Efficacy and safety of a stepped-care regimen using olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with moderate-to-severe hypertension: An open-label, long-term study

Massimo Volpe, Cristina Miele, Uwe Haag

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This longterm open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ). Methods: Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP ≥ 90mmHg and ≥140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/ amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg. Results: In total, 692 patients entered the open-label phase (691 on olmesartan/ amlodipine 40/5 mg). The majority of patients remained on olmesartan/ amlodipine 40/5mg without dose elevation, and, of these, 74.3% achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10mg and olmesartan/ amlodipine/HCTZ 40/10/12.5mg, the respective proportions who reached goal BP were 59.0% and 47.1%. Overall, 66.9% of patients achieved the European guideline recommended goal BP of SBP > 140mmHg and DBP > 90mmHg for patients without diabetes mellitus, and SBP > 130mmHg and DBP

Original languageEnglish
Pages (from-to)381-391
Number of pages11
JournalClinical Drug Investigation
Volume29
Issue number6
DOIs
Publication statusPublished - 2009

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Amlodipine
Hydrochlorothiazide
Hypertension
Safety
Blood Pressure
Olmesartan Medoxomil
olmesartan
Guidelines
Therapeutics
Diabetes Mellitus

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

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title = "Efficacy and safety of a stepped-care regimen using olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with moderate-to-severe hypertension: An open-label, long-term study",
abstract = "Background: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This longterm open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ). Methods: Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP ≥ 90mmHg and ≥140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/ amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg. Results: In total, 692 patients entered the open-label phase (691 on olmesartan/ amlodipine 40/5 mg). The majority of patients remained on olmesartan/ amlodipine 40/5mg without dose elevation, and, of these, 74.3{\%} achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10mg and olmesartan/ amlodipine/HCTZ 40/10/12.5mg, the respective proportions who reached goal BP were 59.0{\%} and 47.1{\%}. Overall, 66.9{\%} of patients achieved the European guideline recommended goal BP of SBP > 140mmHg and DBP > 90mmHg for patients without diabetes mellitus, and SBP > 130mmHg and DBP",
author = "Massimo Volpe and Cristina Miele and Uwe Haag",
year = "2009",
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AU - Haag, Uwe

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N2 - Background: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This longterm open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ). Methods: Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP ≥ 90mmHg and ≥140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/ amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg. Results: In total, 692 patients entered the open-label phase (691 on olmesartan/ amlodipine 40/5 mg). The majority of patients remained on olmesartan/ amlodipine 40/5mg without dose elevation, and, of these, 74.3% achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10mg and olmesartan/ amlodipine/HCTZ 40/10/12.5mg, the respective proportions who reached goal BP were 59.0% and 47.1%. Overall, 66.9% of patients achieved the European guideline recommended goal BP of SBP > 140mmHg and DBP > 90mmHg for patients without diabetes mellitus, and SBP > 130mmHg and DBP

AB - Background: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This longterm open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ). Methods: Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP ≥ 90mmHg and ≥140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/ amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg. Results: In total, 692 patients entered the open-label phase (691 on olmesartan/ amlodipine 40/5 mg). The majority of patients remained on olmesartan/ amlodipine 40/5mg without dose elevation, and, of these, 74.3% achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10mg and olmesartan/ amlodipine/HCTZ 40/10/12.5mg, the respective proportions who reached goal BP were 59.0% and 47.1%. Overall, 66.9% of patients achieved the European guideline recommended goal BP of SBP > 140mmHg and DBP > 90mmHg for patients without diabetes mellitus, and SBP > 130mmHg and DBP

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