Aggrastat® high dose
bolus EU approval for (NSTE-ACS) PCI patients
re-informs the debate on
triple anti-platelet therapy
Aggrastat® high dose bolus EU approval
Triple anti-platelet therapy—which patients and why? Euro PCR, Paris, 17-20 May 2011
Iroko Cardio
Aggrastat® high dose bolus EU approval
High dose bolus (HDB) Aggrastat® for the treatment of acute coronary syndrome (NSTE-ACS) patients undergoing percutaneous coronary intervention (PCI) received EU regulatory approval in September 2010. National approvals have since followed in The Netherlands, UK, Germany, Finland, and Belgium and the process will be concluded in the Mutual Recognition Process (MRP) member states in 2011. Regulatory variations are in process for other global markets where Aggrastat® is available.
The PCI HDB dosing for Aggrastat® is 25?g/kg over 3 minutes followed by an infusion of 0.15?g/kg/min for 18-24 and up to 48 hoursi.
Triple anti-platelet therapy—which patients and why?
Triple anti-platelet therapy (aspirin, thienopyridine plus GPIIbIIIa receptor antagonist) may not be for everyone but, despite the availability of compelling clinical data and treatment guidelines, high risk patients often remain under-treated. The recent label change was the stimulus for a debate between Dr. A. van't Hof (Netherlands) and Dr. T. Cuisset (France), chaired by Dr. Valgimigli (Italy) hosted near Geneva by Iroko Cardio and joined online by cardiologists from Europe, Middle East, Asia, and Latin America.
Summarising the debate, Dr. Valgimigli concluded that "high risk patients undergoing PCI should be considered for aggressive anti-platelet therapy." Dr. Valgimigli went on to say that "despite the availability of newer agents and more potent oral options, l believe there is still room for GPIs in high risk ACS patients. In this respect, tirofiban offers doctors a potent, safe and cost-effective therapeutic option for their high risk ACS patients."
Euro PCR, Paris, 17-20 May 2011
Iroko Cardio will support a medical information lounge at Euro PCR and welcomes customers to a 'How should I treat' session chaired by Prof. Christian Hamm.
"While there's clear clinical trial evidence that triple anti-platelet therapy is beneficial for high risk PCI's, the underuse of this treatment regimen is unsatisfactory. Therefore, it is important to discuss the appropriate anti-thrombotic regime patient by patient in the context of combining new anti-thrombotic and anti-platelet drugs. At Euro PCR we will use a "how should I treat" session to translate study results to individual patient cases", said Prof. Hamm.
Iroko Cardio
Iroko Cardio is a privately held pharmaceutical company located in Geneva, Switzerland and Philadelphia, USA. It manufactures and markets Aggrastat® worldwide (with the exception of the USA) in collaboration with regional distribution partners. Iroko Cardio aims to contribute to the reduction of MACE.
Aggrastat® is a registered trade mark of Iroko Cardio LLC, Philadelphia USA. For Aggrastat® prescribing information and further information on Iroko Cardio, visit: [Ссылки доступны только зарегистрированным пользователям ]
Iroko Cardio does not recommend the use of Aggrastat® in any manner other than as described in local prescribing information. Further information is available from the Iroko Cardio Medical Information Center: [Ссылки доступны только зарегистрированным пользователям ], +41 22 907 7970
About Aggrastat®
Aggrastat® is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from Aggrastat® treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA.
Patients managed with early invasive strategy (4-48 hrs. after diagnosis)
Initial intravenous infusion rate: 0.4 ?g /kg/min for 30 minutes. Maintenance infusion rate: 0.1 ?g /kg/min
Dosage information for patients undergoing PCI
Patients undergoing PCI demonstrated clinical efficacy with treatment with Aggrastat® utilizing an initial bolus of 25 ?g/kg given over a 3 minute period, followed by a continuous infusion at a rate of 0.15 ?g/kg/min for 18-24, and up to 48 hours.
In patients with severe kidney failure (creatinine clearance <30mL/min), the dosage of Aggrastat® should be reduced by 50%.
Aggrastat® should be administered with unfractionated heparin and oral antiplatelet therapy unless contra-indicated.
Contraindications
Hypersensitivity to active substance or excipient; previous thrombocytopenia with GPIIb/IIIa receptor antagonist; stroke within previous 30 days; history of haemorrhagic stroke; history of intracranial disease; clinically relevant bleeding (within the previous 30 days); malignant hypertension; trauma or major surgical intervention within the past six weeks; thrombocytopenia (platelet count <100,000/mm3), disorders of platelet function; clotting disturbances; severe liver failure.
Warnings and Precautions
Monitor patients for bleeding during treatment. In cases of haemorrhage, consider discontinuing Aggrastat®. In cases of severe uncontrollable bleeding discontinue Aggrastat® immediately.
For all other SPCs please refer to local prescribing information.
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