傲坦研究匯總產(chǎn)品知識(shí)--奧美沙坦(傲坦)

1、.1.2J Clin Hypertens. 2004;6:168-174; 6. Ther Adv Cardiovasc Dis 2007;1(2):97106; 7. Am J Hypertens 2005; .3.4.安慰劑安慰劑氯沙坦氯沙坦 50 mg厄貝沙坦厄貝沙坦 150 mg OLM 20 mg纈沙坦纈沙坦 80 mg入選標(biāo)準(zhǔn)入選標(biāo)準(zhǔn): 袖帶坐位袖帶坐位.*Significant vs olmesartan medoxomilMean baseline BP: 155-157/104 mm Hg SeDBP: seated diastolic blood pressureSeSBP

2、: seated systolic blood pressureOparil S, et al. J Clin Hypertens. 2001;3:283-291,318.OLM: olmesartan medoxomilLOS: losartan potassiumVAL: valsartan IRB: irbesartanMean in BP (mm Hg)*P = 0.0002P 0.001P = 0.041*OLM20 mg/d(n = 145)LOS50 mg/d(n = 146)VAL80 mg/d(n = 142)IRB150 mg/d(n = 145)OLM20 mg/d(n

3、= 145)LOS50 mg/d(n = 146)VAL80 mg/d(n = 142)IRB150 mg/d(n = 145)Mean in BP (mm Hg).*p0.005; p0.05 vs olmesartan *Oparil et al. J Clin Hypertens 2001; 3: 283291Olmesartan medoxomil 20 mgLosartan 50 mgValsartan 80 mgIrbesartan 150 mgChange in ABP (mmHg)ABP = ambulatory blood pressure.Smith et al. Am J

4、 Cardiovasc Drugs 2005; 5 (1): 4150*p0.001; p0.05 vs olmesartan *ABP = ambulatory blood pressureOlmesartan medoxomil 20 mgLosartan 50 mgValsartan 80 mgIrbesartan 150 mgChange from baselinein ABP (mmHg).*ABP = ambulatory blood pressure*p0.001; p0.05 vs olmesartan Smith et al. Am J Cardiovasc Drugs 20

5、05; 5 (1): 4150Olmesartan medoxomil 20 mgLosartan 50 mgValsartan 80 mgIrbesartan 150 mgChange from baselinein ABP (mmHg).19.20.入選標(biāo)準(zhǔn)入選標(biāo)準(zhǔn): 袖帶袖帶SeDBP: 100-115 mm Hg ABPM: 日間日間DBP 90-119 mmHgN=440.Chrysant et al. Blood Press Monit 2006; 11: 135141.25.*p0.001 vs placebop0.05 vs placebo*Patients achieving

6、 BP target (%)Change in BP (mmHg)Olmesartan 20 mgAmlodipine 5 mgPlaceboBasile & Chrysant. J Hum Hypertens 2006; 20: 169175.0-2-4-6-8-10-12-14 纈沙坦纈沙坦 厄貝沙坦厄貝沙坦 坎地沙坦坎地沙坦 替米沙坦替米沙坦依普羅沙坦依普羅沙坦傲坦傲坦氯沙坦氯沙坦 安慰劑安慰劑Change in SBP (mmHg)Fabia et al. J Hypertension 2007;25:1327360-2-4-6-8-10Change in DBP (mmHg)

7、P=0.03P=0.002.Fabia et al. J Hypertension 2007; 25: 13271336.Fabia et al. J Hypertension 2007; 25: 13271336.0-2-4-18-6-8-10-12-14-160-2-4-6-8-10-12-14纈沙坦纈沙坦厄貝沙坦厄貝沙坦坎地沙坦坎地沙坦替米沙坦替米沙坦依普羅沙坦依普羅沙坦傲坦傲坦氯沙坦氯沙坦安慰劑安慰劑Fabia et al. J Hypertension 2007; 25: 13271336Change in DBP (mmHg)Change in SBP (mmHg)P=0.04P=

