Management of patients receiving long-term treatment with mifepristone

Fertil Steril. 2005 Dec;84(6):1719-26. doi: 10.1016/j.fertnstert.2005.05.056.

Abstract

Objective: To determine clinical side effects and biochemical and hematological abnormalities in patients with nonresectable meningioma on long-term mifepristone (RU 486) therapy.

Design: Long-term mifepristone administration in patients with meningioma.

Setting: Outpatient clinic of a university hospital.

Patient(s): Sixteen women and 9 men aged 22-80 years with nonresectable meningioma.

Intervention(s): Mifepristone (200 mg daily). One patient received treatment for more than 13 years; six received treatment for 10-12 years; five received treatment for 4-9 years; eight received treatment for 1-4 years; and the remainder received treatment for 4-10 months.

Main outcome measure(s): Evaluation of side effects and of hematological and biochemical abnormalities.

Result(s): Fatigue was observed in 22 of 25 patients. Endometrial hyperplasia occurred in one premenopausal woman and one postmenopausal woman. Another two women had endometrial thickening without hyperplasia. There were no consistent abnormalities in liver or renal function or in any other biochemical or hematological parameters. One subject (on long-term dexamethasone) developed hypoadrenalism, which responded to treatment.

Conclusion(s): Mifepristone can be administered for prolonged periods. Ultrasound should be performed if irregular vaginal bleeding occurs. In asymptomatic women, it should be performed annually. If endometrial thickening is observed, then endometrial biopsy is recommended. Because biochemical hypothyroidism has been reported during long-term mifepristone therapy, thyroid function tests should be performed annually.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Insufficiency / chemically induced
  • Adrenal Insufficiency / pathology
  • Adult
  • Aged
  • Aged, 80 and over
  • Amenorrhea / chemically induced
  • Amenorrhea / pathology
  • Drug Monitoring / methods
  • Endometrial Hyperplasia / chemically induced
  • Endometrial Hyperplasia / pathology
  • Female
  • Hormone Antagonists / administration & dosage*
  • Hormone Antagonists / adverse effects
  • Humans
  • Male
  • Meningeal Neoplasms / drug therapy*
  • Meningioma / drug therapy*
  • Middle Aged
  • Mifepristone / administration & dosage*
  • Mifepristone / adverse effects
  • Time Factors

Substances

  • Hormone Antagonists
  • Mifepristone