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Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract and tolerability in postmenopausal women

Komi, J; Lankinen, K S; Härkönen, Pirkko LU ; DeGregorio, M W; Voipio, S; Kivinen, S; Tuimala, R; Vihtamaki, T; Vihko, K and Ylikorkala, O, et al. (2005) In Menopause 12(2). p.202-209
Abstract
OBJECTIVE: To compare ospemifene and raloxifene regarding their effects on hormones, lipids, genital tract, and tolerability in postmenopausal women. DESIGN: A randomized, double-blind study in which 118 healthy postmenopausal women received 30 (n = 29), 60 (n = 30), or 90 mg (n = 30) of ospemifene or 60 mg (n = 29) of raloxifene for 3 months. RESULTS: There were no significant differences in the baseline characteristics between study groups. In comparison with raloxifene, follicle-stimulating hormone levels decreased significantly more in the 90-mg ospemifene group and sex hormone-binding globulin levels increased more in all ospemifene groups. Total cholesterol and low-density lipoprotein cholesterol levels decreased more in raloxifene... (More)
OBJECTIVE: To compare ospemifene and raloxifene regarding their effects on hormones, lipids, genital tract, and tolerability in postmenopausal women. DESIGN: A randomized, double-blind study in which 118 healthy postmenopausal women received 30 (n = 29), 60 (n = 30), or 90 mg (n = 30) of ospemifene or 60 mg (n = 29) of raloxifene for 3 months. RESULTS: There were no significant differences in the baseline characteristics between study groups. In comparison with raloxifene, follicle-stimulating hormone levels decreased significantly more in the 90-mg ospemifene group and sex hormone-binding globulin levels increased more in all ospemifene groups. Total cholesterol and low-density lipoprotein cholesterol levels decreased more in raloxifene than in ospemifene groups, although the difference in low-density lipoprotein cholesterol between 90-mg ospemifene and raloxifene was not significant. Endometrial thickness did not change in any study group and endometrial biopsies showed atrophy in the majority of subjects at 3 months. All ospemifene groups demonstrated a clear estrogenic effect on the vaginal epithelium, as seen in Pap smears. This was in sharp contrast to the raloxifene group, which had no effect on the vaginal epithelium. Kupperman index decreased in all study groups during treatment. The adverse events were mild, mainly single cases, and no clustering of events was observed. There were no clinically significant abnormal findings in laboratory safety parameters. CONCLUSIONS: Ospemifene, at the dose of 90 mg/day, was more estrogenic than raloxifene, as shown by changes in serum follicle-stimulating hormone and sex hormone-binding globulin levels. Neither agent stimulated endometrium, but in contrast to raloxifene, ospemifene had a clear estrogenic effect in the vagina. Further studies with ospemifene are needed in subjects with vaginal atrophy. (Less)
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Contribution to journal
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published
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keywords
Selective estrogen receptor modulators, Ospemifene, Raloxifene, Postmenopausal, Vaginal atrophy
in
Menopause
volume
12
issue
2
pages
202 - 209
publisher
Lippincott-Raven Publishers
external identifiers
  • scopus:20144388972
ISSN
1530-0374
language
English
LU publication?
yes
id
f09980c6-183b-4431-b491-1bd095d3a151 (old id 1133683)
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http://ovidsp.tx.ovid.com/spb/ovidweb.cgi
date added to LUP
2008-06-17 14:12:38
date last changed
2017-10-01 03:44:07
@article{f09980c6-183b-4431-b491-1bd095d3a151,
  abstract     = {OBJECTIVE: To compare ospemifene and raloxifene regarding their effects on hormones, lipids, genital tract, and tolerability in postmenopausal women. DESIGN: A randomized, double-blind study in which 118 healthy postmenopausal women received 30 (n = 29), 60 (n = 30), or 90 mg (n = 30) of ospemifene or 60 mg (n = 29) of raloxifene for 3 months. RESULTS: There were no significant differences in the baseline characteristics between study groups. In comparison with raloxifene, follicle-stimulating hormone levels decreased significantly more in the 90-mg ospemifene group and sex hormone-binding globulin levels increased more in all ospemifene groups. Total cholesterol and low-density lipoprotein cholesterol levels decreased more in raloxifene than in ospemifene groups, although the difference in low-density lipoprotein cholesterol between 90-mg ospemifene and raloxifene was not significant. Endometrial thickness did not change in any study group and endometrial biopsies showed atrophy in the majority of subjects at 3 months. All ospemifene groups demonstrated a clear estrogenic effect on the vaginal epithelium, as seen in Pap smears. This was in sharp contrast to the raloxifene group, which had no effect on the vaginal epithelium. Kupperman index decreased in all study groups during treatment. The adverse events were mild, mainly single cases, and no clustering of events was observed. There were no clinically significant abnormal findings in laboratory safety parameters. CONCLUSIONS: Ospemifene, at the dose of 90 mg/day, was more estrogenic than raloxifene, as shown by changes in serum follicle-stimulating hormone and sex hormone-binding globulin levels. Neither agent stimulated endometrium, but in contrast to raloxifene, ospemifene had a clear estrogenic effect in the vagina. Further studies with ospemifene are needed in subjects with vaginal atrophy.},
  author       = {Komi, J and Lankinen, K S and Härkönen, Pirkko and DeGregorio, M W and Voipio, S and Kivinen, S and Tuimala, R and Vihtamaki, T and Vihko, K and Ylikorkala, O and Erkkola, R},
  issn         = {1530-0374},
  keyword      = {Selective estrogen receptor modulators,Ospemifene,Raloxifene,Postmenopausal,Vaginal atrophy},
  language     = {eng},
  number       = {2},
  pages        = {202--209},
  publisher    = {Lippincott-Raven Publishers},
  series       = {Menopause},
  title        = {Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract and tolerability in postmenopausal women},
  volume       = {12},
  year         = {2005},
}