Antiplatelet Effect Durability of a Novel, 24-Hour, Extended-Release Prescription Formulation of Acetylsalicylic Acid in Patients With Type 2 Diabetes Mellitus

Abstract

High platelet reactivity and high platelet turnover have been implicated in incomplete platelet inhibition during immediate-release acetylsalicylic acid therapy in patients with type 2 diabetes mellitus (DM). An extended-release acetylsalicylic acid (ER-ASA; Durlaza) formulation was developed to provide 24-hour antithrombotic effects with once-daily dosing. The objective of the study was to evaluate the antiplatelet effects of ER-ASA in patients with DM. In this open-label, single-center study, patients with DM (n= 40) and multiple cardiovascular risk factors received ER-ASA 162.5mg/day for 14 ± 4days. Multiple platelet function tests, serum and urinary thromboxane B2 metabolites, prostacyclin metabolite, and high-sensitive C-reactive protein levels were assessed at 1, 12, 16, and 24hours post-dose. Patients with high platelet turnover and/or high platelet reactivity were treated with ER-ASA 325mg/day for 14 ± 4days, and laboratory analyses were repeated. All patients responded to ER-ASA 162.5mg/day as measured by arachidonic acid-induced aggregation, and there was no loss of the platelet inhibitory effect of ER-ASA 162.5mg/day over 24hours post-dose (p= not significant). The antiplatelet effect was sustained over 24hours for all platelet function measurements. Mean 1- to 24-hour serum thromboxane B2 levels were low with both doses and were lower with ER-ASA 325mg/day compared with 162.5mg/day therapy (p= 0.002). In conclusion, ER-ASA 162.5mg daily dose provided sustained antiplatelet effects over 24hours in patients with type 2 DM and multiple cardiovascular risk factors and had a favorable tolerability profile.