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- Title
PI-20.
- Authors
Dieterich, H.; Kemp, C.; Vaidyanathan, S.; Yeh, C.
- Abstract
Background: Combination of the oral renin inhibitor aliskiren with a diuretic is expected to provide increased antihypertensive efficacy. This study investigated the pharmacokinetics of aliskiren, alone or in combination with the diuretic hydrochlorothiazide (HCTZ).Methods: Open-label, two-period, multiple dose study in 22 healthy volunteers aged 18-45 years. Subjects received HCTZ 25 mg once daily on days 1-4 followed by a 4-day wash out. Aliskiren 300 mg once daily was administered on days 9-19 with HCTZ 25 mg added on days 16-19. Blood samples were taken on days 4, 15 and 19 for pharmacokinetic profiling.Results: Steady-state AUC0-τ values for aliskiren (mean±SD) were not significantly altered by HCTZ (aliskiren AUC0-τ 2310±934 alone vs 2210±1157 ng.h/mL with HCTZ, ratio of geometric means 0.93[90% CI 0.83-1.05]). Aliskiren Cmaxwas slightly lowered by HCTZ (aliskiren Cmax 425±216 vs 309±150 ng/mL, mean ratio 0.78[0.64-0.95]) but this is unlikely to be of clinical significance. Median tmax values for aliskiren were essentially unchanged (aliskiren tmax 2.2 vs 1.5h). Steady-state AUC0-τand Cmax for HCTZ were slightly decreased by aliskiren (mean ratios: AUC0-τ 0.90[0.87-0.93]; Cmax 0.74[0.69-0.79]) but these changes are unlikely to be clinically significant. Aliskiren was well tolerated in combination with HCTZ.Conclusions: In healthy volunteers, aliskiren was well tolerated in combination with HCTZ and drug interactions were either insignificant or of unlikely clinical significance.Clinical Pharmacology & Therapeutics (2005) 79, P12–P12; doi: 10.1016/j.clpt.2005.12.041
- Subjects
CLINICAL pharmacology; RENIN; DRUG side effects; ASPARTIC proteinases; DRUG interactions; DIURETICS
- Publication
Clinical Pharmacology & Therapeutics, 2006, Vol 79, Issue 2, pP12
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1016/j.clpt.2005.12.041