2014

Nearly 80 Percent of Cardiologists Say Ischemic Stroke Risk Reduction is Their Primary Goal in Non-valvular Atrial Fibrillation Treatment, New Survey Shows Cardiologists also believe their patients' top concern is the fear of experiencing a clot that leads to a stroke; real-world challenges may influence treatment decisions

RIDGEFIELD, Conn., March 28, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced results from a new survey of cardiologists to understand their perceptions about anticoagulation, stroke risk reduction and goals for non-valvular atrial fibrillation (NVAF) therapy when prescribing warfarin or a novel oral anticoagulant. The online survey, conducted by Harris Poll on behalf of BIPI, included 300 licensed U.S. cardiologists who treat at least five NVAF patients per month.

Cardiologists overwhelmingly responded that reducing the risk of ischemic stroke was their primary treatment goal for patients with NVAF (79 percent). When asked which one of a number of factors has the most impact when determining oral anticoagulation therapy for patients with NVAF, cardiologists said efficacy in reducing risk of ischemic stroke (42 percent), followed by cost to the patient (15 percent), overall safety profile of the medication (14 percent), patient preferences (7 percent), patient medical history (6 percent) and risk of bleeding due to anticoagulant (5 percent). Additionally, 69 percent of cardiologists said that fear of experiencing a clot that leads to a stroke is their patients' top concern with respect to their NVAF treatment.

Despite the strong consensus on the top treatment priority, cardiologists say that nearly half the time (47 percent) they prescribe an oral vitamin K antagonist, an anticoagulant that only 13 percent of respondents believe to be most effective at reducing ischemic stroke risk in patients with NVAF.

"The risk of ischemic stroke is a significant concern for physicians treating patients with NVAF, and a top fear for our patients," said Eric D. Peterson, MD, MPH, Director of the Duke Clinical Research Institute, Duke University Medical Center in Durham, North Carolina. "While many important factors, including safety and cost, must be considered when making treatment decisions, it is important that physicians evaluate all of the data available for the novel oral anticoagulants versus vitamin K antagonists in reducing the risk of ischemic stroke in NVAF."

Survey Also Reveals Real-World Challenges Faced by Cardiologists
Even though nearly four out of five cardiologists (79 percent) believe their NVAF patients with a treatment plan have at least a moderate understanding of the potential severity of an ischemic stroke due to NVAF, almost all (98 percent) believe there are some barriers to reducing ischemic stroke risk. Nearly all cardiologists acknowledge that they usually consider many factors, not just efficacy, when choosing a treatment (96 percent). 

The cardiologists surveyed said the most common barriers to reducing the risk of stroke due to NVAF they experience are patient complaints related to logistical, lifestyle or cost issues associated with medicines that reduce the risk of ischemic stroke (74 percent) and concerns about the risk of bleeding (71 percent). Cardiologists believe their patients are very or extremely concerned about a number of issues related to the medicines they are taking to reduce their risk of ischemic stroke due to NVAF, including cost (77 percent), risk of bleeding (75 percent), side effects (69 percent), the need for regular follow-up appointments for monitoring of anticoagulation (51 percent), and inconvenient dosing (42 percent).

"The good news is that the majority of patients understand the connection between atrial fibrillation and stroke risk. As health care professionals, we must make sure patients understand how anticoagulant treatment can reduce their stroke risk and what anticoagulant is right for them," said Peter R. Kowey, MD, Chief of the Division of Cardiovascular Diseases at Lankenau Hospital Main Line Health System, Philadelphia, Pennsylvania. "Ultimately, good physician-patient communication early on can help overcome barriers to treatment."

Clinical Data: Reducing Ischemic Stroke Risk with Pradaxa® (dabigatran etexilate mesylate) in NVAF

PRADAXA is the only direct thrombin inhibitor approved in the United States for stroke risk reduction in NVAF, and was the first oral anticoagulant (OAC) approved for that indication by the U.S. Food and Drug Administration in more than 50 years. PRADAXA is the only OAC with clinical data demonstrating superiority compared to warfarin in reducing ischemic stroke in patients with NVAF. Nearly nine out of 10 strokes caused by atrial fibrillation are ischemic strokes.

