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Verheyen, N.
Effect of Eplerenone on Parathyroid Hormone Levels in Primary Hyperparathyroidism
Doktoratsstudium der Medizinischen Wissenschaft; Humanmedizin; [ Dissertation ] Graz Medical University; 2019. pp. 93 [OPEN ACCESS]


Authors Med Uni Graz:
Fahrleitner-Pammer Astrid
Pieske Burkert Mathias
Pilz Stefan
Tomaschitz Andreas

Background Mounting evidence supports the concept of a reciprocal interaction between parathyroid hormone (PTH) and aldosterone. This interweavement is increasingly seen as a potential mechanistic background for increased risk of cardiovascular disease and osteoporosis in primary hyperparathyroidism (pHPT). Methods The single-center, randomized, double-blind, parallel-group, placebo-controlled Effect of Eplerenone on PAraTHyroid hormone levels in patients with primary hyperparathyroidism (EPATH) trial had the primary aim to test the hypothesis that the mineralocorticoid receptor antagonist eplerenone alters plasma concentrations of intact PTH (iPTH) in patients with pHPT. Surrogate parameters of cardiovascular health and bone turnover markers were evaluated as secondary endpoints. Results Including subjects with a biochemical diagnosis of pHTP, 25-hydroxyvitamin D ≥ 20 ng/ml and estimated glomerular filtration rate ˃ 50 ml/min/1.73m², we enrolled 110 individuals. Subjects were 1:1 randomly assigned to receive either 25mg eplerenone once daily (up-titration after 4 weeks to 50 mg/day) or matching placebo for a treatment period of 8 weeks. Mean age ± SD was 67.5 ± 9.5 years and 78.4% were female. Study participation was successfully finalized in 97 subjects who were eligible for the primary endpoint analysis. The mean treatment effect (95% confidence interval) on iPTH was 1.0 (0.9–1.1; P=0.777) pg/ml. Mean 24-h ambulatory blood pressure decreased significantly by -6.3 (-9.4 to -3.3)/-3.7 (-5.7 to -1.7) mmHg. No differences were seen in any further secondary endpoints. The rate of adverse events was similar between groups.   Conclusion Treatment with eplerenone had neutral effects on circulating plasma levels of iPTH when compared to placebo. Eplerenone significantly lowered blood pressure and was well tolerated and safe.

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