Sitagliptin on Carotid Intima-Media Thickness in Type 2 Diabetes Mellitus Patients and Anemia: A Subgroup Analysis of the PROLOGUE Study

Abstract EN

Introduction.

Randomized clinical trials have not shown an additional clinical benefit of sitagliptin treatment over conventional treatment alone.

However, studies of sitagliptin treatment have not examined the relationship between anemia and treatment group outcomes.

Methods.

The PROLOGUE study is a prospective clinical trial of 442 participants with type 2 diabetes mellitus (T2DM) randomized to sitagliptin treatment or conventional treatment which showed no treatment differences [Estimated mean (± standard error) common carotid intima-media thickness (CIMT) was 0.827±0.007 mm and 0.837±0.007 mm, respectively, with a mean difference of -0.009 mm (97.2% CI −0.028 to 0.011, p=0.309) at 24 mo of follow-up].

This is a post hoc subanalysis using data obtained from the PROLOGUE study; the study population was divided into anemic groups (n=94) and nonanemic group (n=343) based on hemoglobin level.

And we analyzed for the changes in each CIMT parameter from baseline to 24 months in subgroups.

Results.

The treatment group difference in baseline-adjusted mean common carotid artery- (CCA-) IMT at 24 months was −0.003 mm (95% CI −0.022 to 0.015, p=0.718) in the nonanemic subgroup and −0.007 mm (95% CI −0.043 to 0.030, p=0.724) in the anemic subgroup.

Although there were no significant differences in the other CIMT parameters between the treatment groups in the anemic subgroup, the changes in mean and max ICA-IMT at 24 months in the nonanemic subgroup were significantly lower in the sitagliptin group than the conventional group [−0.104 mm (95% CI −0.182 to −0.026), p=0.009 and −0.142 mm (−0.252 to −0.033), p=0.011, respectively].

Conclusion.

These data suggest that nonanemia may indicate a potentially large subgroup of those with T2DM patients that sitagliptin therapy has a better antiatherosclerotic effect than conventional therapy.

Further research is needed to confirm these preliminary observations.