Long-term effects of addition of mineralocorticoid receptor antagonist to angiotensin II receptor blocker in patients with diabetic nephropathy: a randomized clinical trial.

What Was Tested

This randomized controlled trial looks at Spironolactone.

Addition of spironolactone (SPR) to angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) might provide antiproteinuric effects beyond what is gained by either medication alone.

Who Took Part

The study group was 136 patients.

By PubMed's age tags, the people studied were middle-aged adults, both men and women.

In an open-label, parallel-group, single-center, randomized clinical trial (NCT01667614), 136 patients with diabetes and proteinuria, already treated with enalapril and losartan, were included.

In 74 patients, ACE inhibitors were discontinued.

How the Study Was Run

The design is described as randomized, open-label and parallel-group.

Because people in this Spironolactone study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Spironolactone study: the patients and staff both knew the treatment.

Groups ran in parallel: each of the patients stayed in one arm throughout.

The remainder of the patients (n = 62) received ACE inhibitors and ARBs as before.

During each visit, systolic and diastolic blood pressure (BP), urinary albumin excretion (UAE), serum creatinine, estimated glomerular filtration rate (eGFR) and serum potassium concentrations were determined.

What Was Measured

Topics PubMed links to this paper include Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Blood Pressure, Diabetic Nephropathies, Glomerular Filtration Rate, Mineralocorticoid Receptor Antagonists and Prognosis.

Author keywords: blood pressure control, diabetic nephropathy and urinary albumin excretion.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Spironolactone in 136 patients.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2013 (Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association), a journal based in England.

More context: all human trials.