NEWS & RELEASES
News and information about DAMIAN and Primary Aldosteronism.
News and information about DAMIAN and Primary Aldosteronism.
DAMIAN announces publication in the British Journal of Clinical Pharmacology of phase 1 data of dexfadrostat phosphate in healthy volunteers
Today DAMIAN announces the publication of study DP13C101, a phase 1 study evaluating the efficacy and safety of dexfadrostat phosphate in healthy volunteers in the British Journal of Clinical Pharmacology.
Dexfadrostat phosphate is a novel aldosterone synthase inhibitor (ASI), which acts to directly control the production of aldosterone at its origin. “By inhibiting the 3 enzymatic conversions mediated by aldosterone synthase, dexfadrostat phosphate was shown to demonstrate a dose-dependent reduction of the aldosterone-to-renin ratio (ARR, a marker of sodium retention) without affecting the adrenal stress response or the hypothalamic-pituitary-gonadal axis.”
DAMIAN announced in October 2022 the successful completion of a phase 2 study evaluating dexfadrostat phosphate in patients with primary aldosteronism. The study met both its primary endpoints (ARR, ambulatory systolic blood pressure reduction) with high statistical significance following 8 weeks of once-daily treatment. The study also demonstrated a good safety and tolerability profile.
Mulatero et al., Brit J Clinical Pharmacol. 2023 Mar 13; doi: 10.1111/bcp.15713. Online ahead of print
Cardiometabolic outcomes and mortality in medically treated primary aldosteronism: a retrospective cohort study
This study by Hundemer et al. evaluated the electronic health records of PA patients on mineralocorticoid receptor antagonist (MRA) therapy and matched hypertensives to investigate the risk of cardiovascular events. The study demonstrated that in PA patients, the risks were higher than in patients with essential hypertension, independent of blood pressure control. The authors speculate that this may have to do, in part, with patients not responding adequately to MRA therapy.
Hundemer et al., Lancet Diabetes Endocrinol. 2018 Jan;6(1):51-59; doi: 10.1016/S2213-8587(17)30367-4
Is primary aldosteronism still largely unrecognized?
This review article highlights the disconnect between prospective, selective PA studies, which show a relatively high incidence rate, and real-world clinical data which demonstrate that PA remains under diagnosed and under treated. Diagnosis and referral rates remain low, despite the long-term risks associated with uncontrolled PA.
Buffolo et al., Horm Metab Res. 2017;49:908-914; doi: 10.1055/s-0043-119755
Endocrine Society Guidelines for Primary Aldosteronism
The Endocrine Society published an update to their clinical practice guidelines for management of patients with Primary Aldosteronism. These guidelines, based on data from systematic reviews and primary studies, provide an update to the recommendations of whom should be screened and the diagnostic pathway.
J Clin Endocrinol Metab, May 2016, 101(5):1889 –1916; doi: 10.1210/jc.2015-4061