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dc.contributor.author | Senni, M. | |
dc.contributor.author | McMurray, John J. V. | |
dc.contributor.author | Wachter, R. | |
dc.contributor.author | McIntyre, H. F. | |
dc.contributor.author | Reyes, A. | |
dc.contributor.author | Majercak, I. | |
dc.contributor.author | Andreka, P. | |
dc.contributor.author | Shehova-Yankova, Nina | |
dc.contributor.author | Anand, I. | |
dc.contributor.author | Yilmaz, M. B. | |
dc.contributor.author | Gogia, H. | |
dc.contributor.author | Martínez Sellés Oliveria Soares, Manuel | |
dc.contributor.author | Fischer, S. | |
dc.contributor.author | Zilahi, Z. | |
dc.contributor.author | Cosmi, F. | |
dc.contributor.author | Gelev, V. | |
dc.contributor.author | Galve Basilio, Enrique | |
dc.contributor.author | Gómez Doblas, J. J. | |
dc.contributor.author | Nociar, J. | |
dc.contributor.author | Radomska, M. | |
dc.contributor.author | Sokolova, B. | |
dc.contributor.author | Volterrani, M. | |
dc.contributor.author | Sarkar, A. | |
dc.contributor.author | Reimund, B. | |
dc.contributor.author | Chen, F. | |
dc.contributor.author | Charney, A. | |
dc.date.accessioned | 2016-12-14T11:21:11Z | |
dc.date.available | 2016-12-14T11:21:11Z | |
dc.date.issued | 2016 | |
dc.identifier.citation | Senni, M., McMurray, J. J., Wachter, R., McIntyre, H. F., Reyes, A., Majercak, I., ... & Gogia, H. (2016). Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double‐blind, randomized comparison of two uptitration regimens. European journal of heart failure, 18(9), 1193–1202. DOI: 10.1002/ejhf.548 | spa |
dc.identifier.issn | 13889842 | |
dc.identifier.issn | 18790844 | |
dc.identifier.uri | http://hdl.handle.net/11268/6090 | |
dc.description.abstract | The aim is tassess 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%). 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’. 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. | spa |
dc.description.sponsorship | Novartis Pharmaceuticals Corporation, USA | spa |
dc.language.iso | eng | spa |
dc.rights | Reconocimiento-NoComercial-SinObraDerivada 4.0 Internacional | * |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es_ES | * |
dc.title | Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens | spa |
dc.type | article | spa |
dc.description.impact | 6.968 JCR (2016) Q1, 11/126 Cardiac and Cardiovascular Systems | spa |
dc.identifier.doi | 10.1002/ejhf.548 | |
dc.rights.accessRights | openAccess | spa |
dc.subject.uem | Insuficiencia cardíaca | spa |
dc.subject.uem | Corazón - Enfermedades | spa |
dc.subject.unesco | Enfermedad cardiovascular | spa |
dc.description.filiation | UEM | spa |
dc.peerreviewed | Si | spa |