Department of Medicine, Imperial College London, London SW7 2AZ, UK.
BMJ. 2011 Jan 4;344:d7541. doi: 10.1136/bmj.d7541.
To assess if very elderly people with hypertension obtain early benefit from antihypertensive treatment.
One year open label active treatment extension of randomised controlled trial (Hypertension in the Very Elderly Trial (HYVET)).
Hospital and general practice based centres mainly in eastern and western Europe, China, and Tunisia.
People on double blind treatment at the end of HYVET were eligible to enter the extension.
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.
The primary outcome was all stroke; other outcomes included total mortality, cardiovascular mortality, and cardiovascular events.
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).
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.
评估非常高龄的高血压患者是否能从降压治疗中早期获益。
在一项随机对照试验(HYVET)中进行了为期 1 年的开放性标签活性治疗扩展。
主要在东欧、西欧、中国和突尼斯的医院和基层医疗中心进行。
HYVET 结束时接受双盲治疗的患者有资格进入扩展阶段。
接受活性降压治疗的患者继续服用活性药物;接受安慰剂的患者接受活性降压治疗。治疗方案与主要试验中使用的相同-吲达帕胺 SR 1.5 毫克(如有需要,加用培哚普利 2-4 毫克)-目标血压低于 150/80 毫米汞柱。
主要结局为所有卒中;其他结局包括总死亡率、心血管死亡率和心血管事件。
在 1882 名符合进入扩展阶段条件的患者中,有 1712 名(91%)同意参与。在扩展期间,共获得 1682 患者年。在 6 个月时,两组之间的血压差异为 1.2/0.7 毫米汞柱。比较先前接受活性药物治疗和安慰剂治疗的患者,卒中(n=13;危险比 1.92,95%置信区间 0.59 至 6.22)或心血管事件(n=25;0.78,0.36 至 1.72)无显著差异。总死亡率(47 例死亡;危险比 0.48,0.26 至 0.87;P=0.02)和心血管死亡率(11 例死亡;0.19,0.04 至 0.87;P=0.03)存在差异。
非常高龄的高血压患者可能会从治疗中立即获益。总死亡率和心血管死亡率持续降低的差异强化了获益,并支持早期和长期治疗的必要性。
临床试验 NCT00122811。