Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study.
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.


CONCLUSIONS
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.
Vieira
Carolina Sales
CS
Department of Gynecology and Obstetrics at the University of São Paulo, Ribeirão Preto School of Medicine, Ribeirão Preto, Brazil. carol.sales@uol.com.br
Pereira
Fábio Vasconcelos
FV
de Sá
Marcos Felipe Silva
MF
Paulo
Louzada Júnior
LJ
Martins
Wellington Paula
WP
Ferriani
Rui Alberto
RA
D008076:Cholesterol, HDL / Q000097:blood; D004311:Double-Blind Method; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000097:blood / Q000172:deficiency*; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D009652:Norpregnenes / Q000627:therapeutic use*; D010865:Pilot Projects; D017698:Postmenopause / Q000097:blood; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D020847:Estrogen Receptor Modulators; D004967:Estrogens; D009652:Norpregnenes; D014280:Triglycerides; C027385:tibolone