TY - JOUR
T1 - Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas
AU - Palomba, Stefano
AU - Orio, Francesco
AU - Russo, Tiziana
AU - Falbo, Angela
AU - Cascella, Teresa
AU - Doldo, Patrizia
AU - Nappi, Carmine
AU - Lombardi, Gaetano
AU - Mastrantonio, Pasquale
AU - Zullo, Fulvio
PY - 2004/6
Y1 - 2004/6
N2 - Background: Our aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas. Methods: Fifty pre-menopausal women with uterine leiomyomas were treated with leuprolide acetate depot at dose of 3.75 mg/28 days and raloxifene hydrochloride at 60 mg/day for 18 cycles. At admission and after each six cycles of treatment, bone mineral density (BMD), uterine, leiomyoma and non-leiomyoma dimensions, serum bone metabolism markers, lipid, glucose and insulin levels were evaluated. Leiomyoma-related and climacteric-like symptoms were assessed using a daily diary. Results: Throughout the study, no significant change in BMD or in any bone metabolism markers was observed. A significant decrease in uterine, leiomyoma and non-leiomyoma sizes was detected in comparison with baseline already after 6 months. No other significant change was observed at the successive follow-up visits. No significant change in lipid and glucose profile was detected throughout the study. The treatments were well tolerated. All treatment withdrawals (16%, eight out of 50) were due to lack of compliance, and none to drug-related adverse experiences. Conclusion: GnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.
AB - Background: Our aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas. Methods: Fifty pre-menopausal women with uterine leiomyomas were treated with leuprolide acetate depot at dose of 3.75 mg/28 days and raloxifene hydrochloride at 60 mg/day for 18 cycles. At admission and after each six cycles of treatment, bone mineral density (BMD), uterine, leiomyoma and non-leiomyoma dimensions, serum bone metabolism markers, lipid, glucose and insulin levels were evaluated. Leiomyoma-related and climacteric-like symptoms were assessed using a daily diary. Results: Throughout the study, no significant change in BMD or in any bone metabolism markers was observed. A significant decrease in uterine, leiomyoma and non-leiomyoma sizes was detected in comparison with baseline already after 6 months. No other significant change was observed at the successive follow-up visits. No significant change in lipid and glucose profile was detected throughout the study. The treatments were well tolerated. All treatment withdrawals (16%, eight out of 50) were due to lack of compliance, and none to drug-related adverse experiences. Conclusion: GnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.
KW - Bone loss
KW - GnRH a
KW - Leiomyomas/Metabolism/Raloxifene
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U2 - 10.1093/humrep/deh296
DO - 10.1093/humrep/deh296
M3 - Article
C2 - 15117890
AN - SCOPUS:3042683626
VL - 19
SP - 1308
EP - 1314
JO - Human Reproduction
JF - Human Reproduction
SN - 0268-1161
IS - 6
ER -