Unit of Innovation and Organization, Navarre Health Service, Pamplona, Spain.
Navarre Institute for Health Research (IdiSNA), Pamplona, Spain.
Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
This is the third update of the review first published in 2017. Hypertension is a prominent preventable cause of premature morbidity and mortality. People with hypertension and established cardiovascular disease are at particularly high risk, so reducing blood pressure to below standard targets may be beneficial. This strategy could reduce cardiovascular mortality and morbidity but could also increase adverse events. The optimal blood pressure target in people with hypertension and established cardiovascular disease remains unknown.
To determine if lower blood pressure targets (systolic/diastolic 135/85 mmHg or less) are associated with reduction in mortality and morbidity compared with standard blood pressure targets (140 mmHg to 160mmHg/90 mmHg to 100 mmHg or less) in the treatment of people with hypertension and a history of cardiovascular disease (myocardial infarction, angina, stroke, peripheral vascular occlusive disease).
For this updated review, we used standard, extensive Cochrane search methods. The latest search date was January 2022. We applied no language restrictions.
We included randomized controlled trials (RCTs) with more than 50 participants per group that provided at least six months' follow-up. Trial reports had to present data for at least one primary outcome (total mortality, serious adverse events, total cardiovascular events, cardiovascular mortality). Eligible interventions involved lower targets for systolic/diastolic blood pressure (135/85 mmHg or less) compared with standard targets for blood pressure (140 mmHg to 160 mmHg/90 mmHg to 100 mmHg or less). Participants were adults with documented hypertension and adults receiving treatment for hypertension with a cardiovascular history for myocardial infarction, stroke, chronic peripheral vascular occlusive disease, or angina pectoris.
We used standard Cochrane methods. We used GRADE to assess the certainty of the evidence.
We included seven RCTs that involved 9595 participants. Mean follow-up was 3.7 years (range 1.0 to 4.7 years). Six of seven RCTs provided individual participant data. None of the included studies was blinded to participants or clinicians because of the need to titrate antihypertensive drugs to reach a specific blood pressure goal. However, an independent committee blinded to group allocation assessed clinical events in all trials. Hence, we assessed all trials at high risk of performance bias and low risk of detection bias. We also considered other issues, such as early termination of studies and subgroups of participants not predefined, to downgrade the certainty of the evidence. We found there is probably little to no difference in total mortality (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.91 to 1.23; 7 studies, 9595 participants; moderate-certainty evidence) or cardiovascular mortality (RR 1.03, 95% CI 0.82 to 1.29; 6 studies, 9484 participants; moderate-certainty evidence). Similarly, we found there may be little to no differences in serious adverse events (RR 1.01, 95% CI 0.94 to 1.08; 7 studies, 9595 participants; low-certainty evidence) or total cardiovascular events (including myocardial infarction, stroke, sudden death, hospitalization, or death from congestive heart failure (CHF)) (RR 0.89, 95% CI 0.80 to 1.00; 7 studies, 9595 participants; low-certainty evidence). The evidence was very uncertain about withdrawals due to adverse effects. However, studies suggest more participants may withdraw due to adverse effects in the lower target group (RR 8.16, 95% CI 2.06 to 32.28; 3 studies, 801 participants; very low-certainty evidence). Systolic and diastolic blood pressure readings were lower in the lower target group (systolic: mean difference (MD) -8.77 mmHg, 95% CI -12.82 to -4.73; 7 studies, 8657 participants; diastolic: MD -4.50 mmHg, 95% CI -6.35 to -2.65; 6 studies, 8546 participants). More drugs were needed in the lower target group (MD 0.56, 95% CI 0.16 to 0.96; 5 studies, 7910 participants), but blood pressure targets at one year were achieved more frequently in the standard target group (RR 1.20, 95% CI 1.17 to 1.23; 7 studies, 8699 participants).
AUTHORS' CONCLUSIONS: We found there is probably little to no difference in total mortality and cardiovascular mortality between people with hypertension and cardiovascular disease treated to a lower compared to a standard blood pressure target. There may also be little to no difference in serious adverse events or total cardiovascular events. This suggests that no net health benefit is derived from a lower systolic blood pressure target. We found very limited evidence on withdrawals due to adverse effects, which led to high uncertainty. At present, evidence is insufficient to justify lower blood pressure targets (135/85 mmHg or less) in people with hypertension and established cardiovascular disease. Several trials are still ongoing, which may provide an important input to this topic in the near future.
