Comparison of High-Dose Bolus Tirofiban With Other Anticoagulants in 41 Clinical Studies Involving 38,645 Patients Selected as iMPACT Trial
WINNIPEG, Feb. 23, 2016 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, today announced that a study titled "Comparison of High-Dose Bolus Tirofiban With Other Anticoagulation Strategies for Percutaneous Coronary Intervention: A Network Meta-Analysis of Randomized Controlled Trials" was presented by primary investigator and lead author, Dr. Michael J. Lipinski, M.D., Ph.D., of the MedStar Heart and Vascular Institute in Washington, DC at the Cardiovascular Research Technologies (CRT) 2016 conference.
The CRT conference, which concludes today at the Omni Shoreham Hotel in Washington, DC, is one of the leading educational forums on new cardiovascular technology and procedures for physicians and health care professionals.
The study was selected as a late-breaking iMPACT Trial at the CRT conference. iMPACT Trials are those studies selected to be innovative and providing the latest breakthroughs in clinical science, and are expected to highlight new improvements in quality of patient care and significantly "iMPACT" the field of interventional cardiology.
The investigators pooled data from 41 randomized clinical trials to perform a network meta-analysis to directly and indirectly compare different glycoprotein IIb/IIIa inhibitor (GPI) strategies for percutaneous coronary intervention with a focus on the impact of High-Dose Bolus (HDB) tirofiban. A total of 38,645 patients were included in the analysis (2,654 randomized to HDB tirofiban, 6,752 to abciximab, 1,669 to eptifibatide, 16,500 to heparin, and 11,070 to bivalirudin). Results of the analysis found that HDB tirofiban had a significant reduction in all-cause mortality when compared with both heparin and eptifibatide (Integrilin®, Merck & Co., Inc.) (p<0.05). There was no significant difference among the GPI therapies for other outcomes including MI, MACE, and major bleeding.
For complete information, the study abstract can be accessed on the JACC Cardiovascular Interventions website at http://interventions.onlinejacc.org/article.aspx?articleid=2492247.
This meta-analysis does not imply comparable efficacy, safety or product interchangeability. Some of the patient populations were outside of the approved patient populations for AGGRASTAT. Refer to U.S. Prescribing Information for complete product information.
Indications and Usage
AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
In clinical studies with the HDB regimen, Aggrastat was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients for typically ≤24 hours.
Known hypersensitivity to any component of Aggrastat, History of thrombocytopenia with prior exposure to Aggrastat, Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month.
Warnings and Precautions
Aggrastat can cause serious bleeding. If bleeding cannot be controlled discontinue Aggrastat. Thrombocytopenia: Discontinue Aggrastat and heparin.
Bleeding is the most commonly reported adverse reaction.
For more information on AGGRASTAT, please refer to Full Prescribing Information available at www.aggrastatHDB.com.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. hospital market. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for non-ST elevation acute coronary syndrome in the United States, where it is sold through the Company's U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
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SOURCE Medicure Inc.