Sung Jidong, Jeong Jin-Ok, Kwon Sung Uk, Won Kyung Heon, Kim Byung Jin, Cho Byung Ryul, Kim Myeong-Kon, Lee Sahng, Kim Hak Jin, Lim Seong-Hoon, Park Seung Woo, Park Jeong Euy
Division of Cardiology, Department of Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea.
Korean Circ J. 2016 Mar;46(2):222-8. doi: 10.4070/kcj.2016.46.2.222. Epub 2016 Mar 21.
When monotherapy is inadequate for blood pressure control, the next step is either to continue monotherapy in increased doses or to add another antihypertensive agent. However, direct comparison of double-dose monotherapy versus combination therapy has rarely been done. The objective of this study is to compare 10 mg of amlodipine with an amlodipine/valsartan 5/160 mg combination in patients whose blood pressure control is inadequate with amlodipine 5 mg.
This study was conducted as a multicenter, open-label, randomized controlled trial. Men and women aged 20-80 who were diagnosed as having hypertension, who had been on amlodipine 5 mg monotherapy for at least 4 weeks, and whose daytime mean systolic blood pressure (SBP) ≥135 mmHg or diastolic blood pressure (DBP) ≥85 mmHg on 24-hour ambulatory blood pressure monitoring (ABPM) were randomized to amlodipine (A) 10 mg or amlodipine/valsartan (AV) 5/160 mg group. Follow-up 24-hour ABPM was done at 8 weeks after randomization.
Baseline clinical characteristics did not differ between the 2 groups. Ambulatory blood pressure reduction was significantly greater in the AV group compared with the A group (daytime mean SBP change: -14±11 vs. -9±9 mmHg, p<0.001, 24-hour mean SBP change: -13±10 vs. -8±8 mmHg, p<0.0001). Drug-related adverse events also did not differ significantly (A:AV, 6.5 vs. 4.5 %, p=0.56).
Amlodipine/valsartan 5/160 mg combination was more efficacious than amlodipine 10 mg in hypertensive patients in whom monotherapy of amlodipine 5 mg had failed.
当单一疗法不足以控制血压时，下一步措施要么是增加剂量继续单一疗法，要么添加另一种抗高血压药物。然而，很少有人对双倍剂量单一疗法与联合疗法进行直接比较。本研究的目的是在血压控制不佳的患者中，比较10毫克氨氯地平与氨氯地平/缬沙坦5/160毫克联合用药的效果，这些患者之前使用5毫克氨氯地平控制血压效果不佳。
本研究为多中心、开放标签、随机对照试验。年龄在20 - 80岁之间，被诊断为高血压，接受5毫克氨氯地平单一疗法至少4周，且在24小时动态血压监测（ABPM）中白天平均收缩压（SBP）≥135毫米汞柱或舒张压（DBP）≥85毫米汞柱的男性和女性，被随机分为氨氯地平（A）10毫克组或氨氯地平/缬沙坦（AV）5/160毫克组。随机分组后8周进行24小时动态血压监测随访。
两组的基线临床特征无差异。与A组相比，AV组的动态血压降低幅度显著更大（白天平均SBP变化：-14±11对-9±9毫米汞柱，p<0.001；24小时平均SBP变化：-13±10对-8±8毫米汞柱，p<0.0001）。药物相关不良事件也无显著差异（A组：AV组，6.5%对4.5%，p = 0.56）。
在5毫克氨氯地平单一疗法失败的高血压患者中，氨氯地平/缬沙坦5/160毫克联合用药比10毫克氨氯地平更有效。
