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Efficacy and safety of two dosages of canrenone as add-on therapy in hypertensive patients taking ace-inhibitors or angiotensin II receptor blockers and hydrochlorothiazide at maximum dosage in a randomized clinical trial: The ESCAPE-IT trial.
- Source :
-
Cardiovascular therapeutics [Cardiovasc Ther] 2017 Feb; Vol. 35 (1), pp. 47-54. - Publication Year :
- 2017
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Abstract
- Aim: To evaluate the effects of canrenone as add-on therapy in patients already treated with angiotensin-converting enzyme inhibitors (ACE-I) or angiotensin II receptor blockers (ARBs) and hydrochlorothiazide at the maximum dosage (25 mg/d).<br />Method: In this randomized, open-label, controlled trial, we enrolled 175 Caucasian patients with essential hypertension not well controlled by concomitant ACE-I or ARBs and hydrochlorothiazide. At baseline, 87 patients (57 males and 30 females) were randomized to add canrenone 50 mg, and 88 (56 males and 32 females) patients to canrenone 100 mg, once a day, for 3 months. At baseline and after 3 months, we evaluated blood pressure (BP), pulse pressure (PP), heart rate (HR), fasting plasma glucose (FPG), homeostasis model assessment insulin (HOMA Index), lipid profile, electrolytes, uric acid, estimated glomerular filtration rate (eGFR), plasma urea, aldosterone, B-type natriuretic peptide (BNP), and galectin-3.<br />Results: Blood pressure decreased with both dosages of canrenone, with a better effect with canrenone 100 mg (-20.26 vs -23.68 mm Hg for SBP, and -10.58 vs -12.38 mm Hg for DBP), without a clinically relevant increase in potassium levels. We did not observe any differences regarding FPG or HOMA Index, nor of lipid profile, with the exception of triglycerides, which increased compared to baseline with canrenone 50 mg (+0.25 vs +0.34 mEq/L). Creatinine slightly increased with canrenone 100 mg (+0.02 vs +0.05 mg/dL), although no variations of eGFR were observed in neither groups. There was an increase in aldosterone levels with canrenone 50 mg. No changes in BNP or galectin-3 were recorded.<br />Conclusion: Both canrenone dosages gave a decrease in blood pressure, with a better effect with the higher dose, with only a slight increase in potassium and creatinine levels, which were not clinically relevant. Clinical Trials Registration Eudract number: 2010-023606-13; ClinicalTrials.gov NCT02687178.<br /> (© 2016 The Authors. Cardiovascular Therapeutics Published by John Wiley & Sons Ltd.)
- Subjects :
- Aged
Angiotensin II Type 1 Receptor Blockers adverse effects
Angiotensin-Converting Enzyme Inhibitors adverse effects
Antihypertensive Agents adverse effects
Biomarkers blood
Canrenone adverse effects
Drug Therapy, Combination
Essential Hypertension
Female
Humans
Hydrochlorothiazide adverse effects
Hypertension blood
Hypertension diagnosis
Hypertension physiopathology
Italy
Male
Middle Aged
Mineralocorticoid Receptor Antagonists adverse effects
Sodium Chloride Symporter Inhibitors adverse effects
Time Factors
Treatment Outcome
Angiotensin II Type 1 Receptor Blockers administration & dosage
Angiotensin-Converting Enzyme Inhibitors administration & dosage
Antihypertensive Agents administration & dosage
Blood Pressure drug effects
Canrenone administration & dosage
Hydrochlorothiazide administration & dosage
Hypertension drug therapy
Mineralocorticoid Receptor Antagonists administration & dosage
Sodium Chloride Symporter Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1755-5922
- Volume :
- 35
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cardiovascular therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 27860389
- Full Text :
- https://doi.org/10.1111/1755-5922.12235