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hypertensionCTU

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Published on February 25, 2008

Author: Veronica1

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MICCAT-2: Trial design:  Study population n=1628 (efficacy population); adult >18 years with uncontrolled or untreated stage 1 or stage 2 essential hypertension Study drugs Telmisartan and telmisartan with HCTZ Study endpoints Change in mean 24-hour ABPM SBP and DBP from baseline to study exit Treatment duration 10 weeks Study design Prospective, open-label, phase 4, community-based trial White WB, et al. Am Heart J. 2006;151:176-184. MICCAT-2: Trial design Change in office systolic and diastolic blood pressure Telmisartan reduced mean 24-hour ABPM blood pressure:  Telmisartan reduced mean 24-hour ABPM blood pressure Baseline Final Visit Ambulatory DBP (mm HG) 90 85 75 70 12:00 PM 4:00 PM 8:00 PM 12:00 AM 4:00 AM 8:00 AM 8:00 AM Time of day White WB, et al. Blood Press Monit. 2005;10:157-163. 80 65 60 n=1628 Telmisartan reduced blood pressure in the early-morning hours:  Telmisartan reduced blood pressure in the early-morning hours White WB, et al. Blood Press Monit. 2005;157:157-161. A large percentage of patients achieved blood pressure control:  A large percentage of patients achieved blood pressure control White WB, et al. Am Heart J. 2006;151:176-184. 50 60 70 80 90 100 SBP <140 DBP <90 SBP/DBP <140/90 82% 90% 79% Percentage of patients achieving BP control Office (n=1627) 91% 70% 71% ABPM (n=1628) SBP <130 DBP <85 SBP/DBP <130/85 50 100 90 80 70 60 Comparative efficacy of telmisartan in black patients and white patients in a community-based trial:  Comparative efficacy of telmisartan in black patients and white patients in a community-based trial All patients Monotherapy Combination Le Jacq, Ltd. All rights reserved. This material is the exclusive property of and is provided by Le Jacq Communications, Inc., and/or it’s affiliates, and is protected under US Copyright and international laws. Any use of this material, including downloading for your personal use, will indicate your consent and agreement to the terms stated in this notice. No right, title or interest in the material is conveyed to you as a result of any such downloading or copying, and such downloaded or copied material may not be used for any commercial purpose. Bakris GL, et al. J Clin Hypertens. 2005;7:587-595. In general, BP response in blacks is noticeably less than that in Caucasians with angiotensin II receptor blockers and ACE inhibitors Canadian Telmisartan Study: Trial design:  Study population N=232; adults 28-80 years old with mild-to-moderate essential hypertension (DBP 95-114 mm HG) Study drugs Primary endpoint Comparison of the change in trough DBP from baseline after 12 weeks with telmisartan and placebo Treatment duration 12 weeks Study design Double-blind, randomized, placebo-controlled, parallel-group multicenter study Telmisartan, amlodipine Lacourciere Y, et al. Blood Press Monit. 1998;3:295-302. Comparison in the change from baseline DBP after 12 weeks with amlodipine and placebo Canadian Telmisartan Study: Trial design Telmisartan BP reduction: Early-morning hours:  Telmisartan BP reduction: Early-morning hours n=62 P<.0001 telmisartan vs. placebo at all time points. Mean reduction in ABP from baseline (mm HG) Lacourciere Y, et al. Blood Press Monit. 1998;3:295-302. First 6 hours of dosing Last 4 hours of dosing (early-morning hours) Telmisartan dose range: 40/80/120 mg/day. Median dose: 80 mg/day. Canadian telmisartan study: Blood pressure control:  Canadian telmisartan study: Blood pressure control 160 120 100 80 60 0 2 4 6 8 10 12 14 16 18 20 22 24 140 Placebo (n=58) Telmisartan (40-120 mg) (n=62) SBP DBP Ambulatory Blood Pressure (mm HG) Hours Adapted from Lacourciere Y, et al. Blood Press Monit. 