ACCF/AHA/HRS Add Pradaxa to Leading Practice Guidelines for Atrial Fibrillation

RIDGEFIELD, Conn., Feb. 15, 2011 /PRNewswire/ -- Pradaxa® (dabigatran etexilate mesylate) capsules is now recommended as an alternative to warfarin to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (NVAF) in the Guidelines on the Management of Patients With Atrial Fibrillation, which were jointly developed by the American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and Heart Rhythm Society (HRS).(1) The addition of PRADAXA to the guidelines appeared as a "Focused Update" to the section on emerging antithrombotic agents and is published in Circulation: Journal of the American Heart Association, Journal of the American College of Cardiology and HeartRhythm Journal. (1)

PRADAXA was approved by the U.S. Food and Drug Administration in October of 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (2) and is the only approved treatment that has demonstrated significant reductions in the risk of stroke compared to warfarin. (2) PRADAXA 150mg capsules taken twice daily has been shown to reduce stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin (2) dosed to a target international normalized ratio (INR) of 2.0 to 3.0. (2)  The effects of PRADAXA compared to warfarin were more apparent in patients with lower levels of INR control. (2)

"The atrial fibrillation management guidelines were updated following the approval of dabigatran to reflect a consensus of expert opinions about the role of this important new treatment,” said Eric Prystowsky, M.D., director of Clinical Electrophysiology Laboratory at St. Vincent Indianapolis Hospital. “I applaud the guideline committee for acting so quickly to include dabigatran as an important therapeutic option to reduce the risk of stroke in patients with non-valvular atrial fibrillation. For the first time in decades, physicians have an alternative to warfarin for this patient population."

For reducing the risk of stroke, the updated Practice Guidelines on the Management of Patients With Atrial Fibrillation recommend PRADAXA as a useful alternative to warfarin for patients with paroxysmal to permanent atrial fibrillation, and risk factors for stroke or systemic embolization, who do not have a prosthetic heart valve, hemodynamically significant heart valve disease, severe renal failure or advanced liver disease. (1)

"The swift update of the guidelines following the FDA approval of PRADAXA demonstrates the importance of having an alternative to warfarin for non-valvular atrial fibrillation," said Christopher Corsico, M.D., MPH, medical director, Boehringer Ingelheim Pharmaceuticals, Inc.  "Boehringer Ingelheim is proud to offer this innovative new treatment, which demonstrated significant stroke risk reduction over warfarin in patients with non-valvular atrial fibrillation."

About Atrial Fibrillation and Stroke

Atrial fibrillation, characterized by an irregular heartbeat, (3) can cause blood clots to form in the heart that can travel to the brain and cause a stroke. (3)  An estimated 2.3 million Americans are living with atrial fibrillation, (4) and the prevalence is expected to increase to 5.6 million by 2050. (4)  Non-valvular atrial fibrillation, which accounts for 95 percent of diagnosed cases of atrial fibrillation, (4) refers to cases of atrial fibrillation without rheumatic mitral valve disease, prosthetic heart valve or valve repair, according to the 2006 ACC/AHA/ESC guidelines. (5) Atrial fibrillation increases the risk of stroke nearly five times (5) and is associated with up to 15 percent of all strokes in the U.S. (5) Atrial fibrillation imposes a substantial economic burden to the healthcare system, (6) specifically the high costs associated with stroke. (7)

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS AND PRECAUTIONS

Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

-Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.

ADVERSE REACTIONS

In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain, upper abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in less than 0.1% of patients receiving PRADAXA.

Other Measures Evaluated

The risk of myocardial infarction was numerically greater in patients who received PRADAXA 150 mg than in those who received warfarin.

For full PRADAXA prescribing information, please visit www.pradaxa.com or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

About Boehringer Ingelheim Pharmaceuticals, Inc.

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 142 affiliates in 50 countries and more than 41,500 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 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

(1) Wann, L.S., et al. "2011 ACCF/AHA/HRS Focused Update on the Management of Patients with Atrial Fibrillation(Update on Dabigatran): A Report of the American College of  Cardiology Foundation/American Heart Association Task Force on Practice Guidelines." Circulation. 2011; 123:00-00.

(2) Pradaxa Prescribing Information.

(3) NHLBI website. "What is AFib?" Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Accessed on: August 2, 2010.

(4) Go, A.S., et al. "Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the ATRIA Study." JAMA. 2002; 285:2370-2375.

(5) Fuster, V., et al. "ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation – Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society." Circulation. 2006; 114;700-752.

(6) Coyne, K.S., et al. "Assessing the Direct Costs of Treating Nonvalvular Atrial Fibrillation in the United States." Value in Health.  2006; 9:348-356.

(7) Harley C., et al. "Direct Costs And Health Care Utilization Associated With Stroke in the Presence of Atrial Fibrillation in the United States."  ASAIS Conference, Feb. 2009.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.