For health care professionals >

Breaking news

Scottish Medicines Consortium approves Pradaxa

The Scottish Medicines Consortium (SMC) has accepted Pradaxa® (dabigatran etexilate) for routine use within the National Health Service (NHS) of Scotland for its currently licensed indication: the prevention of venous thromboembolic events in adults who have undergone total hip or knee replacement surgery. The European Commission granted marketing authorisation for Pradaxa® in all 27 EU member states in March 2008.

AntiCoagulation Europe regularly makes submissions to the Scottish Medicines Consortium (SMC) and to The National Institute of Clinical Excellence (NICE) and we welcome the favourable and positive decision by the SMC.

New PLAVIX® (clopidogrel) 300mg loading dose tablet now available
for use in ACS (acute coronary syndrome) patients

The new 300mg loading dose tablet will help ensure treatment of appropriate ACS patients is administered early and in accordance to guidance standards

Wednesday 25 June, Guildford / Uxbridge
Sanofi-aventis and Bristol-Myers Squibb announced today the launch of a new 300mg tablet of the antiplatelet PLAVIX® (clopidogrel), as approved by the European Medicines Evaluation Agency (EMEA) for the treatment of appropriate ACS patients (Unstable Angina, Non-STEMI and STEMI patients <= 75 years of age eligible for thrombolytic therapy) in the UK.

The new 300mg tablet will make it easier for healthcare professionals, including those in the ambulance setting, to administer the Guideline recommended 300mg loading dose of clopidogrel to treat appropriate ACS patients. The administration of clopidogrel closely following an event has been shown to provide protection against recurrent events based on two landmark clinical trials, namely CURE and CLARITY-TIMI-28.

"Effective antiplatelet management is a priority in the immediate care of ACS patients by reducing the risk of further events such as STEMI and reinfarction," said Emergency Nurse Consultant, Mr Nick Castle.

NICE recommends clopidogrel 300mg as an initial loading dose in the treatment of Non-STEMI ACS, followed by continued treatment at a dose of 75mg daily in combination with aspirin for 12 months.

"In an emergency, simple is best, and the availability of the 300mg tablet will be far more convenient to administer [than four 75mg tablets], particularly in the ambulance setting.

"This 300mg tablet will facilitate best practice and NICE guidance adherence by offering the recommended clopidogrel loading dose in one tablet. In emergency cardiac situations this will simplify the administration of the rapid loading dose to help ensure patients receive evidence-based treatment as quickly as possible," concluded Mr Castle.

Clopidogrel will also remain available as a 75mg tablet, and both formulations will be parity priced on a milligram-equivalent basis.

The 300mg tablets will be available to all hospital pharmacies, sold in packs of 30 each containing three blister strips of 10 tablets.