Landmark Clinical Trials of Aldosterone Antagonists

spironolactone clinical trials

landmark clinical trials focusing on aldosterone antagonists (mineralocorticoid receptor antagonists) like spironolactone and eplerenone, which are commonly used in heart failure and other conditions:

1. RALES (1999)

Title: Randomized Aldactone Evaluation Study

Focus: Heart failure with reduced ejection fraction (HFrEF).

Key Finding: Spironolactone reduced mortality by 30% and hospitalizations by 35% in patients with severe HFrEF (NYHA class III-IV).

Published In: The New England Journal of Medicine (NEJM).

2. EPHESUS (2003)

Title: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study

Focus: Post-MI patients with heart failure and reduced ejection fraction.

Key Finding: Eplerenone reduced all-cause mortality by 15% and cardiovascular death by 21%.

Published In: NEJM.

3. TOPCAT (2014)

Title: Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist

Focus: Heart failure with preserved ejection fraction (HFpEF).

Key Finding: Spironolactone reduced HF-related hospitalizations but did not significantly reduce overall mortality. Subgroup analyses revealed possible regional variations in benefit.

Published In: NEJM.

4. AMBER (2019)

Title: Spironolactone in Resistant Hypertension and Chronic Kidney Disease

Focus: Resistant hypertension in patients with CKD.

Key Finding: Spironolactone improved blood pressure control without significantly worsening hyperkalemia.

Published In: The Lancet.

5. PATHWAY-2 (2015)

Title: Optimal Treatment for Resistant Hypertension

Focus: Resistant hypertension.

Key Finding: Spironolactone was the most effective add-on therapy for resistant hypertension compared to other options like bisoprolol or doxazosin.

Published In: The Lancet.

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