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Aliskiren provides renoprotection independent of its blood pressure-lowering effects in patients with hypertension, type 2 diabetes, nephropathy, study data show

Sunday, June 15 2008 | Comments
Evidence Grade 1 What's This?
Aliskiren may have renoprotective effects that are independent of its blood pressure-lowering effects in patients with hypertension, type 2 diabetes, and nephropathy who are also receiving recommended renoprotective treatment, according to study findings.

"During the past 2 decades, the outlook for patients with diabetes who have microalbuminuria or macroalbuminuria has improved, probably owing to early aggressive lowering of blood pressure and blocking of the renin-angiotensin-aldosterone system," the authors of the study wrote. "However, there is still a large, unmet need to develop strategies for the prevention of diabetic nephropathy and its progression to end-stage renal disease."

For the multinational study, 599 patients received losartan 100 mg for 3 months during an open-label run-in period, followed by a double-blind phase in which the patients were continued on losartan and were randomized to add either aliskiren 150 mg/day for 3 months followed by a dose increase to 300 mg/d for another 3 months or placebo for 6 months. The goal of the study was to evaluate the potential renoprotective capacity of direct renin inhibition with aliskiren, an oral direct renin inhibitor, in these patients.

Results indicated that the mean urinary albumin-to-creatinine ratio, the primary efficacy measure, fell by 20% (95% CI, 9%-30%; P<.001) among aliskiren-treated patients as compared with those who received placebo at the end of the study period. This reduction in mean urinary albumin-to-creatinine ratio among aliskiren-treated patients remained statistically significant (18%; 95% CI, 7%-28%; P=.002) after adjusting for changes from baseline in systolic blood pressure.

Similarly, overnight urinary albumin excretion was reduced by 18% (95% CI, 5%-30%) among patients in the aliskiren group as compared with placebo at 24 weeks (P=.009) and did not change appreciably after adjusting for changes in systolic blood pressure from baseline (reduction of 17%; 95% CI, 4%-29%; P=.02).

Furthermore, significant between-group differences in urinary albumin-to-creatinine ratios were evident by week 12, before the dose increase in the aliskiren group (relative reduction of 11%; 95% CI, 2%-20%; P=.02), and a significantly greater proportion of aliskiren-treated patients experienced a 50% or greater reduction in albuminuria than in the placebo group (24.7% vs 12.5%; P<.001).

Rates of serious and nonserious adverse events were similar between aliskiren and placebo groups, as was the rate of withdrawal from the study due to adverse events, the authors noted.

"The present trial shows that treatment with 300 mg of aliskiren daily reduces albuminuria in patients with hypertension, type 2 diabetes, and proteinuria who are receiving the recommended maximal renoprotective treatment with losartan and optimal antihypertensive therapy," the authors concluded. "The benefits of aliskiren appear to be independent of the systemic blood pressure ... ." (Parving HH, et al. N Engl J Med 2008;358:2433-2446.)

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