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Dabigatran etexilate (Pradaxa) green-lighted by NICE for treating and preventing the recurrence of deep vein thrombosis and pulmonary embolism

has announced that the National Institute for Health and Care Excellence (NICE) has approved dabigatran etexilate (Pradaxa®) for use by the National Health Service within its marketing authorisation for treatment of (DVT) and (PE) and prevention of recurrent DVT and PE in adults1.

Venous thrombosis (blood clotting) is a major cause of death in the UK and for those patients that survive PE and DVT, there can be long term complications causing serious illness.4After a first episode of DVT/PE, patients are 40-times more likely overall to suffer a further event compared with previously unaffected individuals.5

This decision allows a new treatment option to be made available to doctors and patients across England and Wales for the treatment of this serious medical condition.

Welcoming the news Charles de Wet Medical Director for Boehringer Ingeheim UK and Ireland said:

“This news broadens the ways in which Pradaxa® can be used allowing patients to have more choices.”

“This is great news for patients and will provide a welcome additional option for the management of DVT/PE.

“Our medicine is already accepted for use in England and Wales for the primary prevention of venous thromboembolism (VTE) after elective total hip or knee replacement surgery and for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation.”

The positive NICE guidance is based on results from four phase III clinical trials involving more than 9,000 patients that demonstrated the efficacy of Pradaxa® 150 mg twice daily in the treatment of DVT and PE and the prevention of recurrence compared to warfarin or placebo.6,7,8

The NICE guidance also mirrors the positive advice from the Scottish Medicines Consortium (SMC), published on 13th October earlier this year.9

Pradaxa® has the longest clinical trial experience in patients with DVT/PE of any of the novel oral anticoagulants (NOACs).8,10,11

Pradaxa® now offers patients in England and Wales with DVT/PE, as well as their physicians, a treatment option which does not require a dose adjustment during the standard course of treatment2,3.

For the treatment of DVT/PE, Pradaxa® is started as a fixed dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin (LMWH) for at least five days2,3.

Source

1. NICE. Dabigatran Etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism NICE TAG 327. Available at guidance.nice.org.uk/ta327. December 2014.

2. Boehringer Ingelheim. Pradaxa 110mg hard capsules Summary of Product Characteristics.

3. Boehringer Ingelheim. Pradaxa 150mg hard capsules Summary of Product Characteristics.

4. LifeBlood Thombosis Charity. An introduction to VTE. http://www.thrombosis-charity.org.uk/an-introduction-to-vte.php Last accessed April 2014.

5. Baglin T, Diagnosis and Treatment of Venous Thomboembolism. CME Geriatric Medicine 2012; 14(2): 43-48

6. Schulman S, et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342-52.

7. . Schulman S, et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709-18.

8. . Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation 2014;129:764-72.

9. Scottish Medicines Consortium (SMC). Dabigatran etexilate for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults https://www.scottishmedicines.org.uk/files/advice/dabigatran_etexilate__Pradaxa__FINAL_Sept_2014_for_website.pdf (accessed 16th December 2014)

10. The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N Engl J Med 2010;363:2499–2510.

11. Agnelli G, et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med 2013;368:699-708.

Source: Boehringer Ingelheim