Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control

Delays in achieving blood pressure (BP) control may increase morbidity and mortality in patients with hypertension. Thus, deciding which antihypertensive agent to use and at what dosage, in addition to determining when to initiate combination therapy and which agents to combine, is important for ach...

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Published in:Vascular health and risk management 2009-01, Vol.5, p.883-892
Main Authors: Zappe, Dion, Papst, Cheraz Cherif, Ferber, Philippe
Format: Article
Language:English
Subjects:
Adult
Aged
Amlodipine - adverse effects
Amlodipine - therapeutic use
Angiotensin II Type 1 Receptor Blockers - adverse effects
Angiotensin II Type 1 Receptor Blockers - therapeutic use
Antihypertensive Agents - adverse effects
Antihypertensive Agents - therapeutic use
Antihypertensives
Blood pressure
Blood Pressure - drug effects
Calcium Channel Blockers - adverse effects
Calcium Channel Blockers - therapeutic use
combination therapy
Diuretics
Diuretics - adverse effects
Diuretics - therapeutic use
Double-Blind Method
Drug Therapy, Combination
efficacy
Europe
Female
Humans
hydrochlorothiazide
Hydrochlorothiazide - adverse effects
Hydrochlorothiazide - therapeutic use
Hypertension
Hypertension - drug therapy
Hypertension - physiopathology
Male
Middle Aged
Original Research
South America
Tetrazoles - adverse effects
Tetrazoles - therapeutic use
Time Factors
titration
tolerability
Treatment Outcome
Valine - adverse effects
Valine - analogs & derivatives
Valine - therapeutic use
Valsartan
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Papst, Cheraz Cherif
Ferber, Philippe
description Delays in achieving blood pressure (BP) control may increase morbidity and mortality in patients with hypertension. Thus, deciding which antihypertensive agent to use and at what dosage, in addition to determining when to initiate combination therapy and which agents to combine, is important for achieving BP control. This randomized, double-blind, 14-week study was conducted to compare the efficacy and tolerability of various doses of valsartan +/- hydrochlorothiazide (HCTZ) versus amlodipine +/- HCTZ for maximizing BP control in 1,285 patients with uncontrolled hypertension. Patients with stage 1 hypertension and naïve to antihypertensive therapy (33.9%) started valsartan 160 mg or amlodipine 5 mg. Treatment-naïve patients with stage 2 hypertension (13.5%) or those uncontrolled on current antihypertensive monotherapy (52.6%) started valsartan 160 mg/HCTZ 12.5 mg or amlodipine 10 mg. At weeks 4, 8, and 11, patients not achieving BP control were up-titrated (maximum: valsartan 320 mg/HCTZ 25 mg, amlodipine 10 mg/HCTZ 25 mg). At study end, 78.8% of patients on valsartan +/- HCTZ were controlled (BP
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Thus, deciding which antihypertensive agent to use and at what dosage, in addition to determining when to initiate combination therapy and which agents to combine, is important for achieving BP control. This randomized, double-blind, 14-week study was conducted to compare the efficacy and tolerability of various doses of valsartan +/- hydrochlorothiazide (HCTZ) versus amlodipine +/- HCTZ for maximizing BP control in 1,285 patients with uncontrolled hypertension. Patients with stage 1 hypertension and naïve to antihypertensive therapy (33.9%) started valsartan 160 mg or amlodipine 5 mg. Treatment-naïve patients with stage 2 hypertension (13.5%) or those uncontrolled on current antihypertensive monotherapy (52.6%) started valsartan 160 mg/HCTZ 12.5 mg or amlodipine 10 mg. At weeks 4, 8, and 11, patients not achieving BP control were up-titrated (maximum: valsartan 320 mg/HCTZ 25 mg, amlodipine 10 mg/HCTZ 25 mg). At study end, 78.8% of patients on valsartan +/- HCTZ were controlled (BP &lt;140/90 mmHg) and still on study medication versus 67.8% on amlodipine +/- HCTZ (P &lt; 0.0001). Amlodipine-treated patients had a higher incidence of peripheral edema (22.4% vs 2.2%) and associated discontinuations (7.3% vs &lt;1%). Initiating therapy earlier with valsartan/HCTZ, rather than titrating monotherapy to its maximum dose before adding a second agent, was superior to amlodipine monotherapy or amlodipine +/- HCTZ for achieving BP control, and avoided excessive treatment adjustments and maintained tolerability.