NICE has issued an updated guideline recommending the use of ulipristal acetate 5mg (Esmya), up to 4 courses, as first-line treatment for patients presenting with heavy menstrual bleeding (HMB) and uterine fibroids 3cm or more in diameter.
Clinical data has shown that 4 courses of ulipristal acetate 5mg resulted in 73% of eligible patients achieving “normal” (controlled) bleeding, and a 72% fibroid volume reduction from baseline.
Current treatment options include major surgery, such as hysterectomy, which can significantly affect a woman’s ability to have children and are costly to the NHS. Surgical treatment for uterine fibroids cost NHS England £119 million in 2015 alone. Ulipristal acetate 5mg, a once-daily pill, offers the first medical treatment licensed for the long-term management of uterine fibroids for the approximate 40,000 women who are treated in hospital in England every year. Until now, roughly half of women presenting with uterine fibroids have been treated with an invasive procedure at least once.
Ertan Saridogan, Consultant Gynaecologist, University College Hospital and The Portland Hospital, said: “Uterine fibroids are extremely common and a significant proportion of women will experience associated symptoms, which can include heavy menstrual bleeding and severe pain.
“Esyma has been proven to target the fibroids directly, both reducing growth and easing these symptoms, therefore improving a woman’s quality of life.”
About 1 in 3 women develop uterine fibroids at some time in their life, and approximately 20-40% of these women will suffer from symptoms. Uterine fibroids are benign (non-cancerous) tumours, which grow in the uterus and are common in women of a child-bearing age.
Around 40% of women diagnosed with fibroids have experienced fertility issues. In addition, 75% of sufferers consider the condition to have a severe impact on the quality of their day-to-day life and half of women with uterine fibroids say that their condition makes them depressed. This is a result of having to cope with on-going symptoms such as prolonged painful bleeding, HMB, pressure on the bladder, alongside pregnancy complications and pain during intercourse.
Dr Sarah Gray of the Primary Care Women’s Health Forum and a GP Specialist in Women’s Health, 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.
“NICE has now affirmed that a medical treatment which requires only the taking of tablets is effective and can be offered to women by experienced doctors. If a woman has fibroid-related problems that are affecting her life, she should go to her healthcare provider and discuss what is best for her as surgery is not inevitable.”
One in 4 women with symptomatic fibroids will wait more than five years before being diagnosed. HMB accounts for the loss of 3.5 million working days in the UK every year; as this is the most common symptom of uterine fibroids, this condition contributes to these lost working days.
Ulipristal acetate 5mg is a selective progesterone receptor modulator, which acts by blocking receptors of the hormone progesterone. Progesterone is involved in controlling the growth of the lining of the womb; however, in some women, it is responsible for promoting the growth of fibroids.