Tags

Type your tag names separated by a space and hit enter

Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial.
Lupus 2013; 22(14):1470-8L

Abstract

OBJECTIVES

The purpose of this study was to identify the effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus (SLE).

METHODS

Subgroup data were analyzed for postmenopausal female SLE patients who participated in a randomized controlled trial of raloxifene on glucocorticoid-induced osteoporosis. Patients who were receiving a stable daily dose of prednisolone (≤10 mg) for ≥6 months were assigned to receive raloxifene (60 mg/day) or placebo on top of calcium and vitamin D. Disease activity was assessed by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA), SLE disease activity index (SLEDAI) and physicians' global assessment (PGA) every three months. Lupus flares were assessed by the SELENA flare instrument. Serial serum levels of homocysteine, high-sensitivity C-reactive protein (hsCRP) and soluble thrombomodulin (sTM) were measured.

RESULTS

A total of 62 patients (30 raloxifene, 32 placebo) were studied (age 52.5 ± 6.7 years; SLE duration 9.3 ± 7.6 years; menopause duration 7.2 ± 6.6 years). The SLEDAI at entry was 1.8 ± 2.3 (SLEDAI ≥ 6 in 8%). After 12 months, a significant gain in bone mineral density (BMD) of the lumbar spine (1.6%, p = 0.02), and reduction in bone resorption and formation markers was observed in the raloxifene but not in the placebo treated patients. The SELENA-SLEDAI and PGA scores area under the curve over 12 months were not significantly different between the two groups. There were three episodes of mild/moderate lupus flares (33% musculoskeletal, 33% dermatological) in the raloxifene group, compared to nine episodes of mild/moderate flares (27% musculoskeletal, 45% dermatological) in the placebo group (p = 0.11). The low density lipoprotein (LDL) cholesterol level increased significantly in the placebo but not raloxifene treated patients. No significant changes in homocysteine, hsCRP and sTM levels were observed in either group of patients.

CONCLUSIONS

Raloxifene significantly improves lumbar spine BMD in SLE patients but does not cause an increase in lupus activity or flares.

Authors+Show Affiliations

1Department of Medicine, Tuen Mun Hospital, Hong Kong.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24113197

Citation

Mok, C C., et al. "Effect of Raloxifene On Disease Activity and Vascular Biomarkers in Patients With Systemic Lupus Erythematosus: Subgroup Analysis of a Double-blind Randomized Controlled Trial." Lupus, vol. 22, no. 14, 2013, pp. 1470-8.
Mok CC, Ying SK, Ma KM, et al. Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial. Lupus. 2013;22(14):1470-8.
Mok, C. C., Ying, S. K., Ma, K. M., & Wong, C. K. (2013). Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial. Lupus, 22(14), pp. 1470-8. doi:10.1177/0961203313507987.
Mok CC, et al. Effect of Raloxifene On Disease Activity and Vascular Biomarkers in Patients With Systemic Lupus Erythematosus: Subgroup Analysis of a Double-blind Randomized Controlled Trial. Lupus. 2013;22(14):1470-8. PubMed PMID: 24113197.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial. AU - Mok,C C, AU - Ying,Shirley K Y, AU - Ma,K M, AU - Wong,C K, Y1 - 2013/10/10/ PY - 2013/10/12/entrez PY - 2013/10/12/pubmed PY - 2014/8/30/medline KW - Lupus KW - activity KW - biomarkers KW - flares KW - selective estrogen modulation SP - 1470 EP - 8 JF - Lupus JO - Lupus VL - 22 IS - 14 N2 - OBJECTIVES: The purpose of this study was to identify the effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus (SLE). METHODS: Subgroup data were analyzed for postmenopausal female SLE patients who participated in a randomized controlled trial of raloxifene on glucocorticoid-induced osteoporosis. Patients who were receiving a stable daily dose of prednisolone (≤10 mg) for ≥6 months were assigned to receive raloxifene (60 mg/day) or placebo on top of calcium and vitamin D. Disease activity was assessed by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA), SLE disease activity index (SLEDAI) and physicians' global assessment (PGA) every three months. Lupus flares were assessed by the SELENA flare instrument. Serial serum levels of homocysteine, high-sensitivity C-reactive protein (hsCRP) and soluble thrombomodulin (sTM) were measured. RESULTS: A total of 62 patients (30 raloxifene, 32 placebo) were studied (age 52.5 ± 6.7 years; SLE duration 9.3 ± 7.6 years; menopause duration 7.2 ± 6.6 years). The SLEDAI at entry was 1.8 ± 2.3 (SLEDAI ≥ 6 in 8%). After 12 months, a significant gain in bone mineral density (BMD) of the lumbar spine (1.6%, p = 0.02), and reduction in bone resorption and formation markers was observed in the raloxifene but not in the placebo treated patients. The SELENA-SLEDAI and PGA scores area under the curve over 12 months were not significantly different between the two groups. There were three episodes of mild/moderate lupus flares (33% musculoskeletal, 33% dermatological) in the raloxifene group, compared to nine episodes of mild/moderate flares (27% musculoskeletal, 45% dermatological) in the placebo group (p = 0.11). The low density lipoprotein (LDL) cholesterol level increased significantly in the placebo but not raloxifene treated patients. No significant changes in homocysteine, hsCRP and sTM levels were observed in either group of patients. CONCLUSIONS: Raloxifene significantly improves lumbar spine BMD in SLE patients but does not cause an increase in lupus activity or flares. SN - 1477-0962 UR - https://www.unboundmedicine.com/medline/citation/24113197/Effect_of_raloxifene_on_disease_activity_and_vascular_biomarkers_in_patients_with_systemic_lupus_erythematosus:_subgroup_analysis_of_a_double_blind_randomized_controlled_trial_ L2 - http://journals.sagepub.com/doi/full/10.1177/0961203313507987?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -