Study Finds No Drug-Drug Interaction Between Aggrenox® (aspirin/extended-release dipyridamole) 25mg/200mg Capsules and Omeprazole, a Widely Used PPI

RIDGEFIELD, Conn., Feb. 3, 2012 /PRNewswire/ -- Boehringer Ingelheim presented results of a drug interaction study that found Aggrenox® (aspirin/extended-release dipyridamole), an antiplatelet medication, is not affected by the co-administration of omeprazole, a proton pump inhibitor (PPI), frequently used to treat several gastrointestinal conditions. These data were presented at the International Stroke Conference (ISC) in New Orleans.

"Omeprazole has been shown to interact with some medications that are metabolized through the CYP2C19 system. AGGRENOX is not metabolized through the CYP2C19 system, however we wanted to understand if it would be affected when given together with omeprazole," said John Smith, MD, PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are pleased that these data have shown that omperazole does not interact with AGGRENOX."

This multiple-dose, open-label, randomized crossover study was performed in 60 healthy volunteers. The pharmacokinectics of the extended release dipyridamole component of AGGRENOX, and the pharmacodynamics of the aspirin component of AGGRENOX were studied in two dosing sequences: AGGRENOX followed by omeprazole and omeprazole followed by AGGRENOX. The primary endpoints of this study were steady-state maximum concentration (Cmax) and area under the curve (AUC) for the dipyridamole component, as well as the inhibition of platelet aggregation (IPA) by the aspirin component.

The 90 percent confidence intervals of the Cmax and AUC of the dipyridamole component fell within the accepted window of 80 – 125 percent in both dosing sequences indicating no significant interaction. Likewise, no significant effect on IPA was shown with either dosing sequence at four or 12 hours post dose.

Aggrenox® (aspirin/extended-release dipryidamole) Potential Drug Interactions
The following medications are known to have the potential to interact with aspirin: ACE inhibitors, acetazolamide, anticoagulants, anticonvulsants, beta blockers, diuretics, methotrexate, NSAIDs, and oral hypoglycemic and uricosuric agents. The following have the potential to interact with dipyridamole: adenosine and cholinesterase inhibitors. Co-administration of AGGRENOX with anticoagulants or NSAIDs can increase risk of bleeding. Decreased renal function can occur with co-administration with NSAIDs.

Important Safety Information About Aggrenox® (aspirin/extended-release dipryidamole)
AGGRENOX is a prescription medication used to lower the risk of stroke in people who have had a "mini-stroke" (transient ischemia attack or TIA) or stroke due to a blood clot.

AGGRENOX should be avoided in patients allergic to any ingredient in AGGRENOX, allergic to non-steroidal anti-inflammatory drugs (NSAIDS), or who have the combination of asthma, runny nose and nasal polyps. AGGRENOX should not be given to a child or teenager due to the risk of Reye's syndrome.

AGGRENOX may cause an increased bleeding risk, including into the brain, stomach or intestines and any bleeding may take longer to stop. AGGRENOX should be avoided in patients with a history of stomach ulcers or those who drink three or more alcoholic drinks a day due to the risk of bleeding. Patients should inform their doctor of all medications they are currently taking including NSAIDS or blood thinners.

AGGRENOX should be avoided during pregnancy, especially in the third trimester, or in patients with severe liver or kidney problems. The most common side effects of AGGRENOX are headache, upset stomach and diarrhea.

Please click here for full AGGRENOX Prescribing Information, including Patient Information. 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 145 affiliates and more than 42,000 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.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.