Efficacy and Tolerability of the Combination Valsartan/Hydrochlorothiazide Compared with Amlodipine in a Mild-to-moderately Hypertensive Brazilian Population

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dc.contributor.authorFranco, Roberto J.S. [UNESP]
dc.contributor.authorGoldflus, Suely
dc.contributor.authorMcQuitty, Mari
dc.contributor.authorOigman, Wille
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionNovartis Biociências SA
dc.contributor.institutionNovartis Pharma AG
dc.contributor.institutionUniv. Estadual do Rio de Janeiro
dc.date.accessioned2014-05-27T11:20:56Z
dc.date.available2014-05-27T11:20:56Z
dc.date.issued2003-12-01
dc.description.abstractMost hypertensive patients need more than one drug to reach recommended blood-pressure targets. We investigated the effects on 24-h ambulatory blood pressure (ABP) of the angiotensin-receptor blocker, valsartan, in combination with hydrochlorothiazide (HCTZ), compared with the calcium-channel blocker amlodipine in a Brazilian population in a multicentre, double-blind, double-dummy, parallel group, controlled study in 373 patients with essential hypertension. After a 2-week washout period, patients with a mean sitting systolic blood pressure (SBP) of 160-190 mmHg were randomized to receive either valsartan 160 mg o.d., or amlodipine 5 mg o.d. for 2 weeks and subsequently force-titrated to valsartan 160 mg/HCTZ 25 mg o.d. or amlodipine 10 mg o.d. This regimen was continued until the end of the study at week 8. The primary efficacy parameter was the change from baseline to week 8 in mean 24-h SBP. Secondary endpoints were change in mean 24-h diastolic blood pressure (DBP), tolerability and safety of treatments. Valsartan/HCTZ achieved a mean reduction in systolic ABP of -19.1 ± 11.3 mmHg compared with -20.7 ± 12.0 mmHg with amlodipine (p = 0.324 for the comparison) and in diastolic ABP by -11.1 ± 7.4 mmHg vs -11.6 ± 7.2 mmHg by amlodipine (p = 0.853 for the comparison). The valsartan/HCTZ group exhibited markedly lower rates of adverse events and discontinuations than the amlodipine group. Peripheral oedemas were far more frequent with amlodipine than with valsartan/HCTZ (1.6% with valsartan/HCTZ; 16.8% with amlodipine). Thus, the valsartan 160 mg/HCTZ 25 mg combination appears to be as efficacious as amlodipine 10 mg in this patient population but better tolerated.en
dc.description.affiliationBotucatu Medical School Department of Medicine Nephrology Division, São Paulo
dc.description.affiliationNovartis Biociências SA, São Paulo
dc.description.affiliationNovartis Pharma AG, Basel
dc.description.affiliationClínica Médica Univ. Estadual do Rio de Janeiro, Rio de Janeiro
dc.description.affiliationNovartis Biociências SA, Av. Professor Vicente Rao, 90, CEP: 04706-900 São Paulo
dc.description.affiliationUnespBotucatu Medical School Department of Medicine Nephrology Division, São Paulo
dc.format.extent41-47
dc.identifierhttp://dx.doi.org/10.1080/080380203100022399
dc.identifier.citationBlood Pressure, Supplement, v. 12, n. 2, p. 41-47, 2003.
dc.identifier.doi10.1080/080380203100022399
dc.identifier.issn0803-8023
dc.identifier.scopus2-s2.0-1642512279
dc.identifier.urihttp://hdl.handle.net/11449/67485
dc.language.isoeng
dc.relation.ispartofBlood Pressure, Supplement
dc.rights.accessRightsAcesso restrito
dc.sourceScopus
dc.subjectAngiotensin-receptor blocker
dc.subjectCalcium-channel blocker
dc.subjectCombination therapy
dc.subjectEthnicity
dc.subjectHypertension
dc.subjectamlodipine
dc.subjectcreatinine
dc.subjecthydrochlorothiazide
dc.subjectvalsartan
dc.subjectdrug derivative
dc.subjecttetrazole derivative
dc.subjectvaline
dc.subjectadult
dc.subjectaged
dc.subjectantihypertensive therapy
dc.subjectblood pressure monitoring
dc.subjectblood pressure regulation
dc.subjectBrazil
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectcreatinine blood level
dc.subjectdiastolic blood pressure
dc.subjectdisease severity
dc.subjectdizziness
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectessential hypertension
dc.subjectfemale
dc.subjectheadache
dc.subjectheart palpitation
dc.subjecthuman
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectperipheral edema
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectside effect
dc.subjectblood pressure
dc.subjectchemically induced disorder
dc.subjectcomparative study
dc.subjectdrug combination
dc.subjectdrug effect
dc.subjectedema
dc.subjectethnology
dc.subjecthypertension
dc.subjectmiddle aged
dc.subjectrace
dc.subjecttreatment outcome
dc.subjectAged
dc.subjectAmlodipine
dc.subjectBlood Pressure
dc.subjectBlood Pressure Monitoring, Ambulatory
dc.subjectContinental Population Groups
dc.subjectDouble-Blind Method
dc.subjectDrug Therapy, Combination
dc.subjectEdema
dc.subjectFemale
dc.subjectHumans
dc.subjectHydrochlorothiazide
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectTetrazoles
dc.subjectTreatment Outcome
dc.subjectValine
dc.titleEfficacy and Tolerability of the Combination Valsartan/Hydrochlorothiazide Compared with Amlodipine in a Mild-to-moderately Hypertensive Brazilian Populationen
dc.typeArtigo
dcterms.licensehttp://informahealthcare.com/userimages/ContentEditor/1255620309227/Copyright_And_Permissions.pdf
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Medicina, Botucatupt

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