standard care.

4. Although the crude incidence of mortality, cv death, arrhythmic death, and CV death-non-fatal MI-CVA in both severe and non-severe hypoglycemia is higher in the glargine group than the standard group, overall there was no difference in mortality or cv events between the two groups if one includes both hypoglycemia and absence of hypoglycemia.

5. The findings of an association between severe hypoglycemia and CV outcomes is consistent with prior studies showing a similar association.

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