VANCOUVER, BC—Durlaza, an extended-release aspirin formulation, provides “sustained antiplatelet effects over 24 hours” in patients with type 2 diabetes mellitus (T2DM), “and had a favorable tolerability profile,” reported authors of a study presented at the 68th AAN Annual Meeting.
In patients with T2DM, immediate-release aspirin is associated with high platelet turnover, which has been implicated in incomplete platelet inhibition and high on-treatment platelet reactivity. To provide 24-hour antithrombotic effects with once-daily dosing, oral Durlaza 162.5mg/day was developed, stated Jeff Patrick, PharmD, Chief Scientific Officer of New Haven Pharmaceuticals, Inc., North Haven, CT and coauthors. The findings were reported in a poster session.
To assess the agent’s serial antiplatelet effects over 24 hours, 40 patients with T2DM and a history of cardiovascular disease or multiple cardiovascular risk factors received Durlaza 162.5mg/day for 14 days, plus or minus 4 days (after an initial 7- to 10-day run-in period with 81mg/day).
Antiplatelet effects were determined by light transmittance aggregation (LTA) Plateletworks® (Helena Laboratories), Multiplate analyzer, TEG® PlateletMapping® (Haemonetics Corporation), VerifyNow aspirin assays, and serum thromboxane B2 at 1, 12, 16, and 24 hours postdose,” Dr. Patrick and coauthors reported.
Results showed the prevalence of high platelet turnover to be 47% of patients. “No drug-related serious adverse events, or adverse events of the GI system, were reported during the study,” the coauthors wrote.
No significant loss of antiplatelet effect at 12, 16, and 24 hours was observed. Platelet mapping aspirin assay (% aggregation) at 1, 12, 16, and 24 hours postdose was 41 ± 36, 41 ± 39, 37 ± 36, and 42 ± 33, respectively; VerifyNow aspirin assay (aspirin reaction units) was 485 ± 69, 499 ± 72, 504 ± 62, and 487 ± 71, respectively.