Titre du document / Document title

Improved glycemic control with decreased hypoglycemia prevents long-term complications in type 2 diabetes patients : long-term simulation analysis using the "Diabetes Mellitus Model"

Auteur(s) / Author(s)

MAXION-BERGEMANN S. ; HUPPERTZ E. ; JACOBS L.-D. ; MüLLER E. ; WALLESER S. ;

Résumé / Abstract

Objective: The purpose of this study was to compare the effect of insulin glargine (glargine) and NPH insulin (NPH) on long-term outcomes in type 2 diabetes patients using the Diabetes Mellitus Model (DMM). Methods: The DMM predicts short- and long-term complications over ten years using data in studies published previously. The main effect on outcome is the influence of the treatment on the HbA_1c level which is simulated over time. The simulation was based on a cohort size of 10,000 type 2 diabetes patients taking either glargine or NPH. The best scenario, baseline scenario and worst case scenario were simulated based on differences of 0.13%, 0.44% and 0.85%, respectively, in HbA_1c values and corresponding to potentially attainable improvements with comparable or lower hypoglycemia rates in glargine-treated patients and NPH-treated patients. Assumptions for scenarios 1, 2 and 3 were based on a regression analysis of clinical trial data (pooled data clinical trials comparing glargine and NPH) in which the effect of glargine on the HbA_1c/hypoglycemia incidence ratio was superior to that of NPH. Results: The relative risks (RR, glargine/NPH) obtained for scenarios 1, 2 and 3 were 0.97, 0.89 and 0.81, respectively, for long-term microvascular complications and 0.99,0.95 and 0.91, respectively, for long-term macrovascular complications. RR reductions ranged from 1% in the less optimistic scenario to > 20% in the "best case" scenario. Sensitivity analyses showed that variations in the mean baseline HbA_1c values and duration of the diabetes were without effect on these outcomes. Conclusions: Although there is a need to corroborate the results of these simulations with real, long-term clinical data, they have demonstrated that, assuming comparable or lower rates of hypoglycemia, a better glycemic control (HbA_1c reduction) can be expected with glargine when compared to NPH together with a reduction in long-term complications, mortality and associated costs.

Revue / Journal Title

International journal of clinical pharmacology and therapeutics   ISSN 0946-1965 

Source / Source

2005, vol. 43, n^o6, pp. 271-281 [11 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

Dustri, München, ALLEMAGNE  (1994) (Revue)

Localisation / Location

INIST-CNRS, Cote INIST : 15902, 35400012493350.0030