Harms of treatment with cholesterol-lowering drugs in children: A systematic review of the published literature
Public Deposited- Last Modified
- March 18, 2020
- Creator
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Haywood, Jonathan
- Affiliation: Gillings School of Global Public Health, Public Health Leadership Program
- Abstract
- Background: Some clinical guidelines recommend pharmacologic treatment for children with hyperlipidemia. These medications decrease cholesterol levels, but their side effects or potential harms in children are not well understood. Objective: To systematically review published trials of cholesterol-lowering medications in children and quantify their harms. Design/Methods: A comprehensive search was used to identify prospective studies evaluating the use of cholesterol-lowering drugs compared to controls in children with hyperlipidemia. Titles and abstracts were independently reviewed by authors and appropriate articles were fully evaluated. Blinded investigators completed quality assessments of included studies, followed by data extraction of all reported side effects or other harms using a standardized form. Results: A systematic search of the published literature identified 1070 titles and abstracts for potential inclusion. The 17 articles that met final inclusion criteria varied widely in quality, were generally not powered to detect adverse effects, and more than half disclosed pharmaceutical company sponsorship. None followed subjects for > 6 years. All included subjects (N=1604) with a probable diagnosis of heterozygous familial hyperlipidemia Studies evaluated the following therapies: HMG CoA reductase inhibitors (statins) versus placebo (10 studies), bile acid sequestrants (4 studies), bile acid sequestrants as add-on therapy to statins (1 study), statins as add-on therapy to bile acid sequestrants (1 study), and ezetemibe (1 study). Statins generally had similar harms to placebo, except in 7 of the 11 studies there was an increase in muscle symptoms or abnormal muscle enzyme laboratory values. Additionally, 3 of 5 statin studies evaluating dihydroepiandrosterone (DHEAS) reported significant changes in hormone levels. Two of 5 studies that evaluated bile acid sequestrants reported an increase in gastrointestinal symptoms. Ezetimibe therapy added to statin therapy increased myalgias (5.6% combined therapy vs. 0.8% placebo, p=0.03). Conclusions: Published studies of pharmacotherapy for hyperlipidemia in children are limited by small numbers, short follow-up periods, and a unique population. The available studies suggest that statins, bile acid sequestrants, and cholesterol absorption blockers all have associated side effects. Unfortunately, currently available studies have not fully assessed longer term harms, complicating treatment decisions.
- Date of publication
- August 2010
- DOI
- Resource type
- Rights statement
- In Copyright
- Note
- Paper type: Research or research design
- Track: HC&P
- Advisor
- Steiner, Michael
- Degree
- Master of Public Health
- Degree granting institution
- University of North Carolina at Chapel Hill
- Graduation year
- 2010
- Language
- Deposit record
- b6f6bdeb-f0b9-4907-a2ad-769b5d2e1080
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