Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas.
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.


CONCLUSIONS
GnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.
Palomba
Stefano
S
Department of Obstetrics and Gynecology, University 'Magna Graecia' of Catanzaro, Italy. stefanopalomba@tin.it
Orio
Francesco
F
Russo
Tiziana
T
Falbo
Angela
A
Cascella
Teresa
T
Doldo
Patrizia
P
Nappi
Carmine
C
Lombardi
Gaetano
G
Mastrantonio
Pasquale
P
Zullo
Fulvio
F
D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D015519:Bone Density / Q000187:drug effects; D016723:Bone Remodeling / Q000187:drug effects; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D016729:Leuprolide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008137:Longitudinal Studies; D008875:Middle Aged; D010352:Patient Dropouts; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D014666:Vasomotor System / Q000503:physiopathology
D018931:Antineoplastic Agents, Hormonal; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D008055:Lipids; D020845:Selective Estrogen Receptor Modulators; D007987:Gonadotropin-Releasing Hormone; D020849:Raloxifene Hydrochloride; D016729:Leuprolide