这是 2017 年首次发表的综述的第三次更新。高血压是导致过早发病和死亡的一个突出的可预防病因。患有高血压和已发生心血管疾病的人群风险尤其高,因此将血压降低至低于标准目标可能是有益的。这一策略可能降低心血管死亡率和发病率,但也可能增加不良事件。患有高血压和已发生心血管疾病的人群的最佳血压目标仍不清楚。
确定在治疗患有高血压和心血管疾病病史(心肌梗死、心绞痛、中风、外周血管闭塞性疾病)的人群中,与标准血压目标(140mmHg 至 160mmHg/90mmHg 至 100mmHg 或更低)相比,较低的血压目标(收缩压/舒张压 135/85mmHg 或更低)是否与死亡率和发病率降低相关。
对于本次更新的综述,我们使用了标准的、广泛的 Cochrane 检索方法。最新的检索日期是 2022 年 1 月。我们没有对语言进行限制。
我们纳入了每组超过 50 名参与者的随机对照试验(RCT),并提供了至少 6 个月的随访。试验报告必须提供至少一个主要结局(总死亡率、严重不良事件、总心血管事件、心血管死亡率)的数据。纳入的干预措施涉及与标准血压目标(140mmHg 至 160mmHg/90mmHg 至 100mmHg 或更低)相比,收缩压/舒张压的目标值更低(135/85mmHg 或更低)。参与者为有记录的高血压成人和正在接受高血压治疗的成人,且有心肌梗死、中风、慢性外周血管闭塞性疾病或心绞痛的心血管疾病史。
我们使用了标准的 Cochrane 方法。我们使用 GRADE 评估证据的确定性。
我们纳入了 7 项 RCT,涉及 9595 名参与者。平均随访时间为 3.7 年(范围 1.0 至 4.7 年)。7 项 RCT 中的 6 项提供了个体参与者数据。由于需要将降压药物滴定至特定的血压目标,因此没有一项研究对参与者或临床医生进行盲法处理。然而,所有试验都由一个独立的委员会对组间分配进行盲法评估,以评估临床事件。因此,我们评估了所有试验的高偏倚风险和低检测偏倚风险。我们还考虑了其他问题,例如研究提前终止和未预定义的亚组参与者,以降低证据的确定性。我们发现,在总死亡率(RR 1.05,95%置信区间(CI)0.91 至 1.23;7 项研究,9595 名参与者;中等确定性证据)或心血管死亡率(RR 1.03,95% CI 0.82 至 1.29;6 项研究,9484 名参与者;中等确定性证据)方面,差异可能很小或没有差异。同样,我们发现,在严重不良事件(RR 1.01,95% CI 0.94 至 1.08;7 项研究,9595 名参与者;低确定性证据)或总心血管事件(包括心肌梗死、中风、猝死、住院或充血性心力衰竭(CHF)导致的死亡)(RR 0.89,95% CI 0.80 至 1.00;7 项研究,9595 名参与者;低确定性证据)方面,差异也可能很小或没有。关于因不良事件而退出的证据非常不确定。然而,研究表明,较低目标组中可能有更多的参与者因不良事件而退出(RR 8.16,95% CI 2.06 至 32.28;3 项研究,801 名参与者;非常低确定性证据)。较低目标组的收缩压和舒张压读数较低(收缩压:MD-8.77mmHg,95% CI-12.82 至-4.73;7 项研究,8657 名参与者;舒张压:MD-4.50mmHg,95% CI-6.35 至-2.65;6 项研究,8546 名参与者)。较低目标组需要更多的药物(MD 0.56,95% CI 0.16 至 0.96;5 项研究,7910 名参与者),但标准目标组在一年内达到血压目标的频率更高(RR 1.20,95% CI 1.17 至 1.23;7 项研究,8699 名参与者)。
我们发现,与标准血压目标相比,患有高血压和心血管疾病的人群将血压降至较低水平与总死亡率和心血管死亡率降低之间可能差异很小或没有差异。严重不良事件或总心血管事件也可能差异很小或没有差异。这表明,收缩压目标降低(135/85mmHg 或更低)不会带来净健康获益。我们发现关于因不良事件而退出的证据非常有限,这导致了高度的不确定性。目前,证据不足以支持将血压目标降低(135/85mmHg 或更低)应用于患有高血压和已发生心血管疾病的人群。目前仍有几项试验正在进行中,这可能在不久的将来为该主题提供重要的研究结果。