Effects of basal insulin glargine and omega-3 on lower limb arterial disease outcome in patients with dysglycaemia: An analysis of the Outcome Reduction with an Initial Glargine INtervention (ORIGIN) trial

Diabetes Obes Metab. 2019 Jun;21(6):1502-1505. doi: 10.1111/dom.13674. Epub 2019 Mar 20.

Abstract

The impact of insulin or omega-3 supplements on the incidence and progression of peripheral artery disease (PAD) in patients with dysglycaemia has not been well studied. The Outcome Reduction with an Initial Glargine INtervention (ORIGIN) trial randomized participants with dysglycaemia and cardiovascular risk factors to titrated insulin glargine vs standard care, and to either 1 g of omega-3 per day or placebo. We assessed incident PAD, defined as the composite of either asymptomatic or symptomatic PAD according to the randomized interventions in the 11 119 ORIGIN participants whose baseline ankle-brachial index (ABI) was >0.9 (no PAD), and PAD progression in the 971 ORIGIN participants whose baseline ABI was ≤0.9. Hazard ratios (HR) were adjusted for confounders. During a 6.2-year follow-up period, allocation to insulin glargine vs standard care had a neutral effect on the composite of PAD incidence (HR, 0.99; 95% CI, 0.86-1.15) and progression (HR, 0.88; 95% CI, 0.63-1.22). Similar findings were noted for allocation to omega-3 vs placebo for PAD incidence (HR, 1.02; 95% CI, 0.89-1.18) and progression (HR, 0.93; 95% CI, 0.67-1.28). In this large study, neither insulin glargine nor omega-3 affected the incidence or progression of PAD.

Keywords: diabetes; insulin; omega-3; peripheral artery disease.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Glucose
  • Diabetes Mellitus, Type 2* / complications
  • Diabetes Mellitus, Type 2* / drug therapy
  • Disease Progression
  • Fatty Acids, Omega-3 / administration & dosage
  • Fatty Acids, Omega-3 / therapeutic use*
  • Female
  • Humans
  • Insulin Glargine / administration & dosage
  • Insulin Glargine / therapeutic use*
  • Male
  • Middle Aged
  • Peripheral Arterial Disease* / complications
  • Peripheral Arterial Disease* / physiopathology
  • Treatment Outcome

Substances

  • Blood Glucose
  • Fatty Acids, Omega-3
  • Insulin Glargine