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

被引：13

作者：

Toth, P. P. ^{[1
,2
]}

Morrone, D. ^{[3
]}

Weintraub, W. S. ^{[3
]}

Hanson, M. E. ^{[4
]}

Lowe, R. S. ^{[4
]}

Lin, J. ^{[5
]}

Shah, A. K. ^{[5
]}

Tershakovec, A. M. ^{[6
]}

机构：

[1] CGH Med Ctr, Sterling, IL USA

[2] Univ Illinois, Coll Med, Peoria, IL 61656 USA

[3] Christiana Care Hlth Syst, Christiana Ctr Outcomes Res, Newark, DE USA

[4] Merck Sharp & Dohme Corp, Global Sci & Med Publicat, Whitehouse Stn, NJ USA

[5] Merck Sharp & Dohme Corp, Clin & Quantitat Sci, Whitehouse Stn, NJ USA

[6] Merck Sharp & Dohme Corp, Project Leadership & Management, Whitehouse Stn, NJ USA

来源：

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE | 2012年 / 66卷 / 08期

关键词：

CORONARY-HEART-DISEASE; LIPID-ALTERING EFFICACY; DENSITY-LIPOPROTEIN CHOLESTEROL; GOING SIMVASTATIN TREATMENT; TYPE-2; DIABETES-MELLITUS; DOUBLE-BLIND TRIAL; ATORVASTATIN; 20; MG; C GOAL ATTAINMENT; HYPERCHOLESTEROLEMIC PATIENTS; HIGH-RISK;

D O I：

10.1111/j.1742-1241.2012.02964.x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 624 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-naive or rendered drug-naive 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 X 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 X 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.

引用

页码：800 / 812

页数：13