X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Facilities & Operation

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

Yuvraj_pawp by Yuvraj_pawp
19th November 2015
in Facilities & Operation

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).

 

“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.”

Previous Post

Boehringer Ingelheim initiates pivotal programme for novel third-generation EGFR targeting lung cancer compound

Next Post

Boehringer Ingelheim Announces Completed Enrollment of Phase III Clinical Trial for Biosimilar Candidate to Adalimumab

Related Posts

New Concept Allows Physical Partnering Event
Facilities & Operation

New Concept Allows Physical Partnering Event

11th September 2020
Pfizer and Flatiron Health Announce Expanded Strategic Collaboration to Unlock Power of Real-World Evidence in Oncology
Facilities & Operation

Pfizer and Flatiron Health Announce Expanded Strategic Collaboration to Unlock Power of Real-World Evidence in Oncology

27th September 2019
Catalent To Open New Clinical Supply Facility In San Diego
Drug Development

Catalent To Open New Clinical Supply Facility In San Diego

17th September 2019
IQVIA MedTech
Facilities & Operation

IQVIA Launches IQVIA MedTech Dedicated to Medical Device and Diagnostics Industry

14th May 2019
Catalent Invests $14 Million At Its Eberbach, Germany Softgel Facility
Facilities & Operation

Catalent Invests $14 Million At Its Eberbach, Germany Softgel Facility

24th April 2019
Blackstone Life Sciences and Novartis Launch Anthos Therapeutics to Develop Innovative Medicines for Cardiovascular Disease
Facilities & Operation

Blackstone Life Sciences and Novartis Launch Anthos Therapeutics to Develop Innovative Medicines for Cardiovascular Disease

1st March 2019
Next Post

Boehringer Ingelheim Announces Completed Enrollment of Phase III Clinical Trial for Biosimilar Candidate to Adalimumab

Latest News

Envirotainer introduces the RAP for the future - part of the Releye series
Packaging & Logistic

Envirotainer introduces the RAP for the future – part of the Releye series

14th February 2022
United Cargo Meets Growing Demand for Pharmaceuticals with New TempControl Containers
Packaging & Logistic

Opticooler receives technical approval by Japanese major airlines

14th February 2022
Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease
Press Statements

Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease

14th February 2022
Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
News

Indian Scientists Claim To Design Vaccine For All Variants

9th February 2022
Drones for Delivery To Carry Pharmaceutical Weight Forward
News

Drones for Delivery To Carry Pharmaceutical Weight Forward

9th February 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In