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Cited by 240Hormonal Regulation and HypertensionBlood Pressure and Hypertension StudiesRenin-Angiotensin System Studies

The DOI matches its Crossref record; 35 of the 35 references it cites were found in a registry or an index.

Effects of a Novel Aldosterone Synthase Inhibitor for Treatment of Primary Hypertension: Results of a Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Trial

Calhoun, David A., White, William B., Krum, Henry, Guo, Weinong, Bermann, Georgina, Trapani, Angelo, Lefkowitz, Martin P., Ménard, Joël·2011·Circulation
DOI 10.1161/circulationaha.111.029892
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Abstract

Background—: LCI699, a novel inhibitor of aldosterone synthase, reduces serum aldosterone, and may have benefit in the treatment of hypertension. Methods and Results—: We performed the first double-blind, randomized trial with LCI699 in patients with primary hypertension. We randomized 524 patients to LCI699 0.25 mg once daily (n=92), 0.5 mg once daily (n=88), 1.0 mg once daily (n=86), and 0.5 mg twice daily (n=97); eplerenone 50 mg twice daily (n=84); or placebo (n=77) for 8 weeks. Adrenocorticotropic hormone (250 μg IV) stimulation testing was performed in a subset of patients to quantify the selectivity of LCI699 for aldosterone synthase compared with 11-β-hydroxylase. Reductions in clinic diastolic blood pressure were significant for LCI699 1.0 mg (−7.1 mm Hg; P =0.0012) and eplerenone 50 mg twice daily (−7.9 mm Hg; P <0.0001) compared with placebo (−2.6 mm Hg) but not other doses of LCI699. Significant reductions in clinic systolic blood pressure were observed with all doses of LCI699 ( P <0.005 or better) and eplerenone ( P <0.0001). All doses of LCI699 significantly reduced 24-hour ambulatory blood pressure compared with placebo ( P <0.01). Adrenocorticotropic hormone stimulation of cortisol was suppressed in ≈20% of subjects receiving LCI699 at a total daily dose of 1.0 mg. Safety and tolerability were similar among LCI699, placebo, and eplerenone. Conclusions—: Aldosterone synthase inhibition with LCI699 significantly lowered clinic and ambulatory blood pressure. A minority of subjects developed blunted adrenocorticotropic hormone–stimulated release of cortisol. These results support additional research to evaluate use of aldosterone synthase inhibition in primary hypertension and/or patients characterized by aldosterone excess. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00758524.

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Crossref · 10.1161/circulationaha.111.029892

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Metadata

Authors
Calhoun, D. A., White, W. B., Krum, H., Guo, W., Bermann, G., Trapani, A., Lefkowitz, M. P., & Ménard, J.
Affiliations
Novartis (Switzerland) (CH)
ORCID
Venue
Circulation
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2011-11
Volume
124
Issue
18
Pages
1945-1955
ISSN
  • 0009-7322 (ISSN-L)
  • 1524-4539
DOI
10.1161/circulationaha.111.029892
OpenAlex
W2014029753
Cited by
227
References
35
Citations by year
2026: 22 · 2025: 15 · 2024: 18 · 2023: 11 · 2022: 3 · 2021: 6 · 2020: 4 · 2019: 10 · 2018: 9 · 2017: 10 · 2016: 16 · 2015: 23 · 2014: 29 · 2013: 26 · 2012: 24
FWCI
20.99
Type
journal article
Language
en
Open access
closed
Locations
  • Circulation (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Renin-Angiotensin System Studies
Keywords
aldosterone synthase inhibitors, essential hypertension, eplerenone, blood pressure reduction, ambulatory blood pressure, adrenocorticotropic hormone stimulation, cortisol suppression, aldosterone excess
MeSH terms
Adrenocorticotropic Hormone, Adult, Aged, Aged, 80 and over, Aldosterone, Blood Pressure, Double-Blind Method, Enzyme Inhibitors, Female, Hormones, Humans, Hydrocortisone, Hypertension, Male, Middle Aged, Placebos, Renin, Cytochrome P-450 CYP11B2

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