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European Heart Journal Advance Access published online on January 16, 2006
European Heart Journal, doi:10.1093/eurheartj/ehi695
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received May 18, 2005
Revised November 23, 2005
Accepted December 1, 2005

Clinical research

The effect of tibolone and continuous combined conjugated equine oestrogens plus medroxyprogesterone acetate on progression of carotid intima-media thickness: the Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study

Michiel L. Bots 1 *, Gregory W. Evans 2, Ward Riley 3, Karen H. McBride 4, Electra D. Paskett 5, Frans A. Helmond 6, Diederick E. Grobbee 1, and for the OPAL Investigators

1 Julius Center for Health Sciences and Primary Care, HP Str. 6.131 University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands
2 Department of Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA
3 Department of Neurology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA
4 Organon Pharmaceutical USA, Inc., Roseland, NJ, USA
5 Ohio State University Medical Center, Columbus, OH, USA
6 Organon International, Roseland, NJ, USA

* To whom correspondence should be addressed.
Michiel L. Bots, E-mail: m.l.bots{at}umcutrecht.nl


  Abstract

Aims At the time of the design of the Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study in 1996, oral hormone therapy (HT) was assumed to reduce cardiovascular risk. The evidence mainly came from the effects of combined conjugated equine oestrogens plus medroxyprogesterone acetate (CEE/MPA) therapy. Other HT regimes had not been studied widely. Tibolone, a selective tissue oestrogenic activity regulator, has several effects on cardiovascular risk factors, one of which is HDL lowering. Because the overall effect of tibolone on cardiovascular risk was unknown, the OPAL study was designed.

Methods and results The OPAL study was a three-arm, randomized, placebo-controlled, double-blind study to determine the effect of tibolone (2.5 mg daily) and of CEE/MPA (0.625/2.5 mg daily) over 3 years on progression of carotid intima-media thickness (CIMT) in 866 healthy post-menopausal women. The women were recruited from six US and five European centres. The primary outcome was change in mean common CIMT. Annual common CIMT progression rates in the tibolone and CEE/MPA groups were higher than in the placebo group: 0.0077 mm [95% confidence interval (CI) 0.0051-0.0103] in the tibolone group, 0.0074 mm (0.0048-0.0099) in the CEE/MPA group, and 0.0035 mm (0.009-0.0061) in the placebo group. The differences with placebo (0.0042 mm/year for tibolone and 0.0039 mm/year for CEE/MPA) were statistically significant. HDL cholesterol increased in CEE/MPA group and was lowered in the tibolone group.

Conclusion Both tibolone and CEE/MPA showed increased progression of common CIMT. Translation of the increased common CIMT progression of the CEE/MPA group into cardiovascular disease risk could not fully explain the observed increased cardiovascular risk as observed in the Women's Health Initiative study. This suggests that the net effect of tibolone and CEE/MPA on cardiovascular events may depend on the combined effects on the arterial wall, clotting factors, and possibly inflammation.

Keywords: Cardiovascular disease prevention; Atherosclerosis; Oestrogen; Osteoporosis: randomized clinical trial; Selective tissue oestrogenic activity regulator.
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