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Effect of sacubitri...
Effect of sacubitril/valsartan on recurrent events in the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF)
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Mogensen, U. M. (author)
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Gong, J. J. (author)
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Jhund, P. S. (author)
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Shen, L. (author)
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Kober, L. (author)
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Desai, A. S. (author)
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Lefkowitz, M. P. (author)
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Packer, M. (author)
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Rouleau, J. L. (author)
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Solomon, S. D. (author)
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Claggett, B. L. (author)
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- Swedberg, Karl, 1944 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
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Zile, M. R. (author)
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Mueller-Velten, G. (author)
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McMurray, J. J. V. (author)
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(creator_code:org_t)
- 2018-02-12
- 2018
- English.
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In: European Journal of Heart Failure. - : Wiley. - 1388-9842. ; 20:4, s. 760-768
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Abstract
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- Aims Recurrent hospitalizations are a major part of the disease burden in heart failure (HF), but conventional analyses consider only the first event. We compared the effect of sacubitril/valsartan vs. enalapril on recurrent events, incorporating all HF hospitalizations and cardiovascular (CV) deaths in PARADIGM-HF, using a variety of statistical approaches advocated for this type of analysis.& para;& para;Methods and results In PARADIGM-HF, a total of 8399 patients were randomized and followed for a median of 27 months. We applied various recurrent event analyses, including a negative binomial model, the Wei, Lin and Weissfeld (WLW), and Lin, Wei, Ying and Yang (LWYY) methods, and a joint frailty model, all adjusted for treatment and region. Among a total of 3181 primary endpoint events (including 1251 CV deaths) during the trial, only 2031 (63.8%) were first events (836 CV deaths). Among a total of 1195 patients with at least one HF hospitalization, 410 (34%) had at least one further HF hospitalization. Sacubitril/valsartan compared with enalapril reduced the risk of recurrent HF hospitalization using the negative binomial model [rate ratio (RR) 0.77, 95% confidence interval (CI) 0.67-0.89], the WLW method [hazard ratio (HR) 0.79, 95% CI 0.71-0.89], the LWYY method (RR 0.78, 95% CI 0.68-0.90), and the joint frailty model (HR 0.75, 95% CI 0.66-0.86) (all P <0.001). The effect of sacubitril/valsartan vs. enalapril on recurrent HF hospitalizations/CV death was similar.& para;& para;Conclusions In PARADIGM-HF, approximately one third of patients with a primary endpoint (time-to-first) experienced a further event. Compared with enalapril, sacubitril/valsartan reduced both first and recurrent events. The treatment effect size was similar, regardless of the statistical approach applied.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Heart failure
- Hospitalization
- Recurrent events
- Neprilysin inhibitor
- receptor neprilysin inhibition
- composite end-points
- clinical-trials
- time data
- hospitalizations
- regression
- enalapril
- efficacy
- model
- Cardiovascular System & Cardiology
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Mogensen, U. M.
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Gong, J. J.
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Jhund, P. S.
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Shen, L.
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Kober, L.
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Desai, A. S.
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show more...
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Lefkowitz, M. P.
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Packer, M.
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Rouleau, J. L.
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Solomon, S. D.
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Claggett, B. L.
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Swedberg, Karl, ...
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Zile, M. R.
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Mueller-Velten, ...
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McMurray, J. J. ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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European Journal ...
- By the university
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University of Gothenburg