傲坦研究汇总产品知识--奥美沙坦(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.安慰剂安慰剂氯沙坦氯沙坦 50 mg厄贝沙坦厄贝沙坦 150 mg OLM 20 mg缬沙坦缬沙坦 80 mg入选标准入选标准: 袖带坐位袖带坐位.*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.入选标准入选标准: 袖带袖带SeDBP: 100-115 mm Hg ABPM: 日间日间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 缬沙坦缬沙坦 厄贝沙坦厄贝沙坦 坎地沙坦坎地沙坦 替米沙坦替米沙坦依普罗沙坦依普罗沙坦傲坦傲坦氯沙坦氯沙坦 安慰剂安慰剂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缬沙坦缬沙坦厄贝沙坦厄贝沙坦坎地沙坦坎地沙坦替米沙坦替米沙坦依普罗沙坦依普罗沙坦傲坦傲坦氯沙坦氯沙坦安慰剂安慰剂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周时，如果降压无效，则剂量加倍周时，如果降压无效，则剂量加倍Ball et al. J Hypertens 2001; 19 (Suppl 1): S49S56Stumpe & Ludwig. J Hum Hypertens 2002; 16 (Suppl 2): S24S28安慰剂安慰剂3周周评价评价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.* 氢氯噻嗪, 氨氯地平, 肼苯达嗪VIOSVIOS研究设计研究设计洗脱期筛选20 mg40 mg50 mg100 mg奥美沙坦酯奥美

11、沙坦酯维持治疗增加其他抗高血压药物*阿替洛尔阿替洛尔- 40241252随机并剂量滴定周周活检活检N=55N=10028活检活检N=49Ronald D. Smith. Journal of the American Society of Hypertension 2(3) (2008) 165172.42VIOSVIOS研究设计研究设计.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周周阿替洛尔阿替洛尔奥美沙坦奥美沙坦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奥美沙坦逆转动脉粥样硬化多中心研究奥美沙坦逆转动脉粥样硬化多中心研究Stumpe KO, et al. Ther Adv Cardiovasc Dis 2007;1(2):97106.47MOREMORE研

13、究设计研究设计.Klaus O. Stumpe,Therapeutic Advances in Cardiovascular Disease 2007; 1; 97.根据需要加用根据需要加用HCTZ 25 mg血压超声血压超声安慰剂导入阶安慰剂导入阶段段2 04828104剂量递增阶段剂量递增阶段周周521216血压超声血压超声血压超声血压超声血压超声血压超声评估阶段评估阶段根据需要剂量倍增根据需要剂量倍增根据需要剂量倍增根据需要剂量倍增奥美沙坦奥美沙坦 20 mg阿替洛尔阿替洛尔50 mg12.5 mg根据需要加用根据需要加用HCTZ 25 mg12.5 mg安慰剂安慰剂HCTZ = 双氢克

14、脲塞双氢克脲塞Klaus O. Stumpe,Therapeutic Advances in Cardiovascular Disease 2007; 1; 97.阿替洛尔阿替洛尔奥美沙坦奥美沙坦21.5 mmHg24.6 mmHg*13.8 mmHg15.2 mmHg*p=0.120 vs atenolol; *p=0.075 vs atenolol 与基线比较的变化与基线比较的变化02852104708090100130140150160收缩压收缩压舒张压舒张压周周血压血压 (mmHg)157.195.996.3157.6Klaus O. Stumpe,Therapeutic Advanc

15、es in Cardiovascular Disease 2007; 1; 97. *p0.0001 与基线比较Klaus O. Stumpe,Therapeutic Advances in Cardiovascular Disease 2007; 1; 97.*p=0.044 vs 基线, 0.083 vs 阿替洛尔*p=0.036 vs基线, 0.032 vs阿替洛尔*p=0.014 vs基线, 0.023 vs阿替洛尔1216404 802852104阿替洛尔阿替洛尔奥美沙坦奥美沙坦研究周数研究周数PVPV的变化的变化 ( (LL) )*PV:斑块体积Klaus O. Stumpe,Th

16、erapeutic Advances in Cardiovascular Disease 2007; 1; 97. 傲坦逆转左室肥厚研究傲坦逆转左室肥厚研究Takayoshi Tsutamoto, et al. Hypertension Research (2010) 33, 118122.55研究设计研究设计.奥美沙坦和坎地沙坦对高血压病人血浆奥美沙坦和坎地沙坦对高血压病人血浆AngIIAngII水平和左室肥厚的长期作用比较水平和左室肥厚的长期作用比较: :试验入选了50例门诊使用坎地沙坦超过1年的高血压病人, 随机分为两组: 对照组: 继续使用原剂量的坎地沙坦; 奥美沙坦组: 将坎地沙坦改

17、为奥美沙坦. 随访1年观察血浆AngII水平和左室肥厚的变化. 结果显示: 对照组血压,左室肥厚和血浆AngII水平没有明显变化; 而奥美沙坦组虽然血压没有明显变化, 但是无论是血浆AngII水平还是左室肥厚程度较换药前都有明显降低.Tsudamoto et al. Hypertens Res 2010.Tsudamoto et al. Hypertens Res 2010血浆AngII浓度左室质量指数.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 终末期肾病终末期肾病.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.厄贝沙坦厄贝沙坦 37.5300 mg / HCTZ 6.25-25 mg (N=683)缬沙坦缬沙坦 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项独立项独立,双盲的研究双盲的研究, 每个研究都是以第每个研究都是以第8周时平均周时平均DBP相比基线值的变化作为主要观察指相比基线值的变化作为主要观察指标标 患者都接受了安慰剂患者都接受了安慰剂,ARB HCTZ 的治疗的治疗 在最后一次给药后的在最后一次给药后的24小时观察血压变化小时观察血压变化 DBP的平均基线的平均基线: 100104.4 mmHg SBP的平均基线的平均基线: 151156.6 mmHg安慰剂安慰剂8 周周24周安慰剂导入周安慰剂导入Ram. J Clin Hypertens 2004; 6: 569577安慰剂安慰剂安慰剂安慰剂