A New Haven Pharmaceuticals study has shown that its “Durlaza” extended release aspirin capsules can deliver sustained antiplatelet control for a 24-hour period in diabetic patients. The data was released during a poster presentation at the American Heart Association (AHA)’s Scientific Sessions event in Orlando, USA.
According to New Haven, this 162.5mg aspirin capsule is the first prescription, low dose, extended-release (162.5mg), aspirin product for the secondary prevention of stroke and acute cardiac events, including myocardial infarction.
“The DURATION trial was the first study to characterise the durability of platelet inhibition from Dularza (162.5mg), the first extended-release, low-dose aspirin, in this prothrombotic patient population. The primary endpoint of this study was the change in platelet aggregation between 1 hour and 24 hours post-dosing. In the DURATION study, there was no change in mean platelet aggregation at any time in that 23 hour time interval following dosing of (162.5mg) DURLAZA. These data demonstrate the maintenance of stable platelet inhibition over the entire 24 hour dosing interval,” says Paul Gurbel, director of the Inova Center for Thrombosis Research and Drug Development and Director of Interventional Cardiology and Cardiovascular Medicine Research at Inova Heart and Vascular Institute, professor of medicine, Johns Hopkins University, USA and adjunct professor of medicine, Duke University, USA.
In an open-label, single-centre study, high-risk patients with type II diabetes with a history of CV disease (or multiple CV risk factors) were treated daily with Dulaza for 14 days +/- 4 days. The assessment concluded that the new, extended-release orally administered aspirin formulation provided sustained antiplatelet effects over 24 hours in patients with a favourable safety profile.
“We know that immediate release aspirin has an unacceptably short half-life of approximately 20 minutes. Certain populations such as those with underlying vascular disease and diabetic patients are known to have even higher platelet production rates, making them even more prone to persistent platelet-induced thrombotic vulnerability. As the DURATION study demonstrated in patients with diabetes, Durlaza addresses this issue through its novel release system. DURLAZA (162.5 mg) daily doses produce smoother and more prolonged anti-platelet effects. Durlaza has been approved for use in secondary prevention, and I will surely take advantage of this simple yet remarkable opportunity to better control a prominent risk in my ASCVD patients,” say Seth J. Baum, medical director of Women’s Preventive Cardiology, and Christine E. Lynn, Women’s Health & Wellness Institute, Boca Raton Regional Hospital, USA.