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Dementia-related ad...
Dementia-related adverse events in PARADIGM-HF and other trials in heart failure with reduced ejection fraction
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Cannon, J. A. (författare)
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Shen, L. (författare)
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Jhund, P. S. (författare)
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Kristensen, S. L. (författare)
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Kober, L. (författare)
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Chen, F. (författare)
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Gong, J. (författare)
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Lefkowitz, M. P. (författare)
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Rouleau, J. L. (författare)
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Shi, V. C. (författare)
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- Swedberg, Karl, 1944 (författare)
- 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. (författare)
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Solomon, S. D. (författare)
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Packer, M. (författare)
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McMurray, J. J. (författare)
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(creator_code:org_t)
- 2016-11-20
- 2017
- Engelska.
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Ingår i: European journal of heart failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 19:1, s. 129-137
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Abstract
Ämnesord
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- AIMS: Inhibition of neprilysin, an enzyme degrading natriuretic and other vasoactive peptides, is beneficial in heart failure with reduced ejection fraction (HFrEF), as shown in PARADIGM-HF which compared the angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan with enalapril. As neprilysin is also one of many enzymes clearing amyloid-beta peptides from the brain, there is a theoretical concern about the long-term effects of sacubitril/valsartan on cognition. Therefore, we have examined dementia-related adverse effects (AEs) in PARADIGM-HF and placed these findings in the context of other recently conducted HFrEF trials. METHODS AND RESULTS: In PARADIGM-HF, patients with symptomatic HFrEF were randomized to sacubitril/valsartan 97/103 mg b.i.d. or enalapril 10 mg b.i.d. in a 1:1 ratio. We systematically searched AE reports, coded using the Medical Dictionary for Regulatory Activities (MedDRA), using Standardized MedDRA Queries (SMQs) with 'broad' and 'narrow' preferred terms related to dementia. In PARADIGM-HF, 8399 patients aged 18-96 years were randomized and followed for a median of 2.25 years (up to 4.3 years). The narrow SMQ search identified 27 dementia-related AEs: 15 (0.36%) on enalapril and 12 (0.29%) on sacubitril/valsartan [hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.33-1.59]. The broad search identified 97 (2.30%) and 104 (2.48%) AEs (HR 1.01, 95% CI 0.75-1.37), respectively. The rates of dementia-related AEs in both treatment groups in PARADIGM-HF were similar to those in three other recent trials in HFrEF. CONCLUSION: We found no evidence that sacubitril/valsartan, compared with enalapril, increased dementia-related AEs, although longer follow-up may be necessary to detect such a signal and more sensitive tools are needed to detect lesser degrees of cognitive impairment. Further studies to address this question are warranted.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
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Till lärosätets databas
- Av författaren/redakt...
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Cannon, J. A.
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Shen, L.
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Jhund, P. S.
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Kristensen, S. L ...
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Kober, L.
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Chen, F.
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visa fler...
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Gong, J.
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Lefkowitz, M. P.
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Rouleau, J. L.
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Shi, V. C.
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Swedberg, Karl, ...
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Zile, M. R.
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Solomon, S. D.
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Packer, M.
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McMurray, J. J.
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visa färre...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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European journal ...
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Göteborgs universitet