高血压的治疗：新的循环医学证据

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1、高血压治疗新的循证医学证据华中科技大学协和医院心内科廖玉华高血压治疗：新的循证医学证据1.ADVANCE研究 固定复方制剂2.VALIDD研究 降压与心室舒张功能3.A meta-analysis of RCTs4.中国人高血压临床试验证据ADVANCE研究研究:在在11,140例例2型糖尿病患者中进行的降压型糖尿病患者中进行的降压与强化血糖控制的析因随机临床试验与强化血糖控制的析因随机临床试验培哚普利吲达帕胺固定复方制剂（百普乐）培哚普利吲达帕胺固定复方制剂（百普乐）对重要血管事件的影响对重要血管事件的影响Inclusion criteria Type 2 diabetes mellitus

2、Age 55 years or olderAdditional risk of vascular event Age 65 years History of major macrovascular disease History of major microvascular disease First diagnosis of diabetes 10 years prior to entry Other major risk factor Hypertensive or normotensiveRandomised study treatmentsBlood pressure lowering

3、 Double-blind perindopril-indapamide versus matching placebo 2.0/0.625mg or placebo for first 3 months 4.0/1.25mg or placebo thereafter Blood glucose lowering(ongoing)Open-label gliclazide MR-based intensive therapy targeting an HbA1c of 6.5%versus usual guideline-based careAmong patients with diabe

4、tes,does blood pressure lowering therapy:n Produce additional benefits when systolic pressure is lowered below 145 mmHg?n Produce similar benefits for hypertensive and non-hypertensive patients?n Add to the benefits produced by other cardiovascular preventive therapies including ACE inhibitors?ADVAN

5、CE study hypothesesPerindopril-indapamide armADVANCETrial profile12877 with type 2 diabetes registered 11140 randomised5569 assigned perindopril-indapamide combination 1737 withdrew during run-inScheduled end of follow-up:4.3 years 4908(88%)assessed at final visit 4081(73%)adherent to treatment4 los

6、t to follow-up11 lost to follow-upScheduled end of follow-up:4.3 years 4863(87%)assessed at final visit 4143(74%)adherent to treatment5571 assigned matching placebo 血压降低情况血压降低情况 2.2 mmHg(95%CI 2.0-2.4);p0.001 5.6 mmHg(95%CI 5.2-6.0);p0.001DiastolicSystolic安慰剂组安慰剂组培哚普利培哚普利/吲达帕胺组吲达帕胺组Mean Blood Pressu

7、re(mmHg)65758595105115125135145155165Follow-up(Months)R6121824303642485460140.3 mmHg134.7 mmHgAverage BP during follow-up77.0 mmHg74.8 mmHg全因死亡率全因死亡率Follow-up(months)01006121824303642485460 安慰剂组安慰剂组 培哚普利培哚普利/吲达帕胺组吲达帕胺组 Cumulative incidence(%)Relative risk reduction 14%:95%CI 2-25%p=0.0255死亡分析死亡分析心血管

8、死亡心血管死亡Follow-up(months)612 182430 36424854 60安慰剂组培哚普利/吲达帕胺组非心血管死亡非心血管死亡Follow-up(months)612 182430 36424854 60安慰剂组培哚普利/吲达帕胺组相对危险降低相对危险降低 18%;p=0.027相对危险降低相对危险降低 8%;p=0.415%5%Cumulative incidence(%)Coronary events*2P=0.02Non-fatal MI or death from coronary heart diseaseUnstable angina requiring hosp

9、italisation,coronary revascularisation or silent MIMajor coronary heart disease265294 11%(-6 to 24)All coronary heart disease468535 14%(2 to 24)Other coronary heart disease283324 14%(-1 to 27)*Number of eventsPer-IndPlacebo(n=5,569)(n=5,571)Relative riskreduction(95%CI)FavoursPer-IndFavoursPlaceboHa

