Mallion Jean-Michel, Heagerty Anthony, Laeis Petra
Cardiologie et Hypertension Arterielle, Service de Cardiologie et Hypertension artérielle, Hopital A. Michallon CHU, BP 217-38043 Grenoble Cedex, France.
J Hypertens. 2007 Oct;25(10):2168-77. doi: 10.1097/HJH.0b013e328287ad0d.
The prevalence of isolated systolic hypertension (ISH) is high in the elderly, and the objective of this study was to compare the antihypertensive efficacy of olmesartan medoxomil with that of nitrendipine in elderly (65-74 years) and very elderly (>/= 75 years) male and female patients with ISH.
Patients were randomized to 24 weeks of treatment with either olmesartan medoxomil 20 mg daily (n = 256) or nitrendipine 20 mg (n = 126) twice daily, with possible dose increase (to 40 mg daily) and addition of hydrochlorothiazide (HCTZ) 12.5 or 25 mg daily if required.
On the primary endpoint [reduction in mean sitting systolic blood pressure (SBP) after 12 weeks of treatment], the two treatments were similar (olmesartan medoxomil, -30.0 mmHg; nitrendipine, -31.4 mmHg). No significant difference between the treatment groups was observed, and non-inferiority of olmesartan medoxomil to nitrendipine was demonstrated using an analysis of covariance (ANCOVA) model. Reductions in mean sitting and standing SBP and diastolic blood pressure (DBP) up to week 24 were also similar with both treatments. Blood pressure (BP) goal attainment rates (sitting SBP </= 135 mmHg) increased consecutively, and were higher with olmesartan medoxomil (62.5%) than with nitrendipine (56.0%) at week 24 (not significant). Both treatments were well tolerated.
In elderly patients with ISH, the mean reduction in SBP produced by olmesartan is similar to that produced by nitrendipine.
老年人群中单纯收缩期高血压(ISH)的患病率较高,本研究旨在比较奥美沙坦酯与尼群地平对65 - 74岁及≥75岁ISH老年男性和女性患者的降压疗效。
患者被随机分为两组,分别接受为期24周的治疗,一组每日服用20 mg奥美沙坦酯(n = 256),另一组每日两次服用20 mg尼群地平(n = 126),必要时可增加剂量(至每日40 mg),并根据需要加用12.5或25 mg每日的氢氯噻嗪(HCTZ)。
在主要终点指标(治疗12周后平均坐位收缩压[SBP]的降低幅度)方面,两种治疗方法相似(奥美沙坦酯,降低30.0 mmHg;尼群地平,降低31.4 mmHg)。未观察到治疗组之间的显著差异,通过协方差分析(ANCOVA)模型证明了奥美沙坦酯不劣于尼群地平。两种治疗方法在第24周时,平均坐位和站位SBP以及舒张压(DBP)的降低幅度也相似。血压(BP)达标率(坐位SBP≤135 mmHg)持续升高,在第24周时,奥美沙坦酯组(62.5%)高于尼群地平组(56.0%)(差异不显著)。两种治疗方法耐受性均良好。
在ISH老年患者中,奥美沙坦酯降低SBP的均值与尼群地平相似。