Independent and additive impact of blood pressure control and angiotensin II receptor blockade on renal outcomes in the irbesartan diabetic nephropathy trial: clinical implications and limitations.

What Was Tested

The paper reports a study of Amlodipine and Antihypertensive Agents in the context of low blood pressure and orthostatic hypotension, published as a randomized controlled trial.

Elevated arterial pressure is a major risk factor for progression to ESRD in diabetic nephropathy.

However, the component of arterial pressure and level of BP control for optimal renal outcomes are disputed.

Who Took Part

The study group was 1590 patients.

Data from 1590 hypertensive patients with type 2 diabetes in the Irbesartan Diabetic Nephropathy Trial (IDNT), a randomized, double-blind, placebo-controlled trial performed in 209 clinics worldwide, were examined, and the effects of baseline and mean follow-up systolic BP (SBP) and diastolic BP and the interaction of assigned study medications (irbesartan, amlodipine, and placebo) on progressive renal failure and all-cause mortality were assessed.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

The patients were allocated by chance, so the Amlodipine group and the comparison group should start out alike.

Blinding on both sides kept the patients and researchers unaware of who received Amlodipine.

A placebo (an inactive look-alike) gave the Amlodipine group a baseline to be compared against.

What Was Measured

However, the component of arterial pressure and level of BP control for optimal renal outcomes are disputed.

Follow-up achieved SBP most strongly predicted renal outcomes.

The subject headings attached to it are Amlodipine, Angiotensin II Type 1 Receptor Blockers, Antihypertensive Agents, Biphenyl Compounds, Diabetic Nephropathies, Hypertension and Irbesartan.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Amlodipine and Antihypertensive Agents in 1590 patients in people with low blood pressure and orthostatic hypotension.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2005 (Journal of the American Society of Nephrology : JASN), a journal based in United States.

More context: Low blood pressure and orthostatic hypotension research.