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Effect of Vericigua...
Effect of Vericiguat, a Soluble Guanylate Cyclase Stimulator, on Natriuretic Peptide Levels in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction : The SOCRATES-REDUCED Randomized Trial.
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- Gheorghiade, Mihai (författare)
- Northwestern University Feinberg School of Medicine, Chicago, USA
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- Greene, Stephen J (författare)
- Duke University Medical Center, Durham, North Carolina, USA
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- Butler, Javed (författare)
- Stony Brook University, Stony Brook, New York, USA
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- Filippatos, Gerasimos (författare)
- Athens University Hospital Attikon and Kapodistrian University of Athens, Athens, Greece
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- Lam, Carolyn S P (författare)
- National Health Center, Singapore and Duke, National University of Singapore, Singapore
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- Maggioni, Aldo P (författare)
- Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy
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- Ponikowski, Piotr (författare)
- Medical University, Wroclaw, Poland
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- Shah, Sanjiv J (författare)
- Northwestern University Feinberg School of Medicine, Chicago, USA
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- Solomon, Scott D (författare)
- Brigham and Women's Hospital Boston, Massachusetts, USA
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- Kraigher-Krainer, Elisabeth (författare)
- Charite University Medicine Berlin-Campus Virchow Klinikum, Berlin, Germany
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- Samano, Eliana T (författare)
- Bayer, Sao Paulo, Brazil
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- Müller, Katharina (författare)
- Bauer Pharma, Wuppertal, Germany
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- Roessig, Lothar (författare)
- Bauer Pharma, Wuppertal, Germany
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- Burkert, Pieske (författare)
- Charité University Medicine Berlin–Campus Virchow Klinikum and German Heart Center Berlin, Germany
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(creator_code:org_t)
- American Medical Association (AMA), 2015
- 2015
- Engelska.
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Ingår i: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 314:21, s. 2251-2262
- Relaterad länk:
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https://jamanetwork....
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- IMPORTANCE: Worsening chronic heart failure (HF) is a major public health problem.OBJECTIVE: To determine the optimal dose and tolerability of vericiguat, a soluble guanylate cyclase stimulator, in patients with worsening chronic HF and reduced left ventricular ejection fraction (LVEF).DESIGN, SETTING, AND PARTICIPANTS: Dose-finding phase 2 study that randomized 456 patients across Europe, North America, and Asia between November 2013 and January 2015, with follow-up ending June 2015. Patients were clinically stable with LVEF less than 45% within 4 weeks of a worsening chronic HF event, defined as worsening signs and symptoms of congestion and elevated natriuretic peptide level requiring hospitalization or outpatient intravenous diuretic.INTERVENTIONS: Placebo (n = 92) or 1 of 4 daily target doses of oral vericiguat (1.25 mg [n = 91], 2.5 mg [n = 91], 5 mg [n = 91], 10 mg [n = 91]) for 12 weeks.MAIN OUTCOMES AND MEASURES: The primary end point was change from baseline to week 12 in log-transformed level of N-terminal pro-B-type natriuretic peptide (NT-proBNP). The primary analysis specified pooled comparison of the 3 highest-dose vericiguat groups with placebo, and secondary analysis evaluated a dose-response relationship with vericiguat and the primary end point.RESULTS: Overall, 351 patients (77.0%) completed treatment with the study drug with valid 12-week NT-proBNP levels and no major protocol deviation and were eligible for primary end point evaluation. In primary analysis, change in log-transformed NT-proBNP levels from baseline to week 12 was not significantly different between the pooled vericiguat group (log-transformed: baseline, 7.969; 12 weeks, 7.567; difference, -0.402; geometric means: baseline, 2890 pg/mL; 12 weeks, 1932 pg/mL) and placebo (log-transformed: baseline, 8.283; 12 weeks, 8.002; difference, -0.280; geometric means: baseline, 3955 pg/mL; 12 weeks, 2988 pg/mL) (difference of means, -0.122; 90% CI, -0.32 to 0.07; ratio of geometric means, 0.885, 90% CI, 0.73-1.08; P = .15). The exploratory secondary analysis suggested a dose-response relationship whereby higher vericiguat doses were associated with greater reductions in NT-proBNP level (P < .02). Rates of any adverse event were 77.2% and 71.4% among the placebo and 10-mg vericiguat groups, respectively.CONCLUSIONS AND RELEVANCE: Among patients with worsening chronic HF and reduced LVEF, compared with placebo, vericiguat did not have a statistically significant effect on change in NT-proBNP level at 12 weeks but was well-tolerated. Further clinical trials of vericiguat based on the dose-response relationship in this study are needed to determine the potential role of this drug for patients with worsening chronic HF.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01951625.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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Gheorghiade, Mih ...
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Greene, Stephen ...
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Butler, Javed
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Filippatos, Gera ...
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Lam, Carolyn S P
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Maggioni, Aldo P
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Ponikowski, Piot ...
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Shah, Sanjiv J
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Solomon, Scott D
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Kraigher-Krainer ...
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Samano, Eliana T
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Müller, Katharin ...
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Roessig, Lothar
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Burkert, Pieske
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