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Yosprala: A Fixed Dose Combination of Aspirin and Omeprazole
1From the Department of Pharmacy Practice, Touro College of Pharmacy, New York, NY; and Department of Pharmacy, Montefiore Medical Center, Bronx, NY.
Insights
High-risk cardiovascular patients often struggle with daily aspirin adherence due to gastrointestinal side effects. A new fixed-dose aspirin and omeprazole combination aims to improve adherence and reduce adverse events for better secondary prevention.
Area of Science:
- Cardiology
- Gastroenterology
- Pharmacology
Background:
- Cardiovascular disease is a leading cause of death in the US.
- Secondary prevention is crucial for patients with prior cardiovascular or cerebrovascular events.
- Low-dose aspirin is fundamental for secondary prevention but adherence is challenged by gastrointestinal side effects.
Purpose of the Study:
- To introduce Yosprala, a novel fixed-dose combination of aspirin and omeprazole.
- To address the challenge of poor adherence to aspirin therapy in high-risk patients.
- To present a new therapeutic option for improving secondary cardiovascular event prevention.
Main Methods:
- Review of existing studies on aspirin adherence and gastrointestinal side effects.
- FDA approval of a fixed-dose combination product (Yosprala).
- Description of Yosprala as delayed-release aspirin with immediate-release omeprazole.
Main Results:
- Proton-pump inhibitors significantly reduce upper gastrointestinal adverse events in aspirin users.
- Yosprala is the first fixed-dose combination of aspirin and omeprazole approved in the US.
- Yosprala offers a new option to potentially improve adherence to daily aspirin therapy.
Conclusions:
- Yosprala represents a significant advancement in managing high-risk cardiovascular patients.
- Improved adherence to aspirin therapy can lead to better cardiovascular outcomes.
- This combination therapy provides a valuable tool for healthcare providers and patients.
Abstract:
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. Patients who survive a primary cerebrovascular or cardiovascular event are at increased risk of a subsequent occurrence. Antiplatelet therapy plays an essential role for secondary prevention in individuals with stroke, transient ischemic attack, acute or chronic artery disease, or peripheral arterial disease. Maintaining high-risk patients on low-dose aspirin therapy is a fundamental component of management. However, poor adherence, secondary to the drug's gastrointestinal side effects, has been associated with negative cardiovascular outcomes. Numerous studies have indicated that proton-pump inhibitors significantly reduce the risk of upper gastrointestinal adverse events in aspirin-treated patients. The US Food and Drug Administration approved Yosprala (Aralez Pharmaceuticals), a fixed-dose combination of delayed-release aspirin and immediate-release omeprazole, on September 15, 2016. It is the first product to become available in the United States that combines these 2 pharmacologic drug classes, and represents a new therapeutic option for patients and healthcare providers who strive to improve adherence to daily aspirin therapy.
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