Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin
converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both.
Recent evidence has provided robust evidence that aldostrone escape plays an important role
in this regard. It is believed that aldostrone escape occurs quite commonly with reports
indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial
of patients with diabetes and hypertension it was shown that treatment of aldostrone escape
with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number
of other trials have similarly observed that addition of spironolactone to an ACE inhibitor
based regimen provides additional benefits on proteinuria reduction, blood pressure control,
and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in
this regard are of short duration (e.g. three months), and have added spironolactone to an
ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating
efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS
blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to
determine the effects of addition of spironolactone 25 mg daily to losartan over a period of
18 months.