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Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study.
Maturitas 2009; 62(3):311-6M

Abstract

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.

Authors+Show Affiliations

Department of Gynecology and Obstetrics at the University of São Paulo, Ribeirão Preto School of Medicine, Ribeirão Preto, Brazil. carol.sales@uol.com.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19193505

Citation

Vieira, Carolina Sales, et al. "Tibolone in Postmenopausal Women With Systemic Lupus Erythematosus: a Pilot Study." Maturitas, vol. 62, no. 3, 2009, pp. 311-6.
Vieira CS, Pereira FV, de Sá MF, et al. Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study. Maturitas. 2009;62(3):311-6.
Vieira, C. S., Pereira, F. V., de Sá, M. F., Paulo, L. J., Martins, W. P., & Ferriani, R. A. (2009). Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study. Maturitas, 62(3), pp. 311-6. doi:10.1016/j.maturitas.2008.12.021.
Vieira CS, et al. Tibolone in Postmenopausal Women With Systemic Lupus Erythematosus: a Pilot Study. Maturitas. 2009 Mar 20;62(3):311-6. PubMed PMID: 19193505.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tibolone in postmenopausal women with systemic lupus erythematosus: a pilot study. AU - Vieira,Carolina Sales, AU - Pereira,Fábio Vasconcelos, AU - de Sá,Marcos Felipe Silva, AU - Paulo,Louzada Júnior, AU - Martins,Wellington Paula, AU - Ferriani,Rui Alberto, Y1 - 2009/02/03/ PY - 2008/04/12/received PY - 2008/12/23/revised PY - 2008/12/29/accepted PY - 2009/2/6/entrez PY - 2009/2/6/pubmed PY - 2009/6/12/medline SP - 311 EP - 6 JF - Maturitas JO - Maturitas VL - 62 IS - 3 N2 - 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. SN - 1873-4111 UR - https://www.unboundmedicine.com/medline/citation/19193505/Tibolone_in_postmenopausal_women_with_systemic_lupus_erythematosus:_a_pilot_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5122(09)00006-1 DB - PRIME DP - Unbound Medicine ER -