Company: Aralez Pharmaceuticals
Approval Status: Approved September 2016
Specific Treatments: prevention of cardiovascular and cerebrovascular events
Therapeutic Areas Cardiology/Vascular Diseases
Yosprala is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI).
Yosprala is specifically indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
Yosprala is supplied as delayed-release tablets for oral administration. The recommended dose is one tablet daily at least 60 minutes before a meal.
The FDA approval of Yosprala was based on two randomized, multi-center, double-blind trials (Study 1 and Study 2) which evaluated the omeprazole component by comparing the incidence of gastric ulcer formation in 524 patients randomized to Yosprala 325 mg/40 mg tablets and 525 patients randomized to EC-aspirin 325 mg. Patients were included with a cerebro- or cardiovascular diagnosis if they had been taking daily aspirin 325 mg for at least 3 months, were expected to require daily aspirin 325 mg therapy for at least 6 months and were over 55 years old. Subjects between 18 and 55 years old were also required to have a documented history of gastric or duodenal ulcer within the past 5 years. Studies 1 and 2 showed that Yosprala given as 325 mg/40 mg tablets once daily statistically significantly reduced the 6-month cumulative incidence of gastric ulcers compared to EC-aspirin 325 mg once daily. In both trials, patients receiving Yosprala 325 mg/40 mg tablets had a statistically significantly lower 6-month cumulative incidence of gastric and/or duodenal ulcers compared to EC-aspirin 325 mg (3% vs. 12%).
Adverse effects associated with the use of Yosprala may include, but are not limited to, the following:
- gastric polyps
- non-cardiac chest pain
Mechanism of Action
Yosprala is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI). Aspirin (acetylsalicylic acid) is an inhibitor of both prostaglandin synthesis and platelet aggregation. Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the [H+ /K+ ]-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is doserelated and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
For additional information regarding Yosprala or the prevention of cardiovascular and cerebrovascular events, please visit http://www.yospralahcp.com/