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Effect of eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism: results from the EPATH randomized, placebo-controlled trial
Open accessAbstract
BACKGROUND: Accumulating evidence points toward mutual interaction between parathyroid hormone (PTH) and aldosterone as potential mechanism for increasing cardiovascular risk in primary hyperparathyroidism (pHPT). METHODS: The Eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism (EPATH) trial is a single-center, randomized, double-blind, parallel-group, placebo-controlled trial. The primary aim is to evaluate the effects of the mineralocorticoid receptor antagonist eplerenone on plasma intact PTH (iPTH) concentration in patients with pHPT. Secondary end points comprised surrogate parameters of cardiovascular health [24-h ambulatory SBP and DBP and echocardiographic parameters related to systolic/diastolic function as well as to cardiac dimensions]. RESULTS: We enrolled 110 study participants with pHPT, 25-hydroxyvitamin D at least 20 ng/ml and estimated glomerular filtration rate more than 50 ml/min per 1.73 m. Patients were 1 : 1 randomly assigned to receive either 25 mg eplerenone once daily (up-titration after 4 weeks to 50 mg/day) or matching placebo for a treatment period of 8 weeks.The study was completed by 97 participants [mean (SD) age: 67.5 ± 9.5 years; 78.4% women). The mean treatment effect (95% confidence interval) for iPTH was 1.0 (0.9-1.1; P = 0.777) pg/ml. Mean 24-h ambulatory SBP and DBP decreased significantly [mean change (95% confidence interval) -6.3 (-9.4 to -3.3) and -3.7 (-5.7 to -1.7) mmHg, respectively; P < 0.001]. No differences were seen in any further secondary outcomes or frequency of adverse events. CONCLUSION: In pHPT, treatment with eplerenone compared with placebo had no effect on circulating iPTH levels. Eplerenone treatment was well tolerated and safe and followed by significant decrease of ambulatory blood pressure.
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Metadata
- Authors
- Tomaschitz, A., Verheyen, N., Meinitzer, A., Pieske, B., Belyavskiy, E., Brussee, H., Haas, J., März, W., Pieske-Kraigher, E., Verheyen, S., Ofner-Ziegenfuss, L., Hartaigh, B. Ó., Schwetz, V., Aberer, F., Grübler, M., Lang, F., Alesutan, I., Voelkl, J., Gaksch, M., Horina, J. H., Dimai, H.-P., Rus-Machan, J., Stiegler, C., Ritz, E., Fahrleitner-Pammer, A., & Pilz, S.
- Affiliations
- University of Mannheim (DE)
- Medical University of Graz (AT)
- Corresponding author
- Pilz, Stefan
- ORCID
- Venue
- Journal of Hypertension
- Published
- 2016-07
- Volume
- 34
- Issue
- 7
- Pages
- 1347-1356
- ISSN
- 0263-6352 (ISSN-L)
- OpenAlex
- W2338117764
- Cited by
- 24
- References
- 43
- Citations by year
- 2024: 2 · 2023: 1 · 2022: 2 · 2021: 2 · 2020: 3 · 2019: 2 · 2018: 3 · 2017: 7 · 2016: 2
- FWCI
- 4.69
- Type
- journal article
- Language
- en
- Open access
- green
- pure.amsterdamumc.nl
- Licence
- other-oa
- Locations
- Journal of Hypertension (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Pfizer
- Oesterreichische Nationalbank (14621, 13905, 13878)
- Karl-Franzens-Universität Graz
- Medizinische Universität Graz
- Topics
- Health Sciences › Medicine › Nephrology › Parathyroid Disorders and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
- Keywords
- eplerenone, primary hyperparathyroidism, parathyroid hormone, mineralocorticoid receptor antagonists, aldosterone, cardiovascular risk, ambulatory blood pressure, systolic and diastolic function, echocardiography
- MeSH terms
- Eplerenone, Aged, Mineralocorticoid Receptor Antagonists, Blood Pressure, Diastole, Double-Blind Method, Echocardiography, Female, Humans, Hypertension, Male, Middle Aged, Parathyroid Hormone, Spironolactone, Systole, Vitamin D, Blood Pressure Monitoring, Ambulatory, Hyperparathyroidism, Primary
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