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RENAAL Baseline Characteristics (I) Age, years Male, % Female, % Race, % Asian Black Caucasian Hispanic Other Systolic (mmHg) Diastolic (mmHg) BMI (kg/m.

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Presentation on theme: "RENAAL Baseline Characteristics (I) Age, years Male, % Female, % Race, % Asian Black Caucasian Hispanic Other Systolic (mmHg) Diastolic (mmHg) BMI (kg/m."— Presentation transcript:

1 RENAAL Baseline Characteristics (I) Age, years Male, % Female, % Race, % Asian Black Caucasian Hispanic Other Systolic (mmHg) Diastolic (mmHg) BMI (kg/m 2 ) % Losartan (+CT) (n=751) Placebo (+CT) (n=762) Brenner BM et al New Engl J Med 2001;345(12):

2 RENAAL Baseline Characteristics (II) Medical History Treatment for Hypertension Angina Pectoris Myocardial Infarction Coronary Revascularization Stroke Lipid Disorders Amputation Neuropathy Retinopathy Smoking (current) Losartan (+CT) (n=751) % Placebo (+CT) (n=762) % Brenner BM et al New Engl J Med 2001;345(12):

3 RENAAL Baseline Characteristics (III) Laboratory Urinary alb:creat (median) (mg/g) Serum Creatinine (mg/dL) Serum Cholesterol (mg/dL) Total LDL HDL Serum Triglycerides (mg/dL) Hemoglobin (g/dL) Glycosylated Hemoglobin (%) Losartan (+CT) (n=751) Placebo (+CT) (n=762) p=NS for all values Brenner BM et al New Engl J Med 2001;345(12):

4 RENAAL Primary Components ESRD Months % with event p=0.002 Risk Reduction: 28% P (+CT) L (+CT) ESRD or Death P (+ CT) L (+ CT) Months % with event P (+CT) L (+CT) p=0.01 Risk Reduction: 20% Doubling of Serum Creatinine Months % with event p=0.006 Risk Reduction: 25% P (+ CT) L (+ CT) P (+CT) L (+CT) P (+ CT) L (+ CT) Brenner BM et al New Engl J Med 2001;345(12):

5 RENAAL First Hospitalization for Heart Failure Months % with event Risk Reduction: 32% p=0.005 P (+CT) L (+CT) P (+CT) L (+CT) Brenner BM et al New Engl J Med 2001;345(12):

6 RENAAL Change from Baseline in Proteinuria Proteinuria measured as the urine albumin:creatinine ratio from a first morning void Months Median Percent Change p<0.001 P (+CT) L (+CT) P (+CT) L (+CT) 35% Overall Reduction Brenner BM et al New Engl J Med 2001;345(12):

7 insufficiency RENAAL Most Common Clinical and Laboratory Adverse Experiences Leading to Discontinuation of Study Therapy HeartESRDMyocard.StrokeWorseningsCrHyper- Failureinfarction renalincreasedkalemia Percentage Laboratory AE Clinical AE 3% 6% 2% 3% 1% 2% 1% 1.5% 1.2%1.1% 0.5% Losartan Placebo (+CT) Presented by Brenner B. Reduction of endpoints in non-insulin-dependent diabetes mellitus with angiotensin II antagonist losartan. Program and abstracts of the 16th Annual Meeting of the American Society of Hypertension; May 16-19, 2001; San Francisco, California

8 RENAAL Summary In patients with Type 2 diabetes and nephropathy:In patients with Type 2 diabetes and nephropathy: –losartan delayed the onset of the primary composite endpoint (DsCr/ESRD/Death) and delayed the progression to ESRD. –losartan reduced proteinuria and the rate of decline in renal function (1/sCr slope). –losartan reduced the incidence of hospitalization for heart failure. –these benefits were largely independent of achieved blood pressure. –losartan and placebo, on a background of conventional therapy, showed no significant difference on all-cause mortality, MI, stroke, revascularization, hospitalizations for unstable angina, and death due to CV disease. –losartan was generally well tolerated in this patient population. Brenner BM et al New Engl J Med 2001;345(12):


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