Depto de Farmacologia Clinica, Facultad de Medicina, Universidad de Costa Rica, San Pedro de Montes de Oca, Costa Rica.
Escuela de Enfermeria, Facultad de Medicina, University of Costa Rica, San Jose, Costa Rica.
Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD004349. doi: 10.1002/14651858.CD004349.pub3.
This is the first update of this review first published in 2009. When treating elevated blood pressure, doctors usually try to achieve a blood pressure target. That target is the blood pressure value below which the optimal clinical benefit is supposedly obtained. "The lower the better" approach that guided the treatment of elevated blood pressure for many years was challenged during the last decade due to lack of evidence from randomised trials supporting that strategy. For that reason, the standard blood pressure target in clinical practice during the last years has been less than 140/90 mm Hg for the general population of patients with elevated blood pressure. However, new trials published in recent years have reintroduced the idea of trying to achieve lower blood pressure targets. Therefore, it is important to know whether the benefits outweigh harms when attempting to achieve targets lower than the standard target.
The primary objective was to determine if lower blood pressure targets (any target less than or equal to 135/85 mm Hg) are associated with reduction in mortality and morbidity as compared with standard blood pressure targets (less than or equal to 140/ 90 mm Hg) for the treatment of patients with chronic arterial hypertension. The secondary objectives were: to determine if there is a change in mean achieved systolic blood pressure (SBP) and diastolic blood pressure (DBP associated with "lower targets" as compared with "standard targets" in patients with chronic arterial hypertension; and to determine if there is a change in withdrawals due to adverse events with "lower targets" as compared with "standard targets", in patients with elevated blood pressure.
The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to May 2019: the Cochrane Hypertension Specialised Register, CENTRAL (2019, Issue 4), Ovid MEDLINE, Ovid Embase, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions.
Randomised controlled trials (RCTs) comparing patients allocated to lower or to standard blood pressure targets (see above).
Two review authors (JAA, VL) independently assessed the included trials and extracted data. Primary outcomes were total mortality; total serious adverse events; myocardial infarction, stroke, congestive heart failure, end stage renal disease, and other serious adverse events. Secondary outcomes were achieved mean SBP and DBP, withdrawals due to adverse effects, and mean number of antihypertensive drugs used. We assessed the risk of bias of each trial using the Cochrane risk of bias tool and the certainty of the evidence using the GRADE approach. MAIN RESULTS: This update includes 11 RCTs involving 38,688 participants with a mean follow-up of 3.7 years. This represents 7 new RCTs compared with the original version. At baseline the mean weighted age was 63.1 years and the mean weighted blood pressure was 155/91 mm Hg. Lower targets do not reduce total mortality (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.86 to 1.05; 11 trials, 38,688 participants; high-certainty evidence) and do not reduce total serious adverse events (RR 1.04, 95% CI 0.99 to 1.08; 6 trials, 18,165 participants; moderate-certainty evidence). This means that the benefits of lower targets do not outweigh the harms as compared to standard blood pressure targets. Lower targets may reduce myocardial infarction (RR 0.84, 95% CI 0.73 to 0.96; 6 trials, 18,938 participants, absolute risk reduction (ARR) 0.4%, number needed to treat to benefit (NNTB) 250 over 3.7 years) and congestive heart failure (RR 0.75, 95% CI 0.60 to 0.92; 5 trials, 15,859 participants, ARR 0.6%, NNTB 167 over 3.7 years) (low-certainty for both outcomes). Reduction in myocardial infarction and congestive heart failure was not reflected in total serious adverse events. This may be due to an increase in other serious adverse events (RR 1.44, 95% CI 1.32 to 1.59; 6 trials. 18,938 participants, absolute risk increase (ARI) 3%, number needed to treat to harm (NNTH) 33 over four years) (low-certainty evidence). Participants assigned to a "lower" target received one additional antihypertensive medication and achieved a significantly lower mean SBP (122.8 mm Hg versus 135.0 mm Hg, and a lower mean DBP (82.0 mm Hg versus 85.2 mm Hg, than those assigned to "standard target".
