Document Detail

Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study.
MedLine Citation:
PMID:  19193505     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine the influence of the use of tibolone on the frequency of flares of systemic lupus erythematosus (SLE) in postmenopausal patients. METHODS: Thirty patients with inactive or controlled SLE were included in the study. Patients were randomized to receive a 12-month course of either tibolona (2.5 mg/day) or placebo. The following were investigated: hypoestrogenism symptoms by Kupperman index, weight; anti-dsDNA antibodies; SLE flares (frequency) assessed by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI); and biochemical profile (total cholesterol, high-density lipoprotein cholesterol [HDL-C], triglycerides, complement components [C3/C4], alpha1-acid glycoprotein, urea, creatinine, 24-h proteinuria, C-reactive protein and erythrocyte sedimentation rate). RESULTS: The reduction in Kupperman index was greater in the patients using tibolone than in those using placebo. The mean SLEDAI was not different between the groups during the study as well as SLE flare frequency (tibolone: 2/15 [13.3%] vs. placebo: 1/15 [6.7%]; p=0.54). All cases of flares were considered mild to moderate. Although the groups were similar at the baseline evaluation, after 6 and 12 months of treatment lower values were found in the tibolone group for triglycerides (6 months: 161.6+/-30.9 mg/dl vs. 194.4+/-46.5; p=0.04; 12 months 163.7+/-29.8 mg/dl vs. 204.1+/-49.9 mg/dl; p=0.02; tibolone vs. placebo group, respectively) and for HDL-C (6 months: 40.7+/-10.7 mg/dl vs. 53.4+/-16.5; p=0.02; 12 months: 47.2+/-7.9 mg/dl vs. 63.2+/-16.3mg/dl; p<0.01; tibolone vs. placebo group, respectively). There were no differences between the two groups in any of the remaining variables. CONCLUSION: In patients with inactive or stable SLE, the short-term use of tibolone did not significantly affect the frequency of flares. In addition, tibolone was well tolerated and effective to control hypoestrogenism related symptoms in SLE patients.
Carolina Sales Vieira; Fábio Vasconcelos Pereira; Marcos Felipe Silva de Sá; Louzada Júnior Paulo; Wellington Paula Martins; Rui Alberto Ferriani
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2009-02-03
Journal Detail:
Title:  Maturitas     Volume:  62     ISSN:  1873-4111     ISO Abbreviation:  Maturitas     Publication Date:  2009 Mar 
Date Detail:
Created Date:  2009-03-30     Completed Date:  2009-06-11     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7807333     Medline TA:  Maturitas     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  311-6     Citation Subset:  IM    
Department of Gynecology and Obstetrics at the University of São Paulo, Ribeirão Preto School of Medicine, Ribeirão Preto, Brazil.
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MeSH Terms
Cholesterol, HDL / blood
Double-Blind Method
Estrogen Receptor Modulators / therapeutic use*
Estrogen Replacement Therapy*
Estrogens / blood,  deficiency*
Lupus Erythematosus, Systemic / blood,  drug therapy*
Middle Aged
Norpregnenes / therapeutic use*
Pilot Projects
Postmenopause / blood
Severity of Illness Index
Treatment Outcome
Triglycerides / blood
Reg. No./Substance:
0/Cholesterol, HDL; 0/Estrogen Receptor Modulators; 0/Estrogens; 0/Norpregnenes; 0/Triglycerides; 5630-53-5/tibolone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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