New study data have shown that low-dose, extended-release aspirin (162.5 mg) (Durlaza, New Haven Pharmaceuticals) is well tolerated, with a safety profile comparable to that of low-dose, immediate-release aspirin, and delivers antiplatelet control for 24 hours in high-risk cardiovascular and diabetes patients.
Findings from three double-blind studies were presented at the annual American College of Preventive Medicine meeting in Arlington, Virginia.
In September 2015, Durlaza received FDA approval for the secondary prevention of stroke and acute cardiac events, including myocardial infarction, in high-risk cardiovascular and diabetes patients. In an open-label, single-center study, high-risk patients with type-2 diabetes with a history of cardiovascular (CV) disease or multiple CV risk factors were treated daily with Durlaza for 14 days. Treatment with Durlaza provided sustained antiplatelet effects over 24 hours, with a favorable safety profile.
Durlaza uses extended-release, microcapsule technology to prolong aspirin release.
Immediate-release aspirin, not Durlaza, should be used in situations where a rapid onset of action is required, such as acute treatment of myocardial infarction or before percutaneous coronary intervention. The product is contraindicated in patients with hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) and in patients with asthma, rhinitis, or nasal polyps. Durlaza increases the risk of bleeding and may cause severe urticaria, angioedema, or bronchospasm.
Source: New Haven Pharmaceuticals; February 29, 2016.