Abstract:
AIMS:To assess the tolerability of initiating/uptitrating sacubitril/valsartan (LCZ696) from 50 to 200 mg twice daily (target dose) over 3 and 6 weeks in heart failure (HF) patients (ejection fraction ≤35%). METHODS AND RESULTS:A 5-day open-label run-in (sacubitril/valsartan 50 mg twice daily) preceded an 11-week, double-blind, randomization period [100 mg twice daily for 2 weeks followed by 200 mg twice daily ('condensed' regimen) vs. 50 mg twice daily for 2 weeks, 100 mg twice daily for 3 weeks, followed by 200 mg twice daily ('conservative' regimen)]. Patients were stratified by pre-study dose of angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker (ACEI/ARB; low-dose stratum included ACEI/ARB-naïve patients). Of 540 patients entering run-in, 498 (92%) were randomized and 429 (86.1% of randomized) completed the study. Pre-defined tolerability criteria were hypotension, renal dysfunction and hyperkalaemia; and adjudicated angioedema, which occurred in ('condensed' vs. 'conservative') 9.7% vs. 8.4% (P = 0.570), 7.3% vs. 7.6% (P = 0.990), 7.7% vs. 4.4% (P = 0.114), and 0.0% vs. 0.8% of patients, respectively. Corresponding proportions for pre-defined systolic blood pressure <95 mmHg, serum potassium >5.5 mmol/L, and serum creatinine >3.0 mg/dL were 8.9% vs. 5.2% (P = 0.102), 7.3% vs. 4.0% (P = 0.097), and 0.4% vs. 0%, respectively. In total, 378 (76%) patients achieved and maintained sacubitril/valsartan 200 mg twice daily without dose interruption/down-titration over 12 weeks (77.8% vs. 84.3% for 'condensed' vs. 'conservative'; P = 0.078). Rates by ACEI/ARB pre-study dose stratification were 82.6% vs. 83.8% (P = 0.783) for high-dose/'condensed' vs. high-dose/'conservative' and 84.9% vs. 73.6% (P = 0.030) for low-dose/'conservative' vs. low-dose/'condensed'. CONCLUSIONS:Initiation/uptitration of sacubitril/valsartan from 50 to 200 mg twice daily over 3 or 6 weeks had a tolerability profile in line with other HF treatments. More gradual initiation/uptitration maximized attainment of target dose in the low-dose ACEI/ARB group.
journal_name
Eur J Heart Failjournal_title
European journal of heart failureauthors
Senni M,McMurray JJ,Wachter R,McIntyre HF,Reyes A,Majercak I,Andreka P,Shehova-Yankova N,Anand I,Yilmaz MB,Gogia H,Martinez-Selles M,Fischer S,Zilahi Z,Cosmi F,Gelev V,Galve E,Gómez-Doblas JJ,Nociar J,Radomska M,Sdoi
10.1002/ejhf.548subject
Has Abstractpub_date
2016-09-01 00:00:00pages
1193-202issue
9eissn
1388-9842issn
1879-0844journal_volume
18pub_type
杂志文章,随机对照试验abstract:AIMS:To evaluate in patients with heart failure (HF) due to systolic dysfunction the occurrence of polypharmacy, alternative medicine, immunization against influenza, and patients' knowledge about their medication. METHODS AND RESULTS:Sixty-five patients, 49 men, mean age 60.5+/-12.0 years answered a confidential ques...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2003.09.009
更新日期:2004-03-01 00:00:00
abstract::Transthyretin amyloidosis (ATTR) is a rare, yet underdiagnosed disease characterized by progressive impairment of neurologic and cardiac function due to deposition of misfolded transthyretin. Despite great efforts, such as the introduction of orthotopic liver transplant, the devastating prognosis for both variant and ...
journal_title:European journal of heart failure
pub_type: 杂志文章,评审
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journal_title:European journal of heart failure
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doi:10.1016/s1388-9842(02)00091-0
更新日期:2002-10-01 00:00:00
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journal_title:European journal of heart failure
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doi:10.1002/ejhf.131
更新日期:2014-10-01 00:00:00
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journal_title:European journal of heart failure
pub_type: 杂志文章,随机对照试验
doi:10.1093/eurjhf/hfq043
更新日期:2010-06-01 00:00:00
abstract:BACKGROUND:In most animal models of chronic hemodynamic overload of the left ventricle (LV) as well as in human end stage heart failure, the sarcoplasmic reticulum (SR) Ca2+-ATPase (SERCA2a) mRNA levels are decreased in parallel with increased atrial natriuretic peptide (ANP) mRNA levels. The situation in the remote my...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2004.10.007
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journal_title:European journal of heart failure
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1999-08-01 00:00:00
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journal_title:European journal of heart failure
pub_type: 杂志文章
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journal_title:European journal of heart failure
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journal_title:European journal of heart failure
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journal_title:European journal of heart failure
pub_type: 杂志文章
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journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2012-12-01 00:00:00
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journal_title:European journal of heart failure
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journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.212
更新日期:2015-02-01 00:00:00
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journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2006.01.013
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journal_title:European journal of heart failure
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journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究,随机对照试验
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