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European Heart Journal Advance Access published online on August 9, 2006
European Heart Journal, doi:10.1093/eurheartj/ehl183
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received August 4, 2005
Revised June 13, 2006
Accepted July 14, 2006

Article

Randomized trial of effects of continuous combined HRT on markers of lipids and coagulation in women with acute coronary syndromes: WHISP Pilot Study

Peter Collins 1 *, Marcus Flather 2, Belinda Lees 2, Rebecca Mister 3, Anthony J. Proudler 4, and John C. Stevenson 5, on behalf of the WHISP (Women's Hormone Intervention Secondary Prevention Study) Pilot Study Investigators

1 Cardiac Medicine, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK; Department of Cardiology, Royal Brompton & Harefield NHS Trust, Sydney Street, London SW3 6NP, UK
2 Clinical Trials and Evaluation Unit, Royal Brompton & Harefield NHS Trust, London, UK
3 NH & MRC Clinical Trials Centre, University of Sydney, Sydney, Australia
4 Faculty of Medicine, Imperial College London, London, UK
5 Department of Cardiology, Royal Brompton & Harefield NHS Trust, Sydney Street, London SW3 6NP, UK; Faculty of Medicine, Imperial College London, London, UK

* To whom correspondence should be addressed.
Peter Collins, E-mail: peter.collins{at}imperial.ac.uk


  Abstract

Aims Randomized trials have not demonstrated coronary heart disease benefit from hormone replacement therapy (HRT). We hypothesized that low-dose HRT may avoid harm.

Methods and results We studied the effects of HRT on lipids and coagulation in women with acute coronary syndromes. A total of 100 post-menopausal women >55 years were enrolled between 2 and 28 days after an acute coronary syndrome and randomized to oral oestradiol-17{beta} 1 mg plus norethisterone acetate 0.5 mg daily, or matching placebo, and followed for up to 12 months. Levels of lipids, lipoproteins, and haemostasis markers were measured at baseline, 3, and 6 months. There were no significant differences in lipid levels between the two groups, probably due to concomitant statin use. Antithrombin and factor VII levels were significantly lower in the HRT group, whereas fibrinogen was significantly decreased in the placebo group. No evidence of increased coagulation activation was observed, nor of adverse cardiovascular outcomes [odds ratio (OR) 0.63 (95% confidence intervals 0.31-1.31)].

Conclusion Low-dose HRT may give cardiovascular benefit. These findings require confirmation in a full clinical trial with evaluation of cardiovascular outcomes as the primary objective.

Keywords: CHD; HRT; Lipids; Haemostasis.
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