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标题：Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure
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作者：Inder S Anand ; Anita Deswal ; Dean J Kereiakes 等
期刊名称：Vascular Health and Risk Management
印刷版ISSN：1176-6344
电子版ISSN：1178-2048
出版年度：2010
卷号：6
页码：449-455
DOI：10.2147/VHRM.S11090
出版社：Dove Medical Press Ltd
摘要：Clinical trial registration information: www.clinicaltrials.gov/ct2/show/NC T00294086 Unique identification number: NC T00294086 Background: The safety of once-daily (qd) dosing of valsartan in heart failure (HF) patients is not known. Hypothesis: This 10-week, double-blind trial examined the relative safety and efficacy of valsartan administered qd versus twice-daily (bid). Methods: HF patients (NYHA class II–III) receiving diuretics (87%), angiotensin-converting enzyme inhibitors (98%), beta-blockers (92%), aldosterone antagonists (25%), or digoxin (32%) were randomized to valsartan 40 mg bid (n = 60) or 80 mg qd (n = 55) and titrated to a maximum dose of 320 mg/day; doubling the dose every 2 weeks. Clinical and biochemical parameters were measured at Weeks 2, 4, 6, and 10. Results: The average dose of valsartan at the end of study was 245 mg in the bid group vs 256 mg in the qd group ( P = NS). Similar proportions of patients tolerated qd vs bid dosing (bid 67% vs qd 68%). Outcome measures including reduction in blood pressure, incidence of hypotension, renal impairment, orthostatic dizziness or fatigue, changes in serum K⁺, creatinine, cystatin-C, and estimated glomerular filtration rate were similar between the 2 groups at all time-points. Brain natriuretic peptide levels decreased and plasma renin activity increased from baseline by the same amount in both groups at all time-points. Conclusion: Valsartan administered qd has a similar safety and tolerability profile with comparable 24-hour RAAS blockade, as assessed by increases in PRA, as bid dosing in patients with moderate to severe (NYHA class II–III) heart failure.
关键词：heart failure; angiotensin receptor blocker; valsartan