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RE-COVER Study Evaluating Dabigatran Etexilate Met Primary Outcome for the Six-Month Treatment of Patients with Acute Venous Thromboembolism (VTE)

Monday, December 7, 2009 General News J E 4
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RIDGEFIELD, Conn., Dec. 6 Boehringer Ingelheim today announced results from the RE-COVER(TM) study investigating dabigatran etexilate (150 mg BID), a direct thrombin inhibitor (DTI),(2) compared to dose-adjusted warfarin in patients with acute VTE. Results of the trial were presented at the 51st American Society of Hematology Annual Meeting and simultaneously published online in the New England Journal of Medicine.(1)

Dabigatran etexilate met the primary outcome of the trial, six month incidence of recurrent symptomatic VTE and related deaths, and was non-inferior to dose-adjusted warfarin in patients with acute VTE (2.4 percent versus 2.1 percent).(1) There were 37 percent fewer patients treated with dabigatran etexilate (71) who experienced major or clinically relevant non-major bleeds versus patients treated with warfarin (111).(1) The percentage of patients experiencing major bleeds was 1.6 in the dabigatran etexilate group and 1.9 in the warfarin group.(1) The number of patients with any bleeding was 29 percent lower in the group treated with dabigatran etexilate.(1)

Among adverse events with an incidence of at least three percent, dyspepsia was the only one that was more common between treatment arms (2.9 percent in the dabigatran etexilate group versus 0.6 percent in the warfarin group).(1) There were 115 patients in the dabigatran etexilate group (9.0 percent) and 86 patients in the warfarin group (6.8 percent) who had an adverse event that led to discontinuation of the study drug (HR, 1.33; 95 percent CI, 1.01 to 1.76; P=0.05).(1)

"The standard of care for patients with VTE is anticoagulation," said Dr. Janet Schnee, clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc. "It is encouraging to see that the results of this study suggest that dabigatran etexilate has the potential to be an alternative treatment for VTE."

Venous thromboembolism is a condition which includes deep vein thrombosis (DVT) and its potentially fatal acute complication pulmonary embolism (PE). The condition results from the formation of blood clots that block the flow of blood in the veins, most frequently occurring in the legs (DVT). Clots that become dislodged from affected veins can migrate to and obstruct the blood vessels that supply the lungs (PE). Venous thromboembolism is the third most common cause of cardiovascular death after myocardial infarction and stroke.(1)

Current guidelines recommend treating acute, clinically documented VTE with a parenteral heparin preparation for at least five days followed by oral anticoagulation with a vitamin K antagonist, such as warfarin.(3)

"We are committed to improving the treatment options for patients with thromboembolic diseases," said Wa'el Hashad, vice president, Cardiovascular and Metabolics Marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "The RE-COVER study results suggest dabigatran etexilate could potentially provide a convenient treatment option for patients with VTE."

In total, four trials involving 8,900 patients are exploring dabigatran etexilate in VTE: RE-COVER(TM) and RE-COVER(TM)II in acute VTE and RE-MEDY(TM) and RE-SONATE(TM) in prevention of secondary VTE.(1,4,5,6)

About RE-COVER(TM)(1)

RE-COVER(TM) is a global, phase III, randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of oral dabigatran etexilate (150 mg BID) to warfarin (target INR 2.0-3.0) for six months of treatment of acute symptomatic VTE, following initial treatment with a parenteral anticoagulant approved for this indication. The study involved 2,539 patients. The primary efficacy endpoint was a composite of recurrent symptomatic VTE and deaths related to VTE.

About VTE

Venous thromboembolism refers to blood clots (thrombi) which originate in the veins, and includes DVT and its potentially fatal acute complication PE. Pulmonary embolism is a leading cause of in-hospital death, accounting for approximately 10 percent of all hospital deaths.(7)

About dabigatran etexilate

Dabigatran etexilate is an investigational oral DTI,(2) being studied in the prevention and treatment of acute and chronic thromboembolic diseases.(4,5,6,8,9,10,11,12,13,14) Dabigatran etexilate is not approved by the FDA. Dabigatran etexilate is approved and marketed as PradaxaŽ in 40 countries outside the U.S. for the primary prevention of venous thromboembolic events (blood clots) in patients who have undergone elective total hip or elective total knee replacement surgery.