8、0.02.Captopril 12.5 mg bid*Olmesartan 5 mg*04128*4周和周和8周時(shí)，如果降壓無(wú)效，則劑量加倍周時(shí)，如果降壓無(wú)效，則劑量加倍Ball et al. J Hypertens 2001; 19 (Suppl 1): S49S56Stumpe & Ludwig. J Hum Hypertens 2002; 16 (Suppl 2): S24S28安慰劑安慰劑3周周評(píng)價(jià)評(píng)價(jià)WeekN=148mean SeDBP 101.0 mmHgN=143mean SeDBP 102.1 mmHg.*p0.05 vs captoprilBall et al. J

9、 Hypertens 2001; 19 (Suppl 1): S49S56Stumpe & Ludwig. J Hum Hypertens 2002; 16 (Suppl 2): S24S28Olmesartan medoxomil (520 mg/d)Captopril (12.550 mg/d)Change in BP (mmHg)*.34.35Fliser C et al. Circulation. 2004;110:11031107. Fliser et al. Circulation. 2004;110:11031107.*p0.02, *p0.05, #p0.01 vs.

10、baseline, p0.05 olmesartan vs. placeboFliser et al. Circulation. 2004;110:11031107.*p0.02, *p0.05, #p0.01 vs. baseline, p0.05 olmesartan vs. placeboFliser et al. Circulation. 2004;110:11031107.39Smith RD, et al. JASH. 2008;2:165-172.* 氫氯噻嗪, 氨氯地平, 肼苯達(dá)嗪VIOSVIOS研究設(shè)計(jì)研究設(shè)計(jì)洗脫期篩選20 mg40 mg50 mg100 mg奧美沙坦酯奧美

11、沙坦酯維持治療增加其他抗高血壓藥物*阿替洛爾阿替洛爾- 40241252隨機(jī)并劑量滴定周周活檢活檢N=55N=10028活檢活檢N=49Ronald D. Smith. Journal of the American Society of Hypertension 2(3) (2008) 165172.42VIOSVIOS研究設(shè)計(jì)研究設(shè)計(jì).SBPDBPRonald D. Smith. Journal of the American Society of Hypertension 2(3) (2008) 165172.10.012.014.016.018.0正常正常第第1周周第第52周周第第52

12、周周第第1周周阿替洛爾阿替洛爾奧美沙坦奧美沙坦P 0.001血管壁腔比血管壁腔比(%)Ronald D. Smith. Journal of the American Society of Hypertension 2(3) (2008) 165172.MORE StudyMulticenter Olmesartan Atherosclerosis Regression Evaluation奧美沙坦逆轉(zhuǎn)動(dòng)脈粥樣硬化多中心研究奧美沙坦逆轉(zhuǎn)動(dòng)脈粥樣硬化多中心研究Stumpe KO, et al. Ther Adv Cardiovasc Dis 2007;1(2):97106.47MOREMORE研

13、究設(shè)計(jì)研究設(shè)計(jì).Klaus O. Stumpe,Therapeutic Advances in Cardiovascular Disease 2007; 1; 97.根據(jù)需要加用根據(jù)需要加用HCTZ 25 mg血壓超聲血壓超聲安慰劑導(dǎo)入階安慰劑導(dǎo)入階段段2 04828104劑量遞增階段劑量遞增階段周周521216血壓超聲血壓超聲血壓超聲血壓超聲血壓超聲血壓超聲評(píng)估階段評(píng)估階段根據(jù)需要?jiǎng)┝勘对龈鶕?jù)需要?jiǎng)┝勘对龈鶕?jù)需要?jiǎng)┝勘对龈鶕?jù)需要?jiǎng)┝勘对鰥W美沙坦奧美沙坦 20 mg阿替洛爾阿替洛爾50 mg12.5 mg根據(jù)需要加用根據(jù)需要加用HCTZ 25 mg12.5 mg安慰劑安慰劑HCTZ = 雙氫克

