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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Spence, R. Mandagere, A. Richards, D. B. Magee, M. H. Dufton, C. Boinpally, R. |
| Description | Country affiliation: United States Author Affiliation: Spence R ( Gilead Sciences, Inc., Boulder, Colorado, USA.) |
| Abstract | Ambrisentan (ABS), approved for the treatment of pulmonary arterial hypertension and administered as an oral dose once daily, is an ET(A)-selective endothelin receptor antagonist (ERA) and a potential substrate for cytochrome P450 (CYP) 3A4, organic anion-transporting polypeptide (OATP), and P-glycoprotein (P-gp). Cyclosporin A (CsA), an inhibitor of CYP3A4, P-gp, and OATP, may be used concomitantly with ABS. In this open-label, parallel-treatment study, 28 healthy subjects received steady-state ABS (5 mg q.d.) either alone or with steady-state CsA (100-150 mg b.i.d.), and 24 other subjects received steady-state CsA either alone or with steady-state ABS. In the presence of CsA, ABS maximum plasma concentration (C(max)) increased 1.5-fold, and area under the plasma concentration-time curve (AUC)(0-τ) increased twofold. Marginal increases were observed for CsA C(max) (906 vs. 1,014 ng/ml) and AUC(0-τ) (3.05 vs. 3.37 µg·h/ml) in the presence of ABS. Frequent adverse events (AEs) were headache and gastrointestinal disorders. The addition of ABS to steady-state CsA appeared less tolerable as compared with the addition of CsA to steady-state ABS. A maximum ABS dose of 5 mg is recommended if it is coadministered with CsA. No change in CsA dose is recommended if it is coadministered with ABS. |
| File Format | HTM / HTML |
| ISSN | 00099236 |
| Issue Number | 4 |
| Volume Number | 88 |
| e-ISSN | 15326535 |
| Journal | Clinical Pharmacology & Therapeutics |
| Language | English |
| Publisher | Wiley |
| Publisher Date | 2010-10-01 |
| Publisher Place | United States |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Pharmacology Antihypertensive Agents Pharmacology Cyclosporine Endothelin Receptor Antagonists Immunosuppressive Agents Phenylpropionates Pyridazines Adult Adverse Effects Pharmacokinetics Area Under Curve Cytochrome P-450 Cyp3a Cytochrome P-450 Cyp3a Inhibitors Drug Interactions Female Humans Male Organic Anion Transporters Antagonists & Inhibitors P-glycoprotein Clinical Trial Journal Article Research Support, Non-u.s. Gov't |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) |
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