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A double-blind, placebo-controlled, clinical trial of dehydroepiandrosterone in severe systemic lupus erythematosus.
Abstract
OBJECTIVE: To determine if dehydroepiandrosterone (DHEA) is beneficial in severe systemic lupus erythematosus (SLE). METHODS: A double-blinded, placebo-controlled, randomized clinical trial in 21 patients with severe and active SLE, manifestated primarily by nephritis, serositis or hematological abnormalities. In addition to conventional treatment with corticosteroids +/- immunosuppressives, patients received DHEA 200 mg/d vs. placebo for 6 months, followed by a 6-month open label period. The primary outcome was a prospectively defined responder analysis, based on a quantitatively specified improvement of the principal severe lupus manifestation at 6 months. RESULTS: Nineteen patients were available for evaluation at 6 months. Baseline imbalance between the groups was noted, with the DHEA group having greater disease activity at baseline (P<0.05 by physician's global assessment). Eleven patients were responders: 7/9 patients on DHEA vs. 4/10 patients on placebo (P<0.10). Of the secondary outcomes, mean improvement in SLE disease activity index (SLE-DAI) score was greater in the DHEA group (-10.3+/-3.1 vs. -3.9+/-1.4. P<0.07). Bone mineral density at the lumbo-sacral spine showed significant reduction in the placebo group, but was maintained in the DHEA group. CONCLUSION: DHEA therapy, when added to conventional treatment for severe SLE, may at most have a small added benefit with respect to lupus outcomes, but baseline imbalances in the study population limit the generalizability of the results. DHEA appears to have a protective effect with respect to corticosteroid-induced osteopenia in such patients.
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“DHEA treatment in glucocorticoid-treated patients with systemic lupus erythematosus (327, 328) led to significant improvement in overall performance and activity.”
From Endocrine and intracrine sources of androgens in women: inhibition of breast cancer and other roles of androgens and their precursor dehydroepiandrosterone (2003) · cites this paper as [328]
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Metadata
- Authors
- van Vollenhoven, R. F., Park, J. L., Genovese, M. C., West, J. P., & McGuire, J. L.
- Affiliations
- Division of Immunology & Rheumatology, Stanford, University Medical Center; Department of Rheumatology, Karolinska Hospital, Stockholm, 17176 Sweden
- Stanford Medicine (US)
- ORCID
- Genovese, M C
- Venue
- Lupus
- Publisher
- SAGE Publications
- Published
- 1999-03
- Volume
- 8
- Issue
- 3
- Pages
- 181-187
- ISSN
- 0961-2033 (ISSN-L)
- 1477-0962
- OpenAlex
- W2117480041
- Cited by
- 144
- References
- 23
- Citations by year
- 2024: 1 · 2023: 6 · 2022: 4 · 2021: 5 · 2020: 3 · 2019: 3 · 2018: 3 · 2017: 4 · 2016: 3 · 2015: 1 · 2014: 3 · 2013: 2 · 2012: 4
- FWCI
- 7.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Lupus (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5p60ar020610-19)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (AR-20610)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Rheumatology › Systemic Sclerosis and Related Diseases
- Keywords
- dehydroepiandrosterone, systemic lupus erythematosus, lupus nephritis, serositis, hematological abnormalities, bone mineral density, SLE disease activity, adjunctive therapy, immunosuppressive therapy
- MeSH terms
- Adrenal Cortex Hormones, Adult, Dehydroepiandrosterone, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Immunosuppressive Agents, Lupus Erythematosus, Systemic, Male, Middle Aged, Prospective Studies, Bone Density, Treatment Outcome
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