Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome
- Nicholas J. A. WebbAffiliated withDepartment of Paediatric Nephrology and Wellcome Trust Children’s Clinical Research Facility, Manchester Academic Health Science Centre, Royal Manchester Children’s Hospital, The University of Manchester Email author
- , Shahnaz ShahinfarAffiliated withS. Shahinfar Consulting Inc.Children’s Hospital of Philadelphia
- , Thomas G. WellsAffiliated withArkansas Children’s Hospital, The University of Arkansas for Medical Sciences
- , Rachid MassaadAffiliated withMSD Belgium
- , Gilbert W. GleimAffiliated withMerck Sharp & Dohme Corp
- , Christine McCrary SiskAffiliated withMerck Sharp & Dohme Corp
- , Chun LamAffiliated withMerck Sharp & Dohme Corp
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A previous subgroup analysis of a 12-week, double-blind study demonstrated that losartan significantly lowered proteinuria versus placebo and amlodipine and was well tolerated in children (1–17 years old) with proteinuria secondary to Alport syndrome. The present subgroup analysis of the open-label, extension phase of this study assessed the long-term efficacy and tolerability of losartan versus enalapril.
Patients who had completed the double-blind study were re-randomized to losartan or enalapril and followed for proteinuria and renal function for up to 3 years.
Twenty-seven patients with Alport syndrome were randomized to losartan (0.44-2.23 mg/kg/day; n = 15) or enalapril (0.07-0.72 mg/kg/day; n = 12). The least-squares (LS) mean percent change from week 12 in urinary protein to creatinine ratio (UPr/Cr was +1.1 % in the losartan group versus a further 13.9 % reduction in the enalapril group (GMR [95 % CI] = 1.2 [0.7, 2.0]); the LS mean change from week 12 in estimated glomerular filtration rate (eGFR) was −6.4 ml/min/1.73 m2 in the losartan group versus −9.1 ml/min/1.73 m2 in the enalapril group. The adverse event incidence was low and comparable in both treatment groups.
In children with proteinuria secondary to Alport syndrome, losartan maintained proteinuria reduction, and enalapril produced a further proteinuria reduction over the 3-year study period. Both agents were generally well tolerated.
KeywordsAlport syndrome Children Chronic kidney disease Clinical trial Enalapril Glomerular filtration rate Losartan Pediatric Proteinuria
- Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome
Volume 28, Issue 5 , pp 737-743
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- Alport syndrome
- Chronic kidney disease
- Clinical trial
- Glomerular filtration rate
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- Author Affiliations
- 1. Department of Paediatric Nephrology and Wellcome Trust Children’s Clinical Research Facility, Manchester Academic Health Science Centre, Royal Manchester Children’s Hospital, The University of Manchester, Manchester, M13 9WL, UK
- 2. S. Shahinfar Consulting Inc., Newtown Square, PA, USA
- 3. Children’s Hospital of Philadelphia, Philadelphia, PA, USA
- 4. Arkansas Children’s Hospital, The University of Arkansas for Medical Sciences, Little Rock, AR, USA
- 5. MSD Belgium, Brussels, Belgium
- 6. Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA