Chiesi USA Announces First Analysis from the CAMEO Registry Assessing KENGREAL® (cangrelor) Use and Transition to Oral P2Y12 Inhibitors in Routine Clinical Practice

2022年06月01日21:00

  • The CAMEO registry, an ongoing study to provide real-world data on KENGREAL® (cangrelor), has published interim results in the Journal of the American Heart Association.
  • This analysis from CAMEO is the first analysis of its kind to describe acute medication administration in a percutaneous coronary intervention (PCI) setting with transition of care from the cardiac catheterization laboratory to the ward.

CARY, N.C., June 01, 2022 (GLOBE NEWSWIRE) -- Chiesi USA (key-ay-zee), the U.S. affiliate of Chiesi Farmaceutici, an international research-focused healthcare Group (Chiesi Group), today announced its first full analysis publication from the CAMEO (Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes) registry that evaluated KENGREAL® (cangrelor) use and transition to oral P2Y12 inhibitors in routine clinical practice. These results of the ongoing registry are now published in the Journal of the American Heart Association and can be accessed here.

The CAMEO registry is a multicenter, retrospective observational study examining platelet inhibition strategies during the early management of myocardial infarction (MI) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. The registry aims to collect information on 3,000 patients with NSTEMI or STEMI treated with KENGREAL or an oral P2Y12 inhibitor among 12 sites. Sites were selected to represent a wide geographic distribution and variety of types of U.S. university- and non-university based hospitals.

This first analysis included data from approximately 800 patients among nine study sites. Inter-hospital use of KENGREAL in acute MI varied, and the utilization also differed among patient presentations. The analysis was able to characterize KENGREAL dosing and patterns of transition to an oral P2Y12 inhibitor in routine practice.

“The CAMEO registry leverages real time observations on treatment gaps and opportunities, and provides a forum for participating clinicians to gain feedback and key insights that can be shared more broadly to promote quality improvement and best practices,” said Martin Marciniak, Vice President and Head of U.S. Medical Affairs at Chiesi. “This initiative demonstrates Chiesi USA’s continued commitment to supporting healthcare provider education and advancing patient care by establishing meaningful collaborations in partnership with top-tier research facilities such as the Duke Clinical Research Institute.”

Select findings from this first analysis were also presented at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, D.C., from April 2-4.

“CAMEO has captured invaluable patient data that reflects contemporary P2Y12 inhibitor use from a variety of health centers across the U.S. This registry will be helpful in evaluating how, when and in what patients KENGREAL is currently being utilized in clinical practice,” said Jennifer A. Rymer, MD, MBA, MHS, co-investigator and interventional cardiologist at Duke University Medical Center. “We need to improve processes and systems of care to ensure patients receive the full benefit of KENGREAL.”

The CAMEO registry has achieved nearly 80% enrollment to-date, and subsequent analyses will provide insights on uptake and utilization of cangrelor in routine clinical practice among U.S. PCI centers and observations into real-world outcomes in MI patients.

Indication

KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Important Safety Information

KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding.

KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.

Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL® than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour.

The most common adverse reaction is bleeding.

Please see Full Prescribing Information.

About Chiesi USA

Chiesi USA, Inc., headquartered in Cary, North Carolina, is a specialty pharmaceutical company focused on commercialization of products for the hospital and target office-based specialties. The Company is a wholly-owned subsidiary of family-owned Chiesi Farmaceutici S.p.A, a global R&D-focused pharmaceutical company based in Parma, Italy. In the United States, the Company delivers therapies and enhances care for patients in the areas of acute cardiology, neonatology and cystic fibrosis. Recognized as a Certified B Corporation™, Chiesi is dedicated to improving the health and well-being of its communities through its employee-led corporate social responsibility program, Chiesi in the Community. Innovation, collaboration and impact are the cornerstones of the Chiesi culture. For more information, visit www.chiesiusa.com.

About Chiesi Group

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative therapeutic solutions in its three focus areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support specialty care and consumer-facing self-care). The Group’s Research and Development center is based in Parma and works alongside 6 other important research and development hubs in France, the U.S., Canada, China, the UK and Sweden to pursue its pre-clinical, clinical and regulatory programs. Chiesi, since 2019, is the world’s largest B Corp certified pharmaceutical group. The global B Corp movement promotes business as a force for good. Moreover, Chiesi Farmaceutici S.p.A. has changed in 2018 its legal status to a Benefit Corporation, by incorporating a double purpose for the creation of shared value, and to generate value for its business, for society and the environment. As a Benefit Corporation, Chiesi Farmaceutici S.p.A. is required by law to include objectives of common benefit in its bylaws and to report annually in a transparent way. The Group is committed to becoming carbon neutral by the end of 2035.

Contacts

Media: FleishmanHillard, Elizabeth Comtois, (919) 334-3786, elizabeth.comtois@fleishman.com

Chiesi USA: Allyson Stevens, (919) 678-6611 x1516, allyson.stevens@chiesi.com

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