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A comparison of the effects of raloxifene and conjugated equine estrogen on bone and lipids in healthy postmenopausal women.
Arch Intern Med. 2004 Apr 26; 164(8):871-9.AI

Abstract

BACKGROUND

Although many studies have assessed the effects of estrogen and raloxifene hydrochloride on bone mineral density and serum lipid concentrations, there are few direct comparative data.

METHODS

Randomized placebo-controlled trial for 3 years, intention-to-treat analysis. Six hundred nineteen postmenopausal women with prior hysterectomy (mean age, 53.0 years) were studied in 38 centers in Europe, North America, Australasia, and South Africa. They were randomized to 60 mg/d or 150 mg/d of raloxifene, 0.625 mg/d of conjugated equine estrogen (CEE), or placebo. Bone density of the lumbar spine and proximal femur, biochemical markers of bone turnover, and fasting serum lipid concentrations were assessed for 3 years.

RESULTS

Compared with baseline, bone density in the lumbar spine progressively declined by 2.0% in the placebo group (P <.05), was stable in the 2 raloxifene groups, and increased 4.6% in the subjects receiving CEE (P <.001). Effects in both raloxifene groups were different from those observed in the CEE and placebo groups (P <.001). Bone density in the total hip showed similar results. Conjugated equine estrogen produced significantly greater depression of serum osteocalcin, bone-specific alkaline phosphatase, and urine C-telopeptide, compared with raloxifene. Each of the active treatments caused comparable depression of low-density lipoprotein cholesterol below placebo levels (P <.001 at most time points). Raloxifene did not affect high-density lipoprotein cholesterol, whereas CEE increased it by 13.4% compared with placebo at 3 years (P <.001). Triglyceride concentrations increased 24.6% in the CEE group at 3 years (P <.003), a significantly greater change than in the raloxifene groups, which were 4.9% and 8.0% above baseline (P < or =.002) but not different from placebo. Urinary incontinence was reported in 11 women receiving CEE, but in only 1 or 2 in each of the other groups (P < or =.01 compared with the other groups). Hernias occurred less frequently in those receiving 150 mg/d of raloxifene or CEE (P =.03 vs placebo).

CONCLUSIONS

Raloxifene and CEE have beneficial effects on bone density and bone turnover, although effects of CEE are more marked. Raloxifene and CEE produce different patterns of lipid responses and have distinct adverse effect profiles.

Authors+Show Affiliations

Department of Medicine, University of Auckland, PB 92019, Auckland, New Zealand. i.reid@auckland.ac.nzNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15111373

Citation

Reid, Ian R., et al. "A Comparison of the Effects of Raloxifene and Conjugated Equine Estrogen On Bone and Lipids in Healthy Postmenopausal Women." Archives of Internal Medicine, vol. 164, no. 8, 2004, pp. 871-9.
Reid IR, Eastell R, Fogelman I, et al. A comparison of the effects of raloxifene and conjugated equine estrogen on bone and lipids in healthy postmenopausal women. Arch Intern Med. 2004;164(8):871-9.
Reid, I. R., Eastell, R., Fogelman, I., Adachi, J. D., Rosen, A., Netelenbos, C., Watts, N. B., Seeman, E., Ciaccia, A. V., & Draper, M. W. (2004). A comparison of the effects of raloxifene and conjugated equine estrogen on bone and lipids in healthy postmenopausal women. Archives of Internal Medicine, 164(8), 871-9.
Reid IR, et al. A Comparison of the Effects of Raloxifene and Conjugated Equine Estrogen On Bone and Lipids in Healthy Postmenopausal Women. Arch Intern Med. 2004 Apr 26;164(8):871-9. PubMed PMID: 15111373.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of the effects of raloxifene and conjugated equine estrogen on bone and lipids in healthy postmenopausal women. AU - Reid,Ian R, AU - Eastell,Richard, AU - Fogelman,Ignac, AU - Adachi,Jonathon D, AU - Rosen,Amy, AU - Netelenbos,Coen, AU - Watts,Nelson B, AU - Seeman,Ego, AU - Ciaccia,Angelina V, AU - Draper,Michael W, PY - 2004/4/28/pubmed PY - 2004/5/22/medline PY - 2004/4/28/entrez SP - 871 EP - 9 JF - Archives of internal medicine JO - Arch Intern Med VL - 164 IS - 8 N2 - BACKGROUND: Although many studies have assessed the effects of estrogen and raloxifene hydrochloride on bone mineral density and serum lipid concentrations, there are few direct comparative data. METHODS: Randomized placebo-controlled trial for 3 years, intention-to-treat analysis. Six hundred nineteen postmenopausal women with prior hysterectomy (mean age, 53.0 years) were studied in 38 centers in Europe, North America, Australasia, and South Africa. They were randomized to 60 mg/d or 150 mg/d of raloxifene, 0.625 mg/d of conjugated equine estrogen (CEE), or placebo. Bone density of the lumbar spine and proximal femur, biochemical markers of bone turnover, and fasting serum lipid concentrations were assessed for 3 years. RESULTS: Compared with baseline, bone density in the lumbar spine progressively declined by 2.0% in the placebo group (P <.05), was stable in the 2 raloxifene groups, and increased 4.6% in the subjects receiving CEE (P <.001). Effects in both raloxifene groups were different from those observed in the CEE and placebo groups (P <.001). Bone density in the total hip showed similar results. Conjugated equine estrogen produced significantly greater depression of serum osteocalcin, bone-specific alkaline phosphatase, and urine C-telopeptide, compared with raloxifene. Each of the active treatments caused comparable depression of low-density lipoprotein cholesterol below placebo levels (P <.001 at most time points). Raloxifene did not affect high-density lipoprotein cholesterol, whereas CEE increased it by 13.4% compared with placebo at 3 years (P <.001). Triglyceride concentrations increased 24.6% in the CEE group at 3 years (P <.003), a significantly greater change than in the raloxifene groups, which were 4.9% and 8.0% above baseline (P < or =.002) but not different from placebo. Urinary incontinence was reported in 11 women receiving CEE, but in only 1 or 2 in each of the other groups (P < or =.01 compared with the other groups). Hernias occurred less frequently in those receiving 150 mg/d of raloxifene or CEE (P =.03 vs placebo). CONCLUSIONS: Raloxifene and CEE have beneficial effects on bone density and bone turnover, although effects of CEE are more marked. Raloxifene and CEE produce different patterns of lipid responses and have distinct adverse effect profiles. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/15111373/A_comparison_of_the_effects_of_raloxifene_and_conjugated_equine_estrogen_on_bone_and_lipids_in_healthy_postmenopausal_women_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinte.164.8.871 DB - PRIME DP - Unbound Medicine ER -