Olmesartan Medoxomil: in Children and Adolescents with Hypertension

Overview

Journal Drugs

Specialty Pharmacology

Date 2010 Dec 15

PMID 21142262

Citations 4

Authors

Victoria J Muir

Gillian M Keating

Affiliations

Soon will be listed here.

Abstract

Olmesartan medoxomil is an orally administered angiotensin II receptor antagonist, selective for the angiotensin II type 1 receptor, which has established antihypertensive efficacy in adults. In children and adolescents with hypertension (n = 302), oral olmesartan medoxomil significantly and dose-dependently reduced seated systolic blood pressure (BP) and seated dystolic BP from baseline (the primary endpoint) in a 3-week, dose-response period in a well designed phase II/III clinical trial. Patients received olmesartan medoxomil high dose (20 or 40 mg once daily depending on bodyweight) or low dose (2.5 or 5.0 mg once daily depending on bodyweight). The response was significant for both cohorts, which were stratified by race (cohort A was mixed race [62% White] and cohort B was 100% Black). In addition, BP control was maintained in olmesartan recipients relative to placebo recipients in cohort A and the combined cohort A + B, but not for patients in cohort B, during a placebo-controlled withdrawal period of this trial. Oral olmesartan medoxomil was generally well tolerated in children and adolescents with hypertension. The majority of adverse events were of mild to moderate intensity.

Citing Articles

Population Pharmacokinetic Modeling of Olmesartan, the Active Metabolite of Olmesartan Medoxomil, in Patients with Hypertension.

Kodati D, Kotakonda H, Yellu N Eur J Drug Metab Pharmacokinet. 2016; 42(4):573-581.

PMID: 27535556 DOI: 10.1007/s13318-016-0371-0.

Olmesartan medoxomil in children and adolescents with hypertension†: profile report.

Muir V, Keating G Paediatr Drugs. 2012; 14(3):209-10.

PMID: 22497554 DOI: 10.2165/11207290-000000000-00000.

Therapeutic options for the treatment of hypertension in children and adolescents.

Stephens M, Fox B, Maxwell L Clin Med Insights Circ Respir Pulm Med. 2012; 6:13-25.

PMID: 22408373 PMC: 3296488. DOI: 10.4137/CCRPM.S7602.

Olmesartan medoxomil for the treatment of hypertension in children and adolescents.

Tocci G, Volpe M Vasc Health Risk Manag. 2011; 7:177-81.

PMID: 21490943 PMC: 3072741. DOI: 10.2147/VHRM.S11672.

References

Laeis P, Puchler K, Kirch W . The pharmacokinetic and metabolic profile of olmesartan medoxomil limits the risk of clinically relevant drug interaction. J Hypertens Suppl. 2001; 19(1):S21-32. DOI: 10.1097/00004872-200106001-00004. View

Rohatagi S, Lee J, Shenouda M, Haworth S, Bathala M, Allison M . Pharmacokinetics of amlodipine and olmesartan after administration of amlodipine besylate and olmesartan medoxomil in separate dosage forms and as a fixed-dose combination. J Clin Pharmacol. 2008; 48(11):1309-22. DOI: 10.1177/0091270008322176. View

. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004; 114(2 Suppl 4th Report):555-76. View

Ostchega Y, Carroll M, Prineas R, McDowell M, Louis T, Tilert T . Trends of elevated blood pressure among children and adolescents: data from the National Health and Nutrition Examination Survey1988-2006. Am J Hypertens. 2008; 22(1):59-67. DOI: 10.1038/ajh.2008.312. View

Din-Dzietham R, Liu Y, Bielo M, Shamsa F . High blood pressure trends in children and adolescents in national surveys, 1963 to 2002. Circulation. 2007; 116(13):1488-96. DOI: 10.1161/CIRCULATIONAHA.106.683243. View

Jones M, Sealey J, Laragh J . Effects of angiotensin receptor blockers on ambulatory plasma Renin activity in healthy, normal subjects during unrestricted sodium intake. Am J Hypertens. 2007; 20(8):907-16. DOI: 10.1016/j.amjhyper.2007.04.009. View

