Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment
| Autor: | Ching-Ming Yeh, Hans Armin Dieterich, Marie-Noelle Bizot, Vance Warren, Sujata Vaidyanathan, William P. Dole |
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| Rok vydání: | 2007 |
| Předmět: |
medicine.medical_specialty
medicine.drug_class Cmax Pharmacology Gastroenterology Renin inhibitor chemistry.chemical_compound Liver disease Pharmacokinetics Fumarates Internal medicine Renin–angiotensin system Renin medicine Humans Pharmacology (medical) Antihypertensive Agents business.industry Liver Diseases Aliskiren medicine.disease Amides Confidence interval chemistry Tolerability business |
| Zdroj: | Journal of clinical pharmacology. 47(2) |
| ISSN: | 0091-2700 |
| Popis: | Aliskiren is the first in a new class of orally active, direct renin inhibitors for the treatment of hypertension. This open-label, nonrandomized, single-center, parallel-group study compared the pharmacokinetics and safety of a single 300-mg oral dose of aliskiren in patients with mild, moderate, or severe hepatic impairment to that in healthy subjects. When pooled across subgroups, there were no significant differences between patients with hepatic impairment and healthy subjects in aliskiren AUC(0-infinity) (ratio of geometric means, 1.12; 90% confidence interval, 0.85, 1.48) or Cmax (mean ratio, 1.19; 90% confidence interval, 0.84, 1.68), and there was no correlation between severity of hepatic impairment and either AUC(0-infinity) or Cmax. Aliskiren was well tolerated by healthy subjects and patients with hepatic impairment. In conclusion, hepatic impairment has no significant effect on the pharmacokinetics of aliskiren following single-dose administration, and dosage adjustment is unlikely to be needed in patients with liver disease. |
| Databáze: | OpenAIRE |
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