Clinical Development & Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
J Hum Hypertens. 2010 Jul;24(7):483-91. doi: 10.1038/jhh.2009.90. Epub 2009 Dec 10.
This prospective, 6-week, multicenter, double-blind study examined the benefits of initiating treatment with combination valsartan/hydrochlorothiazide (HCTZ) compared with initial valsartan monotherapy for 648 patients with stage-1 or stage-2 hypertension (age=52.6+/-10 years; 54% male; baseline blood pressure (BP)=161/98 mm Hg, 32% stage 1). Patients were randomized to valsartan 80 mg (V-low), valsartan 160 mg (V-high) or valsartan/HCTZ 160/12.5 mg (V/HCTZ), and electively titrated after weeks 2 and 4 to the next dosage level (maximum dose valsartan/HCTZ 160/25 mg) if BP remained >140/90 mm Hg. At end of the study, patients initiated with V/HCTZ required less titration steps compared with the initial valsartan monotherapy groups (63 vs 86% required titration by study end, respectively) and reached the target BP goal of <140/90 mm Hg in a shorter period of time (2.8 weeks) (P<0.0001) vs V-low (4.3 weeks) and V-high (3.9 weeks). Initial combination therapy was also associated with higher BP control rates and greater reductions in both systolic and diastolic BP from baseline (63%, -27.7+/-13/-15.1+/-8 mm Hg) compared with V-low (46%, -21.2+/-13/-11.4+/-8 mm Hg, P<0.0001) or V-high (51%, -24.0+/-13/-12.0+/-10 mm Hg, P<0.01). Overall and drug-related AEs were mild to moderate and were similar between V/HCTZ (53.1 and 14.1%, respectively) and the two monotherapy groups, V-low (50.5 and 13.8%) and V-high (50.7 and 11.8%). In conclusion, initiating therapy with a combination of valsartan and low-dose HCTZ results in early, improved BP efficacy with similar tolerability as compared with starting treatment with a low or higher dose of valsartan for patients with stage-1 and stage-2 hypertension.
这项前瞻性、6 周、多中心、双盲研究考察了起始治疗时联合使用缬沙坦/氢氯噻嗪（HCTZ）与起始缬沙坦单药治疗对 648 例 1 期或 2 期高血压患者（年龄=52.6+/-10 岁；54%为男性；基线血压（BP）=161/98mmHg，32%为 1 期）的益处。患者被随机分配至缬沙坦 80mg（V-低）、缬沙坦 160mg（V-高）或缬沙坦/HCTZ 160/12.5mg（V/HCTZ），如果血压仍>140/90mmHg，则在第 2 和 4 周后选择加量至下一剂量水平（最大剂量缬沙坦/HCTZ 160/25mg）。研究结束时，与起始缬沙坦单药治疗组相比，起始 V/HCTZ 治疗的患者需要较少的滴定步骤（分别有 63%和 86%需要在研究结束时滴定，P<0.0001），且在更短的时间内达到<140/90mmHg 的目标血压（2.8 周）（V-低为 4.3 周，V-高为 3.9 周）。起始联合治疗还与更高的血压控制率以及更大的收缩压和舒张压降低相关，与 V-低（46%，-21.2+/-13/-11.4+/-8mmHg，P<0.0001）或 V-高（51%，-24.0+/-13/-12.0+/-10mmHg，P<0.01）相比。总体和药物相关不良事件为轻度至中度，在 V/HCTZ（分别为 53.1%和 14.1%）和两个单药治疗组（V-低为 50.5%和 13.8%，V-高为 50.7%和 11.8%）之间相似。总之，与起始治疗时使用低剂量或高剂量缬沙坦相比，起始使用缬沙坦和低剂量 HCTZ 联合治疗可早期改善血压疗效，且耐受性相似。
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