First Data from Boehringer Ingelheim, Anthem and HealthCore Multi-Year Study Show Gaps in Non-valvular Atrial Fibrillation Care

RIDGEFIELD, Conn. and WILMINGTON, Del., Nov. 14, 2016 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc., Anthem, Inc. and HealthCore Inc. today announced the final results from the first phase of a three phase, large-scale research collaboration to generate real-world evidence to help inform the development of new medicines, guidelines and interventions. The study assessed oral anticoagulant (OAC) treatment and persistence in NVAF patients, and showed a discrepancy between treatment guidelines and clinical practice at diagnosis and throughout the treatment journey. NVAF is an important risk factor for stroke and clinical trial data has shown that OAC therapy substantially reduces stroke risk in NVAF patients. The findings were presented at the American Heart Association Scientific Sessions 2016 in New Orleans.

"As the first joint research project of its kind, we believe these data have the potential to help us identify treatment gaps in NVAF patient care," said Mark Cziraky, vice president of research of HealthCore, Inc., the independent outcomes research subsidiary of Anthem. "In the next phases, we will focus our research on why these gaps exist, what can be done to bridge these gaps and how this may help improve patient outcomes." 

The retrospective observational study evaluated records for 45,092 newly diagnosed NVAF patients in the United States from the HealthCore Integrated Research Database from November 1, 2010 to November 30, 2013. Although treatment guidelines recommend OAC treatment for all NVAF patients at high stroke risk (i.e., CHADS₂ score ≥2), researchers found less than half (41.1 percent) of the study patients were treated with an OAC (warfarin, dabigatran, rivaroxaban or apixaban).

Compared to untreated patients (n=26,543), treated patients (n=18,549) were younger (mean of 70±12.2 years vs. 71±14.3 years), more likely to be male (59.7% vs. 52.5%), with higher CHADS₂ scores (stroke risk; 2.03±1.3 vs. 1.98±1.4) and lower HEMORR₂HAGES scores (bleed risk; 2.55±1.8 vs. 2.8±1.9).

Patients at the highest risk of stroke, however, did not have the highest treatment rate. Higher stroke risk (measured by CHADS₂ score) was associated with a higher bleed risk (measured by HEMORR₂HAGES score) in all patients suggesting the risk of bleeding may be a critical component in OAC treatment decision making.

"For patients with NVAF, the primary goal of anticoagulation treatment is to reduce the risk of stroke. As atrial fibrillation accounts for more than 15 percent of all strokes in the United States, it is critical that we continue to educate physicians and patients on the benefits, risks and importance of treatment to reduce this risk," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "At Boehringer Ingelheim, we believe cross-industry collaborations such as this one are essential in understanding how medicines are being used and where there are gaps in care in order to drive real change for patients."

Among those patients who were treated with an OAC (n= 18,549), the majority initiated treatment on warfarin (60.1%). Nearly one-fourth (23%) of treated patients stopped taking their medication within three months and more than half (55%) stopped within the first year. At follow-up (average of 2.25 years later), 72.7 percent of patients had stopped taking their medication.

As follow up to this research, Boehringer Ingelheim and HealthCore are surveying patients and their providers to gain a better understanding of disease management and adherence challenges, treatment decision-making factors and treatment experiences. The next phases of the project are currently underway and results are anticipated in 2017.

About the Research Collaboration

In 2014, Boehringer Ingelheim Pharmaceuticals, Inc., Anthem, Inc. and HealthCore Inc. commenced a five-year research project to identify and address unmet medical needs across populations of mutual interest. The collaboration will enable the companies to generate real-world evidence and develop health economic and outcomes data to inform the development and evaluation of new medicines, guidelines and interventions.

The first research topic under the agreement is non-valvular atrial fibrillation (NVAF). With the entry of newer anticoagulant therapies, after more than five decades of warfarin use, there is an important opportunity to understand how NVAF is being managed in a new era of treatment.

Together, the companies plan to explore issues related to appropriate use of existing and new therapies and interventions and the impact these have on clinical and economic outcomes that matter the most to patients.

About Pradaxa® (dabigatran etexilate mesylate)

What is PRADAXA?

PRADAXA is a prescription blood thinner medicine that lowers the chance of blood clots forming in your body. PRADAXA is used to:

• reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should.  This can lead to blood clots forming and increase your risk of a stroke. 
• treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again.

PRADAXA is not for use in people with artificial (prosthetic) heart valves.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

For people taking PRADAXA for atrial fibrillation:  Do not stop taking PRADAXA without talking to the doctor who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke.  PRADAXA may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking PRADAXA and when you may start taking it again. If you have to stop taking PRADAXA, your doctor may prescribe another medicine to help prevent a blood clot from forming.

PRADAXA can cause bleeding which can be serious and sometimes lead to death.  Don't take PRADAXA if you:

• currently have abnormal bleeding;
• have ever had an allergic reaction to it;
• have had or plan to have a valve in your heart replaced

Your risk of bleeding with PRADAXA may be higher if you:

• are 75 years old or older
• have kidney problems
• have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
• take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
• have kidney problems and take dronedarone (Multaq^®) or ketoconazole tablets (Nizoral^®)

Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:

• any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
• unusual or unexpected bruising
• coughing up or vomiting blood; or vomit that looks like coffee grounds
• pink or brown urine; red or black stools (looks like tar)
• unexpected pain, swelling, or joint pain
• headaches and feeling dizzy or weak

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

• a thin tube called an epidural catheter is placed in your back to give you certain medicine
• you take NSAIDs or a medicine to prevent blood from clotting
• you have a history of difficult or repeated epidural or spinal punctures
• you have a history of problems with your spine or have had surgery on your spine.

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

Take PRADAXA exactly as prescribed.  It is important to tell your doctors about all medicines (prescription and over-the-counter), vitamins, and supplements you take.  Some medicines may affect the way PRADAXA works. 

PRADAXA can cause indigestion, stomach upset or burning, and stomach pain. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide.

About Anthem

Anthem (NYSE:ANTM) is working to transform health care with trusted and caring solutions. Our health plan companies deliver quality products and services that give their members access to the care they need. With more than 72 million people served by its affiliated companies, including more than 39 million enrolled in its family of health plans, Anthem is one of the nation's leading health benefits companies. For more information about Anthem's family of companies, please visit www.antheminc.com/companies.

About HealthCore

HealthCore, Inc. is the wholly-owned, independently operating health outcomes research subsidiary of Anthem, Inc. We work with life sciences companies, payers and providers, and government and academic organizations to provide real-world evidence in support of a wide variety of health care decisions. Our research capabilities include extensive experience in HEOR, Late Phase, Safety and Epidemiology and Survey-Based research services and solutions with our work designed to improve quality, safety and affordability in health care. With more than 20 years of experience, clinical and scientific research expertise, and exclusive access to a robust, integrated research environment containing information on nearly 60 million individuals from multiple health plans across the U.S., HealthCore delivers unparalleled clarity and actionable information to health care decision makers. To learn more about HealthCore, go to www.healthcore.com.

About Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.  

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.