Randomized trial of effects of continuous combined HRT on markers of lipids and coagulation in women with acute coronary syndromes: WHISP Pilot Study.
OBJECTIVE
Randomized trials have not demonstrated coronary heart disease benefit from hormone replacement therapy (HRT). We hypothesized that low-dose HRT may avoid harm.


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-17beta 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)].


CONCLUSIONS
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.
Collins
Peter
P
Cardiac Medicine, National Heart and Lung Institute, Imperial College London, Dovehouse Street, London SW3 6LY, UK.
Flather
Marcus
M
Lees
Belinda
B
Mister
Rebecca
R
Proudler
Anthony J
AJ
Stevenson
John C
JC
D000368:Aged; D015415:Biomarkers / Q000097:blood; D001777:Blood Coagulation / Q000187:drug effects; D003327:Coronary Disease / Q000097:blood / Q000517:prevention & control*; D004338:Drug Combinations; D004797:Enzyme-Linked Immunosorbent Assay; D004958:Estradiol / Q000008:administration & dosage*; D005167:Factor VII / Q000378:metabolism; D005240:Feasibility Studies; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects; D006487:Hemostasis / Q000502:physiology; D020249:Hormone Replacement Therapy; D006801:Humans; D008055:Lipids / Q000097:blood*; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077563:Norethindrone Acetate; D010865:Pilot Projects
D015415:Biomarkers; D004338:Drug Combinations; D008055:Lipids; D004958:Estradiol; D005167:Factor VII; D000077563:Norethindrone Acetate; D009640:Norethindrone