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A randomized trial of neprilysin inhibition with sacubitril/valsartan vs irbesartan in chronic kidney disease
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Judge, Parminder K. (2020) A randomized trial of neprilysin inhibition with sacubitril/valsartan vs irbesartan in chronic kidney disease. PhD thesis, University of Warwick.
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Official URL: http://webcat.warwick.ac.uk/record=b3492828~S15
Abstract
BACKGROUND:
The effects of neprilysin inhibition in people with advanced chronic kidney disease (CKD) are unclear. UK Heart and Renal Protection (HARP)-III aimed to examine the effects of sacubitril/valsartan compared with irbesartan, on kidney function, other renal and cardiovascular outcomes and safety in CKD.
METHODS:
UK HARP-III was a randomized trial, including 414 people with CKD with an estimated glomerular filtration rate (GFR) of 20 to 60 mL/min/1.73m2 . Participants were allocated to sacubitril/valsartan or irbesartan. The primary outcome was measured GFR at 12 months. All analyses were intention to treat.
RESULTS:
207 participants were allocated sacubitril/valsartan and 207 irbesartan. At 12 months, there was no difference in measured GFR among those allocated sacubitril/valsartan compared with irbesartan (mean difference -0.1 [SE 0.7] mL/min/1.73m2 ). The effect of sacubitril/valsartan did not differ in a range of prespecified subgroups. There was no significant difference in urinary albumin:creatinine ratio (study average difference -9%; 95% CI -18 to 1) or estimated GFR (mean difference 0.1 mL/min/1.73m2 ; 95% CI -0.5 to 0.7; P=0.66) over 12 months between treatments. Sacubitril/valsartan, compared with irbesartan, significantly reduced study average systolic and diastolic blood pressure by 5.4 (95% CI 3.4-7.4) and 2.1 (95% CI 1.0-3.3) mmHg respectively. Concentrations of cardiac biomarkers N-terminal of prohormone brain natriuretic peptide and troponin I were by reduced by 18% (95% CI 11-25) and 16% (95% CI 8- 23) respectively. Incidence of serious adverse events (29.5% versus 28.5%; RR 1.07; 95% CI 0.75-1.53), non-serious adverse reactions (36.7% versus 28.0%; rate ratio 1.35; 95% CI 0.96-1.90) and renal adverse events were not significantly different between randomized treatments.
CONCLUSIONS:
Over 12 months allocation to sacubitril/valsartan, compared with irbesartan, had no significant effects on kidney function or albuminuria, but did significantly reduce blood pressure and cardiac biomarkers. It was not associated with any major adverse effects in people with advanced CKD.
Item Type: | Thesis (PhD) | ||||
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Subjects: | Q Science > QP Physiology R Medicine > RC Internal medicine |
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Library of Congress Subject Headings (LCSH): | Enkephalinase -- Inhibitors, Chronic renal failure -- Treatment, Cardiovascular system -- Diseases -- Treatment | ||||
Official Date: | 2020 | ||||
Dates: |
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Institution: | University of Warwick | ||||
Theses Department: | Warwick Medical School | ||||
Thesis Type: | PhD | ||||
Publication Status: | Unpublished | ||||
Supervisor(s)/Advisor: | Haynes, Richard ; Sharples, Edward ; Mitchell, Daniel A. | ||||
Format of File: | |||||
Extent: | 200 leaves, 110 leaves in various pagings : illustrations (some colour) | ||||
Language: | eng |
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