New oral anticoagulant launched
Boehringer Ingelheim GmbH
Pradaxa stock will be available late April 2008 |
Dabigatran
etexilate, the first new oral anticoagulant introduced in the UK since vitamin K antagonists were developed almost 60 years ago, is set to become available.
Marketed by Boehringer Ingelheim as Pradaxa, dabigatran etexilate is
a direct thrombin inhibitor given as a fixed once-daily dose in capsule
form. It is indicated for primary prevention of venous thromboembolism
(VTE) in adult patients who have undergone elective total hip replacement
surgery or total knee replacement surgery.
There is no requirement for
coagulation or thrombocytopenia monitoring and the drug is not affected
by food intake so it can be given as a fixed dose, independent of meals
and without dietary restrictions.
After oral administration, dabigatran etexilate is rapidly absorbed and
converted by esterase-catalysed hydrolysis in plasma and the liver into
dabigatran, a potent, competitive, reversible direct thrombin inhibitor.
Boehringer Ingelheim says that, because dabigatran etexilate is not metabolised
by cytochrome P450 enzymes, it has a low potential for drug-drug interactions.
Dabigatran etexilate is contraindicated in a number of patient groups
and should be used with caution for people taking certain medicines that
may increase risk of haemorrhage.
Beyond its current licensed indications, dabigatran etexilate is also
being evaluated for the treatment of acute VTE, secondary prevention
of VTE, prevention of stroke for patients with atrial fibrillation and
prevention of cardiac events for patients with acute coronary syndrome.
Dabigatran etexilate is the first oral direct thrombin inhibitor to be
available in the UK. Safety concerns led AstraZeneca to terminate
the development of its oral direct thrombin inhibitor ximelagatran in 2006
before the drug’s UK launch (PJ, 25 February 2006, p222).
Boehringer Ingelheim says that Pradaxa will be available before the end
of April 2008. |
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