Sparta, NJ—Draft recommendations issued by the U.S. Preventive Services Task Force (USPSTF) have created some confusion, and a pharmaceutical company with a novel aspirin product is seeking to clarify the issue.

A press release from PLx Pharma Inc. points out that the draft USPSTF document pertains only to the use of aspirin for prevention of a first cardiovascular event (CVE). The recommendations do not relate to patients who have already had a CVE, such as a heart attack or clot-related stroke, and  are taking aspirin at their physician’s direction.  

PLx has a clinically validated and patent-protected PLxGuard drug-delivery platform designed to more safely deliver its products, Vazalore 325-mg and Vazalore 81-mg liquid-filled aspirin capsules.

“VAZALORE’s targeted population is those patients with a history of cardiovascular disease and who are already on a physician prescribed aspirin therapy to help prevent another heart attack or clot-related stroke,” says Natasha Giordano, president and CEO of PLx Pharma. “As cardiologists continue to recommend aspirin for their cardiovascular disease patients, VAZALORE is an innovative aspirin with its unique delivery system designed to help protect the stomach. We strongly recommend patients consult with their doctors before starting or stopping aspirin therapy.”

The company notes that cardiologists closely follow American College of Cardiology and American Heart Association guidelines limiting aspirin use in patients without established cardiovascular disease (CVD). Those recommendations emphasize that the use of aspirin is an established practice for secondary prevention of a heart attack or clot-related stroke.

For adults aged 40 to 59 years with a 10% or greater 10-year CVD risk, the panel advises, “The decision to initiate low-dose aspirin use for the primary prevention of CVD in adults ages 40 to 59 years who have a 10% or greater 10-year CVD risk should be an individual one. Evidence indicates that the net benefit of aspirin use in this group is small. Persons who are not at increased risk for bleeding and are willing to take low-dose aspirin daily are more likely to benefit.”

For adults aged 60 years and older, however, the USPSTF recommends against initiating low-dose aspirin use for primary prevention of CVD.

The draft statement is open for public comments until November 8, 2021, 11:59 PM EDT.

Vazalore has a different delivery mechanism from plain and enteric-coated aspirin products and allows targeted release of aspirin, which limits direct contact with the stomach. The product was approved by the FDA in March 2021 and became available OTC in August.

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