Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome |
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Authors: | Nicholas J A Webb Shahnaz Shahinfar Thomas G Wells Rachid Massaad Gilbert W Gleim Christine McCrary Sisk Chun Lam |
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Institution: | 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
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Abstract: | Background 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. Methods 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. Results 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. Conclusions 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. |
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