Evaluation of the Effect of Alogliptin on Tissue Characteristics of the Carotid Wall: Subanalysis of the SPEAD-A Trial

INTRODUCTION: Ultrasonic tissue characterization of the carotid wall using gray-scale median (GSM) reflects its composition and low-GSM plaque is considered to be unstable. The present study evaluated the effect of alogliptin, a dipeptidyl peptidase-4 inhibitor, on the longitudinal change in GSM, an index of the tissue characteristics of the carotid wall, in patients with type 2 diabetes (T2DM). METHODS: This is a post hoc subanalysis using data obtained from the SPEAD-A trial, a randomized controlled trial that demonstrated the beneficial effect of alogliptin treatment on the progression of carotid intima-media thickness in patients with T2DM with no past history of apparent cardiovascular disease. A total of 322 subjects (161 in the alogliptin treatment group and 161 in the conventional treatment group) were enrolled. The primary outcome was the change from baseline in mean GSM-CCA (common carotid artery) during the 104-week observation period. RESULTS: Both alogliptin treatment and conventional treatment significantly increased the mean GSM-CCA (from 60.7 ± 12.3 to 65.9 ± 10.1, p < 0.001 and 58.8 ± 14.4-65.2 ± 12.2, p < 0.001, respectively) and there was no significant difference in changes in mean GSM-CCA between the treatment groups (p = 0.95). Additionally, there were no differences in the changes in the left and right GSM-CCA between the groups. CONCLUSIONS: A post hoc subanalysis revealed an improvement of tissue characteristics in the carotid arterial wall in both the alogliptin treatment group and the conventional treatment group during the 104-week treatment period and that there was no significant difference between the treatment groups. CLINICAL TRIAL REGISTRATION: UMIN000019951.