Ann J Melvin1, Grace Montepiedra, Lisa Aaron, William A Meyer, Hans M Spiegel, William Borkowsky, Mark J Abzug, Brookie M Best, Marilyn J Crain, Peggy R Borum, Bobbie Graham, Patricia Anthony, Katherine Shin, George K Siberry. 1. From the *Division of Pediatric Infectious Disease, Department of Pediatrics, University of Washington and Seattle Children's Research Institute, Seattle, Washington; †Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts; ‡Quest Diagnostics, Baltimore, Maryland; §HJF-DAIDS, a Division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ¶Department of Pediatrics, New York University School of Medicine, New York City, New York; ‖Department of Pediatrics (Infectious Diseases), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado; **UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences and School of Medicine, University of California San Diego, San Diego, California; ††Department of Pediatrics and Microbiology, University of Alabama at Birmingham Pediatric Infectious Diseases, Birmingham, Alabama; ‡‡Department of Food Science and Human Nutrition, University of Florida, Gainesville, Florida; §§Frontier Science Inc., Buffalo, New York; ¶¶University of Southern California Maternal Child Adolescent Virology Research Lab, Los Angeles, California; ‖‖Pharmaceutical Affairs Branch Division of AIDS, NIAID, NIH, Bethesda, Maryland; and ***Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Abstract
BACKGROUND: Human immunodeficiency virus (HIV)-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population. METHODS: HIV-infected youth 10 to <24 years of age on stable ART with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL for ≥6 months initiated atorvastatin 10 mg once daily. Atorvastatin was increased to 20 mg if LDL-C efficacy criteria (LDL-C < 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy. RESULTS: Twenty-eight youth initiated atorvastatin; 7 were 10-15 years and 21 were 15-24 years. Mean baseline LDL-C was 161 mg/dL (standard deviation 19 mg/dL). Efficacy criteria were met at week 4 by 17 of 27 (63%) participants. Atorvastatin was increased to 20 mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% confidence interval: 26%, 35%) at week 4, 28% (90% confidence interval: 23%, 33%) at week 24 and 26% (90% confidence interval: 20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12 and 46% at weeks 24 and 48. Total cholesterol, non high-density lipoprotein (non-HDL)-C and apolipoprotein B decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin. CONCLUSIONS: Atorvastatin lowered total cholesterol, LDL-C, non HDL-C and apolipoprotein B in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.
BACKGROUND: Human immunodeficiency virus (HIV)-infectedchildren receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population. METHODS:HIV-infected youth 10 to <24 years of age on stable ART with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL for ≥6 months initiated atorvastatin 10 mg once daily. Atorvastatin was increased to 20 mg if LDL-C efficacy criteria (LDL-C < 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy. RESULTS: Twenty-eight youth initiated atorvastatin; 7 were 10-15 years and 21 were 15-24 years. Mean baseline LDL-C was 161 mg/dL (standard deviation 19 mg/dL). Efficacy criteria were met at week 4 by 17 of 27 (63%) participants. Atorvastatin was increased to 20 mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% confidence interval: 26%, 35%) at week 4, 28% (90% confidence interval: 23%, 33%) at week 24 and 26% (90% confidence interval: 20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12 and 46% at weeks 24 and 48. Total cholesterol, non high-density lipoprotein (non-HDL)-C and apolipoprotein B decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin. CONCLUSIONS:Atorvastatin lowered total cholesterol, LDL-C, non HDL-C and apolipoprotein B in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infectedchildren with hyperlipidemia, but safety monitoring is important particularly in younger children.
Authors: L E Schanberg; C Sandborg; H X Barnhart; S P Ardoin; E Yow; G W Evans; K L Mieszkalski; N T Ilowite; A Eberhard; L F Imundo; Y Kimura; E von Scheven; E Silverman; S L Bowyer; M Punaro; N G Singer; D D Sherry; D McCurdy; M Klein-Gitelman; C Wallace; R Silver; L Wagner-Weiner; G C Higgins; H I Brunner; L Jung; J B Soep; A M Reed; J Provenzale; S D Thompson Journal: Arthritis Rheum Date: 2012-01
Authors: Matthew S Freiberg; Chung-Chou H Chang; Lewis H Kuller; Melissa Skanderson; Elliott Lowy; Kevin L Kraemer; Adeel A Butt; Matthew Bidwell Goetz; David Leaf; Kris Ann Oursler; David Rimland; Maria Rodriguez Barradas; Sheldon Brown; Cynthia Gibert; Kathy McGinnis; Kristina Crothers; Jason Sico; Heidi Crane; Alberta Warner; Stephen Gottlieb; John Gottdiener; Russell P Tracy; Matthew Budoff; Courtney Watson; Kaku A Armah; Donna Doebler; Kendall Bryant; Amy C Justice Journal: JAMA Intern Med Date: 2013-04-22 Impact factor: 21.873
Authors: Kunjal Patel; Jiajia Wang; Denise L Jacobson; Steven E Lipshultz; David C Landy; Mitchell E Geffner; Linda A Dimeglio; George R Seage; Paige L Williams; Russell B Van Dyke; George K Siberry; William T Shearer; Luciana Young; Gwendolyn B Scott; James D Wilkinson; Stacy D Fisher; Thomas J Starc; Tracie L Miller Journal: Circulation Date: 2013-12-23 Impact factor: 29.690
Authors: Michael J Silverberg; Wendy Leyden; Leo Hurley; Alan S Go; Charles P Quesenberry; Daniel Klein; Michael A Horberg Journal: Ann Intern Med Date: 2009-03-03 Impact factor: 25.391