Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Drug Des Devel Ther. 2020 Jan 23;14:347-360. doi: 10.2147/DDDT.S231293. eCollection 2020.
Head-to-head comparison of the blood pressure (BP) lowering effect of fimasartan versus valsartan, with olmesartan as a reference, on office blood pressure and ambulatory BP.
Of the 369 randomly assigned patients in this study, 365 hypertensive patients were referred as the full analysis set and divided into 3 groups with a 3:3:1 ratio (fimasartan group: 155, valsartan group: 157, olmesartan group: 53). After the 2-week single-blind placebo run-in period, initial standard doses of 60-mg fimasartan, 80-mg valsartan, and 10-mg olmesartan were administered for 2 weeks, then forcibly up-titrated higher doses (fimasartan 120 mg, valsartan 160 mg, olmesartan 20 mg) were given for 4 weeks. ABP was measured before and after the 6-week treatment. Primary endpoint was reduction of sitting office systolic BP (SiSBP) of fimasartan compared to valsartan after 6 weeks. Secondary endpoints were reduction of sitting office diastolic BP (SiDBP) and 24 hrs, day-time, and night-time mean systolic and diastolic ABP (ASBP, ADBP) after 6 weeks.
Patients' mean age was 58.34±7.68 years, and 289 patients were male (79.18%). After the 6-week treatment, SiSBP reduction of fimasartan and valsartan were -16.26±15.07 and -12.81±13.87 (p=0.0298) and SiDBP were -7.63±9.67 and -5.14±8.52 (p=0.0211). Reductions in 24 hrs mean ASBP were -15.22±13.33 and -9.45±12.37 (p=0.0009), and ADBPs were -8.74±7.55 and -5.98±7.85 (p=0.0140). Reductions of night-time ASBPs were -16.80±15.81 and -10.32±14.88 (p=0.0012), and those of night-time ADBPs were -8.89±9.93 and -5.55±9.70 (p=0.0152). Reduction of BP in olmesartan group did not demonstrate significant difference with fimasartan group in all end-points.
Fimasartan 120-mg treatment demonstrated superior efficacy in reduction of SiSBP, SiDBP, and 24 hrs ASBP and ADBP compared to valsartan 160 mg. Reduction of night-time ASBP from baseline was largest in fimasartan group, suggesting that fimasartan may be effective for recovering dipping pattern.
NCT02495324 (Fimasartan Achieving SBP Target (FAST) study).
比较非洛沙坦与缬沙坦对诊室血压和动态血压降低血压的效果，以奥美沙坦作为参考。
在这项研究的 369 名随机分配的患者中，365 名高血压患者被作为全分析集，分为 3 组，比例为 3:3:1（非洛沙坦组：155 人，缬沙坦组：157 人，奥美沙坦组：53 人）。在 2 周的单盲安慰剂导入期后，给予初始标准剂量的 60mg 非洛沙坦、80mg 缬沙坦和 10mg 奥美沙坦 2 周，然后强制滴定更高剂量（非洛沙坦 120mg、缬沙坦 160mg、奥美沙坦 20mg）4 周。在 6 周治疗前后测量动态血压。主要终点是与缬沙坦相比，非洛沙坦治疗 6 周后坐位收缩压（SiSBP）的降低。次要终点是治疗 6 周后坐位舒张压（SiDBP）和 24 小时、白天和夜间平均收缩压和舒张压（ASBP、ADBP）的降低。
患者的平均年龄为 58.34±7.68 岁，289 名男性（79.18%）。经过 6 周的治疗，非洛沙坦和缬沙坦的 SiSBP 降低分别为-16.26±15.07 和-12.81±13.87（p=0.0298），SiDBP 降低分别为-7.63±9.67 和-5.14±8.52（p=0.0211）。24 小时平均 ASBP 的降低分别为-15.22±13.33 和-9.45±12.37（p=0.0009），ADBPs 的降低分别为-8.74±7.55 和-5.98±7.85（p=0.0140）。夜间 ASBP 的降低分别为-16.80±15.81 和-10.32±14.88（p=0.0012），夜间 ADBP 的降低分别为-8.89±9.93 和-5.55±9.70（p=0.0152）。奥美沙坦组与非洛沙坦组在所有终点的降压效果无显著差异。
非洛沙坦 120mg 治疗在降低诊室收缩压、舒张压和 24 小时平均收缩压和舒张压方面优于缬沙坦 160mg。非洛沙坦组夜间 ASBP 从基线的降低幅度最大，提示非洛沙坦可能对恢复夜间血压下降模式有效。
NCT02495324（非洛沙坦实现收缩压目标（FAST）研究）。
