Placing the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial in context

Abstract

The results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial were presented at the American Diabetes Association meeting in June 2012. The purpose of this study was to assess whether there would be any reduction in cardiovascular (CV) events if insulin glargine was started early in the course of diabetes. Therefore, the selected patients were those who were at high risk of CV events, but with impaired fasting glucose, impaired glucose tolerance or recent onset of type 2 diabetes. After 6.5 years, no differences were seen in primary outcomes, namely CV death, myocardial infarction, stroke, revascularisation procedures or hospitalisation for heart failure. However, the early institution of insulin therapy using glargine was found to be an effective means of maintaining glycaemic control in this patient group. As expected, patients on glargine insulin experienced slightly increased rates of both non-severe and severe hypoglycaemia, and slight weight gain. Neither of these problems was considered to be a limiting factor in the early use of glargine insulin. A second arm of the study was designed to assess the role of omega-3 fatty acids in the prevention of CV events. The results of this arm showed no benefit and do not support the use of omega-3 fatty acids as prophylactic therapy in these patients. While the ORIGIN trial is unlikely to alter clinical practice regarding the treatment of either dysglycaemia or new-onset diabetes, it has demonstrated that glargine insulin is relatively safe when used early in diabetes and can maintain near-normal glycaemic control for over six years, without increased cancer risk and with a neutral effect on CV outcomes.