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Uterine Fibroid Treatments

Esmya® for long-term management of Uterine Fibroids

Uterine fibroid treatments

While many patients with mild/moderate symptoms can be managed using various pharmacological treatments, previously patients presenting with moderate/severe symptoms would progress to a point where surgical or radiological interventions would have been required. The main driver for the decision to undertake fibroid surgery is due to the severity of symptoms including uterine bleeding, discomfort, and pain. The size of the uterus and fibroids affects the decision to perform surgery, and which type of surgery is chosen.

Surgical interventions include hysterectomy, or in women who wish to preserve their fertility, the more conservative option is myomectomy.

While myomectomy is a preferable option for women who desire to preserve fertility, it has a higher risk of post-operative pyrexia (fever), pelvic haematoma formation and post-operative adhesions, and may need to be repeated if fibroids reappear. Other less invasive procedures which have been developed include Uterine Artery Embolisation (UAE), and, in women where the dominant symptom is bleeding, fibroid size is relatively small, and fertility is not an issue, endometrial ablation.

Surgery for treatment of uterine fibroids is rarely performed as an emergency procedure, and waiting several months before proceeding to surgery is the standard in European countries for many patients.

An array of various therapies is available to manage uterine fibroids. These fall into two main categories46: pharmacological therapies and surgical treatments.

References

  • 2980 Reference 46 - Unmet Therapeutic Needs for Uterine Myomas. Charles E. Miller. The journal of Minimally Invasive Gynecology, January 2009

Pharmacological Therapies

Approach Appropriate population Description
Esmya®
(Selective Progesterone Receptor Modulator, SPRM)
EU Market only
Young or premenopausal women
  • Orally administered
  • Treats multifactorial symptoms of uterine fibroids such as bleeding, amenorrhea, pain and fibroids size
  • Rapid and sustained reduction in heavy bleeding
  • Continuous reduction of fibroid size
  • Repeated 3-months treatment courses that need to be separated by off-drug interval
GnRH1 agonists Preoperative therapy in young or premenopausal women
  • Temporary treatment (3 to 6 months), fibroid re-growth on cessation
  • Flare effect during the first month
  • Route of administration: Injections
  • Adverse effects including loss of bone mineral density and menopausal symptoms
Pharmacological therapies used for treatment of Heavy Menstrual Bleeding (including LNG-IUS2, COC3, Oral progestogen, NSAIDs4 and tranexamic acid) Young or premenopausal women
  • Focused mainly on bleeding and /or pain. Limited or no effect on fibroid size
  • LNG-IUS are contra-indicated in women with distorted uterus
1 GnRH: Gonadotrophin releasing hormone

2 LNG-IUS: Levonorgesteral-releasing intrauterine system
3 COC: Combined oral contraceptive pill
4 NSAID: Non-steroidal anti-inflammatory drug

References

  • 125 Reference 1 - Esmya® SmPC. May 2015.
  • 126 Reference 2 - Wallach EE, et al. Uterine Myomas: An overview of development, clinical features and management. Obstet Gynecol 2004;104(2):393-406.
  • 127 Reference 3 - Spies JB., et al. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002; 99(2): 290-300.
  • 477 Reference 4 - Downes E., et al. The burden of uterine fibroids in five European countries. Eur J Obstet Gynecol Reprod Biol 2010; 152(1): 96-102.

Surgical treatments

 

Approach Appropriate population Description
Hysterectomy Women who require removal of uterus, who are close to menopause, or who do not desire fertility
  • Definitive therapy
  • Removes entire uterus and therefore prevents fibroid regrowth
  • Loss of fertility
  • Surgical morbidity including post-operative, pain, infection and urinary complications, and/or mortality,
  • Requires hospitalisation and is a costly procedure
Myomectomy Women with visible and/or palpable fibroids
  •  A surgical alternative to treat fibroids in women who wish to preserve their fertility
  • Recurrence of fibroids may occur; a,re-intervention rate of 10% to 25% has been reported
  • Surgical morbidity including post-operative, pain, infection, urinary complications, injury to bladder, bowel, and blood vessels, post-operative adhesions (can cause bladder obstruction and pain), and or/mortality
UAE (Uterine,Artery Embolisation) Women who have small uterine fibroids (<8cm) that are not subserous, submucosal, or pedunculated
  •  Minimally invasive surgical procedure
  • Morbidity including pain, possible, post-embolisation syndrome, possibility of severe complications
  • Impact on fertility is unknown
  • Costly; must be performed by an interventional radiologist
  • Re-intervention rate of 15% to 35%
Myolysis/cryomyolysis Women who do not desire fertility with several, small uterine fibroids
  • Preserves uterus, outpatient surgery
  • Risk of adhesions, less effective for large and multiple fibroids, under treatment or overtreatment, fertility not advised
MRgFUS (Magnetic,Resonance-guided focused Ultrasound Surgery) Women with small uterine fibroids (<8cm)
  •  Incisionless and bloodless (therefore, allows fast return to normal activities)
  • Insufficient data is available regarding the effect of MRgFUS on fertility, likeliness of recurrence of fibroids, and long-term effects
  • Experimental procedure only available at very few centres
  • Costly; must be performed by an interventional radiologist
LUAO (Laparoscopic,Uterine Artery Occlusion) Women with small or large fibroids, subserosal fibroids
  • Requires technical skill 
  • Dependent on fibroid location
  • Recurrence of fibroids may occur
  • Effect on fertility is unclear
  • Data on LUAO is limited, and there is insufficient long-term data available

References

  • 2980 Reference 46 - Unmet Therapeutic Needs for Uterine Myomas. Charles E. Miller. The journal of Minimally Invasive Gynecology, January 2009

Uterine Fibroids Economic Impact

Women with uterine fibroids experience significantly worse Health-Related Quality of Life (HRQoL) than women without fibroids3. Heavy menstrual bleeding (HMB) is common in women with symptomatic fibroids, and is associated with a considerable QoL burden, including psychological and social factors, and disruption to a normal routine39. Uterine fibroids impair productivity, increase absenteeism, and are associated with increased disability claims for symptomatic women40. In the CHASM study4 which was carried out in five European countries (France, Germany, Italy, Spain and UK) and used WPAI-SHP to measure absenteeism scores, employed women with uterine fibroids reported an absenteeism rate of 32.7%. Furthermore productivity was impaired by 36.1% and activity was impaired by 37.9%4.

Surgical treatment for uterine fibroids place a significant demand on health care resources. A further economic burden may be associated with the complications resulting from surgery, or the need for re-surgery, particularly in cases where the women have undergone UAE or myomectomy.

References

  • 127 Reference 3 - Spies JB., et al. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002; 99(2): 290-300.
  • 477 Reference 4 - Downes E., et al. The burden of uterine fibroids in five European countries. Eur J Obstet Gynecol Reprod Biol 2010; 152(1): 96-102.
  • 2903 Reference 39 - Clinical Guideline on Heavy Menstrual Bleeding. January 2007. National Collaborating Centre for Women’s and Children’s Health/ NICE
  • 2905 Reference 40 - Stewart EA. Uterine Fibroids. The Lancet. 2001. Vol 357.
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