title: Efficacy of simvastatin in children with hyperlipidemia secondary to kidney disorders.
abstract: Children with hyperlipidemia secondary to renal disease develop premature atherosclerosis and glomerulosclerosis. The aims of this pilot study were to find the dosage and short-term efficacy of simvastatin and potential adverse events in children with chronic kidney diseases. This was a random, double-blind, placebo-controlled, cross-over clinical trial performed on children with hyperlipidemia secondary to kidney disorders. After being placed on a diet for 3 months, patients were randomly placed in one of two balanced group blocks and treated with diet plus placebo or simvastatin at doses of 5 mg for children weighing 30 kg or less and 10 mg for children weighing over 30 kg, for 1 month, and then doubled for two more months. After this treatment, patients were placed on a diet for a 3-month washout period. During the last trial phase, patients previously treated with simvastatin were administered a placebo, and vice versa. A total of 25 patients with ages ranging from 4 years to 17 years were included in the study. A significant decrease in the levels of serum cholesterol (26.4%), low-density lipoprotein (LDL) (35.4%) and triglycerides (23.1%) was noted during the study, primarily during the simvastatin treatments, in which case cholesterol, LDL and triglycerides decreased by 23.3%, 33.7% and 21%, respectively. High-density lipoprotein (HDL) levels increased moderately (10.7%) during the study but without differences during simvastatin treatment. No differences were found across groups with respect to adverse events. In the short-term the combination of diet and simvastatin was effective in lowering hyperlipidemia in children with renal disorders.
authors.affiliation: Departamento de Nefrología, Instituto Nacional de Pediatría, Insurgentes Sur 3700-C, Colonia Insurgentes Cuicuilco, Mexico City, CP 15900, Mexico. garciadelapuente@hotmail.com
authors.forename: Silvestre
authors.initials: S
authors.lastname: García-de-la-Puente
authors.forename: José Luis
authors.initials: JL
authors.lastname: Arredondo-García
authors.forename: Pedro
authors.initials: P
authors.lastname: Gutiérrez-Castrellón
authors.forename: Aurora
authors.initials: A
authors.lastname: Bojorquez-Ochoa
authors.forename: Edith Reyna
authors.initials: ER
authors.lastname: Maya
authors.forename: María Del Pilar
authors.initials: Mdel P
authors.lastname: Pérez-Martínez
mesh_terms: D002648:Child; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications* / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007674:Kidney Diseases / Q000188:drug therapy*; D010865:Pilot Projects; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D014280:Triglycerides; D002784:Cholesterol; D019821:Simvastatin