Spaced administration of PA32540 and clopidogrel results in greater platelet inhibition than synchronous administration of enteric-coated aspirin and enteric-coated omeprazole and clopidogrel

Prescribed in patients with a history of myocardial infarction, stroke, transient ischemic attack, coronary intervention or bypass surgery, aspirin is one of the medications most commonly used in the secondary prevention of cardiovascular diseases. It has become a mainstay of therapy after years of solid evidence supporting its efficacy in clinical trials. However, a number of risks and side effects accompany its benefits, including the notable risk of bleeding and gastrointestinal side effects. Numerous mechanisms have been proposed to attenuate these effects to promote adherence and to expand the population for which aspirin is a reasonable treatment option. A polypill or combination formulation that includes a proton pump inhibitor, a drug commonly prescribed alongside aspirin, is one potential avenue of therapy. One such combination pill, PA32540, has undergone Phase I and Phase III trials and shows promising safety and efficacy results in these preliminary trials.

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“…In this study, the CYP2C19 and ABCB1 genotypes were identified. Outcomes did not differ significantly by genotype [40] .…”

Section: Pa32540 and Thienopyridinesmentioning

confidence: 72%

PA32540 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers

Duffy

Rooney

Adams

et al. 2014

Expert Review of Cardiovascular Therapy

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“…Another trial, Co-Rx, was a randomized, open-label, single-center crossover study that recruited 30 healthy volunteers to ascertain the differences in platelet inhibition between spaced PA32540 and clopidogrel administration versus synchronous low-dose aspirin, omeprazole and clopidogrel therapy [53]. PA32540 and clopidogrel spaced 10 h apart had greater antiplatelet effects than did synchronously administered aspirin (81 mg), clopidogrel (75 mg) and EC omeprazole (p = 0.004).…”

Section: Clopidogrel-pa32540 Interaction Studiesmentioning

confidence: 97%

“…These results confirm the findings of the SPACING trial and are directly relevant for patients with a high GI risk who require DAPT and gastroprotection. It is also possible that the attenuation future science group of the interaction induced by spacing PA32540 and clopidogrel in selected patients with baseline high platelet reactivity may be clinically relevant [53].…”

Section: Clopidogrel-pa32540 Interaction Studiesmentioning

confidence: 99%

PA Tablets: Investigational Compounds Combining Aspirin and Omeprazole for Cardioprotection

et al. 2013

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For most patients with prior cardiovascular events, preventing future secondary cardiovascular events requires life-long persistence with antiplatelet therapy. PA tablets (P: proton pump inhibitors; A: aspirin) are investigational compounds that were developed to provide the cardioprotective benefits of aspirin with the upper gastrointestinal protection of a proton pump inhibitor (e.g., omeprazole). The tablets are film-coated, coordinated-release tablets for oral administration that contain 40 mg immediate-release omeprazole and either 81 or 325 mg delayed-release aspirin. The goals of the clinical development program were to demonstrate the following: improved gastrointestinal safety of PA relative to enteric-coated aspirin alone; bioequivalence and comparative bioavailability between the PA compounds and currently marketed enteric-coated aspirin; and long-term safety. Two clinical pharmacology studies were also conducted to study the potential for interaction between PA32540 and clopidogrel.

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PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: Results of two 6-month, phase 3 studies

Whellan

Goldstein

Cryer

et al. 2014

American Heart Journal

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Spaced administration of PA32540 and clopidogrel results in greater platelet inhibition than synchronous administration of enteric-coated aspirin and enteric-coated omeprazole and clopidogrel

Cited by 6 publications

References 13 publications

PA32540 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers

PA32540 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers

PA Tablets: Investigational Compounds Combining Aspirin and Omeprazole for Cardioprotection

PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: Results of two 6-month, phase 3 studies

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