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      Effects of the combinations of amlodipine/valsartan versus losartan/hydrochlorothiazide on left ventricular hypertrophy as determined with magnetic resonance imaging in patients with hypertension

      research-article
      1 , 1 , 1 , 2 , 3 , 4 , 4 , 5
      Journal of Drug Assessment
      Taylor & Francis
      Arterial hypertension, left ventricular hypertrophy, end-organ damage, magnetic resonance imaging, treatment, combination therapy, RAAS, Asc. aorta, ascending aorta, A/V, amlodipine plus valsartan, CCB, calcium channel blockers, BP, diastolic blood pressure, IVS, interventricular septum thickness, LA, left atrium, L/H, losartan/hydrochlorothiazide, LVEDV, left ventricular enddiastolic volume, LVEF, left ventricular ejection fraction, LVESV, left ventricular endsystolic volume, LVH, left ventricular hypertrophy, LVM, left ventricular mass, LVMI, left ventricular mass index, MRI, magnetic resonance imaging, norm BSA, adjusted for body surface area, SBP, systolic blood pressure

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          Abstract

          Background

          Left ventricular hypertrophy (LVH), a marker of cardiac end-organ damage, is frequently found in patients with arterial hypertension and is associated with cardiovascular and cerebrovascular morbidity and mortality. Therefore, LVH regression is an important treatment goal. For amlodipine plus valsartan (A/V) no specific study on LVH has been reported to date.

          Methods

          Prospective, open-label, randomized parallel-group study. Patients with essential hypertension and LVH were randomized to 52-week treatment with A/V 10/160 mg ( n = 43) or the active comparator losartan/HCT 100/25 mg (L/H, n = 47). Add-on medication was allowed in case of inadequate blood pressure control. LV parameters were measured by cardiovascular magnetic resonance imaging (MRI), and adjudicated in a blinded manner. Study identifiers were NCT00446563 and EudraCT 2006-001977-17.

          Results

          In addition to the study treatment, 35% of patients in the A/V group and 49% in the L/H group received additional antihypertensive medication. Compared to baseline, both treatments reduced measures of LVH significantly after 52 weeks (e.g. LV mass index in the A/V group from 64.7 g/m 2 by −3.5 g/m 2, in the L/H group from 69.1 g/m 2 by −4.4 g/m 2, p < 0.01 for both). LV ejection fraction and LV volumes were not significantly changed by any regimen. A/V and L/H treatments were well tolerated.

          Conclusions

          Both regimen were effective in reducing LV mass compared to baseline and were well tolerated.

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          Most cited references30

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          Impact of medication adherence on hospitalization risk and healthcare cost.

          The objective of this study was to evaluate the impact of medication adherence on healthcare utilization and cost for 4 chronic conditions that are major drivers of drug spending: diabetes, hypertension, hypercholesterolemia, and congestive heart failure. The authors conducted a retrospective cohort observation of patients who were continuously enrolled in medical and prescription benefit plans from June 1997 through May 1999. Patients were identified for disease-specific analysis based on claims for outpatient, emergency room, or inpatient services during the first 12 months of the study. Using an integrated analysis of administrative claims data, medical and drug utilization were measured during the 12-month period after patient identification. Medication adherence was defined by days' supply of maintenance medications for each condition. The study consisted of a population-based sample of 137,277 patients under age 65. Disease-related and all-cause medical costs, drug costs, and hospitalization risk were measured. Using regression analysis, these measures were modeled at varying levels of medication adherence. For diabetes and hypercholesterolemia, a high level of medication adherence was associated with lower disease-related medical costs. For these conditions, higher medication costs were more than offset by medical cost reductions, producing a net reduction in overall healthcare costs. For diabetes, hypercholesterolemia, and hypertension, cost offsets were observed for all-cause medical costs at high levels of medication adherence. For all 4 conditions, hospitalization rates were significantly lower for patients with high medication adherence. For some chronic conditions, increased drug utilization can provide a net economic return when it is driven by improved adherence with guidelines-based therapy.
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            2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC).

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              Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial.

