Bosentan pk in pah patients concentrations after 62 5 mg single dose
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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

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Bosentan pk in pah patients concentrations after 62 5 mg single dose
Bosentan PK in PAH PatientsConcentrations after 62.5 mg Single Dose

9409.01


Interaction with ketoconazole bosentan trough plasma levels
Interaction with KetoconazoleBosentan Trough Plasma Levels

9416.01


Choice of doses for clinical trials
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


Long term exposure to bosentan
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


Change in wbc and platelets 8 placebo controlled studies
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


Risk of hospitalization ac 052 352
Risk of HospitalizationAC-052-352

9852.02


Patient registry to be discussed with the fda

“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


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