14、脲塞雙氫克脲塞Klaus O. Stumpe,Therapeutic Advances in Cardiovascular Disease 2007; 1; 97.阿替洛爾阿替洛爾奧美沙坦奧美沙坦21.5 mmHg24.6 mmHg*13.8 mmHg15.2 mmHg*p=0.120 vs atenolol; *p=0.075 vs atenolol 與基線比較的變化與基線比較的變化02852104708090100130140150160收縮壓收縮壓舒張壓舒張壓周周血壓血壓 (mmHg)157.195.996.3157.6Klaus O. Stumpe,Therapeutic Advanc

15、es in Cardiovascular Disease 2007; 1; 97. *p0.0001 與基線比較Klaus O. Stumpe,Therapeutic Advances in Cardiovascular Disease 2007; 1; 97.*p=0.044 vs 基線, 0.083 vs 阿替洛爾*p=0.036 vs基線, 0.032 vs阿替洛爾*p=0.014 vs基線, 0.023 vs阿替洛爾1216404 802852104阿替洛爾阿替洛爾奧美沙坦奧美沙坦研究周數(shù)研究周數(shù)PVPV的變化的變化 ( (LL) )*PV:斑塊體積Klaus O. Stumpe,Th

16、erapeutic Advances in Cardiovascular Disease 2007; 1; 97. 傲坦逆轉(zhuǎn)左室肥厚研究傲坦逆轉(zhuǎn)左室肥厚研究Takayoshi Tsutamoto, et al. Hypertension Research (2010) 33, 118122.55研究設(shè)計(jì)研究設(shè)計(jì).奧美沙坦和坎地沙坦對(duì)高血壓病人血漿奧美沙坦和坎地沙坦對(duì)高血壓病人血漿AngIIAngII水平和左室肥厚的長(zhǎng)期作用比較水平和左室肥厚的長(zhǎng)期作用比較: :試驗(yàn)入選了50例門診使用坎地沙坦超過(guò)1年的高血壓病人, 隨機(jī)分為兩組: 對(duì)照組: 繼續(xù)使用原劑量的坎地沙坦; 奧美沙坦組: 將坎地沙坦改

17、為奧美沙坦. 隨訪1年觀察血漿AngII水平和左室肥厚的變化. 結(jié)果顯示: 對(duì)照組血壓,左室肥厚和血漿AngII水平?jīng)]有明顯變化; 而奧美沙坦組雖然血壓沒(méi)有明顯變化, 但是無(wú)論是血漿AngII水平還是左室肥厚程度較換藥前都有明顯降低.Tsudamoto et al. Hypertens Res 2010.Tsudamoto et al. Hypertens Res 2010血漿AngII濃度左室質(zhì)量指數(shù).正常正常 微量蛋白尿微量蛋白尿 蛋白尿蛋白尿 大量蛋白尿大量蛋白尿 終末期腎病終末期腎病.61.ACE-I is acceptable under the same condition of

18、dosage and administration prior to the treatment period .69.Summary of ROADMAP Post-hoc Analysispage 76.77.78.厄貝沙坦厄貝沙坦 37.5300 mg / HCTZ 6.25-25 mg (N=683)纈沙坦纈沙坦 80160 mg / HCTZ 12.5-25 mg (N=871)Olmesartan 1040 mg / HCTZ 12.5-25 mg (N=502)替米沙坦替米沙坦 4080 mg / HCTZ 12.5 mg (N=818) 4項(xiàng)獨(dú)立項(xiàng)獨(dú)立,雙盲的研究雙盲的研究, 每個(gè)研究都是以第每個(gè)研究都是以第8周時(shí)平均周時(shí)平均DBP相比基線值的變化作為主要觀察指相比基線值的變化作為主要觀察指標(biāo)標(biāo) 患者都接受了安慰劑患者都接受了安慰劑,ARB HCTZ 的治療的治療 在最后一次給藥后的在最后一次給藥后的24小時(shí)觀察血壓變化小時(shí)觀察血壓變化 DBP的平均基線的平均基線: 100104.4 mmHg SBP的平均基線的平均基線: 151156.6 mmHg安慰劑安慰劑8 周周24周安慰劑導(dǎo)入周安慰劑導(dǎo)入Ram. J Clin Hypertens 2004; 6: 569577安慰劑安慰劑安慰劑安慰劑