Background: Information on the impact of hormone replacement therapy (HRT) on carotid atherosclerosis is limited. Moreover, transdermal estrogens have not been investigated.
Methods: We examined ...association of HRT use with ultrasonographically assessed carotid atherosclerotic plaque occurrence and mean common carotid artery intima-media thickness (CCA–IMT) progression. Within the Vascular Aging (EVA) Study, a community-based cohort, 815 postmenopausal women aged 59–71 have been followed during 4 years. Among these women, 166 had already used HRT.
Results: Women who had ever used HRT experienced a lower occurrence of plaques (8.6 versus 19.1%,
P=0.003). After adjustment for the main cardiovascular risk factors, odds-ratio for plaque occurrence was 0.41 (95% confidence interval 0.21–0.78,
P=0.01) among ever users of HRT compared with never users. When transdermal route of estrogen administration was used, adjusted odds-ratio was 0.66 (95% confidence interval 0.47–0.99,
P=0.04). The progression of IMT, which was measured at a plaque-free site and adjusted on initial levels of CCA–IMT did not differ between ever and never users of HRT. It was 0.011 mm per year among ever users and 0.012 mm per year among never users (
P=0.61).
Conclusion: These data suggest that HRT use may prevent the development of atherosclerotic plaques in postmenopausal women, especially when estrogens are administered by transdermal route.
•This report summarises the presentation, discussion and action points from the “10 years of clinical trials in DMD – what have we learned?” workshop that took place in The Netherlands, 9–11 december ...2022.•Core themes of the workshop included trial outcomes, disease heterogeneity, meaningfulness of outcomes and the utility of real-world data in trials.•Action points agreed at the workshop include expanding the scope and range of trial outcomes, assessing the efficacy of new trial structures for DMD and discussions with regulators about the clinical meaningfulness and the use of real-world data.
There are multiple avenues for therapeutic development in Duchenne muscular dystrophy (DMD), which are highlighted in the first section of this report for the “10 years of Clinical trials in DMD – What have we learned?” workshop. This report then provides an overview of the presentations made at the workshop grouped into the following core themes: trial outcomes, disease heterogeneity, meaningfulness of outcomes and the utility of real-world data in trials. Finally, we present the consensus that was achieved at the workshop on the learning points from 10 years of clinical trials in DMD, and possible action points from these. This includes further work in expanding the scope and range of trial outcomes and assessing the efficacy of new trial structures for DMD. We also highlight several points which should be addressed during future interactions with regulators, such as clinical meaningfulness and the use of real-world data.
