Real-World Analysis of more than 44,000 Patients Reinforces Safety and Effectiveness of Pradaxa^® in Routine Clinical Care

Ingelheim, Germany, 10 November 2015 – Brigham and Women’s Hospital in Boston, U.S., and Boehringer Ingelheim announce the results of a new interim analysis from a long-term study evaluating the safety and effectiveness of Pradaxa^® (dabigatran etexilate) relative to warfarin in routine clinical practice.¹ These data, from a pooled analysis of two large U.S. commercial health insurance databases, showed that patients with non-valvular atrial fibrillation (AF) treated with Pradaxa^® had fewer strokes and fewer major bleeding events compared to AF patients treated with warfarin.¹ The findings were presented at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando.

“Beyond clinical trials, there is a wealth of available health insurance data that provides an excellent opportunity to grow our knowledge of oral anticoagulant use and outcomes for patients,” said lead investigator John Seeger, PharmD, DrPH, Department of Medicine, Brigham and Women’s Hospital, a teaching-affiliate of Harvard Medical School. “These real-world data further define the safety and effectiveness of dabigatran for patients and its use in routine care, and are consistent with the results of the pivotal RE-LY^® clinical trial.”

The primary study outcomes were stroke and major bleeding rates during Pradaxa^® and warfarin treatment, based on data collected over 32 months from 44,672 AF patients (22,336 propensity score matched Pradaxa^® and warfarin treatment initiators) in two insurance databases — Truven MarketScan (18,276 patients per group) and Optum Clinformatics (4,060 patients per group). Researchers identified 65 strokes for Pradaxa^®-treated patients (0.73 incidence rate per 100 patient years) and 78 strokes for warfarin-treated patients (1.08 incidence rate per 100 patient years), representing a 28% reduction in stroke risk for Pradaxa^® compared to warfarin (HR 0.72; 95% CI 0.52 – 1.00). In addition, researchers reported 395 major bleeding events for Pradaxa^®-treated patients (4.47 incidence rate per 100 patient years), compared to 459 events for warfarin-treated patients (6.42 incidence rate per 100 patient years), representing a 26% reduction in the risk of major bleeding events with Pradaxa^® compared to warfarin (HR 0.74; 95% CI 0.64 – 0.84). There were 238 major gastrointestinal bleeding events for Pradaxa^®-treated patients (2.69 incidence rate per 100 patient years) and 213 for warfarin treated patients ((2.97 incidence rate per 100 patient years); HR 0.95; 95% CI 0.79 - 1.14).¹

“With this long-term study programme, in collaboration with Brigham and Women’s Hospital, we are seeking to expand awareness and understanding of real-world experiences with non-vitamin K antagonist oral anticoagulants (NOACs) and the impact on reducing stroke risk, which remains a major public health concern,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These data add to the robust world of evidence supporting the real-world value of Pradaxa^®, the only NOAC with both proven superiority to warfarin in reducing stroke risk in AF patients and a specific reversal agent.”

NOTES TO THE EDITORS

About the study
The analysis is part of an ongoing research programme to evaluate prescribing patterns and real-world safety and effectiveness of oral anticoagulants, including Pradaxa^®, for reducing stroke risk. Data were collected from the two databases between October 2010 and June 2013.¹

New users of Pradaxa^® or warfarin were matched on various demographic and clinical criteria (“propensity-score-matched”). There were 22,336 propensity-score-matched AF patients in the Pradaxa^® and warfarin groups when numbers were pooled across the two data sources. Patients were followed up until they switched or discontinued anticoagulant treatment, experienced an outcome event, or discontinued enrollment. The average follow-up period was five months for Pradaxa^®-treated patients and four months for warfarin-treated patients. Effectiveness assessments beyond the first six months of therapy were limited by the short average follow-up time.¹ Future analyses from this sequential long term study programme will yield more stable estimates including a larger number of patients.

With this collaboration, Boehringer Ingelheim and Brigham and Women’s Hospital aim to gather data representing more than 100,000 AF patients in the U.S.²

About dabigatran etexilate (Pradaxa^®)
Clinical experience of dabigatran equates to over 4 million patient-years in all licensed indications worldwide. Dabigatran has been in the market for more than 6 years and is approved in over 100 countries.²

Currently approved indications for dabigatran are: ^3,4​

• Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
• Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
• Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults

Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.^3,5 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.⁶ In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.^5,7

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

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

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