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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, BÓ; Schwetz, V; Aberer, F; Grübler, M; Lang, F; Alesutan, I; Voelkl, J; Gaksch, M; Horina, JH; Dimai, HP; Rus-Machan, J; Stiegler, C; Ritz, E; Fahrleitner-Pammer, A; Pilz, S.
Effect of eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism: results from the EPATH randomized, placebo-controlled trial.
J Hypertens. 2016; 34(7):1347-56 Doi: 10.1097/HJH.0000000000000927
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Führende Autor*innen der Med Uni Graz
Tomaschitz Andreas
Verheyen Nicolas Dominik
Co-Autor*innen der Med Uni Graz
Aberer Felix
Belyavskiy Evgeny
Brussee Helmut
Dimai Hans Peter
Fahrleitner-Pammer Astrid
Grübler Martin
Haas Josef
Horina Joerg
Keppel Martin
März Winfried
Meinitzer Andreas
Ofner-Ziegenfuss Lisa
Pieske Burkert Mathias
Pilz Stefan
Stiegler Claudia
Theiler-Schwetz Verena
Verheyen Sarah
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Abstract:
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.
Find related publications in this database (using NLM MeSH Indexing)
Aged - administration & dosage
Blood Pressure - drug effects
Blood Pressure Monitoring, Ambulatory - administration & dosage
Diastole - administration & dosage
Double-Blind Method - administration & dosage
Echocardiography - administration & dosage
Eplerenone - administration & dosage
Female - administration & dosage
Humans - administration & dosage
Hyperparathyroidism, Primary - blood, drug therapy
Hypertension - drug therapy
Male - administration & dosage
Middle Aged - administration & dosage
Mineralocorticoid Receptor Antagonists - adverse effects, therapeutic use
Parathyroid Hormone - blood
Spironolactone - adverse effects, analogs & derivatives, therapeutic use
Systole - administration & dosage
Vitamin D - analogs & derivatives, blood

Find related publications in this database (Keywords)
blood pressure
eplerenone
parathyroid hormone
randomized clinical trial
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