NICE draft guidance recommends dabigatran (Pradaxa) for blood clots

In draft guidance NICE has recommended the anti-blood clotting drug dabigatran (Pradaxa, Boehringer Ingelheim) as an option for treating and preventing recurrent and potentially fatal blood clots in the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) in adults.

Dabigatran is a novel oral anticoagulant (NOAC), a new breed of treatment which is increasingly recognised as beneficial over older drugs like warfarin.

DVT occurs when a blood clot (thrombus) forms in the deep veins of the leg or pelvis. Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg.

If the blood clot dislodges and travels to the lungs, this can lead to a potentially fatal PE when the clot blocks the blood supply to the lungs. Even if blood clots are not fatal, they can still result in long-term illness, including venous ulceration and chronic pain, swelling and skin changes in the affected limb, which can have a significant impact on quality of life.

Risk factors for DVT and PE include a history of DVT, recent surgery, immobility, active cancer or cancer treatment, age over 60 years, obesity, hormone replacement therapy or oestrogen-containing contraceptive therapy and the presence of co-morbidities such as heart disease.

People with suspected DVT or PE are generally treated immediately with anticoagulants, usually with injections of low molecular weight heparin (LMWH). When the diagnosis has been confirmed, this is overlapped with an oral anticoagulant such as warfarin.

The length of treatment is based on a person’s risk of having another DVT or PE, as well as their risk of bleeding. The usual length of treatment in UK practice is three months or more. However, people who are at high risk of having another blood clot may be given life-long treatment with anticoagulants to prevent further episodes.

Professor Carole Longson, NICE Health Technology Evaluation Centre director, explained that using warfarin could be difficult for many people because of the need for frequent tests to see if the blood was clotting properly, and having to adjust the dose of the drug if not.

“The Appraisal Committee felt that dabigatran represents a potential benefit for many people who have had a DVT or PE, particularly those who have risk factors for recurrence of a blood clot and who therefore need longer term treatment. We are pleased, therefore, to be able to recommend dabigatran as a cost-effective option for treating DVT and PE and preventing further episodes in adults,” she said.

The draft guidance is now out for consultation.


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