Hazan L, Hernandez Rodriguez O, Bhorat A, Miyazaki K, Tao B, Heyrman R . A double-blind, dose-response study of the efficacy and safety of olmesartan medoxomil in children and adolescents with hypertension. Hypertension. 2010; 55(6):1323-30. DOI: 10.1161/HYPERTENSIONAHA.109.147702. View

Resnick L, Catanzaro D, Sealey J, Laragh J . Acute vascular effects of the angiotensin II receptor antagonist olmesartan in normal subjects: relation to the renin-aldosterone system. Am J Hypertens. 2004; 17(3):203-8. DOI: 10.1016/j.amjhyper.2003.12.003. View

Bolbrinker J, Huber M, Scholze J, Kreutz R . Pharmacokinetics and safety of olmesartan medoxomil in combination with either amlodipine or atenolol compared to respective monotherapies in healthy subjects. Fundam Clin Pharmacol. 2009; 23(6):767-74. DOI: 10.1111/j.1472-8206.2009.00720.x. View

10.

Puchler K, Nussberger J, Laeis P, Witte P, Brunner H . Blood pressure and endocrine effects of single doses of CS-866, a novel angiotensin II antagonist, in salt-restricted hypertensive patients. J Hypertens. 1998; 15(12 Pt 2):1809-12. DOI: 10.1097/00004872-199715120-00094. View

11.

Kreutz R, Bolbrinker J, Huber M . Pharmacokinetics of olmesartan medoxomil plus hydrochlorothiazide combination in healthy subjects. Clin Drug Investig. 2006; 26(1):29-34. DOI: 10.2165/00044011-200626010-00004. View

12.

Flynn J . Pediatric hypertension: recent trends and accomplishments, future challenges. Am J Hypertens. 2008; 21(6):605-12. DOI: 10.1038/ajh.2008.159. View

13.

Schwocho L, Masonson H . Pharmacokinetics of CS-866, a new angiotensin II receptor blocker, in healthy subjects. J Clin Pharmacol. 2001; 41(5):515-27. DOI: 10.1177/00912700122010393. View

14.

Mizuno M, Sada T, Ikeda M, Fukuda N, Miyamoto M, Yanagisawa H . Pharmacology of CS-866, a novel nonpeptide angiotensin II receptor antagonist. Eur J Pharmacol. 1995; 285(2):181-8. DOI: 10.1016/0014-2999(95)00401-6. View

15.

Hansen M, Gunn P, Kaelber D . Underdiagnosis of hypertension in children and adolescents. JAMA. 2007; 298(8):874-9. DOI: 10.1001/jama.298.8.874. View

16.

Warner G, Jarvis B . Olmesartan medoxomil. Drugs. 2002; 62(9):1345-53; discussion 1354-6. DOI: 10.2165/00003495-200262090-00005. View

17.

Scott L, McCormack P . Olmesartan medoxomil: a review of its use in the management of hypertension. Drugs. 2008; 68(9):1239-72. DOI: 10.2165/00003495-200868090-00005. View

18.

Flynn J, Daniels S . Pharmacologic treatment of hypertension in children and adolescents. J Pediatr. 2006; 149(6):746-54. DOI: 10.1016/j.jpeds.2006.08.074. View

19.

Hasler C, Nussberger J, Maillard M, Forclaz A, Brunner H, Burnier M . Sustained 24-hour blockade of the renin-angiotensin system: a high dose of a long-acting blocker is as effective as a lower dose combined with an angiotensin-converting enzyme inhibitor. Clin Pharmacol Ther. 2005; 78(5):501-7. DOI: 10.1016/j.clpt.2005.08.001. View

20.

Mire D, Silfani T, Pugsley M . A review of the structural and functional features of olmesartan medoxomil, an angiotensin receptor blocker. J Cardiovasc Pharmacol. 2005; 46(5):585-93. DOI: 10.1097/01.fjc.0000180902.78230.fd. View