About the dabigatran etexilate clinical trial program

RE-COVER(TM) is part of Boehringer Ingelheim's clinical trial program evaluating the efficacy and safety of dabigatran etexilate. (4,5,6,8,9,10,11,12,13,14) In addition to RE-COVER, the development program encompasses studies in:

About Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 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 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

References

(1) Schulman S, et al. "Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism." New England Journal of Medicine. 2009; 361.

(2) Di Nisio M, et al. "Direct Thrombin Inhibitors." New England Journal of Medicine. 2005; 353: 1028-40.

(3) Kearon C, et al. Antithrombotic Therapy for Venous Thromboembolic Disease. CHEST. 2008; 133: 454S-545S.

(4) ClinicalTrials.gov. "A Phase III, Randomised, Double Blind, Parallel-Group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication." Available at: http://www.clinicaltrials.gov/ct2/show/NCT00680186?term=dabigatran+etexilate&rank=7. Accessed on: August 25, 2009.

(5) ClinicalTrials.gov. "A Randomised, Multicenter, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Dabigatran Etexilate, 150 mg b.i.d Administered Orally (Capsules) for 18 Months, Compared to Warfarin Tablets p.r.n. (Target INR) for the Secondary Prevention of Venous Thromboembolism." Available at: http://www.clinicaltrials.gov/ct2/show/NCT00329238?term=dabigatran&rank=12. Accessed on: January 28, 2009.

(6) ClinicalTrials.gov. "Twice-Daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-Term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism." Available at: http://www.clinicaltrials.gov/ct2/show/NCT00558259?term=dabigatran&rank=1. Accessed on: April 15, 2009.

(7) Sandler DA, et al. "Autopsy Proven Pulmonary Embolism in Hospital Patients: Are We Detecting Enough Deep Vein Thrombosis?" Journal of the Royal Society of Medicine 1989; 82: 203-205.

(8) Connolly SJ, et al. "Dabigatran versus Warfarin in Patients with Atrial Fibrillation." New England Journal of Medicine.2009; 361: 1139-51.

(9) ClinicalTrials.gov. "RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-Centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)." Available at: http://www.clinicaltrials.gov/ct2/show/NCT00621855?term=dabigatran&rank=11. Accessed on: January 28, 2009.

(10) Eriksson BI, et al. "Dabigatran Etexilate Versus Enoxaparin for Prevention of Venous Thromboembolism After Total Hip Replacement: a Randomized, Double-Blind, Non-Inferiority Trial." The Lancet. 2007; 370: 949-956.

(11) The RE-MOBILIZE Writing Committee. "Oral Thrombin Inhibitor Dabigatran Etexilate vs North American Enoxaparin Regimen for Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery." The Journal of Arthroplasty. 2009; 24: 1-9.

(12) ClinicalTrials.gov. "A Phase III Randomised, Parallel Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)." Available at: http://www.clinicaltrials.gov/ct2/show/NCT00657150?term=dabogatran&rank=7. Accessed on: January 28, 2009.

(13) ClinicalTrials.gov. "RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation Who Completed RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes." Available at: http://www.clinicaltrials.gov/ct2/show/NCT00808067?term=dabigatran&rank=10. Accessed on: July 23, 2009.

(14) Eriksson BI, et al. "Oral Dabigatran Etexilate vs. Subcutaneous Enoxaparin for the Prevention of Venous Thromboembolism After Total Knee Replacement: the RE-MODEL Randomized Trial." Journal of Thrombosis and Haemostasis. 2007; 5: 2178-2185.

-- Primary prevention of VTE in patients undergoing elective total hip and knee replacement surgeries (10,11,14)

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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