Grassi Guido, Seravalle Gino, Brambilla Gianmaria, Dell'Oro Raffaella, Trevano Fosca Quarti, Fici Francesco, van Bortel Luc, Mancia Giuseppe
Clinica Medica, Università Milano-Bicocca, Milan, Italy.
Clinica medica, Università Milano- Bioccca, Milan Italy and Istituto di Ricerca a Carattere Scientifico IRCCS Multimedica, Sesto San Giovanni, Milan, Italy.
Adv Ther. 2017 Jan;33(12):2173-2187. doi: 10.1007/s12325-016-0427-1. Epub 2016 Oct 22.
The present study was aimed at comparing the antihypertensive efficacy, tolerability, and side effects profile of nebivolol/hydrochlorothiazide (NH) vs irbesartan/hydrochlorothiazide (IH) combination in elderly patients with isolated systolic hypertension (ISH).
124 ISH patients aged 69.1 ± 5.1 years (mean ± SD) were enrolled by 13 general practitioners in Netherlands and Belgium and randomized in a double-blind fashion to receive either NH (5/12.5 mg day, n = 62) or IH (150/12.5 mg day, n = 62) for a 12-week period. The primary efficacy endpoint of the study was the comparison of the two combinations in terms of sitting office systolic blood pressure (BP) reduction after 12 weeks of treatment. In addition ambulatory BP, 24-h BP variability, tolerability, and safety profile were also investigated.
122 patients were included in the intention-to-treat analysis. After 12 weeks of treatment the reduction of systolic BP with NH was significantly greater than IH (-25.8 ± 12 vs -21.2 ± 14 mm Hg, P < 0.03). Diastolic BP reduction was significantly greater with NH after 4 and 8 weeks of treatment but similar at the end of the study (or after 12 weeks). In contrast, the magnitude of the 24-h, daytime, and nighttime systolic and diastolic BP reduction was almost similar in the two groups, while heart rate reduction induced by NH was significantly (P < 0.001) greater during the 24-h, daytime, and nighttime period than that induced by IH. NH caused a reduction in 24-h BP variability significantly greater than IH (standard deviation -4.4 ± 2.7 vs -2.2 ± 5.1 mm Hg, P < 0.02, variation coefficient -2.0 ± 2.6 vs -0.3 ± 3.4%, P < 0.01). Both treatment regimens were well tolerated.
These data provide evidence that NH reduces office BP more than IH but has similar effects on 24-h BP. NH reduces 24-h systolic and diastolic BP variability more than IH, suggesting a greater protective effect on a variable known to adversely affect prognosis.
EU clinical Trials Register identifier, 2010-023104-28.
Menarini International Operations Luxembourg.
本研究旨在比较奈必洛尔/氢氯噻嗪（NH）与厄贝沙坦/氢氯噻嗪（IH）联合用药对老年单纯收缩期高血压（ISH）患者的降压疗效、耐受性及副作用情况。
荷兰和比利时的13名全科医生招募了124名年龄为69.1±5.1岁（均值±标准差）的ISH患者，并将其随机分为双盲组，分别接受NH（5/12.5毫克/天，n = 62）或IH（150/12.5毫克/天，n = 62）治疗，为期12周。该研究的主要疗效终点是比较两种联合用药在治疗12周后对坐位办公室收缩压（BP）降低情况。此外，还对动态血压、24小时血压变异性、耐受性和安全性进行了研究。
122名患者纳入意向性分析。治疗12周后，NH组收缩压降低幅度显著大于IH组（-25.8±12 vs -21.2±14毫米汞柱，P<0.03）。治疗4周和8周后，NH组舒张压降低幅度显著大于IH组，但在研究结束时（即12周后）两组相似。相比之下，两组24小时、白天和夜间收缩压及舒张压降低幅度几乎相似，而NH组在24小时、白天和夜间引起的心率降低幅度显著（P<0.001）大于IH组。NH组导致的24小时血压变异性降低幅度显著大于IH组（标准差-4.4±2.7 vs -2.2±5.1毫米汞柱，P<0.02；变异系数-2.0±2.6 vs -0.3±3.4%，P<0.01）。两种治疗方案耐受性均良好。
这些数据表明，NH降低办公室血压的效果优于IH，但对24小时血压的影响相似。NH降低24小时收缩压和舒张压变异性的效果优于IH，这表明对已知会对预后产生不利影响变量的保护作用更大。
欧盟临床试验注册标识符2010-023104-28。
美纳里尼国际运营卢森堡公司。
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