10、zard ratio0.51.02.0Cerebrovascular eventsMajor cerebrovascular disease215218 2%(-18 to 19)All cerebrovascular disease286303 6%(-10 to 20)Other cerebrovascular disease7999 21%(-6 to 41)2.0*2P=0.40Non-fatal stroke or death from cerebrovascular diseaseTransient ischaemic attack or subarachnoid haemorrh

11、ageNumber of eventsPer-IndPlacebo(n=5,569)(n=5,571)Relative riskreduction(95%CI)FavoursPer-IndFavoursPlaceboHazard ratio0.51.0Renal events2.0Hazard ratio0.51.0New or worsening nephropathy 181216 18%(-1 to 32)New microalbuminuria10941317 21%(14 to 27)Total renal events12431500 21%(15 to 27)*2P=总死亡率降低

12、总死亡率降低14%14%心血管死亡降低心血管死亡降低18%18%主要血管事件降低主要血管事件降低9%9%总冠脉事件降低总冠脉事件降低14%14%总肾脏事件降低总肾脏事件降低21%21%这些获益在所有主要亚组都相似。治疗的耐受性非常这些获益在所有主要亚组都相似。治疗的耐受性非常好，副作用很少，遵从治疗的情况与安慰剂组相似。好，副作用很少，遵从治疗的情况与安慰剂组相似。Among patients with diabetes,does blood pressure lowering therapy:n Produce additional benefits when systolic pressu

13、re is lowered below 145 mmHg?n Produce similar benefits for hypertensive and non-hypertensive patients?n Add to the benefits produced by other cardiovascular preventive therapies including ACE inhibitors?Blood pressure lowering in diabetes:Unresolved issues 2000YESYESYESVALIDD研究The Influence of Angi

14、otensin Receptor Blockers and Blood Pressure Lowering on Diastolic Function in Patients with Hypertension and Diastolic Dysfunction:The sartan n iastolic ysfunction 血管紧张素受体拮抗剂(ARB)对高血压和舒张功能不全患者的作用 Solomon S.American College of Cardiology 2007 Scientific Sessions,March 25,2007.研究目的目的:验证下列假说是否正确“ARB较其

15、他非阻断RAAS系统的降压药物更有效改善左室舒张功能”？Solomon S.American College of Cardiology 2007 Scientific Sessions,March 25,2007.研究设计482例初选患者年龄大于45岁、1、2级高血压、无心功能不全病史组织多普勒检查，评价心肌舒张速度，确定舒张功能不全的存在 384例舒张功能不全的患者缬沙坦组(n=186)320mg/d非RAAS拮抗剂降压治疗(n=198)钙拮抗剂、利尿剂、阻滞剂随机分组观察终点38周前后的舒张速度、等容舒张时间（S)、加速时间、E/A、E/E左室容积质量、射血分数随访38周Solomon

16、S.American College of Cardiology 2007 Scientific Sessions,March 25,2007.ARB vs.非RAAS阻断剂组:降压幅度相当o38周后,两组的血压较基线相比降低幅度没有显著差异收缩压较基线的改变(mmHg)缬沙坦组(n=186)非RAAS阻断剂组(n=198)Solomon S.American College of Cardiology 2007 Scientific Sessions,March 25,2007.ARB vs.非RAAS阻断剂组:改善舒张功能疗效相当o38周后,ARB和非RAAS阻断类降压药物均显著改善舒张功能，疗效相当时间/治疗前后的变化心肌舒张速度(cm/s)缬沙坦(n=186)非RAAS阻断剂组(n=198)基线7.57.5治疗38周后8.1*8.0*心肌舒张速度提高心肌舒张速度提高0.66*0.44*每组治疗前后比较P140mmHg相比，SBP降至140mmHg的保护作用更明显，这个发现支持当收缩压为140mmHg时即考虑开始抗高血压治疗的建议2007 ESH-ESC 高血压指南