First New Oral Anticoagulant In More Than 40 Years Approved In Canada

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals;  Blood / Hematology
Article Date: 14 Jun 2008 - 1:00 PST

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Boehringer Ingelheim Canada Ltd. today announced that Health Canada has granted marketing authorization of PRADAX™ (dabigatran etexilate), a novel oral direct thrombin inhibitor (DTI) for the prevention of venous thromboembolism (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery. The approval of PRADAX™ makes it the first new oral anticoagulant to be approved in Canada in more than 40 years.

Venous thromboembolism (VTE) is comprised of both deep vein thrombosis (DVT), a blood clot that forms in a deep vein of the calf, upper leg or pelvis and pulmonary embolism (PE), a potentially fatal blood clot that has broken loose and traveled to the lungs. Venous thromboembolism (VTE) kills more people each year than breast cancer, AIDS and motor vehicle crashes combined.[ii]

"For many years, we have needed an equally effective oral anticoagulant to what is currently available, but with a good safety profile and without a need for routine monitoring," says Dr. David Backstein, orthopaedic surgeon at Mount Sinai Hospital in Toronto. "Now, with the approval of PRADAX™, we have an attractive alternative to protect our patients from VTE - a serious condition that many refer to as a 'silent killer'."

PRADAX™ is a novel, once-daily anticoagulant that differs from commonly used anticoagulants in Canada. Unlike warfarin, a commonly used anticoagulant, PRADAX™ does not require extensive anticoagulation monitoring (regular blood tests to measure for blood clotting activity). PRADAX™ is taken orally and no injections are needed. PRADAX™ does not interact with food and has a low potential for drug-drug interactions.[iii]

"We hear daily the concerns of orthopaedic patients, and the risk of blood clots post-surgery is among the most prominent," says Angelique Berg, Executive Director, Canadian Orthopaedic Foundation. "As Canadians age and the demand for hip and knee replacements skyrockets, the incidence of these potentially life-threatening clots could rise accordingly. Orthopaedic patients need safe, effective and convenient therapeutic option, and the arrival of the first innovation in 40 years is encouraging indeed."

Expert guidelines recommend the use of preventative blood thinning medication (thromboprophylaxis) for patients undergoing knee replacement surgery for at least 10 days, and extended thromboprophylaxis of 28 to 35 days for patients undergoing hip replacement surgery.[iv] However, there is evidence that in certain patient populations, less than one in five patients discharged from hospital following hip and knee replacement surgery received a thromboprophylaxis.[v] Without the use of preventative therapy as many as 60 per cent of patients will develop DVT.4

"Because patients are spending less time in hospital there is a greater need for safe and convenient treatment options like PRADAX™ as patients are discharged," says Dr. Michael Tanzer, orthopaedic surgeon at the Montreal General Hospital. "The average hospital stay following hip and knee replacement surgery has been substantially shortened, which means that the care and management of patients has shifted from in-hospital to at-home. Because there is little to no blood monitoring required with PRADAX™ and no food interactions, patients are now able to conveniently and safely continue therapy in an out-of-hospital setting."

About PRADAX™

The Canadian approval of PRADAX™ is based on data from the RE-NOVATE, RE-MOBILIZE and RE-MODEL trials.

With all anticoagulant agents it is important to optimize the balance of efficacy and safety. In addition to the critically important bleeding profile, liver safety needs to be considered. In the three pivotal trials, a low incidence and severity of major bleeding (including those occurring at the surgical site) was reported in patients treated with PRADAX™, which was similar to those treated with enoxaparin (a commonly used injectable anticoagulant).3,[vi],[vii]

Rates of liver enzyme alanine aminotransferase (ALT) elevations greater than three times the upper limit of normal (3x ULN) were also low and comparable to enoxaparin at any time post-baseline with PRADAX™, supporting liver safety.3,6,7

PRADAX® is approved in all 27 European Union member states, most recently in the United Kingdom.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
http://www.boehringer-ingelheim.com

References:

[i] Canadian Institute for Health Information, Canadian Joint Replacement Registry (CJJR) 2007 Annual Report. - Hip and Knee Replacements in Canada (Ottawa: CIHI, 2008)
[ii] Canadian Patient Safety Institute Getting started kit: Venous thromboembolism prevention how-to guide., March 2008
[iii] PRADAX Product Monograph, June 10, 2008
[iv] Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126:338S-400S
[v] Rahme E, Dasgupta K, et al. Postdischarge thromboprophylaxis and mortality risk after hip-or-knee replacement surgery. CMAJ 2008;178(12)1545-1554
[vi] Eriksson BI, Dahl OE, Kurth AA et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007;5:2178-2185
[vii] Eriksson BI, Dahl OE, Rosencher N et al. Dabigatran etexilate compared with enoxaparin for the extended prevention of venous thromboembolism following total hip replacement. Lancet 2007;370:949-956