A team of scientists have carried out a study on the symptoms of the menopause, which re-analysed the data from a previous study. This study had examined the effects of MLE4901, a compound which affected Neurokin 3, a substance produced in the brain. This treatment reduced the incidence and severity of hot flushes, which are associated with the menopause, after 3 days. The scientists were from Imperial College, London and King’s College, London and from Millendo Therapeutics, TPS Pharmaceutical Consulting and Astra Zeneca, three drug companies which are developing the drug. Some of the authors were employed by pharmaceutical companies or declared an interest in patents for the drug examined. The study was published in Menopause, a peer-reviewed journal and is open access.
The small study recruited 45 women, aged between 40-62 years, who had not had a period for a year and who were experiencing 7 or more hot flushes a day. The study began with 2 weeks of recording symptoms and answering questionnaires about their health before the treatment and study began. The women were asked to fill out questionnaires about their health throughout the study. The questionnaires excluded 8 women before the study began. The rest were allocated to either 4 weeks of treatment with MLE4901 or a placebo. Following the 4 weeks of treatment, the women were given 2 weeks off treatment before being put on another 4 weeks with an exchange of drug: those given the drug previously were given the placebo and vice versa. 9 women stopped taking part in the study. The original study examined the number of hot flushes women had after 4 weeks of the drug.
The new analysis compared the mean daily total of hot flushes on day 3 of the treatment between the 2 groups and then examined the mean weekly totals after each week of treatment. The scientists also looked for other outcomes, including the severity of the hot flushes, the women’s associated distress and the quality of sleep. The results were shown as a percentage change from baseline but did not report actual numbers of hot flushes.
The scientists found that the women who were being treated with MLE4901 experienced 75% reduction in hot flushes when compared to the group who were taking the placebo (25%). This difference stayed the same throughout the week, although it had risen to 53% points difference by the fourth week. Participants also experienced a lessening of the severity and distress of hot flushes, but by a lesser amount. There was 37% point reduction in severity between the women taking the treatment and the group on the placebo and 42% point reduction in distress. Sleeping problems reduced by 56% points by week 4, although one of the questionnaires showed very little difference when compared to the placebo on day 3. The scientists did not really examine the side effects of the drug, but suggested that it was ‘well-tolerated’. In the original study, 3 women showed a slight rise in liver enzymes following treatment, but there were too few participants to assess the side effects thoroughly.
The study authors say that larger-scale studies to enable the assessment of safety, optimal dosing strategy and efficacy are already taking place. They feel that this drug could offer a good alternative to HRT, but it is likely to be some time before the drug is fully tested and ready for market.
HRT is good for reducing the symptoms of the menopause, including hot flushes, difficulty concentrating and disturbed sleep, but it is not suitable for all women, because of the slightly raised risk of developing breast cancer or blood clots as well as some side effects. Women who are finding the symptoms of the menopause difficult to cope with, can go and see their GP and ask about a range of treatments including different types of HRT, relaxation techniques, cognitive behavioural therapy or CBT, exercise and diet changes.
Prague JK, et al., Neurokinin 3 receptor antagonism rapidly improves vasomotor symptoms with sustained duration of action, Menopause, March 2018