the REPLACE Study

Bayer Announces Publication of Phase IV Adempas® (riociguat) Data in The Lancet Respiratory Medicine

Retrieved on: 
Monday, March 29, 2021
Health, Clinical trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Chemical compounds, Companies, Pyrimidines, Aspirin, Bayer, IG Farben, Leverkusen, Riociguat, Industry economics), Risk Evaluation and Mitigation Strategies, Rems, the REPLACE Study, Pulmonary Arterial Hypertension, Adempas® (riociguat), Bayer

For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.

Key Points: 
  • For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
  • Adempas, the first sGC stimulator of this collaboration, is developed by Bayer and MSD.
  • For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
  • Our online press service is just a click away: www.bayer.us/en/newsroom
    BAYER, the Bayer Cross, and Adempas(R) are registered trademarks of Bayer.

Bayer Phase IV Study Met its Primary Endpoint in PAH Patients Who Had Transitioned to Adempas® (riociguat) After Insufficient Response to PDE5 Inhibitors

Retrieved on: 
Monday, September 7, 2020
Biotechnology, FDA, Health, Pharmaceutical, Clinical trials, Health, Clinical research, Medical research, Design of experiments, Food and Drug Administration, Clinical trials, Organofluorides, Riociguat, Placebo-controlled study, Placebo, Risk Evaluation and Mitigation Strategies, PDE5 inhibitor, the REPLACE Study, Pulmonary Arterial Hypertension (PAH), Adempas® (riociguat), Bayer

It is therefore gratifying to see that forty-one percent of REPLACE study participants attained the clinical improvement endpoint when transitioning from PDE5 inhibitor therapy to Adempas.

Key Points: 
  • It is therefore gratifying to see that forty-one percent of REPLACE study participants attained the clinical improvement endpoint when transitioning from PDE5 inhibitor therapy to Adempas.
  • For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
  • Response rates were consistent with the overall results across the different types of PAH and pre-treatment therapies.
  • In the placebo-controlled clinical trials, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients.