Zappe Dion H, Crikelair Nora, Kandra Albert, Palatini Paolo
aNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA bNovartis Pharma AG, Basel, Switzerland cDepartment of Medicine, University of Padova, Padova, Italy.
J Hypertens. 2015 Feb;33(2):385-92. doi: 10.1097/HJH.0000000000000397.
Studies suggest that bedtime dosing of an angiotensin-converting enzyme (ACE)-inhibitor or angiotensin receptor blocker shows a more sustained and consistent 24-h antihypertensive profile, including greater night-time blood pressure (BP) reduction. We compared the antihypertensive effects of morning (a.m.) and evening (p.m.) dosing of valsartan on 24-h BP.
This 26-week, multicentre, randomized, double-blind study evaluated the efficacy and safety of valsartan 320 mg, dosed a.m. or p.m., versus lisinopril 40 mg (a.m.), a long-acting ACE-inhibitor, in patients with grade 1-2 hypertension and at least one additional cardiovascular risk factor. Patients (n = 1093; BP = 156 ± 11/91 ± 8 mmHg; 62 years, 56% male, 99% white) received (1 : 1 : 1) valsartan 160 mg a.m. or p.m. or lisinopril 20 mg a.m. for 4 weeks, then force-titrated to double the initial dose for 8 weeks. At Week 12, hydrochlorothiazide (HCTZ) 12.5 mg was added for 14 weeks if office BP was more than 140/90 mmHg and/or ambulatory BP more than 130/80 mmHg.
Mean 24-h ambulatory SBP change from baseline to Weeks 12 and 26 was comparable between valsartan a.m. (-10.6 and -13.3 mmHg) and p.m. (-9.8 and -12.3 mmHg) and lisinopril (-10.7 and -13.7 mmHg). There was no benefit of valsartan p.m. versus a.m. on night-time BP, early morning BP and morning BP surge. Evening dosing also did not improve BP lowering in patients requiring add-on HCTZ or in nondippers at baseline. All treatments were well tolerated.
Once-daily dosing of valsartan 320 mg results in equally effective 24-h BP efficacy, regardless of dosing time.
ClinicalTrials.gov Identifier: NCT00241124.
研究表明，睡前服用血管紧张素转换酶（ACE）抑制剂或血管紧张素受体阻滞剂可呈现更持续且稳定的24小时降压效果，包括更大程度的夜间血压降低。我们比较了缬沙坦早晨（上午）和晚上（下午）给药对24小时血压的降压效果。
这项为期26周的多中心、随机、双盲研究评估了320毫克缬沙坦上午或下午给药与40毫克赖诺普利（上午）（一种长效ACE抑制剂）在1-2级高血压且至少有一项其他心血管危险因素患者中的疗效和安全性。患者（n = 1093；血压 = 156±11/91±8 mmHg；62岁，56%为男性，99%为白人）接受（1:1:1）上午或下午服用160毫克缬沙坦或上午服用20毫克赖诺普利，为期4周，然后强制滴定至初始剂量的两倍，持续8周。在第12周，如果诊室血压高于140/90 mmHg和/或动态血压高于130/80 mmHg，则加用12.5毫克氢氯噻嗪（HCTZ），持续14周。
从基线到第12周和第26周，缬沙坦上午组（-10.6和-13.3 mmHg）、下午组（-9.8和-12.3 mmHg）和赖诺普利组（-10.7和-13.7 mmHg）的24小时动态收缩压平均变化相当。缬沙坦下午给药在夜间血压、清晨血压和早晨血压波动方面并不优于上午给药。晚上给药也未改善需要加用HCTZ的患者或基线时非勺型血压患者的血压降低情况。所有治疗耐受性良好。
每日一次服用320毫克缬沙坦，无论给药时间如何，均可产生同样有效的24小时血压疗效。
ClinicalTrials.gov标识符：NCT00241124。
