Orange County Research Center, Tustin, CA 92780, USA.
J Clin Hypertens (Greenwich). 2012 Apr;14(4):206-15. doi: 10.1111/j.1751-7176.2012.00595.x. Epub 2012 Feb 23.
This 8-week, randomized, double-blind, controlled study compared efficacy and tolerability of telmisartan/amlodipine (T/A) single-pill combination (SPC) vs the respective monotherapies in 858 patients with severe hypertension (systolic/diastolic blood pressure [SBP/DBP] ≥180/95 mm Hg). At 8 weeks, T/A provided significantly greater reductions from baseline in seated trough cuff SBP/DBP (-47.5 mm Hg/-18.7 mm Hg) vs T (P<.0001) or A (P=.0002) monotherapy; superior reductions were also evident at 1, 2, 4, and 6 weeks. Blood pressure (BP) goal and response rates were consistently higher with T/A vs T or A. T/A was well tolerated, with less frequent treatment-related adverse events vs A (12.6% vs 16.4%) and a numerically lower incidence of peripheral edema and treatment discontinuation. In conclusion, treatment of patients with substantially elevated BP with T/A SPCs resulted in high and significantly greater BP reductions and higher BP goal and response rates than the respective monotherapies. T/A SPCs were well tolerated.
这项为期 8 周、随机、双盲、对照研究比较了替米沙坦/氨氯地平(T/A)单片复方(SPC)与各自单药治疗在 858 例重度高血压(收缩压/舒张压[SBP/DBP]≥180/95mmHg)患者中的疗效和耐受性。8 周时,T/A 与 T(P<.0001)或 A(P=.0002)单药治疗相比,坐位袖带 SBP/DBP 的谷值从基线显著更大幅度下降(-47.5mmHg/-18.7mmHg);在 1、2、4 和 6 周时也观察到了更好的降低。T/A 的血压(BP)目标和反应率始终高于 T 或 A。T/A 耐受性良好,与 A 相比,治疗相关不良事件的发生频率较低(12.6%比 16.4%),且外周水肿和停药的发生率略低。总之,用 T/A SPC 治疗血压显著升高的患者,血压降低幅度更大、BP 目标和反应率更高,优于各自的单药治疗。T/A SPC 耐受性良好。