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 at GI Risk

Jay L. Goldstein, David J. Whellan, James M. Scheiman, Byron L. Cryer, Glenn M. Eisen, Angel Lanas, John G. Fort

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)59-66
Number of pages8
JournalCardiovascular Therapeutics
Volume34
Issue number2
DOIs
StatePublished - Apr 1 2016

Fingerprint

Enteric-Coated Tablets
Omeprazole
Aspirin
Cardiovascular Diseases
Safety
Stomach Ulcer
Therapeutics
Myocardial Infarction
Dyspepsia
Duodenal Ulcer
Gastroesophageal Reflux
Population
Endoscopy

Keywords

  • Aspirin
  • Dyspepsia
  • Gastroesophageal reflux disease
  • Gastrointestinal
  • Omeprazole
  • Secondary cardiovascular disease prevention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)
  • Pharmacology

Cite this

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 at GI Risk. / Goldstein, Jay L.; Whellan, David J.; Scheiman, James M.; Cryer, Byron L.; Eisen, Glenn M.; Lanas, Angel; Fort, John G.

In: Cardiovascular Therapeutics, Vol. 34, No. 2, 01.04.2016, p. 59-66.

Research output: Contribution to journalArticle

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abstract = "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.",
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T1 - 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 at GI Risk

AU - Goldstein, Jay L.

AU - Whellan, David J.

AU - Scheiman, James M.

AU - Cryer, Byron L.

AU - Eisen, Glenn M.

AU - Lanas, Angel

AU - Fort, John G.

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AB - 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.

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