A drug treatment has been approved for the management of benign tumours in the uterus by the NHS in England, potentially providing an alternative to invasive procedures for many patients.
Ulipristal acetate (Esmya) has now been recommended as a first-line treatment of uterine fibroids by the National Institute for Health and Care Excellence.
“Up until now we have only been able to remove or shrink them using procedures”
The recommendation was included in an update to its heavy menstrual bleeding guideline, which was published earlier this week.
NICE said it had looked again at its 2007 clinical guideline on heavy menstrual bleeding after a routine review in 2015 identified new evidence on progesterone-receptor modulators.
Following consultation, it said two new recommendations had now been added to the guideline for treating fibroids 3 cm or more in diameter.
Under the updated guideline, up to four courses of ulipristal acetate 5mg should be offered to women with heavy menstrual bleeding and fibroids of 3cm or more in diameter, and a haemoglobin level of 102g per litre or below.
In addition, ulipristal acetate 5mg – again up to four courses – should be considered for women with heavy menstrual bleeding and fibroids of 3cm or more in diameter, and a haemoglobin level above 102g per litre.
Alternative options include major surgery, such as hysterectomy. Roughly half of women presenting with uterine fibroids have previously been treated with an invasive procedure at least once.
Ulipristal acetate, manufactured by pharmaceutical firm Gedeon Richter, is a selective progesterone receptor modulator that is taken once a day in pill form.
It acts by blocking receptors of progesterone. The hormone is involved in controlling the growth of the lining of the womb, but in some women it is responsible for promoting the growth of fibroids.
According to Gedeon Richter, clinical data has shown that four courses of the drug resulted in 73% of eligible patients achieving “normal” bleeding, and a 72% fibroid volume reduction from baseline.
Fibroids are common in women of child-bearing age and around a third develop them at some stage in their life, of which 20-40% will experience symptoms including prolonged painful bleeding, heavy menstrual bleeding, bladder pressure, pregnancy complications and pain during intercourse.
Dr Sarah Gray, from the the Primary Care Women’s Health Forum and a GP specialist in women’s health from Cornwall, said: “Uterine fibroids are common and can cause women significant problems due to their size, position or effect on bleeding.
“Up until now we have only been able to remove or shrink them using procedures that require hospital admission,” she said. “NICE has now affirmed that a medical treatment which requires only the taking of tablets is effective.”