Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract and tolerability in postmenopausal women
(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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https://lup.lub.lu.se/record/1133683
- author
- organization
- publishing date
- 2005
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Selective estrogen receptor modulators, Ospemifene, Raloxifene, Postmenopausal, Vaginal atrophy
- in
- Menopause
- volume
- 12
- issue
- 2
- pages
- 202 - 209
- publisher
- Lippincott Williams & Wilkins
- external identifiers
-
- scopus:20144388972
- ISSN
- 1530-0374
- language
- English
- LU publication?
- yes
- additional info
- Department affilation moved from v1000588 (Tumour Biology, Malmö) to v1000562 (Department of Translational Medicine) on 2016-01-18 14:39:32.
- id
- f09980c6-183b-4431-b491-1bd095d3a151 (old id 1133683)
- alternative location
- http://ovidsp.tx.ovid.com/spb/ovidweb.cgi
- date added to LUP
- 2016-04-01 11:57:10
- date last changed
- 2022-02-10 23:53:06
@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}},
keywords = {{Selective estrogen receptor modulators; Ospemifene; Raloxifene; Postmenopausal; Vaginal atrophy}},
language = {{eng}},
number = {{2}},
pages = {{202--209}},
publisher = {{Lippincott Williams & Wilkins}},
series = {{Menopause}},
title = {{Effects of ospemifene and raloxifene on hormonal status, lipids, genital tract and tolerability in postmenopausal women}},
url = {{http://ovidsp.tx.ovid.com/spb/ovidweb.cgi}},
volume = {{12}},
year = {{2005}},
}