Prasugrel (Efient): increased risk of bleeding

New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction.

From:
Medicines and Healthcare products Regulatory Agency
Published
11 December 2014
Therapeutic area:
Anaesthesia and intensive care, Cardiovascular disease and lipidology

Article date: January 2014

Prasugrel (Efient) is a member of the thienopyridine class of medicines, and it inhibits platelet activation and aggregation. Prasugrel is indicated, in combination with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention (PCI).

The licensed dose of prasugrel is a loading dose of 60 mg, followed by 10 mg (or 5 mg, see advice below) once a day. Treatment for up to 1 year is recommended, unless discontinuation is clinically indicated. The appropriate timing of the loading dose in patients with non-ST segment elevation myocardial infarction (NSTEMI) or unstable angina has now been clarified as a result of new data from the ACCOAST trial.[footnote 1]

ACCOAST was a randomised trial of about 4000 NSTEMI patients that compared the effects of prasugrel loading dose of 30 mg before coronary angiography and a further 30 mg dose at the time of PCI, with that of a loading dose of 60 mg given at the time of PCI.

The trial found an increased risk of bleeding but no additional benefit in the experimental, split loading-dose group compared with those who received 60 mg at the time of PCI.

Advice for healthcare professionals:

  • Prasugrel is approved as a single 60 mg loading dose (followed by a maintenance dose recommended for up to 1 year); this remains unchanged
  • Patients with unstable angina or NSTEMI, who undergo coronary angiography within 48 hours of admission, should be given a loading dose of 60 mg at the time of PCI only, to minimise bleeding risk
  • Remember that a reduced maintenance dose of 5 mg once daily should be used (recommended for up to 1 year) if patients are age 75 years or older, or if their bodyweight is less than 60 kg

Further information

See letter for healthcare professionals sent in December 2013

Article citation: Drug Safety Update volume 7 issue 6, January 2014: A1.

  1. Montelascot G, for the ACCOAST trial investigators. N Engl J Med 2013; 369: 999–1010 ↩

Updates to this page

Published 11 December 2014
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