1 / 7

Bosentan PK in PAH Patients Concentrations after 62.5 mg Single Dose

Bosentan PK in PAH Patients Concentrations after 62.5 mg Single Dose. 9409.01. Interaction with Ketoconazole Bosentan Trough Plasma Levels. 9416.01. Choice of Doses for Clinical Trials. Maintenance / Target Dose

jaguar
Download Presentation

Bosentan PK in PAH Patients Concentrations after 62.5 mg Single Dose

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Bosentan PK in PAH PatientsConcentrations after 62.5 mg Single Dose 9409.01

  2. Interaction with KetoconazoleBosentan Trough Plasma Levels 9416.01

  3. Choice of Doses for Clinical Trials Maintenance / Target Dose • 100/125 mg bid – top of hemodynamic dose response (decrease BP) • Higher doses – higher incidence of elevated LFTs • 250 mg bid – exploratory Starting dose • 62.5 mg bid for 4 weeks(due to increased worsening HF with high starting doses and rapid up-titration in CHF patients) 9459.01

  4. Long-term Exposureto Bosentan Exposure (years) Total pt-yrs Range Mean  SD Studies N PAH Studies NC15462+OL ENABLE* 235 267 1613 0.58  0.37 0.87  1.16 1.13  0.48 0.07 – 1.71 0.00 – 4.11 0.00 – 1.93 137.2 233.5 1824.2 * Treatment still blinded (approximately 807 patients on bosentan) 9511.01

  5. Change in WBC and Platelets8 Placebo-controlled Studies Placebo Bosentan Mean change from BL WBC Platelets Marked decrease [n (%)] WBC Platelets 0.0% 3.2% 2/273 (0.7%) 2/262 (0.8%) 9.3% 0.9% 7/640 (1.1%) 3/600 (0.5%) 9837.01

  6. Risk of HospitalizationAC-052-352 9852.02

  7. “1-800-ACTELION” • Central clearing house • Patient + physician database • PHYSICIAN • Liver Monitoring reminder • Spontaneous AE reporting • PATIENT • Ship drug • Liver monitoring reminder • Follow-up discontinuations/ AE reporting Patient Registry(To Be Discussed with the FDA) Specialty pharmacy network 9858.01

More Related