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DIRECT-Renal: Candesartan did not prevent microalbuminuria

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Renal Week 2008

PHILADELPHIA — Researchers reported no statistical benefit of candesartan cilexetil in the prevention of microalbuminuria in patients with diabetes over a median follow-up of 4.7 years.

Rudy W. Bilous, MD, PhD, presented data on the effects of candesartan cilexetil 32 mg per day (Atacand, AstraZeneca/Takeda) on the development and progression of microalbuminuria among patients enrolled in DIRECT (n=5,231). DIRECT, which consists of three randomized, double-blind, placebo-controlled, multicenter studies, investigated the effects of candesartan cilexetil on diabetic retinopathy; the study was not powered for its renal endpoints.

During nearly five years of follow-up, 401 patients developed microalbuminuria. These patients were older and had higher HbA1c, systolic blood pressure and urinary albumin excretion rates at baseline.

Candesartan-treated patients experienced a nonsignificant 5% reduction in risk for microalbuminuria (HR=0.95; P=.06).

“We cannot conclude that use of candesartan is of benefit in preventing diabetic nephropathy in patients with normoalbuminuria over a short period of time,” Bilous, chair in clinical medicine at the University of Newcastle upon Tyne in the United Kingdom, said during Renal Week 2008.

Rate of change of urinary albumin excretion rate was modestly but significantly reduced by 5.7% in patients assigned to candesartan (P=.02).

Additionally, 704 patients (287 receiving candesartan) received open-label renin-angiotensin system blockers during the study. Censoring at time of commencement did not affect the incidence of microalbuminuria; however rate of change of urinary albumin excretion rate was lower with candesartan (8%; P=.003).

These data are consistent with those from the EUCLID and HOPE trials, according to Bilous. – by Katie Kalvaitis

We had all been told that this new angiotensin receptor blocker would lead to improvements in microalbuminuria. Surprisingly, we did not see a positive effect of candesartan as much as we had expected. Yet, at the end of his session, Dr. Bilous did indicate that there should be further follow-up with randomized multicenter trials. Although he did not report a positive protective effect, it still left the door open that there could be effects found in a larger study. This is not the final word on candesartan.

– Frederick J. Kaskel, MD, PhD

Director, Pediatric Nephrology, Children’s Hospital at Montefiore

For more information:

• Bilous RW. LB-003. Presented at: Renal Week 2008, American Society of Nephrology 41st Annual Meeting and Scientific Exposition; Nov. 4-9, 2008; Philadelphia.