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Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension.
J Clin Pharmacol. 2011 Jun; 51(6):933-42.JC

Abstract

The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multicenter, multiple-dose, open-label, 4-cohort, parallel-group study. Eligible patients were randomly allocated to the dual combination of valsartan + HCTZ, amlodipine + valsartan, or amlodipine + HCTZ and nonrandomly allotted to amlodipine + valsartan + HCTZ triple combination treatment. After 6 days of treatment with a half-maximal dose of different combinations, patients were up-titrated to the maximal drug doses from day 7 through day 17. PK parameters of corresponding analytes from the triple- and dual-treatment groups were estimated on day 17 and compared. Safety and tolerability of all treatments was assessed. The C (ssmax) and AUC(0-τ) values of amlodipine or HCTZ remained unaffected when administered with valsartan + HCTZ or valsartan + amlodipine, respectively. On the other hand, valsartan exposure increased by 10% to 25% when coadministered with HCTZ and amlodipine, which is not considered clinically relevant. In conclusion, there were no clinically relevant PK interactions with amlodipine, valsartan, and HCTZ triple combination compared with the corresponding dual combinations. All treatments were safe and well tolerated.

Authors+Show Affiliations

Translational Medicine-Scientific Operations, Novartis Healthcare Pvt Ltd, Hitech City, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20852001

Citation

Bhad, Prafulla, et al. "Evaluation of Pharmacokinetic Interactions Between Amlodipine, Valsartan, and Hydrochlorothiazide in Patients With Hypertension." Journal of Clinical Pharmacology, vol. 51, no. 6, 2011, pp. 933-42.
Bhad P, Ayalasomayajula S, Karan R, et al. Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension. J Clin Pharmacol. 2011;51(6):933-42.
Bhad, P., Ayalasomayajula, S., Karan, R., Leon, S., Riviere, G. J., Sunkara, G., & Jarugula, V. (2011). Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension. Journal of Clinical Pharmacology, 51(6), 933-42. https://doi.org/10.1177/0091270010376963
Bhad P, et al. Evaluation of Pharmacokinetic Interactions Between Amlodipine, Valsartan, and Hydrochlorothiazide in Patients With Hypertension. J Clin Pharmacol. 2011;51(6):933-42. PubMed PMID: 20852001.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension. AU - Bhad,Prafulla, AU - Ayalasomayajula,Surya, AU - Karan,Rajesh, AU - Leon,Selene, AU - Riviere,Gillies-Jacques, AU - Sunkara,Gangadhar, AU - Jarugula,Venkateswar, Y1 - 2010/09/17/ PY - 2010/9/21/entrez PY - 2010/9/21/pubmed PY - 2011/9/7/medline SP - 933 EP - 42 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 51 IS - 6 N2 - The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multicenter, multiple-dose, open-label, 4-cohort, parallel-group study. Eligible patients were randomly allocated to the dual combination of valsartan + HCTZ, amlodipine + valsartan, or amlodipine + HCTZ and nonrandomly allotted to amlodipine + valsartan + HCTZ triple combination treatment. After 6 days of treatment with a half-maximal dose of different combinations, patients were up-titrated to the maximal drug doses from day 7 through day 17. PK parameters of corresponding analytes from the triple- and dual-treatment groups were estimated on day 17 and compared. Safety and tolerability of all treatments was assessed. The C (ssmax) and AUC(0-τ) values of amlodipine or HCTZ remained unaffected when administered with valsartan + HCTZ or valsartan + amlodipine, respectively. On the other hand, valsartan exposure increased by 10% to 25% when coadministered with HCTZ and amlodipine, which is not considered clinically relevant. In conclusion, there were no clinically relevant PK interactions with amlodipine, valsartan, and HCTZ triple combination compared with the corresponding dual combinations. All treatments were safe and well tolerated. SN - 1552-4604 UR - https://www.unboundmedicine.com/medline/citation/20852001/Evaluation_of_pharmacokinetic_interactions_between_amlodipine_valsartan_and_hydrochlorothiazide_in_patients_with_hypertension_ L2 - https://doi.org/10.1177/0091270010376963 DB - PRIME DP - Unbound Medicine ER -