Hepatotoxicity of Statins as determined by Serum Alanine Aminotransferase in a Pediatric Cohort with Dyslipidemia

Objective: To evaluate the hepatotoxicity of statins, as determined by serum alanine aminotransferase (ALT), in children and adolescents with dyslipidemia in real world clinical practice. Study design: Clinical and laboratory data were prospectively collected between September 2010 and March 2014. We compared ALT levels between patients prescribed versus not prescribed 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitors (statins), and then compared ALT before and after initiation of statins. Results: Over the 3.5-year observation period, there were 2704 ALT measurements among 943 patients. The mean age was 14 years; 54% were male, 47% obese, and 208 patients were treated with statins. Median follow-up after first ALT was 18 months. The mean (SD) ALT in statin and non-statin users was 23 (20) U/L and 28 (28) U/L, respectively. In models adjusted for age, sex and race, ALT was 2.1 U/L (95% CI 0.1, 4.4; p = 0.04) lower among statin users, which was attenuated after adjustment for weight category. Patients started on statins during the observation period did not demonstrate an increase in ALT over time (ALT 0.9 U/L [95% CI −5.2, 3.4] increase per year; p = 0.7). Conclusion: In our study population, we did not observe a higher burden of ALT elevations among pediatric patients on statins as compared to those with dyslipidemia who are not on statins, supporting the hepatic safety of statin use in childhood. Address correspondence and reprint requests to Nirav K. Desai, Boston Children's Hospital, Division of Gastroenterology, Hepatology, and Nutrition, 300 Longwood Ave, Boston, MA 02225 (e-mail: Nirav.desai@childrens.harvard.edu). Received 23 March, 2018 Accepted 9 September, 2018 Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). Nirav K. Desai and Michael M. Mendelson These authors contributed equally as co-first authors. Maureen M. Jonas and Sarah D. de Ferranti These authors contributed equally as co-senior authors. Funding: MMM was supported by the NHLBI K99 HL136875 and The Tommy Kaplan Fund, Department of Cardiology, Boston Children's Hospital, Boston, MA. JPZ was funded by NHLBI K23 HL111335 The funding sources had no role in the design of this study and did not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Disclosures: No author has any relevant disclosures. NKD is currently an employee of Shire Plc; however, the study, analysis, and preparation of the final manuscript occurred prior to beginning this employment. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

from Gastroenterology via xlomafota13 on Inoreader https://ift.tt/2PDARd3
via IFTTT