Pharmacokinetics and Drug-Drug Interaction of Allisartan Isoproxil and Indapamide Sustained-Release Formulation.
allisartan isoproxil
combined administration
hypertension
indapamide
pharmacokinetic
safety
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
received:
27
06
2022
accepted:
27
07
2023
medline:
2
11
2023
pubmed:
10
10
2023
entrez:
10
10
2023
Statut:
ppublish
Résumé
Allisartan isoproxil (AI) is an angiotensin II type 1 receptor blocker and be converted into the active substance EXP3174 in vivo. We evaluated the drug-drug interactions of AI and an indapamide sustained-release (Ind SR) preparation, as well as the pharmacokinetic characteristics and safety of AI and Ind SR in healthy subjects. The trial was set up in 6 sequences and 3 cycles, and each cycle contained a 7-day washout period. Subjects received 3 different trial drugs (A, AI; B, Ind SR; C, AI + Ind SR) during 3 different cycles. Twenty-four subjects were enrolled in the clinical trial. Of these, 22 completed the study, 2 subjects dropped out due to adverse events (AEs). For subjects given AI alone or combined with Ind SR, the pharmacogenetic parameters C
Substances chimiques
Indapamide
F089I0511L
losartan carboxylic acid
GD76OCH73X
allisartan isoproxil
0
Delayed-Action Preparations
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1051-1059Informations de copyright
© 2023, The American College of Clinical Pharmacology.
Références
Wang Z, Chen Z, Zhang L, et al. China hypertension survey investigators. Status of hypertension in China: Results from the China Hypertension Survey, 2012-2015. Circulation. 2018;137(22):2344-2356.
Cameron AC, Lang NN, Touyz RM. Drug treatment of hypertension: focus on vascular health. Drugs. 2016;76(16):1529-1550.
Wu MY, Ma XJ, Yang C, et al. Effects of allisartan, a new AT(1) receptor blocker, on blood pressure and end-organ damage in hypertensive animals. Acta Pharmacol Sin. 2009;30(3):307-13.
Yi W, Yan P, Lin S, et al. Pharmacokinetics and safety of a single dose and multiple doses of allisartan isoproxil, an angiotensin II receptor blocker, in healthy chinese people. Clin Pharmacol Drug Dev. 2022;11(1):43-50.
Thomopoulos C, Parati G, Zanchetti A. Effects of blood-pressure-lowering treatment on outcome incidence. 12. Effects in individuals with high-normal and normal blood pressure: overview and meta-analyses of randomized trials. J Hypertens. 2017;35(11):2150-2160.
Verdecchia P, Gentile G, Angeli F, Reboldi G. Beyond blood pressure: evidence for cardiovascular, cerebrovascular, and renal protective effects of renin-angiotensin system blockers. Ther Adv Cardiovasc Dis. 2012;6(2):81-91.
de Leeuw PW. Combination perindopril/indapamide for the treatment of hypertension: a review. Expert Opin Pharmacother. 2011;12(11):1827-33.
Sassard J, Bataillard A, McIntyre H. An overview of the pharmacology and clinical efficacy of indapamide sustained release. Fundam Clin Pharmacol. 2005;19(6):637-45.
Schiavi P, Jochemsen R, Guez D. Pharmacokinetics of sustained and immediate release formulations of indapamide after single and repeated oral administration in healthy volunteers. Fundam Clin Pharmacol. 2000;14(2):139-46.
Robinson DM, Wellington K. Indapamide sustained release: a review of its use in the treatment of hypertension. Drugs. 2006;66(2):257-71.
Campbell DB, Brackman F. Cardiovascular protective properties of indapamide. Am J Cardiol. 1990;65(17):11H-27H.
Molyneaux LM, Willey KA, Yue DK. Indapamide is as effective as captopril in the control of microalbuminuria in diabetes. J Cardiovasc Pharmacol. 1996;27(3):424-7.
Gorostidi M, de la Sierra A. Combination therapies for hypertension - why we need to look beyond RAS blockers. Expert Rev Clin Pharmacol. 2018;11(9):841-853.
Zhang X, Zhao Z, Xu C, et al. Allisartan ameliorates vascular remodeling through regulation of voltage-gated potassium channels in hypertensive rats. BMC Pharmacol Toxicol. 2021;22(1):33.
Li Y, Li YH, Huang ZJ, et al. A randomized, double blind, placebo-controlled, multicenter phase II trial of allisartan isoproxil in essential hypertensive population at low-medium risk. PLoS ONE.2015;10(2):e0117560.
Mishra S. Diuretics in primary hypertension - Reloaded. Indian Heart J. 2016;68(5):720-723.
Damien G, Huet de Barochez B, Schiavi P. Galenic development and pharmacokinetic profile of indapamide sustained release 1.5 mg. Clin Pharmacokinet. 1999;37(1):13-9.
Asmar R, Garcia-Puig J, Gosse P, et al. Ambulatory blood pressure in hypertensive patients with left ventricular hypertrophy: efficacy of first-line combination perindopril/indapamide therapy. Vasc Health Risk Manag. 2007;3(4):371-80.
Ambrosioni E, Safar M, Degaute JP, et al. Low-dose antihypertensive therapy with 1.5 mg sustained-release indapamide: results of randomised double-blind controlled studies. European study group. J Hypertens. 1998;16(11):1677-84.