Massimo Volpe1, Cristina Miele, Uwe Haag. 1. Specialty School of Cardiology, University of Rome 'La Sapienza', Rome, Italy. massimo.volpe@uniroma1.it
Abstract
BACKGROUND: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This long-term 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 5 mg/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 40/5 mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP >/=90 mmHg 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 40/5 mg 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 onolmesartan/amlodipine 40/10 mg and olmesartan/amlodipine/HCTZ 40/10/12.5 mg, 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 <140 mmHg and DBP <90 mmHg for patients without diabetes mellitus, and SBP <130 mmHg and DBP <80 mmHg for patients with diabetes. Treatment was generally well tolerated, with no unexpected safety concerns. CONCLUSIONS: A treatment algorithm based on olmesartan/amlodipine (+/- HCTZ) provides a high degree of BP control in patients with moderate-to-severe hypertension. The open-label study design suggests similar results are obtainable in clinical practice.
RCT Entities:
BACKGROUND: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensivepatients. This long-term open-label study assessed a treatment algorithm based on olmesartanmedoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ). METHODS:Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5 mg/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 40/5 mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP >/=90 mmHg 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 40/5 mg 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 40/10 mg and olmesartan/amlodipine/HCTZ 40/10/12.5 mg, 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 <140 mmHg and DBP <90 mmHg for patients without diabetes mellitus, and SBP <130 mmHg and DBP <80 mmHg for patients with diabetes. Treatment was generally well tolerated, with no unexpected safety concerns. CONCLUSIONS: A treatment algorithm based on olmesartan/amlodipine (+/- HCTZ) provides a high degree of BP control in patients with moderate-to-severe hypertension. The open-label study design suggests similar results are obtainable in clinical practice.
Authors: Giuseppe Mancia; Guy De Backer; Anna Dominiczak; Renata Cifkova; Robert Fagard; Giuseppe Germano; Guido Grassi; Anthony M Heagerty; Sverre E Kjeldsen; Stephane Laurent; Krzysztof Narkiewicz; Luis Ruilope; Andrzej Rynkiewicz; Roland E Schmieder; Harry A J Struijker Boudier; Alberto Zanchetti; Alec Vahanian; John Camm; Raffaele De Caterina; Veronica Dean; Kenneth Dickstein; Gerasimos Filippatos; Christian Funck-Brentano; Irene Hellemans; Steen Dalby Kristensen; Keith McGregor; Udo Sechtem; Sigmund Silber; Michal Tendera; Petr Widimsky; José Luis Zamorano; Serap Erdine; Wolfgang Kiowski; Enrico Agabiti-Rosei; Ettore Ambrosioni; Lars H Lindholm; Margus Viigimaa; Stamatis Adamopoulos; Enrico Agabiti-Rosei; Ettore Ambrosioni; Vicente Bertomeu; Denis Clement; Serap Erdine; Csaba Farsang; Dan Gaita; Gregory Lip; Jean-Michel Mallion; Athanasios J Manolis; Peter M Nilsson; Eoin O'Brien; Piotr Ponikowski; Josep Redon; Frank Ruschitzka; Juan Tamargo; Pieter van Zwieten; Bernard Waeber; Bryan Williams Journal: J Hypertens Date: 2007-06 Impact factor: 4.844
Authors: Luis M Ruilope; Enrico Agabiti Rosei; George L Bakris; Giuseppe Mancia; Neil R Poulter; Stefano Taddei; Thomas Unger; Massimo Volpe; Bernard Waeber; Faiez Zannad Journal: Blood Press Date: 2005 Impact factor: 2.835
Authors: Osvaldo Kohlmann; Wille Oigman; Décio Mion; João Carlos Rocha; Marco Antonio Mota Gomes; Natalino Salgado; Gilson Soares Feitosa; Ernesto Dallaverde; Artur Beltrame Ribeiro Journal: Arq Bras Cardiol Date: 2006-02-13 Impact factor: 2.000
Authors: Katharina Wolf-Maier; Richard S Cooper; Holly Kramer; José R Banegas; Simona Giampaoli; Michel R Joffres; Neil Poulter; Paola Primatesta; Birgitta Stegmayr; Michael Thamm Journal: Hypertension Date: 2003-11-24 Impact factor: 10.190
Authors: Suzanne Oparil; Thomas Giles; Elizabeth O Ofili; Bertram Pitt; Yodit Seifu; Robert Hilkert; Rita Samuel; James R Sowers Journal: J Hypertens Date: 2011-01 Impact factor: 4.844
Authors: Dean J Kereiakes; Steven G Chrysant; Joseph L Izzo; Thomas Littlejohn; Suzanne Oparil; Michael Melino; James Lee; Victor Fernandez; Reinilde Heyrman Journal: J Clin Hypertens (Greenwich) Date: 2012-01-24 Impact factor: 3.738