• Health They demonstrate the effectiveness of a drug against the hot flashes of menopause

Uncomfortable, unexpected... A rise in body heat that can end in an exaggerated blush or sweating and even end in a box of chills. Hot flashes alter the quality of life of women who walk from their fertile stage to menopause. This alteration of the quality of life had no more relief than looking for a fan or a place to 'hide' to spend the 'bad time'.

For a few days now, women in the US will have another option: a drug called fezolinetant. The current one is based on estrogen supplementation, but some women do not accept it and, in cases such as breast cancer survivors, they cannot be given.

"In this case, the product that has been approved by the FDA gives us one more tool to add to our therapeutic arsenal, for the health care of a large percentage of women who for various reasons cannot benefit from menopausal hormone therapy," explains María Fasero, spokesperson for the Spanish Association for the Study of Menopause (AEEM).

Hot flashes are perceived by up to 80% of womenand about 25% are frequent and severe. Not only women in menopause suffer from them, but others with a special risk profile, such as breast cancer survivors who receive hormone cancellation treatment.

Fasero, coordinator and founder of the Healthy Menopause Unit of the Hospital de la Zarzuela, regrets that there is still time for this new resource to reach Europe and even more so in Spain. "There are still many barriers that he has to go through. For a product to be marketed in Spain, it must pass the approval of the EMA (European Medicines Agency), which is expected by the end of the year. Then, it has the green light in Spain by the Aemps (Spanish Agency for Medicines and Health Products). So there's still a long way to commercialize here."

How does the anti-hot flash drug work?

Neurokinin 3 is a small protein that acts as a stimulant of neurons, the cells of the central nervous system. At the level of the brain, in a region known as the hypothalamus, its production is regulated by estrogen, the female ovarian hormones. When the ovary stops working, there is an overproduction of neurokinin 3, which excites the neurons responsible for maintaining temperature control. This is when the high comes.

The result is the sudden sensation of heat, which can appear more or less frequently or intensively, and which, in some women, interferes with sleep, work productivity and other activities of daily living. In women where this problem is particularly acute, such as those subjected to intense ovarian deprivation due to diseases such as breast cancer, the series of hot flashes, frequent and intense in some cases, becomes a determinant of suffering added to the disease itself.

Fasero points out the precise use of this new therapy. "I think effective treatment of some menopausal symptoms, such as hot flashes, should not be confused with the use of menopausal hormone therapy. This therapy encompasses and treats many other symptoms that alter the quality of life of women in menopause, so I think no comparisons can be made."

Therefore, the expert specifies that "the indication for the treatment of hot flashes can be equated to menopausal hormone therapy." But it is not so, "this product goes on the market with the indication of the treatment of vasomotor symptoms in those women who do not want or cannot receive menopausal hormone therapy."

On the time of use, Fasero details that "although the clinical trials that fezolinetant has are 52 weeks, in routine clinical practice, it could be used for as long as the vasomotor symptoms last in women."

Are there any risky side effects?

The new molecules are always accompanied by shadows that can condition their use before administration. "The origin of the fear about liver damage comes from 2017 where a clinical trial on a molecule with a similar mechanism of action, called Pavinetant, had to be interrupted due to the potential harmful effects on the liver," recalls Fasero.

In the case of this new molecule, "it has been shown to be a safer molecule; However, due to this alarm, it is advisable that women who start this treatment perform at the beginning an analysis to assess liver function and a quarterly control during the first nine months of use of the drug. " And the coordinator of the Hospital de La Zarzuela continues with the explanation, "probably this alarm can be eliminated with the use of the product in routine clinical practice, but the safety of the woman must always prevail, so being cautious is always correct".

A drug already tested by Spanish women, but in clinical trials

The Health Research Institute INCLIVA, of the Hospital Clínic de València, participated in international research for the clinical development of new drugs to alleviate the effects of the heats from which these results are derived, recently published in The Lancet.

The spokeswoman of the AEEM explains that "the information of the clinical trials that we have makes us think, that it is a very effective drug for the treatment of hot flashes, that it acts very quickly (in a week you can notice its effect) and above all that they do not act at the level of estrogen receptors. This is important for a large percentage of women who don't want to be treated for hot flashes because they're afraid of hormones."

Other future options still in the test lab

Fasero assures that in the future there will be more news. "Probably by finding the origin of hot flashes at the CNS (central nervous system) level; Pharmacological developments focus on research on these substances that transmit the information. In fact, there are already clinical trials of other substances similar to fezolinetant, such as elinzanetant whose action is twofold, since in addition to acting on the neurons that transmit the impulse of hot flashes, it seems that it could act on the neurons that transmit mood and sleep information, two symptoms also very frequent in women in menopause. "

It also mentions that "new clinical trials are being developed to extend fezolinetant such as the Daylight study in women in whom menopausal hormone therapy is contraindicated."

Living with the side effects of menopause

Among the range of symptoms of menopause, hot flashes are one of the most prevalent and with the greatest negative impact on work activity and quality of life in general. But we must not forget that mood swings, sleep disturbances, headaches and joint pain, among others, also alter routines.

From the Spanish Society of Gynecology and Obstetrics point out that this period varies from one woman to another and the pattern also differs. They can suffer from two and three years before menopause to five after.

  • Gynaecology

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