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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.
Eur Heart J. 2006 Mar; 27(6):746-55.EH

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.

Authors+Show Affiliations

Julius Center for Health Sciences and Primary Care, HP Str. 6.131 University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. m.l.bots@umcutrecht.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16415304

Citation

Bots, Michiel L., et al. "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." European Heart Journal, vol. 27, no. 6, 2006, pp. 746-55.
Bots ML, Evans GW, Riley W, et al. 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. Eur Heart J. 2006;27(6):746-55.
Bots, M. L., Evans, G. W., Riley, W., McBride, K. H., Paskett, E. D., Helmond, F. A., & Grobbee, D. E. (2006). 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. European Heart Journal, 27(6), 746-55.
Bots ML, et al. 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. Eur Heart J. 2006;27(6):746-55. PubMed PMID: 16415304.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Bots,Michiel L, AU - Evans,Gregory W, AU - Riley,Ward, AU - McBride,Karen H, AU - Paskett,Electra D, AU - Helmond,Frans A, AU - Grobbee,Diederick E, AU - ,, Y1 - 2006/01/16/ PY - 2006/1/18/pubmed PY - 2006/5/23/medline PY - 2006/1/18/entrez SP - 746 EP - 55 JF - European heart journal JO - Eur Heart J VL - 27 IS - 6 N2 - 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. SN - 0195-668X UR - https://www.unboundmedicine.com/medline/citation/16415304/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_ L2 - https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehi695 DB - PRIME DP - Unbound Medicine ER -