1998;3:295-302. ATHOS Study: Trial design:  ATHOS Study: Trial design Neldam S, Edwards C, on behalf of the ATHOS Study Group. Am J Geriatr Cardiol. 2006;15(3):151-160. Study population (n=1000, randomized) 60 years, SBP >141 mm HG, DBP ≤95 mm HG 24-hour mean systolic ABP >125 mm HG Study drugs Primary endpoint Reduction in SBP during the last 6 hours of the 24-hour dosing period as measured by ABPM Treatment duration 14 weeks Prospective, randomized, open-label, blinded endpoint study Secondary endpoints Telmisartan 40-80 mg and hydrochlorothiazide 12.5 mg or amlodipine* 5-10 mg and hydrochlorothiazide 12.5 mg Change from baseline in DBP and pulse pressure during the last 6 hours; reduction in 24-hour mean ABP, mean daytime, morning, and nighttime SBP and DBP Study design Reduction in SBP in elderly patients treated with telmisartan:  Reduction in SBP in elderly patients treated with telmisartan Neldam S, Edwards C, on behalf of the ATHOS Study Group. Am J Geriatr Cardiol. 2006;15(3):151-160. No overall differences in effectiveness and safety of telmisartan/hydrochlorothiazide were observed in elderly patients compared with younger patients, but greater sensitivity of some older individuals cannot be ruled out. Telmisartan plus existing therapy: Trial design:  Study population Adults >18 years (n=375) with uncontrolled essential hypertension on existing monotherapy (except ARBs) Study drugs Telmisartan 40 mg or 80 mg Primary endpoint Change from baseline in mean DBP measured over the last 6 hours of the dosing period via ABPM Treatment duration 8 weeks Study design Prospective, multicenter, double-blind, randomized, placebo-controlled, dose titration, parallel-group study Telmisartan plus existing therapy: Trial design Secondary endpoint Change from baseline in mean SBP, in mean 24-hour SBP and DBP, in mean trough seated BP over the last 6 hours Gil-Extremera B, et al. Int J Clin Pract. 2003;57:861-866. Early-morning BP control: Telmisartan plus existing therapy:  HCTZ Early-morning BP control: Telmisartan plus existing therapy Additional DBP reductions (mm HG) when telmisartan is added to patients uncontrolled on current therapy at the end of the dosing period Telmisartan 40mg – 80mg plus current therapy Placebo plus current therapy ACE Inhibitors Beta Blockers CCBs -4.8 n=56 -5.8 n=35 -6.8 n=49 -10.6 n=14 1.9 n=15 -5.2 n=50 -2.3 n=36 -0.2 n=56 Gil-Extremera B, et al. Int J Clin Pract. 2003;57:861-866. ONTARGET: Trial design:  The ONTARGET/TRANSCEND Investigators. Am Heart J. 2004;148:52-61. ONTARGET: Trial design TRANSCEND: Trial Design:  TRANSCEND: Trial Design The ONTARGET/TRANSCEND Investigators. Am Heart J. 2004;148:52-61. PRoFESS: Trial Design:  PRoFESS: Trial Design Diener HC, Sacco R, Yusuf S; PRoFESS Study Group. Cerebrovascular Diseases 2007;23:368-380 Telmisartan Evaluations in Nephropathy:  Telmisartan Evaluations in Nephropathy Endothelial dysfunction of the renal vasculature in patients with type 2 diabetes and hypertension (TRENDY)1 Onset of new nephropathy (ONTARGET)2 Proteinuria in patients with diabetes vs. Iosartan and valsartan (AMADEO and VIVALDI)1 Renal function assessed by glomerular filtration rate in patients with type-2 diabetes and nephropathy (DETAIL)3 1. Weber M. J Hypertens. 2003;21(suppl 6):S37-S46. 2. The ONTARGET/TRANSCEND Investigators. Am Heart J. 2004;148:52-61. 3. Barnett AH. N Engl J Med. 2004;351:1952-1961.

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