Revista Española de Cardiología (English Edition) Revista Española de Cardiología (English Edition)
Rev Esp Cardiol. 2011;64:572-8 - Vol. 64 Num.07 DOI: 10.1016/j.rec.2011.03.004

Effects of Raloxifene on Endothelial Function and Hemostasis in Women With Ischemic Heart Disease

Mercè Roqué a,b,, Marta Sitges a,b, Joan Sala c, Victoria Delgado a, Manuel Morales c, Jaume Marrugat d, Joan Vila d, Isaac Subirana d, Dolors Tàssies e, Juan Carlos Reverter e, Miriam Castro a, Magdalena Duran f

a Departamento de Cardiología, Instituto del Tórax, Hospital Clínic, Barcelona, Spain
b Institut d’ Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain
c Departamento de Cardiología, Hospital Universitari Dr. Josep Trueta, Girona, Spain
d Unidad de Lípidos y Epidemiología Cardiovascular, Institut Municipal d’Investigació Mèdica, Barcelona, Spain
e Departamento de Hemostasia, Hospital Clínic, Barcelona, Spain
f Departamento de Ginecología, Hospital Clínic, Barcelona, Spain

Keywords

Endothelium. Coronary disease. Raloxifene. Fibrinolysis. Thrombosis. Woman.

Abstract

Introduction and objectives

Modulation of vascular tone is one of the most relevant estrogen effects. A beneficial effect on endothelial function in postmenopausal women has also been proposed for the selective estrogen receptor modulator raloxifene. However, its effects in women with established cardiovascular disease have not been fully elucidated. In addition, recent trials have generated controversy regarding thromboembolic risk with raloxifene use. The aim of the study was to assess the effect of raloxifene on: a) endothelial function and b) coagulation and fibrinolysis pathways.

Methods

The MERCED trial was a prospective, randomized clinical trial. Thirty-three postmenopausal women with ischemic heart disease were enrolled in the study. Raloxifene treatment was administered for a 3-month period, according to a double-blind crossover design. Assessment of vascular function and biologic parameters related to coagulation pathways were conducted at various pre-established time-points.

Results

Flow-mediated dilatation was severely impaired in the study population, and raloxifene had no effect on endothelial function. Treatment with raloxifene was associated to decreased levels of fibrinogen (3.41 [3.11-3.74] vs. 3.69 [3.40-4.00], P<.05); prothrombin fragments F1+2 (0.93 [0.77-1.12] vs. 0.94 [0.78-1.15], P<.05); and plasmin/antiplasmin complexes (211 [166-267] vs. 242 [199-295], P<.01).

Conclusions

The present study provides evidence that in postmenopausal women with demonstrated endothelial dysfunction and ischemic heart disease, mid-term treatment with raloxifene does not affect endothelial function. In the MERCED trial, no increased thrombotic risk was observed, but a decreased thrombotic and fibrinolytic activity was observed with raloxifene. Further studies are required to determine whether thrombotic risk is associated with specific clinical characteristics or subgroups of postmenopausal women with cardiovascular disease.

1885-5857/© 2011 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved

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