Tags

Type your tag names separated by a space and hit enter

Aliskiren, a novel orally effective renin inhibitor, exhibits similar pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects.
Br J Clin Pharmacol. 2006 Dec; 62(6):690-8.BJ

Abstract

AIMS

Aliskiren is the first in a new class of orally effective renin inhibitors for the treatment of hypertension. This study compared the pharmacokinetic and pharmacodynamic properties of aliskiren in Japanese and Caucasian subjects.

METHODS

In this open-label, single-centre, parallel-group, single- and multiple-dose study, 19 Japanese and 19 Caucasian healthy young male subjects received a single 300-mg oral dose of aliskiren on day 1 and then aliskiren 300 mg once daily on days 4-10. Blood samples were collected for the measurement of plasma aliskiren concentration, plasma renin concentration (PRC) and plasma renin activity (PRA).

RESULTS

Pharmacokinetic parameters were comparable in Japanese and Caucasian subjects following administration of a single dose of aliskiren {ratio of geometric means: C(max) 1.12 [90% confidence interval (CI) 0.88, 1.43]; AUC(0-72 h) 1.19 [90% CI 1.02, 1.39]} and at steady state [mean ratio: C(max) 1.30 (90% CI 1.00, 1.70); AUC(0-tau) 1.16 (90% CI 0.95, 1.41)]. There was no notable difference in the plasma half-life of aliskiren between Japanese and Caucasian groups (29.7 +/- 10.2 h and 32.0 +/- 6.6 h, respectively). At steady state, peak PRC level and AUC for the concentration-time plot were not significantly different between Japanese and Caucasian subjects (P = 0.64 and P = 0.80, respectively). A single oral dose of aliskiren significantly reduced PRA to a similar extent in Japanese and Caucasian subjects (by 87.5% and 85.7%, respectively, compared with baseline; P < 0.01). Aliskiren was well tolerated by both ethnic groups.

CONCLUSIONS

The oral renin inhibitor aliskiren demonstrated similar pharmacokinetic and pharmacodynamic properties in Japanese and Caucasian subjects.

Authors+Show Affiliations

Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. sujata.vaidyanathan@novartis.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17118124

Citation

Vaidyanathan, Sujata, et al. "Aliskiren, a Novel Orally Effective Renin Inhibitor, Exhibits Similar Pharmacokinetics and Pharmacodynamics in Japanese and Caucasian Subjects." British Journal of Clinical Pharmacology, vol. 62, no. 6, 2006, pp. 690-8.
Vaidyanathan S, Jermany J, Yeh C, et al. Aliskiren, a novel orally effective renin inhibitor, exhibits similar pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects. Br J Clin Pharmacol. 2006;62(6):690-8.
Vaidyanathan, S., Jermany, J., Yeh, C., Bizot, M. N., & Camisasca, R. (2006). Aliskiren, a novel orally effective renin inhibitor, exhibits similar pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects. British Journal of Clinical Pharmacology, 62(6), 690-8.
Vaidyanathan S, et al. Aliskiren, a Novel Orally Effective Renin Inhibitor, Exhibits Similar Pharmacokinetics and Pharmacodynamics in Japanese and Caucasian Subjects. Br J Clin Pharmacol. 2006;62(6):690-8. PubMed PMID: 17118124.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aliskiren, a novel orally effective renin inhibitor, exhibits similar pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects. AU - Vaidyanathan,Sujata, AU - Jermany,Joanne, AU - Yeh,Chingming, AU - Bizot,Marie-Noelle, AU - Camisasca,Riccardo, PY - 2006/11/23/pubmed PY - 2007/5/30/medline PY - 2006/11/23/entrez SP - 690 EP - 8 JF - British journal of clinical pharmacology JO - Br J Clin Pharmacol VL - 62 IS - 6 N2 - AIMS: Aliskiren is the first in a new class of orally effective renin inhibitors for the treatment of hypertension. This study compared the pharmacokinetic and pharmacodynamic properties of aliskiren in Japanese and Caucasian subjects. METHODS: In this open-label, single-centre, parallel-group, single- and multiple-dose study, 19 Japanese and 19 Caucasian healthy young male subjects received a single 300-mg oral dose of aliskiren on day 1 and then aliskiren 300 mg once daily on days 4-10. Blood samples were collected for the measurement of plasma aliskiren concentration, plasma renin concentration (PRC) and plasma renin activity (PRA). RESULTS: Pharmacokinetic parameters were comparable in Japanese and Caucasian subjects following administration of a single dose of aliskiren {ratio of geometric means: C(max) 1.12 [90% confidence interval (CI) 0.88, 1.43]; AUC(0-72 h) 1.19 [90% CI 1.02, 1.39]} and at steady state [mean ratio: C(max) 1.30 (90% CI 1.00, 1.70); AUC(0-tau) 1.16 (90% CI 0.95, 1.41)]. There was no notable difference in the plasma half-life of aliskiren between Japanese and Caucasian groups (29.7 +/- 10.2 h and 32.0 +/- 6.6 h, respectively). At steady state, peak PRC level and AUC for the concentration-time plot were not significantly different between Japanese and Caucasian subjects (P = 0.64 and P = 0.80, respectively). A single oral dose of aliskiren significantly reduced PRA to a similar extent in Japanese and Caucasian subjects (by 87.5% and 85.7%, respectively, compared with baseline; P < 0.01). Aliskiren was well tolerated by both ethnic groups. CONCLUSIONS: The oral renin inhibitor aliskiren demonstrated similar pharmacokinetic and pharmacodynamic properties in Japanese and Caucasian subjects. SN - 0306-5251 UR - https://www.unboundmedicine.com/medline/citation/17118124/Aliskiren_a_novel_orally_effective_renin_inhibitor_exhibits_similar_pharmacokinetics_and_pharmacodynamics_in_Japanese_and_Caucasian_subjects_ DB - PRIME DP - Unbound Medicine ER -