治疗高龄老年高血压患者的早期及晚期获益：来自高龄老年高血压随机对照试验延长期活性药物治疗的结果

Immediate and late benefits of treating very elderly people with hypertension： results from active treatment extension to Hypertension in the Very Elderly randomised controlled trial

目的评估高龄老年高血压患者能否从降压治疗中早期获益。研究设计高龄老年高血压试验（HYVET）延长期开放标签活性药物治疗1年。研究地点主要位于东欧、西欧、中国及突尼斯的医院及全科医学中心。研究对象HYVET试验结束时仍接受双盲治疗的患者进入延长期试验。方法既往服用活性降压药物的患者继续服药，而服用安慰剂的患者也给予活性降压药物治疗。药物方案同试验相仿，即吲达帕胺缓释片1．5mg（需要时可以联用培哚普利2～4mg），血压控制的靶目标仍为〈150／80mmHg。主要评价指标主要终点是各种原因造成的卒中；其他终点包括总死亡、心血管死亡及心血管事件。结果共计1882名患者适宜进入延长期研究，1721（91％）同意参加。在延长期观察中共计1682个病人年。6个月时，组间血压差异为1．2／0．7mmHg。比较既往接受活性药物治疗的患者与接受安慰剂治疗的患者，未发现卒中（13例；风险比HR1．92，95％可信区间0．59—6．22）及心血管事件（25例；HR0．78，95％可信区间0．36～1．72）在两组人群中有差异。总死亡（47例；HR0．48，95％可信区间0．26～0．87；P=0．02）及心血管死亡（11例；HR0．19，95％可信区间O．04～0．87；P=0．03）两组差异显著。结论高龄老年高血压患者可以从降压治疗中尽早获益。总死亡及心血管死亡的持续降低进一步使获益增加，提示有必要尽早并且长期治疗。

Objective To assess if very elderly people with hypertension obtain early benefit from antihypertensive treatment. Design One year open label active treatment extension of randomised controlled trial （ Hypertension in the Very Elderly Trial （HYVET） ） Setting Hospital and general practice based centres mainly in eastern and western Europe, China, and Tunisia. Participants People on double blind treatment at the end of HYVET were eligible to enter the extension. Interventions Participants on active blood pressure lowering treatment continued taking active drug; those on placebo were given active blood pressure lowering treatment. The treatment regimen was as used in the main trial-indapamide SR 1.5 mg （plus perindopril 2-4 mg if required）-with the same target blood pressure of less than 150/80 mm Hg. Main outcome measures The primary outcome was all stroke; other outcomes included total mortality, cardiovascular mortality, and cardiovascular events. Results Of 1882 people eligible for entry to the extension, 1712 （91%） agreed to participate. During the extension period, 1682 patient years were accrued. By six months, the difference in blood pressure between the two groups was 1.2/0. 7 mm Hg. Comparing people previously treated with active drug and those previously on placebo, no significant differences were seen for stroke （n = 13; hazard ratio 1.92, 95% confidence interval 0. 59 to 6. 22） or cardiovascular events （ n = 25; 0. 78, 0. 36 to 1.72）. Differences were seen for total mortality （47 deaths ; hazard ratio 0. 48, 0. 26 to 0. 87 ; P = 0. 02） and cardiovascular mortality （11 deaths; 0. 19, 0.04 to 0. 87; P =0.03）. Conclusion Very elderly patients with hypertension may gain immediate benefit from treatment. Sustained differences in reductions of total mortality and cardiovascular mortality reinforce the benefits and support the need for early and long term treatment. Trial registration Clinical trials NCT00122811 BMJ 2012 ;344 ： d7541