Long‐Term Safety of a Coordinated Delivery Tablet of Enteric‐Coated Aspirin 325 mg and Immediate‐Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients atGIRisk

Autor: Byron L Cryer, James M. Scheiman, Angel Lanas, David J. Whellan, Glenn M. Eisen, Jay L. Goldstein, John G. Fort
Rok vydání: 2016
Předmět:
Male
Peptic Ulcer
Gastrointestinal
medicine.medical_specialty
Enteric coated aspirin
030204 cardiovascular system & hematology
Gastroesophageal reflux disease
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Secondary cardiovascular disease prevention
Original Research Articles
Internal medicine
medicine
Humans
Pharmacology (medical)
In patient
Original Research Article
Immediate release
Dyspepsia
Omeprazole
Aged
Dosage Forms
Pharmacology
Aspirin
business.industry
Proton Pump Inhibitors
General Medicine
Middle Aged
Omeprazole 40 MG
Drug Combinations
Treatment Outcome
Cardiovascular Diseases
Platelet aggregation inhibitor
Female
030211 gastroenterology & hepatology
Long term safety
Cardiology and Cardiovascular Medicine
business
Platelet Aggregation Inhibitors
medicine.drug
Zdroj: Cardiovascular Therapeutics
ISSN: 1755-5922
1755-5914
DOI: 10.1111/1755-5922.12172
Popis: Summary Introduction In two, 6‐month, randomized, double‐blind Phase 3 trials, PA32540 (enteric‐coated aspirin 325 mg and immediate‐release omeprazole 40 mg) compared to aspirin alone was associated with fewer endoscopic gastric and duodenal ulcers in patients requiring aspirin therapy for secondary cardiovascular disease (CVD) prevention who were at risk for upper gastrointestinal (UGI) events. Aims In this 12‐month, open‐label, multicenter Phase 3 study, we evaluated the long‐term cardiovascular and gastrointestinal safety of PA32540 in subjects who were taking aspirin 325 mg daily for ≥3 months for secondary CVD prevention and were at risk for aspirin‐associated UGI events. Enrolled subjects received PA32540 once daily for up to 12 months and were assessed at baseline, month 1, month 6, and month 12. Results The overall safety population consisted of 379 subjects, and 290 subjects (76%) were on PA32540 for ≥348 days (12‐month completers). Adverse events (AEs) caused study withdrawal in 13.5% of subjects, most commonly gastroesophageal reflux disease (1.1%). Treatment‐emergent AEs occurred in 76% of the safety population (11% treatment‐related) and 73% of 12‐month completers (8% treatment‐related). The most common treatment‐related AE was dyspepsia (2%). One subject had a gastric ulcer observed on for‐cause endoscopy. There were five cases of adjudicated nonfatal myocardial infarction, one nonfatal stroke, and one cardiovascular death, but none considered treatment‐related. Conclusions Long‐term treatment with PA32540 once daily for up to 12 months in subjects at risk for aspirin‐associated UGI events is not associated with any new or unexpected safety events.
Databáze: OpenAIRE
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