Real-World Data from Boehringer Ingelheim Show Lower Risk of Stroke and Major Bleeding for Pradaxa® (dabigatran etexilate mesylate) Compared to Warfarin

RIDGEFIELD, Conn., Feb. 24, 2017 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from a real-world analysis showing that Pradaxa® (dabigatran etexilate mesylate) was associated with an improvement in safety and efficacy outcomes compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). The results were presented at the International Stroke Conference.

The study analyzed 7,245 PRADAXA and 14,490 warfarin patients with NVAF who had no prior use of an oral anticoagulant (OAC), using data from an administrative claims database from October 1, 2010, to April 30, 2014. The patients were mostly male (56%), with a mean age of 74 years, and mean CHADS₂ stroke risk score of 2.2.

Compared to warfarin, PRADAXA was associated with a 26 percent reduced risk of stroke (HR, 0.74; 95% Cl, 0.58-0.94) and a 20 percent reduced risk of major bleeding (HR, 0.80; 95% Cl, 0.69-0.92). PRADAXA was also associated with a lower risk for serious secondary outcomes, including a 68 percent reduced risk of hemorrhagic stroke (HR, 0.32; 95% Cl, 0.14-0.76), an 18 percent reduced risk of major extracranial bleeding (HR, 0.82; 95% Cl, 0.70-0.96), a 48 percent reduced risk of venous thromboembolism (HR, 0.52; 95% Cl, 0.38-0.70), and a 27 percent reduced risk of death (HR, 0.73; 95% Cl, 0.61-0.88).

"By combining our deep understanding of the patient journey with access to robust real-world data, we are improving the understanding of treatment for patients with chronic conditions such as NVAF," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "These data offer valuable real-world insights on patient outcomes, and are an important complement to our robust clinical trial program, in which PRADAXA demonstrated superior efficacy and a favorable risk-benefit profile compared to warfarin."

About Pradaxa® (dabigatran etexilate mesylate) capsules

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 Boehringer Ingelheim

About Boehringer Ingelheim Pharmaceuticals, Inc.

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 about 50,000 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.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

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SOURCE Boehringer Ingelheim Pharmaceuticals

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