An evaluation of alanine transaminase and creatine kinase elevations with the use of ezetimibe in an ambulatory care setting

McGinnis, Brandy; Schimmer, Jennifer J.; Hutka, Kara

doi:10.1016/j.jacl.2010.08.024

Cited by 3 publications

(1 citation statement)

References 28 publications

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“…It is possible that men were taking more concomitant medications, which affected drug metabolism and contributed to elevations in liver enzymes. An evaluation of ALT and CK elevation in an ambulatory care setting (N = 4958) found that significant elevations in either ALT or CK during ezetimibe treatment is usually associated with concomitant medications and that rates of ALT and ⁄ or CK elevations were similar to that of placebo (16).…”

Section: Discussionmentioning

confidence: 99%

Safety profile of statins alone or combined with ezetimibe: a pooled analysis of 27 studies including over 22,000 patients treated for 6-24 weeks

Tóth

Morrone

Weintraub

et al. 2012

International Journal of Clinical Practice

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Summary Aims: The aim of this analysis was to assess the overall safety and tolerability profiles of various statins + ezetimibe vs. statin monotherapy and to explore tolerability in sub‐populations grouped by age, race, and sex. Methods: Study‐level data were combined from 27 double‐blind, placebo‐controlled or active‐comparator trials that randomized adult hypercholesterolemic patients to statin or statin + ezetimibe for 6–24 weeks. In the full cohort, % patients with AEs within treatment groups (statin: N = 10,517; statin + ezetimibe: N = 11,714) was assessed by logistic regression with terms for first‐/second‐line therapy (first line = drug‐naïve or rendered drug‐naïve by washout at study entry; second line = ongoing statin at study entry or statin run‐in), trial within first‐/second‐line therapy, and treatment. The same model was fitted for age (< 65, ≥ 65 years), sex, race (white, black, other) and first‐/second‐line subgroups with additional terms for subgroup and subgroup‐by‐treatment interaction. Results: In the full cohort, the only significant difference between treatments was consecutive AST or ALT elevations ≥ 3 × upper limit of normal (ULN) (statin: 0.35%, statin + ezetimibe: 0.56%; p = 0.017). Significantly more subjects reported ≥ 1 AE; drug‐related, hepatitis‐related and gastrointestinal‐related AEs; and CK elevations ≥ 10 × ULN (all p ≤ 0.008) in first‐line vs. second‐line therapy studies with both treatments. AEs were generally similar between treatments in subgroups, and similar rates of AEs were reported within age and race subgroups; however, women reported generally higher AE rates. Conclusions: In conclusion, in second‐line studies, ongoing statin treatment at study entry likely screened out participants for previous statin‐related AEs and tolerability issues. These results describe the safety profiles of widely used lipid‐lowering therapies and encourage their appropriate and judicious use in certain subpopulations.

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Section: Discussionmentioning

confidence: 99%

Safety profile of statins alone or combined with ezetimibe: a pooled analysis of 27 studies including over 22,000 patients treated for 6-24 weeks

Tóth

Morrone

Weintraub

et al. 2012

International Journal of Clinical Practice

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Drugs that affect lipid metabolism

Nestel¹

2012

A Worldwide Yearly Survey of New Data in Adverse Drug Reactions and Interactions

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Ineffective statin monotherapy: alternative therapeutic strategy

Сергиенко

2011

Cardiovasc Ther Prev

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Представлены механизмы воздействия на всасывание холестерина. Рассмотрены ограничения при проведении монотерапии статинами и преимущества использования комбинации статин + эзетимиб. Ключевые слова: эзетимиб, всасывание холестерина, белок, переносящий эфиры холестерина, холестерол эстераза, ацил коэнзим А холестерол ацилтрансфераза, белок Неймана-Пика, тип l1. The paper describes the main mechanisms affecting cholesterol absorption. The limitations of statin monotherapy and the benefits of combined therapy with a statin and ezetimibe are discussed.

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An evaluation of alanine transaminase and creatine kinase elevations with the use of ezetimibe in an ambulatory care setting

Cited by 3 publications

References 28 publications

Safety profile of statins alone or combined with ezetimibe: a pooled analysis of 27 studies including over 22,000 patients treated for 6-24 weeks

Safety profile of statins alone or combined with ezetimibe: a pooled analysis of 27 studies including over 22,000 patients treated for 6-24 weeks

Drugs that affect lipid metabolism

Ineffective statin monotherapy: alternative therapeutic strategy

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