              Hypertension is a leading cause of end-stage renal disease (ESRD) in the United States, with no known treatment to prevent progressive declines leading to ESRD. To compare the effects of 2 levels of blood pressure (BP) control and 3 antihypertensive drug classes on glomerular filtration rate (GFR) decline in hypertension. Randomized 3 x 2 factorial trial with enrollment from February 1995 to September 1998. A total of 1094 African Americans aged 18 to 70 years with hypertensive renal disease (GFR, 20-65 mL/min per 1.73 m(2)) were recruited from 21 clinical centers throughout the United States and followed up for 3 to 6.4 years. Participants were randomly assigned to 1 of 2 mean arterial pressure goals, 102 to 107 mm Hg (usual; n = 554) or 92 mm Hg or less (lower; n = 540), and to initial treatment with either a beta-blocker (metoprolol 50-200 mg/d; n = 441), an angiotensin-converting enzyme inhibitor (ramipril 2.5-10 mg/d; n = 436) or a dihydropyridine calcium channel blocker, (amlodipine 5-10 mg/d; n = 217). Open-label agents were added to achieve the assigned BP goals. Rate of change in GFR (GFR slope); clinical composite outcome of reduction in GFR by 50% or more (or > or =25 mL/min per 1.73 m2) from baseline, ESRD, or death. Three primary treatment comparisons were specified: lower vs usual BP goal; ramipril vs metoprolol; and amlodipine vs metoprolol. Achieved BP averaged (SD) 128/78 (12/8) mm Hg in the lower BP group and 141/85 (12/7) mm Hg in the usual BP group. The mean (SE) GFR slope from baseline through 4 years did not differ significantly between the lower BP group (-2.21 [0.17] mL/min per 1.73 m2 per year) and the usual BP group (-1.95 [0.17] mL/min per 1.73 m2 per year; P =.24), and the lower BP goal did not significantly reduce the rate of the clinical composite outcome (risk reduction for lower BP group = 2%; 95% confidence interval [CI], -22% to 21%; P =.85). None of the drug group comparisons showed consistent significant differences in the GFR slope. However, compared with the metoprolol and amlodipine groups, the ramipril group manifested risk reductions in the clinical composite outcome of 22% (95% CI, 1%-38%; P =.04) and 38% (95% CI, 14%-56%; P =.004), respectively. There was no significant difference in the clinical composite outcome between the amlodipine and metoprolol groups. No additional benefit of slowing progression of hypertensive nephrosclerosis was observed with the lower BP goal. Angiotensin-converting enzyme inhibitors appear to be more effective than beta-blockers or dihydropyridine calcium channel blockers in slowing GFR decline.
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                Author and article information

                Journal
                J Drug Assess
                J Drug Assess
                IJDA
                Journal of Drug Assessment
                Taylor & Francis
                2155-6660
                2012
                16 December 2011
                : 1
                : 1
                : 1-10
                Affiliations
                [1 ]Department of Cardiology and Angiology, Elisabeth Hospital, Essen, Germany
                [2 ]Office-based cardiologist, Berlin, Germany
                [3 ]Office-based internist, Ludwigshafen, Germany
                [4 ]Novartis Pharma GmbH, Clinical and Regulatory Affairs, Nürnberg, Germany
                [5 ]Institute for Myocardial Infarction Research, Ludwigshafen, Germany
                Author notes
                Corresponding author: Oliver Bruder, MD, Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie,Klara-Kopp-Weg 1, D-45138 Essen. Tel.: +49(0)201 897-0; Fax: +49(0)201 897-2249. o.bruder@ 123456contilia.de
                Article
                ijda-1-1
                10.3109/21556660.2011.639418
                4980731
                46a6215b-1681-435e-88f0-7cd33c790a5d
                © 2012 The Author(s). Published by Taylor & Francis

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

                History
                : Accepted on November 02, 2011
                Categories
                Original Articles

                arterial hypertension,left ventricular hypertrophy,end-organ damage,magnetic resonance imaging,treatment,combination therapy,raas,asc. aorta, ascending aorta,a/v, amlodipine plus valsartan,ccb, calcium channel blockers,bp, diastolic blood pressure,ivs, interventricular septum thickness,la, left atrium,l/h, losartan/hydrochlorothiazide,lvedv, left ventricular enddiastolic volume,lvef, left ventricular ejection fraction,lvesv, left ventricular endsystolic volume,lvh, left ventricular hypertrophy,lvm, left ventricular mass,lvmi, left ventricular mass index,mri, magnetic resonance imaging,norm bsa, adjusted for body surface area,sbp, systolic blood pressure

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