Favourable effects of fenofibrate on lipids and cardiovascular disease in women with type 2 diabetes: results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

被引:38
|
作者
d'Emden, Michael C. [1 ,2 ]
Jenkins, Alicia J. [4 ]
Li, Liping [3 ]
Zannino, Diana [3 ]
Mann, Kristy P. [3 ]
Best, James D. [4 ]
Stuckey, Bronwyn G. A. [5 ,6 ]
Park, Kris [7 ]
Saltevo, Juha [8 ]
Keech, Anthony C. [3 ]
机构
[1] Royal Brisbane Hosp, Endocrine Res Unit, Brisbane, Qld 4029, Australia
[2] Univ Queensland, Dept Med, Brisbane, Qld 4000, Australia
[3] Univ Sydney, Natl Hlth & Med Res Council Clin Trials Ctr, Sydney, NSW 1450, Australia
[4] Univ Melbourne, Dept Med, Melbourne, Vic, Australia
[5] Keogh Inst Med Res, Perth, WA, Australia
[6] Sir Charles Gairdner Hosp, Perth, WA, Australia
[7] Nepean Hosp, Sydney, NSW, Australia
[8] Cent Finland Cent Hosp, Dept Med, Jyvaskyla, Finland
基金
英国医学研究理事会;
关键词
Adult; Cardiovascular prevention; Cardiovascular risk; Drug effects; Fibrate; Major clinical study; Non-insulin-dependent diabetes mellitus; Randomised controlled trial; Sex differences; Statin; Type 2 diabetes mellitus; LOW-DENSITY-LIPOPROTEIN; RISK; GEMFIBROZIL; CHOLESTEROL; PREVENTION; METABOLISM; MELLITUS; PLASMA; MEN;
D O I
10.1007/s00125-014-3344-3
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims/hypothesis In the double-blind placebo-controlled Fenofibrate Intervention and Event Lowering in Diabetes trial (n=9,795), fenofibrate reduced major cardiovascular events in type 2 diabetes. Sex-related differences in fenofibrate response could be clinically relevant and were pre-specified analyses. Methods Women (n=3,657) and men (n=6,138) with type 2 diabetes not using statins were assigned fenofibrate (200 mg/ day) or placebo for 5 years. Effects on lipoproteins and total cardiovascular events were evaluated by sex. Results Baseline total, LDL-, HDL- and non-HDL cholesterol and apolipoproteins A-I and B differed between sexes, and these and triacylglycerol levels improved with fenofibrate in both sexes (all p<0.001). Fenofibrate reduced total, LDL- and non-HDL cholesterol and apolipoprotein B more in women (all p<0.001), independent of menopausal status and statin uptake. Adjusted for covariates, fenofibrate reduced total cardiovascular outcomes (cardiovascular death, fatal and non-fatal stroke and carotid and coronary revascularisation) by 30% in women (95% CI 8%, 46%; p=0.008) and 13% in men (95% CI-1%, 24%; p=0.07) with no treatment-by-sex interaction (p>0.1). In patients with high triacylglycerol levels and low HDL-cholesterol, fenofibrate reduced total cardiovascular outcomes by 30% (95% CI-7%, 54%) in women and 24% (95% CI 2%, 42%) in men, with no treatment-by-sex interaction (p>0.1). Conclusions/interpretation Fenofibrate improved the lipoprotein profile more in women than men. Cardiovascular event reductions with fenofibrate were consistently similar in women and men, both overall and among those with low HDL-cholesterol and high triacylglycerol levels. These data provide reassurance about fenofibrate efficacy in women and men. Both sexes with type 2 diabetes should be considered for fenofibrate therapy for cardioprotection.
引用
收藏
页码:2296 / 2303
页数:8
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