The efficacy and safety of PRADAXA were established in the RE-LY® trial, one of the largest stroke prevention clinical studies ever conducted with NVAF patients. The 18,113-patient RE-LY trial showed that, compared to well-controlled warfarin (N=6,022), PRADAXA 150 mg (N=6,076) significantly reduced the risk of stroke and systemic embolism by 35 percent (primary efficacy endpoint: 134 [2.2%] vs. 202 [3.4%] events, HR: 0.65, 95% CI [0.52, 0.81], P=0.0001), ischemic stroke by 25 percent (103 [1.7%] vs. 134 [2.2%] events, HR: 0.75, 95% CI [0.58, 0.97], P=0.0296) and hemorrhagic stroke by 74 percent (12 [0.2%] vs. 45 [0.8%] events, HR: 0.26, 95% CI [0.14, 0.49], P<0.0001). The rate of all-cause mortality was lower with PRADAXA 150 mg than with warfarin (3.6 percent per year versus 4.1 percent per year). PRADAXA had a higher rate of total GI bleeds (N=681 vs. 452) and major GI bleeds (N=186 vs. 125; 50 percent increased risk with the 150 mg dose compared to warfarin). Treatment with PRADAXA 150 mg led to a 59 percent reduction in intracranial hemorrhage, compared to warfarin (38 vs. 90), and showed numerically lower rates of fatal and life-threatening bleeds (28 vs. 39 and 179 vs. 218, respectively).

About the Survey
The Cardiologists and NVAF Treatment survey was conducted online between January 23 and February 7, 2014 by Harris Poll on behalf of Boehringer Ingelheim among 300 licensed cardiologists who practice in the United States and treat at least five patients with NVAF per month. For the full methodology, including weighting variables, please contact BIPI Public Relations.

About Pradaxa® (dabigatran etexilate mesylate) Capsules

Indications and Usage
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

WARNING: DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE. Discontinuing PRADAXA places patients at an increased risk of thrombotic events. If anticoagulation with PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

CONTRAINDICATIONS
PRADAXA is contraindicated in patients with:

  • active pathological bleeding;
  • known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA;
  • mechanical prosthetic heart valve

WARNINGS & PRECAUTIONS
Increased Risk of Stroke with Discontinuation of PRADAXA
Discontinuing PRADAXA in absence of adequate alternative anticoagulation increases the risk of thrombotic events.  If PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Risk of Bleeding

  • PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA in patients with active pathological bleeding.
  • Risk factors for bleeding include concomitant use of medications that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). PRADAXA's anticoagulant activity and half-life are increased in patients with renal impairment.
  • A specific reversal agent for dabigatran is not available. Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding is limited. Activated prothrombin complex concentrates, recombinant Factor VIIa, or concentrates of factors II, IX or X may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
The safety and efficacy of PRADAXA in patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than 3 months prior to enrollment) was evaluated in the phase 2 RE-ALIGN® trial.  RE-ALIGN was terminated early because of significantly more thromboembolic events (valve thrombosis, stroke, transient ischemic attack, and myocardial infarction) and an excess of major bleeding (predominantly post-operative pericardial effusions requiring intervention for hemodynamic compromise) for PRADAXA vs warfarin.  Therefore, the use of PRADAXA is contraindicated in patients with mechanical prosthetic valves.

Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.

Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided.  P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran.  Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.

  • For patients with moderate renal impairment (CrCl 30-50 mL/min), consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and 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 higher rates of major GI bleeds and any GI bleeds compared to warfarin.
  • In patients > 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 <0.1% of patients receiving PRADAXA.

Other Measures Evaluated
In the pivotal trial, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA (0.7 per 100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

Please see full Prescribing Information, including boxed WARNING and Medication Guide.

About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs
For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

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 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.us.boehringer-ingelheim.com/

PRADAXA® is a registered trademark of Boehringer Ingelheim Pharma GmBH and Co. KG and used under license.

RE-LY® is a registered service mark of Boehringer Ingelheim International GmbH and used under license.

RE-ALIGN® is a trademark of Boehringer Ingelheim International GmbH (BII) and is used in the US by Boehringer Ingelheim Pharmaceuticals, Inc. under license from BII.

Photo - http://photos.prnewswire.com/prnh/20140328/NY91570-INFO 

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.



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