AUTHORS' CONCLUSIONS: For the general population of persons with elevated blood pressure, the benefits of trying to achieve a lower blood pressure target rather than a standard target (≤ 140/90 mm Hg) do not outweigh the harms associated with that intervention. Further research is needed to see if some groups of patients would benefit or be harmed by lower targets. The results of this review are primarily applicable to older people with moderate to high cardiovascular risk. They may not be applicable to other populations.
这是首次对 2009 年发表的这篇综述进行更新。在治疗高血压时,医生通常会尝试达到血压目标。该目标是指预计获得最佳临床益处的血压值。多年来,“越低越好”的方法指导了高血压的治疗,但由于缺乏随机试验的证据支持该策略,因此在过去十年中受到了挑战。出于这个原因,在过去几年的临床实践中,一般高血压患者的标准血压目标一直低于 140/90mmHg。然而,近年来发表的新试验重新提出了尝试达到更低血压目标的想法。因此,当试图达到低于标准目标的目标时,确定获益是否超过危害非常重要。
主要目的是确定对于慢性动脉高血压患者,与标准血压目标(≤140/90mmHg)相比,更低的血压目标(任何目标值≤135/85mmHg)是否与死亡率和发病率的降低相关。次要目标是:确定与“标准目标”相比,“较低目标”与慢性动脉高血压患者的平均收缩压(SBP)和舒张压(DBP)的变化相关;并确定与“标准目标”相比,“较低目标”时因不良反应而退出的人数是否发生变化。
Cochrane 高血压信息专家检索了截至 2019 年 5 月的随机对照试验数据库:Cochrane 高血压特藏、CENTRAL(2019 年第 4 期)、Ovid MEDLINE、Ovid Embase、世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov。我们还联系了相关论文的作者,以获取进一步发表和未发表的工作。检索没有语言限制。
比较患者分配到较低或标准血压目标的随机对照试验(见上文)。
两名综述作者(JAA、VL)独立评估了纳入的试验并提取了数据。主要结局是总死亡率;总严重不良事件;心肌梗死、卒中和充血性心力衰竭、终末期肾病和其他严重不良事件。次要结局是实现的平均 SBP 和 DBP、因不良反应而退出的人数以及使用的平均降压药物数量。我们使用 Cochrane 偏倚风险工具评估了每个试验的风险偏倚,并使用 GRADE 方法评估了证据的确定性。
本更新包括 11 项 RCT,涉及 38688 名参与者,平均随访 3.7 年。与原始版本相比,这代表了 7 项新的 RCT。在基线时,平均加权年龄为 63.1 岁,平均加权血压为 155/91mmHg。较低的目标并不能降低总死亡率(风险比(RR)0.95,95%置信区间(CI)0.86 至 1.05;11 项试验,38688 名参与者;高确定性证据),也不能降低总严重不良事件(RR 1.04,95%CI 0.99 至 1.08;6 项试验,18165 名参与者;中等确定性证据)。这意味着与标准血压目标相比,较低目标的获益并不超过危害。较低的目标可能会降低心肌梗死(RR 0.84,95%CI 0.73 至 0.96;6 项试验,18938 名参与者,绝对风险降低(ARR)0.4%,需要治疗的人数(NNTB)为 37 年)和充血性心力衰竭(RR 0.75,95%CI 0.60 至 0.92;5 项试验,15859 名参与者,ARR 0.6%,NNTB 为 37 年)(这两个结局的低确定性)。心肌梗死和充血性心力衰竭的减少并未反映在总严重不良事件中。这可能是由于其他严重不良事件的增加(RR 1.44,95%CI 1.32 至 1.59;6 项试验,18938 名参与者,绝对风险增加(ARI)3%,需要治疗的人数(NNTH)为 37 年)(低确定性证据)。被分配到“较低”目标的参与者接受了一种额外的降压药物,并且实现了明显更低的平均 SBP(122.8mmHg 与 135.0mmHg 相比,平均 DBP 也更低(82.0mmHg 与 85.2mmHg 相比),与分配到“标准目标”的参与者相比。
对于一般高血压患者人群,尝试达到较低血压目标而不是标准目标(≤140/90mmHg)并不能带来获益,反而会增加危害。需要进一步研究以确定某些患者群体是否会因较低的目标而受益或受到伤害。本综述的结果主要适用于中老年人,他们具有较高的心血管风险。它们可能不适用于其他人群。