Dabigatran (Pradaxa): NPS RADAR Review

2 August 2011

The latest issue of NPS RADAR provides an independent review of dabigatran (Pradaxa), an oral anticoagulant, for preventing stroke or systemic embolism in people with non-valvular atrial fibrillaton. In Australia, dabigatran is currently only available on private prescription for this indication. Dabigatran is currently PBS listed for short-term prophylaxis of venous thromboembolism after hip or knee replacement surgery.

Dabigatran is an alternative to warfarin in atrial fibrillation. In a large clinical trial, dabigatran 150mg twice daily reduced the absolute risk of stroke by 0.6% per year compared with dose-adjusted warfarin. The overall rate of major bleeding did not differ between the two treatment groups. Trial participants taking lower dose dabigatran (110 mg twice daily) were at similar risk of stroke or systemic embolism as those receiving warfarin.

NPS Head of Programs, Karen Kaye, says some people with atrial fibrillation may find dabigatran more convenient than warfarin because it does not require any dose titration or regular monitoring.

“Dabigatran may be an option for patients who find it difficult to maintain a therapeutic INR, who are at increased risk of drug and food interactions with warfarin, or for those where regular monitoring of INR is difficult or impractical. Patients on warfarin with an INR consistently in the therapeutic range may not benefit from switching to dabigatran,” said Ms Kaye.

“Dabigatran’s safety has not been established in patients at high risk of bleeding, and follow-up data is limited to 2 years. Individual risks and potential benefits should be taken into account when choosing an oral anticoagulant. Dabigatran is a new medicine and like all new medicines the full range of side effects is not yet known.”

Brief information on the following medicines and PBS listing changes are also included in this edition of NPS RADAR:

  • Varenicline (Champix) safety update: possible increase of serious cardiovascular events
  • 13-Valent pneumococcal conjugate vaccine (Prevenar 13) listed on the National Immunisation program
  • Saxagliptin (Onglyza) tablets PBS listed for type 2 diabetes
  • Dutasteride with tamsulosin (Duodart) PBS listed for benign prostatic hyperplasia
  • Telmisartan with amlodipine (Twynsta) PBS listed
  • Generic brand of fentanyl patches (Denpax) PBS listed.

To read the full reviews go to www.nps.org.au/radar. NPS RADAR is a timely, independent publication published by NPS: Better choices, Better health providing the latest evidence-based assessments of new drugs, PBS listings and the latest research for GPs, pharmacists and other health professionals.

To learn how to evaluate the evidence, the free NPS online learning program Finding Evidence – Recognising Hype teaches critical appraisal and other skills.

For more information about dabigatran, read the Australian Prescriber articles:

New oral anticoagulant drugs – mechanisms of action and New oral anticoagulants – clinical applications.

 

ENDS

Independent, evidence-based and not-for-profit, NPS enables better decisions about medicines and medical tests.We are funded by the Australian Government Department of Health and Ageing.