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- News & views
- 14 March 2018
New drug treats menopausal hot flushes within three days
A new type of experimental drug has been found to reduce hot flushes in menopausal women by almost three quarters in just three days, a new study has revealed.
The treatment has also been shown to reduce the severity of hot flushes by over a third in the same short time period.
The new in-depth analysis of data collected from a clinical trial first published last year also revealed that sleep and concentration significantly improved in the three-day window.
The randomised, double-blind, placebo-controlled trial involved 37 menopausal women aged between 40 and 62, and who experienced seven or more hot flushes a day.
Participants were randomly chosen to first receive either an 80mg daily dose of the drug, MLE4901, or a placebo over the course of a four-week period.
They then switched to receive the other tablet for an additional four weeks, which ensured the women acted as their own controls during the study, and the effects of the drug were clear.
The researchers found that the drug significantly reduced the average total number of flushes during the four-week treatment period, as well as their severity, compared to when the patients received the placebo.
The new experimental compounds are thought to work by blocking the action of a brain chemical called neurokinin B (NKB).
Previous animal and human trials have shown increased levels of NKB may trigger hot flushes.
The drug compound is thought to prevent NKB activating temperature control areas within the brain, which appears to halt hot flushes.
The new data also revealed that the drug was as effective at improving daytime hot flush symptoms as it was at improving night time symptoms.
On top of this, the women reported an 82% decrease in in the amount their hot flushes interrupted their sleep, and a 77% reduction in interruption to their concentration.
However, the team says further research is needed to reveal whether improvements in sleep and concentration were simply due to less disruption from hot flushes, or if the compound also affected sleep and concentration pathways in the brain.
First author of the study Dr Julia Prague said: “As NKB has many targets of action within the brain the potential for this drug class to really improve many of the symptoms of menopause, such as hot flushes, difficulty sleeping, weight gain, and poor concentration, is huge.
“To see the lives of our participants change so dramatically and so quickly was so exciting, and suggests great promise for the future of this new type of treatment.”
Professor Waljit Dhillo of Imperial College London said: “We already knew this compound could be a game change for menopausal women, and get rid of three-quarters of their hot flushes in four weeks. But this new analysis confirms the beneficial effect is obtained very quickly, within just three days.
“This class of new drugs may provide women with a much-needed alternative to HRT.”
HRT, or hormone replacement therapy, is the current treatment for symptoms of menopause, although it is not suitable for all women.
This specific compound of the drug will not be taken further in trials, due to side effects that may affect liver function.
However, two very similar drugs, which also block NKB but do not appear to have the same side effects, have entered larger patient trials, with one trial launched in the US last year.
The menopause occurs when oestrogen levels fall, which leads to a cessation of periods, the inability to have children naturally, and a number of physical and emotional side effects, including hot flushes. The average age of menopause is 51 years.
For many women hot flushes may be little more than an inconvenience, but for some women frequent severe episodes can lead to clothes and bed sheets being drenched from sweat, and disrupted sleep, which can impact working, social and home life.
Page last updated March 2018
A new type of experimental drug has been found to reduce hot flushes in menopausal women by almost three quarters in just three days, a new study has revealed.
The treatment has also been shown to reduce the severity of hot flushes by over a third in the same short time period.
The new in-depth analysis of data collected from a clinical trial first published last year also revealed that sleep and concentration significantly improved in the three-day window.
The randomised, double-blind, placebo-controlled trial involved 37 menopausal women aged between 40 and 62, and who experienced seven or more hot flushes a day.
Participants were randomly chosen to first receive either an 80mg daily dose of the drug, MLE4901, or a placebo over the course of a four-week period.
They then switched to receive the other tablet for an additional four weeks, which ensured the women acted as their own controls during the study, and the effects of the drug were clear.
The researchers found that the drug significantly reduced the average total number of flushes during the four-week treatment period, as well as their severity, compared to when the patients received the placebo.
The new experimental compounds are thought to work by blocking the action of a brain chemical called neurokinin B (NKB).
Previous animal and human trials have shown increased levels of NKB may trigger hot flushes.
The drug compound is thought to prevent NKB activating temperature control areas within the brain, which appears to halt hot flushes.
The new data also revealed that the drug was as effective at improving daytime hot flush symptoms as it was at improving night time symptoms.
On top of this, the women reported an 82% decrease in in the amount their hot flushes interrupted their sleep, and a 77% reduction in interruption to their concentration.
However, the team says further research is needed to reveal whether improvements in sleep and concentration were simply due to less disruption from hot flushes, or if the compound also affected sleep and concentration pathways in the brain.
First author of the study Dr Julia Prague said: “As NKB has many targets of action within the brain the potential for this drug class to really improve many of the symptoms of menopause, such as hot flushes, difficulty sleeping, weight gain, and poor concentration, is huge.
“To see the lives of our participants change so dramatically and so quickly was so exciting, and suggests great promise for the future of this new type of treatment.”
Professor Waljit Dhillo of Imperial College London said: “We already knew this compound could be a game change for menopausal women, and get rid of three-quarters of their hot flushes in four weeks. But this new analysis confirms the beneficial effect is obtained very quickly, within just three days.
“This class of new drugs may provide women with a much-needed alternative to HRT.”
HRT, or hormone replacement therapy, is the current treatment for symptoms of menopause, although it is not suitable for all women.
This specific compound of the drug will not be taken further in trials, due to side effects that may affect liver function.
However, two very similar drugs, which also block NKB but do not appear to have the same side effects, have entered larger patient trials, with one trial launched in the US last year.
The menopause occurs when oestrogen levels fall, which leads to a cessation of periods, the inability to have children naturally, and a number of physical and emotional side effects, including hot flushes. The average age of menopause is 51 years.
For many women hot flushes may be little more than an inconvenience, but for some women frequent severe episodes can lead to clothes and bed sheets being drenched from sweat, and disrupted sleep, which can impact working, social and home life.
Page last updated March 2018
