Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design.

Autor: Hans-Henrik Parving, Barry M. Brenner, John. J. V. McMurray, Dick de Zeeuw, Steven M. Haffner, Scott D. Solomon, Nish Chaturvedi, Mathieu Ghadanfar, Nicole Weissbach, Zhihua Xiang, Juergen Armbrecht, Marc A. Pfeffer
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Zdroj: Nephrology Dialysis Transplantation; May2009, Vol. 24 Issue 5, p1663-1663, 1p
Abstrakt: Background. Patients with type 2 diabetes are at increased risk of macro- and microvascular disease, and the presence of albuminuria and/or reduced kidney function further enhances macrovascular risk. Angiotensin-converting-enzyme inhibitors reduce both macro- and microvascular events, yet the residual renal and cardiovascular risk still remains high. Aliskiren a novel oral direct renin inhibitor that unlike ACEi and ARBs, lowers plasma renin activity, angiotensin I and angiotensin II levels, may thereby provide greater benefit compared to ACEi or ARB alone. Methods. The primary objective of the ALTITUDE trial is to determine whether aliskiren 300 mg once daily, reduces cardiovascular and renal morbidity and mortality compared with placebo when added to conventional treatment (including ACEi or ARB). ALTITUDE is an international, randomized, double-blind, placebo-controlled, parallel-group study, which will include three categories of high-risk patients with type 2 diabetes (aged ≥35 years): those with either urinary albumin/creatinine ratio (UACR) ≥200 mg/g; microalbuminuria (UACR) ≥20 Conclusion. ALTITUDE will determine whether dual RAAS blockade with the direct renin inhibitor aliskiren in combination with an ACEi or ARB will reduce major morbidity and mortality in a broad range of high-risk patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index