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Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial.
- Source :
-
Drugs in R&D [Drugs R D] 2017 Sep; Vol. 17 (3), pp. 441-448. - Publication Year :
- 2017
-
Abstract
- Background: Fluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan.<br />Objective: We performed longitudinal assessments of thoracic bioimpedance in patients with type 2 diabetes mellitus and nephropathy to determine whether a decrease in bioimpedance accurately reflected fluid retention during treatment with atrasentan.<br />Study Design: We conducted a randomized, double-blind, placebo-controlled study in 48 patients with type 2 diabetes mellitus and nephropathy who were receiving stable doses of renin angiotensin system inhibitors and diuretics.<br />Methods: Patients were randomized 1:1:1 to placebo, atrasentan 0.5 mg, or atrasentan 1.25 mg once daily for 8 weeks. Thoracic bioimpedance, vital signs, clinical exams, and serologies were taken at weeks 1, 2, 4, 6, and 8, with the exception of serum hemoglobin, which was not taken at week 1, and serum brain natriuretic peptide, which was only taken at baseline, week 4, and week 8.<br />Results: Alterations in bioimpedance were more often present in those who received atrasentan than in those who received placebo, though overall differences were not statistically significant. Transient declines in thoracic bioimpedance during the first 2 weeks of atrasentan exposure occurred before or during peak increases in body weight and hemodilution (decreased serum hemoglobin).<br />Conclusions: We conclude that thoracic bioimpedance did not reflect changes in weight gain or edema with atrasentan treatment in this study. However, the sample size was small, and it may be of interest to explore the use of thoracic bioimpedance in a larger population to understand its potential clinical use in monitoring fluid retention in patients with chronic kidney disease who receive ET receptor antagonists.
- Subjects :
- Aged
Atrasentan
Diabetes Mellitus, Type 2 complications
Diuretics therapeutic use
Dose-Response Relationship, Drug
Double-Blind Method
Edema chemically induced
Electric Impedance
Endothelin Receptor Antagonists adverse effects
Female
Humans
Longitudinal Studies
Male
Middle Aged
Pyrrolidines adverse effects
Renin-Angiotensin System drug effects
Weight Gain drug effects
Diabetes Mellitus, Type 2 drug therapy
Diabetic Nephropathies drug therapy
Endothelin Receptor Antagonists administration & dosage
Pyrrolidines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1179-6901
- Volume :
- 17
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Drugs in R&D
- Publication Type :
- Academic Journal
- Accession number :
- 28831752
- Full Text :
- https://doi.org/10.1007/s40268-017-0201-0