Key result
Baseline characteristics of the 8,606 randomized patients with type 2 diabetes in the ALTITUDE trial showed a median age of 65 years, with 47.9% having a history of cardiovascular disease.
Why the study?
Does aliskiren 300 mg once daily reduce primary cardiovascular-renal events in high-risk type 2 diabetic patients already receiving an ACEi or ARB?
RCT (n=8,606)
Double-blind
Randomized
Yes
Does aliskiren 300 mg once daily reduce primary cardiovascular-renal events in high-risk type 2 diabetic patients already receiving an ACEi or ARB?
The ALTITUDE trial successfully enrolled a high-risk cohort of type 2 diabetes patients to evaluate the cardio-renal benefits of adding the direct renin inhibitor aliskiren to standard ACEi or ARB therapy.
Validates ALTITUDE's high-risk type 2 diabetes cohort; supports generalizability of findings to similar older patients with cardiovascular disease.
INTRODUCTION: Patients with type 2 diabetes are at enhanced risk for macro- and microvascular complications. Albuminuria and/or reduced kidney function further enhances the vascular risk. We initiated the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). Aliskiren, a novel direct renin inhibitor, which lowers plasma renin activity, may thereby provide greater cardio-renal protection compared with angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) alone. MATERIALS AND METHODS: ALTITUDE is a randomized, double-blind, placebo-controlled study in high risk type 2 diabetic patients receiving aliskiren 300 mg once daily or placebo added to recommended cardio-renal protective treatment including ACEi or ARB, but not both. The number of patients randomized was 8606. RESULTS: Baseline characteristics (median, IQR) are: age 65 (58, 72) years, male 68%, BMI 29.1 (25.7, 32.2) kg/m(2), cardiovascular disease 47.9%, blood pressure 134.7 (126, 150)/74.3 (67, 81) mmHg, HbA(1c) 7.5 (6.6, 8.6)%, LDL-cholesterol 2.4 (1.9, 3.0) mmol/L, haemoglobin 130 (119, 143) g/L, serum creatinine 115 (91, 137) µmol/L, eGFR 51.7 (42, 65) ml/min per 1.73 m(2), geometric mean UACR 198.9 (52, 2886) mg/g and frequency of micro/macroalbuminuria 25.7% and 58.2%. ALTITUDE is an event-driven trial to continue until 1628 patients experience a primary cardiovascular-renal event. CONCLUSIONS: ALTITUDE will determine the potential cardio-renal benefit and safety of aliskiren in combination with ACEi or ARB in high risk patients with type 2 diabetes.
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Parving et al. (2012) conducted an RCT in Type 2 diabetes at high risk for cardiovascular and renal events (n=8,606). Aliskiren vs. Placebo was evaluated on Composite of cardiovascular death, resuscitated sudden death, non-fatal myocardial infarction, non-fatal stroke, unplanned hospitalization for heart failure, ESRD or renal death, or doubling of baseline serum creatinine concentration. Baseline characteristics of the 8,606 randomized patients with type 2 diabetes in the ALTITUDE trial showed a median age of 65 years, with 47.9% having a history of cardiovascular disease.
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