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Public Release Type:
Journal
Publication Year: 2023
Affiliation: 1 Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands
2 Department of Internal Medicine, University Medical Center Utrecht, Utrecht, the Netherlands
3 Department of Internal Medicine, Isala Clinics Zwolle, the Netherlands
DOI:
https://doi.org/10.1111/dme.15183
Authors:
Helmink MAG,
Hageman SHJ,
Visseren FLJ,
de Ranitz-Greven WL,
de Valk HW,
van Sloten TT,
Westerink J
Request IDs:
23476
Studies:
Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications
Objective: To evaluate presence of treatment effect heterogeneity of intensive insulin therapy on the occurrence of major adverse cardiovascular events (MACE) in individuals with type 1 diabetes, to identify characteristics associated with treatment effect differences, and to evaluate the distribution of microvascular complications across the groups of predicted treatment effect. Research Design and Methods: In 1,441 participants from the Diabetes Control and Complications Trial (DCCT), individual treatment effect of intensive insulin therapy (?3 daily insulin injections or an external pump) on the risk of MACE was estimated using a penalized Cox regression model including treatment-by-covariate interaction terms. The study population was divided into groups based on predicted treatment effect and baseline characteristics were compared. Results: The median estimated absolute treatment effect on 30-year risk of MACE when treated with intensive insulin therapy was -0.9% (range -31.8% to +0.7%), i.e. 0.9% absolute risk reduction. 162 participants (11%) were predicted to experience a negative effect from intensive therapy compared to conventional therapy (once or twice daily insulin). Younger age, lower HbA1c, lower LDL-cholesterol and absence of neuropathy and retinopathy were associated with a negative effect. Predicted benefit of intensive insulin therapy on the occurrence of MACE did not seem to be associated with treatment benefit on incident microvascular complications. Conclusions: Although intensive insulin therapy reduces the risk of MACE in the majority of individuals with type 1 diabetes, benefit varies substantially and intensive therapy was even predicted to increase the risk of MACE in a small proportion of individuals.
