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首页> 外文期刊>Current therapeutic research, clinical and experimental. >Results of a 14-Week, Multicenter, Prospective, Randomized, Open-Label, Noninferiority Clinical Trial Comparing the Antihypertensive Effect and Edema Incidence of Lacidipine and Amlodipine in Older Korean Patients with Mild-to-Moderate Hypertension
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Results of a 14-Week, Multicenter, Prospective, Randomized, Open-Label, Noninferiority Clinical Trial Comparing the Antihypertensive Effect and Edema Incidence of Lacidipine and Amlodipine in Older Korean Patients with Mild-to-Moderate Hypertension

机译：14周多中心，前瞻性，随机，开放标签，非劣效性临床试验的结果，比较了拉西地平和氨氯地平对韩国老年轻度至中度高血压患者的降压作用和水肿发生率

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Background: It has been shown that administration of lacidipine markedly reduces systolic blood pressure in elderly patients with hypertension without increasing the incidence of cardiovascular events and total mortality. But in Korea, there were no available data about the effectiveness and safety of lacidipine. Objectives: The goal of our study was to compare the effect of lacidipine and amlodipine besylate on sitting systolic blood pressure (SBP) and edema regression time as primary parameters, and sitting diastolic blood pressure (DBP) and tolerability as a secondary parameter in patients with hypertension. Method: This was a prospective, randomized, open-label, noninferiority study in which patients received 14 weeks of treatment with either lacidipine or amlodipine besylate. Patients aged 55 to 80 years having uncomplicated, mild-to-moderate essential hypertension (SBP 140 to <180 mm Hg or DBP >90 mm Hg) and receiving no antihypertensive medications during the 2 weeks before randomization were randomly assigned to receive lacidipine or amlodipine. The incidence of adverse events was also assessed. Results: In total, 315 patients (154 men, mean age 67.6 years) were included in the intent-to-treat analysis and randomly assigned to receive lacidipine (n = 162) or amlodipine besylate (n = 153); 286 patients were included in the per-protocol analysis (n = 150 for lacidipine, n = 136 for amlodipine) (12 in the lacidipine group and 17 in the amlodipine group were excluded from the per-protocol analysis due to consent withdrawal or protocol violation). There were no differences in demographic profiles between the 2 groups. Mean (SD) SBP changes at 14 weeks were -18.9 (12.7) mm Hg in the lacidipine group and -20.6 (12.4) mm Hg in the amlodipine group (P >0.05). Because the 1-sided 95% CI for the difference in mean SBP changes between groups (—4.18 to 0.72) was within the pre-specified lower limit ( — 5 mm Hg), lacidipine was considered noninferior to amlodipine. There were no differences in mean edema regression time and in mean DBP changes. These results were consistent in the isolated systolic hypertension subgroup analysis. The overall incidence of clinical adverse events was comparable between the 2 groups (ie, 7.4% in the lacidipine group and 11.1% in the amlodipine group [P > 0.05]). The most common adverse events were headache and facial flushing (5 out of 162 patients [3.1%] in the lacidipine group and 11 out of 153 patients [7.2%] in the amlodipine group]. Conclusions: Fourteen weeks of lacidipine treatment significantly reduced blood pressure in older Korean patients with mild-to-moderate hypertension. The efficacy of lacidipine was not inferior to that of amlodipine besylate and tolerability was comparable between the 2 treatment groups. ClinicalTrials.gov identifier: NCT00460915.
机译：背景：已显示，拉西地平的给药可显着降低老年高血压患者的收缩压，而不会增加心血管事件的发生率和总死亡率。但是在韩国，尚无关于拉西地平有效性和安全性的可用数据。目的：我们的研究目的是比较苯磺酸拉地平和氨氯地平对以坐位收缩压（SBP）和水肿消退时间为主要参数，以坐位舒张压（DBP）和耐受性为次要参数的影响高血压。方法：这是一项前瞻性，随机，开放标签，非劣效性研究，其中患者接受拉西地平或苯磺酸氨氯地平治疗14周。 55岁至80岁，无轻度至中度原发性高血压（SBP 140至<180 mm Hg或DBP> 90 mm Hg）且在随机分组前2周内未接受降压药物治疗的患者被随机分配接受拉西平或氨氯地平治疗。还评估了不良事件的发生率。结果：意向性治疗分析共纳入315例患者（154名男性，平均年龄67.6岁），并随机分配接受拉西地平（n = 162）或苯磺酸氨氯地平（n = 153）;协议分析共纳入286例患者（拉西地平150例，氨氯地平n = 136）（拉西地平组12例，氨氯地平组17例由于同意撤回或违反协议而被排除在协议外）。两组之间的人口统计资料没有差异。拉西平组14周的平均（SD）SBP变化为-18.9（12.7）mm Hg，氨氯地平组为-20.6（12.4）mm Hg（P> 0.05）。由于各组之间平均SBP变化的差异（-4.18至0.72）的一侧95％CI在预先设定的下限（-5 mm Hg）之内，因此拉西平被认为不低于氨氯地平。平均水肿消退时间和平均DBP变化无差异。这些结果与单纯收缩期高血压亚组分析一致。两组的临床不良事件的总发生率相当（例如，拉西地平组为7.4％，氨氯地平组为11.1％[P> 0.05]）。最常见的不良事件是头痛和面部潮红（拉西地平组162例患者中有5例[3.1％]，氨氯地平组中153例患者中有11例[7.2％]）结论：拉西地平治疗14周可显着减少血液韩国老年轻度至中度高血压患者的血压升高，拉西地平的疗效不亚于苯磺酸氨氯地平的疗效，并且在两个治疗组之间的耐受性相当。

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