Assessment of Ethnic Differences in the Pharmacokinetics and Pharmacodynamics of Valsartan

Sunkara, Gangadhar; Yeh, Ching-Ming; Saylan, Monica Ligueros-; Kawashita, Hiroto; Koseki, Nozomu

doi:10.4172/jbb.1000043

Cited by 9 publications

(9 citation statements)

References 21 publications

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“…The pharmacokinetic AUC area under the concentration time curve, C max maximum (peak) plasma drug concentration after single-dose administration, CI confidence interval, GMR ratio of geometric mean data of sacubitrilat and valsartan observed in this study is consistent with earlier studies wherein LCZ696 is administered to non-Japanese subjects. Lack of ethnic sensitivity on pharmacokinetic disposition of valsartan was reported earlier [14]. Following administration of LCZ696 in Japanese subjects, dose-proportional increases in C max and AUC of sacubitrilat, the active metabolite, over the tested dose range of LCZ696 20-600 mg was observed.…”

Section: Discussionmentioning

confidence: 64%

Pharmacokinetics After Single Ascending Dose, Food Effect, and Safety of Sacubitril/Valsartan (LCZ696), an Angiotensin Receptor and Neprilysin Inhibitor, in Healthy Japanese Subjects

Akahori

Ayalasomayajula²,

Langenickel

et al. 2016

Eur J Drug Metab Pharmacokinet

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Section: Discussionmentioning

confidence: 64%

Pharmacokinetics After Single Ascending Dose, Food Effect, and Safety of Sacubitril/Valsartan (LCZ696), an Angiotensin Receptor and Neprilysin Inhibitor, in Healthy Japanese Subjects

Akahori

Ayalasomayajula²,

Langenickel

et al. 2016

Eur J Drug Metab Pharmacokinet

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“…This case study is inspired by a publication comparing the pharmacokinetic (PK) exposure of a drug in Caucasian vs. Japanese subjects. The same single oral dose was administered to all subjects.…”

Section: Case Studiesmentioning

confidence: 99%

Effective Visual Communication for the Quantitative Scientist

Vandemeulebroecke

Baillie

Margolskee³

et al. 2019

CPT Pharmacom & Syst Pharma

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Effective visual communication is a core competency for pharmacometricians, statisticians, and, more generally, any quantitative scientist. It is essential in every step of a quantitative workflow, from scoping to execution and communicating results and conclusions. With this competency, we can better understand data and influence decisions toward appropriate actions. Without it, we can fool ourselves and others and pave the way to wrong conclusions and actions. The goal of this tutorial is to convey this competency. We posit three laws of effective visual communication for the quantitative scientist: have a clear purpose, show the data clearly, and make the message obvious. A concise "Cheat Sheet," available on https ://graph icspr incip les.github.io, distills more granular recommendations for everyday practical use. Finally, these laws and recommendations are illustrated in four case studies.

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“…This calculation was based on the assumption of an intrasubject coefficient of variation (CV) of 40% for valsartan, 15% for LBQ657, 20% for HCTZ, 15% for amlodipine, and 35% for carvedilol. 1,[27][28][29] Sample size calculations were performed using NQuery Advisor 7.0 based on logtransformed pharmacokinetic parameters.…”

Section: Statistical Analysesmentioning

confidence: 99%

Pharmacokinetic drug–drug interaction assessment between LCZ696, an angiotensin receptor neprilysin inhibitor, and hydrochlorothiazide, amlodipine, or carvedilol

Hsiao

Langenickel

Greeley

et al. 2015

Clinical Pharm in Drug Dev

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LCZ696 is a first-in-class angiotensin receptor neprilysin inhibitor in development for treatments of hypertension and heart failure indications. In 3 separate studies, pharmacokinetic drug-drug interactions (DDIs) potential was assessed when LCZ696 was coadministered with hydrochlorothiazide (HCTZ), amlodipine, or carvedilol. The studies used a open-label, single-sequence, 3-period, crossover design in healthy subjects. Blood samples were collected to determine the pharmacokinetic parameters of LCZ696 analytes (AHU377, LBQ657, and valsartan), HCTZ, amlodipine, or carvedilol (R[+]- and S[-]-carvedilol) for statistical analysis. When coadministered LCZ696 with HCTZ, the 90% CIs of the geometric mean ratios of AUCtau,ss of HCTZ and that of LBQ657 were within a 0.80-1.25 interval, whereas HCTZ Cmax,ss decreased by 26%, LBQ657 Cmax,ss increased by 19%, and the AUCtau,ss and Cmax,ss of valsartan increased by 14% and 16%, respectively. Pharmacokinetics of amlodipine, R(+)- and S(-)-carvedilol, or LBQ657 were not altered after coadministration of LCZ696 with amlodipine or carvedilol. Coadministration of LCZ696 400 mg once daily (qd) with HCTZ 25 mg qd, amlodipine 10 mg qd, or carvedilol 25 mg twice a day (bid) had no clinically relevant pharmacokinetic drug-drug interactions. LCZ696, HCTZ, amlodipine, and carvedilol were safe and well tolerated when given alone or concomitantly in the investigated studies.

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Assessment of Ethnic Differences in the Pharmacokinetics and Pharmacodynamics of Valsartan

Cited by 9 publications

References 21 publications

Pharmacokinetics After Single Ascending Dose, Food Effect, and Safety of Sacubitril/Valsartan (LCZ696), an Angiotensin Receptor and Neprilysin Inhibitor, in Healthy Japanese Subjects

Pharmacokinetics After Single Ascending Dose, Food Effect, and Safety of Sacubitril/Valsartan (LCZ696), an Angiotensin Receptor and Neprilysin Inhibitor, in Healthy Japanese Subjects

Effective Visual Communication for the Quantitative Scientist

Pharmacokinetic drug–drug interaction assessment between LCZ696, an angiotensin receptor neprilysin inhibitor, and hydrochlorothiazide, amlodipine, or carvedilol

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