</description><identifier>ISSN: 1178-2048</identifier><identifier>ISSN: 1176-6344</identifier><identifier>EISSN: 1178-2048</identifier><identifier>DOI: 10.2147/vhrm.s8062</identifier><identifier>PMID: 19898644</identifier><language>eng</language><publisher>New Zealand: Taylor &amp; Francis Ltd</publisher><subject>Adult ; Aged ; Amlodipine - adverse effects ; Amlodipine - therapeutic use ; Angiotensin II Type 1 Receptor Blockers - adverse effects ; Angiotensin II Type 1 Receptor Blockers - therapeutic use ; Antihypertensive Agents - adverse effects ; Antihypertensive Agents - therapeutic use ; Antihypertensives ; Blood pressure ; Blood Pressure - drug effects ; Calcium Channel Blockers - adverse effects ; Calcium Channel Blockers - therapeutic use ; combination therapy ; Diuretics ; Diuretics - adverse effects ; Diuretics - therapeutic use ; Double-Blind Method ; Drug Therapy, Combination ; efficacy ; Europe ; Female ; Humans ; hydrochlorothiazide ; Hydrochlorothiazide - adverse effects ; Hydrochlorothiazide - therapeutic use ; Hypertension ; Hypertension - drug therapy ; Hypertension - physiopathology ; Male ; Middle Aged ; Original Research ; South America ; Tetrazoles - adverse effects ; Tetrazoles - therapeutic use ; Time Factors ; titration ; tolerability ; Treatment Outcome ; Valine - adverse effects ; Valine - analogs &amp; derivatives ; Valine - therapeutic use ; Valsartan</subject><ispartof>Vascular health and risk management, 2009-01, Vol.5, p.883-892</ispartof><rights>2009. 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At study end, 78.8% of patients on valsartan +/- HCTZ were controlled (BP &lt;140/90 mmHg) and still on study medication versus 67.8% on amlodipine +/- HCTZ (P &lt; 0.0001). Amlodipine-treated patients had a higher incidence of peripheral edema (22.4% vs 2.2%) and associated discontinuations (7.3% vs &lt;1%). Initiating therapy earlier with valsartan/HCTZ, rather than titrating monotherapy to its maximum dose before adding a second agent, was superior to amlodipine monotherapy or amlodipine +/- HCTZ for achieving BP control, and avoided excessive treatment adjustments and maintained tolerability.</abstract><cop>New Zealand</cop><pub>Taylor &amp; Francis Ltd</pub><pmid>19898644</pmid><doi>10.2147/vhrm.s8062</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Aged
Amlodipine - adverse effects
Amlodipine - therapeutic use
Angiotensin II Type 1 Receptor Blockers - adverse effects
Angiotensin II Type 1 Receptor Blockers - therapeutic use
Antihypertensive Agents - adverse effects
Antihypertensive Agents - therapeutic use
Antihypertensives
Blood pressure
Blood Pressure - drug effects
Calcium Channel Blockers - adverse effects
Calcium Channel Blockers - therapeutic use
combination therapy
Diuretics
Diuretics - adverse effects
Diuretics - therapeutic use
Double-Blind Method
Drug Therapy, Combination
efficacy
Europe
Female
Humans
hydrochlorothiazide
Hydrochlorothiazide - adverse effects
Hydrochlorothiazide - therapeutic use
Hypertension
Hypertension - drug therapy
Hypertension - physiopathology
Male
Middle Aged
Original Research
South America
Tetrazoles - adverse effects
Tetrazoles - therapeutic use
Time Factors
titration
tolerability
Treatment Outcome
Valine - adverse effects
Valine - analogs & derivatives
Valine - therapeutic use
Valsartan
title Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control
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