Effects of tibolone or continuous combined oestradiol and norethisterone acetate on lipids, high-density lipoprotein subfractions and apolipoproteins in postmenopausal women in a two-year, randomized, double-blind, placebo-controlled trial
File(s)
Author(s)
Kotecha, Payal Trupti
Godsland, Ian F
Crook, David
Stevenson, John C
Type
Journal Article
Abstract
Objective
To compare the effects of (a) tibolone, (b) continuous combined oestrogen plus progestogen and (c) placebo on plasma lipid and lipoprotein markers of cardiovascular risk in healthy postmenopausal women.
Study design
Randomized, single‐centre, placebo‐controlled, double‐blind study.
Patients
One hundred and one postmenopausal women were randomized (1:1:1) into one of three groups taking daily 2.5 mg tibolone, continuous oral oestradiol‐17β 2 mg plus norethisterone acetate 1 mg daily (E2/NETA) or placebo.
Main outcome measures
Fasting serum lipid, lipoprotein and apolipoprotein concentrations measured at baseline and after 6, 12 and 24 months of treatment.
Results
Both tibolone and E2/NETA lowered plasma total cholesterol concentrations relative to placebo. With tibolone, high‐density lipoprotein cholesterol (HDL‐C) was reduced (−27% at 24 months, P < .001), the greatest effect being in the cholesterol‐enriched HDL2 subfraction (−40%, P < .001). Tibolone's effect on HDL concentrations was also apparent in the principal HDL protein component, apolipoprotein AI (−29% at 24 months, P < .001). However, there was no significant effect of tibolone on low‐density or very low‐density lipoprotein cholesterol (LDL‐C and VLDL‐C, respectively). By contrast, the greatest reduction in cholesterol with E2/NETA was in LDL‐C (−22% at 24 months, P = .008). E2/NETA reduced HDL‐C to a lesser extent than tibolone (−12% at 24 months, P < .001). Effects on HDL apolipoproteins were similarly diminished relative to tibolone. E2/NETA had no effect on VLDL‐C or on the protein component of LDL, apolipoprotein B.
Conclusion
Tibolone reduces serum HDL. E2/NETA reduces LDL cholesterol but not apolipoprotein B, suggesting decreased cholesterol loading of LDL. Any impact these changes may have on CVD risk needs further investigation.
To compare the effects of (a) tibolone, (b) continuous combined oestrogen plus progestogen and (c) placebo on plasma lipid and lipoprotein markers of cardiovascular risk in healthy postmenopausal women.
Study design
Randomized, single‐centre, placebo‐controlled, double‐blind study.
Patients
One hundred and one postmenopausal women were randomized (1:1:1) into one of three groups taking daily 2.5 mg tibolone, continuous oral oestradiol‐17β 2 mg plus norethisterone acetate 1 mg daily (E2/NETA) or placebo.
Main outcome measures
Fasting serum lipid, lipoprotein and apolipoprotein concentrations measured at baseline and after 6, 12 and 24 months of treatment.
Results
Both tibolone and E2/NETA lowered plasma total cholesterol concentrations relative to placebo. With tibolone, high‐density lipoprotein cholesterol (HDL‐C) was reduced (−27% at 24 months, P < .001), the greatest effect being in the cholesterol‐enriched HDL2 subfraction (−40%, P < .001). Tibolone's effect on HDL concentrations was also apparent in the principal HDL protein component, apolipoprotein AI (−29% at 24 months, P < .001). However, there was no significant effect of tibolone on low‐density or very low‐density lipoprotein cholesterol (LDL‐C and VLDL‐C, respectively). By contrast, the greatest reduction in cholesterol with E2/NETA was in LDL‐C (−22% at 24 months, P = .008). E2/NETA reduced HDL‐C to a lesser extent than tibolone (−12% at 24 months, P < .001). Effects on HDL apolipoproteins were similarly diminished relative to tibolone. E2/NETA had no effect on VLDL‐C or on the protein component of LDL, apolipoprotein B.
Conclusion
Tibolone reduces serum HDL. E2/NETA reduces LDL cholesterol but not apolipoprotein B, suggesting decreased cholesterol loading of LDL. Any impact these changes may have on CVD risk needs further investigation.
Date Issued
2020-01-28
Date Acceptance
2020-01-08
Citation
Clinical Endocrinology, 2020, 92 (4), pp.303-311
ISSN
0300-0664
Publisher
Wiley
Start Page
303
End Page
311
Journal / Book Title
Clinical Endocrinology
Volume
92
Issue
4
Copyright Statement
© 2020 John Wiley & Sons Ltd. This is the accepted version of the following article: Kotecha, PT, Godsland, IF, Crook, D, Stevenson, JC. Effects of tibolone or continuous combined oestradiol and norethisterone acetate on lipids, high‐density lipoprotein subfractions and apolipoproteins in postmenopausal women in a two‐year, randomized, double‐blind, placebo‐controlled trial. Clin Endocrinol (Oxf). 2020; 92: 303– 311, which has been published in final form at https://doi.org/10.1111/cen.14155
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000509517100001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
17-beta oestradiol
apolipoprotein
continuous combined HRT
HDL subfractions
tibolone
very low-density lipoprotein
HORMONE REPLACEMENT THERAPY
CARDIOVASCULAR-DISEASE
HEPATIC LIPASE
LONG-TERM
ESTROGEN
PLASMA
CHOLESTEROL
MENOPAUSE
RISK
METABOLISM
Publication Status
Published
Date Publish Online
2020-01-11