A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis.

McWilliam, Stephen J ORCID: 0000-0002-0509-7425, Rosala-Hallas, Anna, Jones, Ashley P, Shaw, Victoria ORCID: 0000-0002-0429-0186, Greenhalf, William, Jaki, Thomas, Smyth, Alan R, Smyth, Rosalind L and Pirmohamed, Munir ORCID: 0000-0002-7534-7266 (2020) A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis. Scientific reports, 10 (1). 1796-.

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Official URL: http://dx.doi.org/10.1038/s41598-020-58790-1

Abstract

The PROteKT study tested the hypothesis that rosuvastatin can inhibit aminoglycoside-induced nephrotoxicity in children with Cystic Fibrosis (CF). This open label, parallel group, randomised controlled trial recruited children and young people aged 6 to 18 years with CF at 13 paediatric CF treatment centres in the UK. Participants were randomised equally to either receive oral rosuvastatin (10 mg once daily) or no intervention (control) throughout clinically indicated treatment with intravenous tobramycin. The primary outcome was the difference between the groups in mean fold-change in urinary Kidney Injury Molecule-1 (KIM-1). Fifty (rosuvastatin n = 23, control n = 27) participants were recruited between May 2015 and January 2017. Primary outcome data was available for 88% (rosuvastatin n = 20, control n = 24). The estimated mean treatment difference in the geometric mean-fold change of normalised KIM-1 was 1.08 (95% CI 0.87-1.35, p = 0.48). In total there were 12 adverse reactions, all mild, reported by five participants randomised to rosuvastatin, and one serious adverse event in each group. Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort. Therefore, we can neither confirm nor refute the hypothesis that rosuvastatin protects against aminoglycoside nephrotoxicity.

Item Type:	Article
Uncontrolled Keywords:	Humans, Cystic Fibrosis, Kidney Diseases, Tobramycin, Anti-Bacterial Agents, Adolescent, Child, Female, Male, Rosuvastatin Calcium, Hepatitis A Virus Cellular Receptor 1
Depositing User:	Symplectic Admin
Date Deposited:	04 Mar 2020 10:02
Last Modified:	18 Jan 2023 23:59
DOI:	10.1038/s41598-020-58790-1
Open Access URL:	https://doi.org/10.1038/s41598-020-58790-1
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3077715