Saiz Luis Carlos, Gorricho Javier, Garjón Javier, Celaya Mª Concepción, Muruzábal Lourdes, Malón Mª Del Mar, Montoya Rodolfo, López Antonio
Drug Prescribing Service, Navarre Health Service, Plaza de la Paz, s/n, 7th floor, Pamplona, Navarre, Spain, 31002.
Cochrane Database Syst Rev. 2017 Oct 11;10(10):CD010315. doi: 10.1002/14651858.CD010315.pub2.
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 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 (≤ 135/85 mmHg) are associated with reduction in mortality and morbidity as compared with 'standard' blood pressure targets (≤ 140 to 160/ 90 to 100 mmHg) in the treatment of people with hypertension and a history of cardiovascular disease (myocardial infarction, angina, stroke, peripheral vascular occlusive disease).
The Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials up to February 2017: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also searched the Latin American and Caribbean Health Science Literature Database (from 1982) and contacted authors of relevant papers regarding further published and unpublished work. There were no language restrictions.
We included randomized controlled trials (RCTs) with more than 50 participants per group and at least six months follow-up. Trial reports needed to present data for at least one primary outcome (total mortality, serious adverse events, total cardiovascular events, cardiovascular mortality). Eligible interventions were lower target for systolic/diastolic blood pressure (≤ 135/85 mmHg) compared with standard target for blood pressure (≤ 140 to 160/90 to 100 mmHg).Participants were adults with documented hypertension or who were receiving treatment for hypertension and cardiovascular history for myocardial infarction, stroke, chronic peripheral vascular occlusive disease or angina pectoris.
Two review authors independently assessed search results and extracted data using standard methodological procedures expected by The Cochrane Collaboration.
We included six RCTs that involved a total of 9795 participants. Mean follow-up was 3.7 years (range 1.0 to 4.7 years). Five RCTs provided individual patient data for 6775 participants.We found no change in total mortality (RR 1.05, 95% CI 0.90 to 1.22) or cardiovascular mortality (RR 0.96, 95% CI 0.77 to 1.21; moderate-quality evidence). Similarly, no differences were found in serious adverse events (RR 1.02, 95% CI 0.95 to 1.11; low-quality evidence). There was a reduction in fatal and non fatal cardiovascular events (including myocardial infarction, stroke, sudden death, hospitalization or death from congestive heart failure) with the lower target (RR 0.87, 95% CI 0.78 to 0.98; ARR 1.6% over 3.7 years; low-quality evidence). There were more participant withdrawals due to adverse effects in the lower target arm (RR 8.16, 95% CI 2.06 to 32.28; very low-quality evidence). Blood pressures were lower in the lower' target group by 9.5/4.9 mmHg. More drugs were needed in the lower target group but blood pressure targets were achieved more frequently in the standard target group.
AUTHORS' CONCLUSIONS: No evidence of a difference in total mortality and serious adverse events was found between treating to a lower or to a standard blood pressure target in people with hypertension and cardiovascular disease. This suggests no net health benefit from a lower systolic blood pressure target despite the small absolute reduction in total cardiovascular serious adverse events. There was very limited evidence on adverse events, which lead to high uncertainty. At present there is insufficient evidence to justify lower blood pressure targets (≤ 135/85 mmHg) in people with hypertension and established cardiovascular disease. More trials are needed to answer this question.
高血压是导致过早发病和死亡的一个主要可预防因素。患有高血压和已确诊心血管疾病的人群风险尤其高,因此将血压降至标准目标以下可能有益。这一策略可能会降低心血管疾病的死亡率和发病率,但也可能增加不良事件。高血压合并已确诊心血管疾病患者的最佳血压目标仍不明确。
确定在治疗患有高血压和心血管疾病史(心肌梗死、心绞痛、中风、外周血管闭塞性疾病)的患者时,与“标准”血压目标(收缩压≤140至160/舒张压≤90至100mmHg)相比,“更低”的血压目标(收缩压/舒张压≤135/85mmHg)是否与死亡率和发病率的降低相关。
Cochrane高血压信息专家检索了以下数据库以查找截至2017年2月的随机对照试验:Cochrane高血压专业注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE(1946年起)、Embase(1974年起)、世界卫生组织国际临床试验注册平台和ClinicalTrials.gov。我们还检索了拉丁美洲和加勒比健康科学文献数据库(1982年起),并联系了相关论文的作者以获取更多已发表和未发表的研究。没有语言限制。
我们纳入每组超过50名参与者且至少随访6个月的随机对照试验(RCT)。试验报告需要呈现至少一项主要结局的数据(总死亡率、严重不良事件、总心血管事件、心血管死亡率)。符合条件的干预措施是与血压标准目标(收缩压≤140至160/舒张压≤90至100mmHg)相比,收缩压/舒张压更低的目标(收缩压/舒张压≤135/85mmHg)。参与者为有高血压记录的成年人或正在接受高血压治疗且有心肌梗死、中风、慢性外周血管闭塞性疾病或心绞痛心血管病史的人。
两名综述作者独立评估检索结果,并使用Cochrane协作网预期的标准方法程序提取数据。
我们纳入了6项RCTs,共涉及9795名参与者。平均随访时间为3.7年(范围1.0至4.7年)。五项RCTs为6775名参与者提供了个体患者数据。我们发现总死亡率(风险比1.05,95%置信区间0.90至1.22)或心血管死亡率(风险比0.96,95%置信区间0.77至1.21;中等质量证据)没有变化。同样,在严重不良事件方面未发现差异(风险比1.02,95%置信区间0.95至1.11;低质量证据)。更低的目标血压可降低致命和非致命心血管事件(包括心肌梗死(MI)、中风、猝死、因充血性心力衰竭住院或死亡)的发生(风险比0.87,95%置信区间0.78至0.98;3.7年期间的绝对风险降低为1.6%;低质量证据)。更低目标血压组因不良反应退出的参与者更多(风险比8.16,95%置信区间2.06至32.28;极低质量证据)。“更低”目标组的血压低9.5/4.9mmHg。更低目标组需要更多药物,但标准目标组更频繁地达到血压目标。
在高血压合并心血管疾病患者中,将血压降至更低目标与标准目标相比,未发现总死亡率和严重不良事件存在差异。这表明尽管总心血管严重不良事件有小幅绝对降低,但更低的收缩压目标并无净健康益处。关于不良事件的证据非常有限,这导致了高度的不确定性。目前,没有足够的证据证明在高血压合并已确诊心血管疾病的患者中采用更低的血压目标(收缩压/舒张压≤135/85mmHg)是合理的。需要更多试验来回答这个问题。