Effect of atorvastatin on dyslipidemia and carotid intima-media thickness in children with refractory nephrotic syndrome: a randomized controlled trial.
Background: Dyslipidemia is an important cardiovascular risk factor in steroid-resistant nephrotic syndrome (SRNS). Efficacy of statins for treatment of hyperlipidemia in children with SRNS is unclear.Methods: This prospective, randomized, double-blind, placebo-controlled, parallel-group clinical tr...
| Publicado en: | Pediatric Nephrology Vol. 33; no. 12; pp. 2299 - 2310 |
|---|---|
| Autores principales: | , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
Dec2018
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=132697976&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 132697976 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0931041X EF1 jtl: Pediatric Nephrology issn: 0931041X maglogo: N pubinfo: dt: Dec2018 vid: 33 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 132697976 132697976 132697976 10.1007/s00467-018-4036-x 132697976 ppf: 2299 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Effect of atorvastatin on dyslipidemia and carotid intima-media thickness in children with refractory nephrotic syndrome: a randomized controlled trial. aug: au: Hari, Pankaj Khandelwal, Priyanka Satpathy, Amit Hari, Smriti Thergaonkar, Ranjeet Lakshmy, R Sinha, Aditi Bagga, Arvind affil: Division of Nephrology, Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, 110029, New Delhi, India sug: subj: Hyperlipidemia In Infancy and Childhood Carotid Intima-Media Thickness In Infancy and Childhood Hyperlipidemia Drug Therapy Atorvastatin Drug Effects Nephrotic Syndrome Human Randomized Controlled Trials Random Assignment Child, Preschool Child Adolescence Prospective Studies Lipoproteins, HDL Cholesterol Blood Atorvastatin Therapeutic Use Placebos Treatment Outcomes Descriptive Statistics Apolipoproteins Child, Preschool: 2-5 years Child: 6-12 years Adolescent: 13-18 years ab: Background: Dyslipidemia is an important cardiovascular risk factor in steroid-resistant nephrotic syndrome (SRNS). Efficacy of statins for treatment of hyperlipidemia in children with SRNS is unclear.Methods: This prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial enrolled 30 patients with SRNS, aged 5-18 years, with serum low-density lipoprotein cholesterol (LDL-C) levels between 130 and 300 mg/dl, to receive a fixed dose of atorvastatin (n = 15, 10 mg/d) or placebo (n = 15) by block randomization in a 1:1 ratio. Primary outcome was change in serum LDL-C at 12 months. Change in levels of other lipid fractions, carotid intima-media thickness (cIMT), flow-mediated dilation (FMD) of the brachial artery, and adverse events were also evaluated.Results: At the end of 12 months, atorvastatin was not superior to placebo in reducing plasma LDL-C levels, median percentage reduction 15.8% and 9.5% respectively, in atorvastatin and placebo arms (n = 14 in each; P = 0.40). Apolipoprotein B levels significantly declined with atorvastatin in modified intention-to-treat analysis (P = 0.01) but not in the per-protocol analysis. There was no significant effect on other lipid fractions, cIMT and FMD. Adverse events were similar between groups. Change in serum albumin was negatively associated with change in serum LDL-C, very low-density lipoprotein cholesterol, total cholesterol, triglyceride, and apolipoprotein B (P < 0.001), irrespective of receiving atorvastatin, age, gender, body mass index, and serum creatinine.Conclusions: Atorvastatin, administered at a fixed daily dose of 10 mg, was not beneficial in lowering lipid levels in children with SRNS; rise in serum albumin was associated with improvement in dyslipidemia. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|