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

Abstract

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.

• Authors: Stefano Palomba, Francesco Orio Jr, Tiziana Russo, Angela Falbo, Teresa Cascella, Patrizia Doldo, Carmine Nappi, Gaetano Lombardi, Pasquale Mastrantonio, Fulvio Zullo
• Journal: Human reproduction (Oxford, England) (Hum Reprod) Vol. 19 Issue 6 Pg. 1308-14 (Jun 2004) ISSN: 0268-1161 [Print] England
• PMID: 15117890 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents, Hormonal
• Blood Glucose
• Delayed-Action Preparations
• Lipids
• Selective Estrogen Receptor Modulators
• Gonadotropin-Releasing Hormone
• Raloxifene Hydrochloride
• Leuprolide

Topics

• Antineoplastic Agents, Hormonal (administration & dosage, adverse effects, therapeutic use)
• Blood Glucose (metabolism)
• Bone Density (drug effects)
• Bone Remodeling (drug effects)
• Delayed-Action Preparations
• Drug Therapy, Combination
• Female
• Gonadotropin-Releasing Hormone (agonists)
• Humans
• Leiomyoma (drug therapy, metabolism, pathology, physiopathology)
• Leuprolide (administration & dosage, adverse effects, therapeutic use)
• Lipids (blood)
• Longitudinal Studies
• Middle Aged
• Patient Dropouts
• Raloxifene Hydrochloride (adverse effects, therapeutic use)
• Selective Estrogen Receptor Modulators (adverse effects, therapeutic use)
• Severity of Illness Index
• Treatment Outcome
• Uterine Neoplasms (drug therapy, metabolism, pathology, physiopathology)
• Vasomotor System (physiopathology)