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@article{Prague:2017:10.1016/S0140-6736(17)30823-1,
author = {Prague, JK and Roberts, RE and Comninos, AN and Clarke, S and Jayasena, CN and Nash, Z and Doyle, C and Papadopoulou, D and Bloom, SR and Mohideen, P and Lin, V and Stern, T and Panay, N and Hunter, MS and Veldhuis, JD and Webber, LC and Huson, L and Dhillo, WS},
doi = {10.1016/S0140-6736(17)30823-1},
journal = {Lancet},
pages = {1809--1820},
title = {Neurokinin 3 receptor antagonism is a highly effective, novel treatment for menopausal hot flushes with rapid onset: a phase 2, randomised, double-blind, placebo-controlled trial},
url = {http://dx.doi.org/10.1016/S0140-6736(17)30823-1},
volume = {389},
year = {2017}
}

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TY  - JOUR
AB  - BackgroundHot flushes affect 70% of menopausal women and often severely impact physical, psychosocial, sexual, and overall wellbeing. Hormone replacement therapy is effective but is not without risk. Neurokinin B signalling is increased in menopausal women, and has been implicated as an important mediator of hot flushes.MethodsThis phase 2, randomised, double-blind, placebo-controlled, single-centre, crossover trial assessed the effectiveness of an oral neurokinin 3 receptor antagonist (MLE4901) on menopausal hot flushes. Eligible participants were healthy women aged 40–62 years, having seven or more hot flushes in every 24 h of which some were reported as being severe or bothersome, who had not had a menstrual period for at least 12 months, and who had not been taking any medication shown to improve menopausal flushes in the preceding 8 weeks. Participants received 4 weeks of MLE4901 (40 mg, orally, twice daily) and placebo (orally, twice daily) in random order separated by a 2 week washout period. Randomisation was completed by a central computer, and participants were allocated to treatment number in numerical order. The primary outcome was the total number of hot flushes during the final week of both treatment periods. Analyses were by intention to treat and per protocol using generalised linear mixed models and standard crossover analysis. All analyses were prespecified in the study protocol. The trial is registered at ClinicalTrials.gov, number NCT02668185.Findings68 women were screened between Feb 3 and Oct 10, 2016, of which 37 were randomly assigned and included in an intention-to-treat analysis. 28 participants completed the trial and were included in a per-protocol analysis. MLE4901 significantly reduced the total weekly number of hot flushes by 45 percentage points (95% CI 22–67) compared with the placebo (intention-to-treat adjusted means: placebo 49·01 [95% CI 40·81–58·56] vs MLE4901 19·35 [15·99&nda
AU  - Prague,JK
AU  - Roberts,RE
AU  - Comninos,AN
AU  - Clarke,S
AU  - Jayasena,CN
AU  - Nash,Z
AU  - Doyle,C
AU  - Papadopoulou,D
AU  - Bloom,SR
AU  - Mohideen,P
AU  - Lin,V
AU  - Stern,T
AU  - Panay,N
AU  - Hunter,MS
AU  - Veldhuis,JD
AU  - Webber,LC
AU  - Huson,L
AU  - Dhillo,WS
DO  - 10.1016/S0140-6736(17)30823-1
EP  - 1820
PY  - 2017///
SN  - 0140-6736
SP  - 1809
TI  - Neurokinin 3 receptor antagonism is a highly effective, novel treatment for menopausal hot flushes with rapid onset: a phase 2, randomised, double-blind, placebo-controlled trial
T2  - Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(17)30823-1
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000423298900052&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/71776
VL  - 389
ER  -

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