For now only in the United States. But the nearly three million Italian patients are anxiously waiting for the therapeutic armamentarium against endometriosis to be enriched by us too. The new drug just approved by the FDA (Food and Drug Administration) for the management of moderate and severe menstrual and pelvic pain associated with the disease is reserved for premenopausal women and is already available in the United States. But a request for approval from the European Medicines Agency should arrive in the coming months.
Endometriosis: the operation of Giorgia Soleri, Damiano dei Maneskin’s girlfriend. What is this disease
by Claudia Carucci
Endometriosis: a new chance to control pain and bleeding
The drug can be taken as a tablet once a day. A mode of recruitment that facilitates compliance with a therapy that – from indications of the companies that have developed it, Pfizer and Myovant Sciences – can be followed for 24 months. It is a mix of hormones – an estrogen, a progestin and a gonadotropin release antagonist, which inhibits ovarian stimulation – which ensures a reduction in pain and bleeding. This is demonstrated by two phase 3 studies published in Lancet, in which the effectiveness of the new active ingredient was verified against a placebo and only one of the molecules contained in the new drug (Relugolix) with an administration lasting six months. The results showed a reduction in pelvic pain caused by endometriosis and dysmenorrhea, the uterine pain that occurs during the menstrual cycle. And without the addition of painkillers, a constant for many of these women before starting the new therapy.
Endometriosis: Cecilia: “15 years of ordeal but the decision to have a child saved me”
by Claudia Carucci
Medical or surgical therapy?
These are, in fact, the main manifestations of endometriosis. A disease characterized by the growth and spread of the endometrium – the mucous membrane that covers the inner surface of the uterus – into different organs. And that requires long-term medical treatment. At the moment, drugs based on progesterone or estrogen and progesterone are used together: the latter is the scheme of the contraceptive pill, prescribed to patients to stop the development of endometrial foci in abnormal locations. Pain, however, is a constant for these patients that the drugs currently in use do not always solve. Hence the need to also resort to painkillers such as paracetamol and NSAIDs. In addition to surgery to remove the parts of the endometrium that grew out of the uterus. A possibility that is not an alternative to medical therapy, but that is reserved for those women (3-4 out of 10) who do not benefit from drugs after six months of therapy. Or that show conditions of occlusion – of the intestine or ureters – which risk compromising the functionality of vital organs.
Endometriosis, a pain not to be underestimated
by Fiammetta Cupellaro
Insidious effect of treatment: loss of bone mass
Hence the continuous search for new therapeutic solutions: effective and well tolerable. The side effects caused by the last therapy, recorded in at least 3 percent of the women treated, proved to be manageable: headache, fatigue, dizziness, nausea and decreased sexual desire. Against which, on the other hand, one of the most insidious manifestations related to endometriosis treatments has been reduced: the loss of bone mass. A consequence that, over the years, can expose postmenopausal women (already at risk) to a greater probability of suffering fractures.
Endometriosis: Less stress and more anti-inflammatory foods to relieve symptoms
by Irma D’Aria
One densitometry per year
In women treated with the new drug – for over a year already available to women suffering from uterine fibroids – less than one percent of bone tissue was lost one year after the start of treatment. These are the evidences collected so far, which the same group of researchers who signed the first two papers intends to verify over a longer period of time to evaluate the effectiveness and any contraindications over time. For the moment, the advice remains to “perform a bone densitometry once a year during the treatment of endometriosis”.
In Italy, the issue of drug reimbursement remains
It is mainly this side effect that discourages the use of such a drug in younger patients. “The ideal target is women between the ages of 40 and 50,” she says Renato Seracchioli, director of the complex operational unit of gynecology and physiopathology of human reproduction of the Sant’Orsola-Malpighi polyclinic in Bologna. A similar drug is actually already available in Italy. But currently only authorized for the treatment of uterine fibroids and abnormal uterine bleeding. “It will be necessary to verify its effectiveness for a longer period, since the target is represented by patients who need chronic therapies”, adds the expert, one of the drafters of the guidelines for the treatment of endometriosis drawn up by the Italian Society of Gynecology and Obstetrics. An aspect that also calls into question the economic sustainability of these treatments, the subject of a paradox in our country: entirely borne by the patients, compared to the recent inclusion in the Essential Levels of Assistance (Lea) of specialist visits and some diagnostic investigations .