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Oral VTE drug shows similar efficacy to enoxaparin in phase 3 study

No significant differences in bleeding rates were seen between patients treated with dabigatran etexilate or enoxaparin, meeting the trial's primary noninferiority endpoint.

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Results from a phase 3 trial show similar efficacy between an oral anticoagulation drug and subcutaneous injections of low-molecular-weight heparin for preventing venous thromboembolism in primary elective total knee arthroplasty patients.

Bengt Eriksson, MD, PhD, of the department of orthopedic surgery at the University Hospital Sahlgrenska/Ostra in Gothenburg, Sweden, conducted the randomized, double-blind, placebo-controlled trial, called RE-MODEL, with colleagues at centers in Europe, South Africa and Australia.

Eriksson presented the results at the American Society of Hematology 48th annual meeting in Orlando, Fla.

In the RE-MODEL trial, investigators assigned 2,076 primary total knee arthroplasty (TKA) patients to either 150 mg or 220 mg of oral dabigatran etexilate (Boehringer Ingelheim Pharmaceuticals Inc.) once daily, administered in half doses on the day of surgery and at 1 to 4 hours postop. These patients were compared to a control group of patients who received 40 mg of enoxaparin once daily by subcutaneous injection initiated 12 hours before surgery.

All venous thromboembolism (VTE) prophylaxis regimens were continued for 6 to 10 days postop, according to a press release from Boehringer Ingelheim announcing the study findings.

Researchers found no significant differences in bleeding rates between patients treated with either dose of dabigatran etexilate or enoxaparin, meeting the trial's primary noninferiority endpoint.

Total VTE and all-cause mortality occurred in 40.5% of patients receiving 150 mg of dabigatran, in 36.4% of patients receiving 220 mg of dabigatran and in 37.7% of those receiving 40 mg of enoxaparin, according to the release.

Researchers found similar rates of proximal deep vein thrombosis and/or pulmonary embolism across treatment arms, occuring in 3.8% of 150 mg dabigatran patients, 2.6% of 220 mg dabigatran patients and 3.5% of enoxaparin patients. In addition, all three groups showed similar rates of major bleeding: 1.3% of 150 mg dabigatran patients, 1.5% of 220 mg dabigatran patients and 1.3% of enoxaparin patients.

The three groups also had similar rates of elevated liver function tests, which were seen in 3.7% of 150 mg dabigatran patients, 2.8% of 220 mg dabigatran patients and 4% of enoxaparin patients, according to the release.

Dabigatran etexilate is an oral direct thrombin inhibitor currently in phase 3 development. The drug is administered orally in a fixed dose that provides predictable anticoagulation that may not require coagulation monitoring.

Boehringer Ingelheim is evaluating the drug for preventing VTE across a variety of medical indications, including total hip arthroplasty.

For more information:

• Eriksson BI, Dahl OE, van Dijk CN, et al. A new oral anticoagulant, dabigatran etexilate, is effective and safe in preventing venous thromboembolism after total knee replacement surgery (The RE-MODEL Trial). Abstract #573. Presented at the American Society of Hematology 48th Annual Meeting. Dec. 9-12, 2006. Orlando, Fla.