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Cardiovascular Disease and Antihypertensives

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Cardiovascular Disease and Antihypertensives. The RENAAL Trial. Reference Brunner BM, and the RENAAL study group. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med . 2001;345(12). Background

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Cardiovascular Disease and Antihypertensives

The RENAAL Trial

Reference

Brunner BM, and the RENAAL study group. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345(12).

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Background

Diabetic nephropathy is a leading cause of end-stage renal disease. The progression of this disease is slowed down by interruption of the rennin–angiotensin pathway in type 1 diabetes. Similar studies are not available for type 2 diabetes. We assessed the role of the angiotensin-II-receptor antagonist losartan in patients with type 2 diabetes and nephropathy.

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Aim

To ascertain effects of losartan on cardiovascular and renal outcomes in patients with nephropathy and type II diabetes.

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Method

Design: The RENAAL trial is a placebo-controlled, double-blind, randomized, multicentre study.

Study population: The study involved 1513 individuals/patients across 250 centers spanning almost all continents.

Treatment regimen: Patients were randomly assigned to receive either losartan 50 mg or placebo once a day along with conventional antihypertensive therapy. The dose was increased after 4 weeks to 100 mg once a day if the trough BP of the patient was below target.

End point: The primary end point was the time taken for the first event of a doubling of serum creatinine concentration, end-stage renal disease or death. The secondary end point was morbidity and mortality from cardiovascular causes like myocardial infarction, fatal or non-fatal stroke, first hospitalization from heart failure.

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Results

The risk of ESRD was reduced by 28% over a mean of 3.4 years (P=0.002). There was a 25% reduction in the serum creatinine concentration and the proteinurea was reduced by 35%. Hospitalization incidences were reduced because of first event of heart failure were reduced by 32%.

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Conclusion

Patients with type 2 diabetes showed reduced risk of renal progression when treated with losartan by 25% where as risk ESRD was reduced by 28% when investigated for a period of 3.4 years.

Losartan resulted in significant renal benefits in patients with type 2 diabetes and nephropathy, and it was generally well tolerated.

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The RENAAL Sub-study

Reduction of end points in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) sub-study

Reference

Brenner BM, Cooper ME, et al. Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) sub-study. Diabetes Care. 2004;27:874–879.

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Background

Diabetes is highly prevalent in Asia and it is predicted to have the largest population of patients with diabetes who are at high risk for renal disease. In the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study, approximately 17% of 1,513 type 2 diabetic patients with clinical proteinuria were Asians.

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Method

  • Study design: The RENAAL sub-study is a double-blind, randomized, placebo-controlled study.
  • Study population: 252 Asian patients (aged 31–70 years) with type 2 diabetic nephropathy and serum creatinine values between 1.3 and 3.0 mg/dl, with a lower limit of 1.5 mg/dl for male patients weighing >60 kg.
  • Treatment regimen: Patients were randomly assigned to receive either Losartan 50 mg or placebo once a day along with conventional anti-hypertensive therapy. The dose was increased after 4 weeks to 100 mg once a day if the trough BP of the patient was below target.
  • End point: The primary end point was the time taken for the first event of a doubling of serum creatinine concentration, end-stage renal disease or death. The secondary end point was morbidity and mortality from cardiovascular causes like myocardial infarction, fatal or non-fatal stroke and first hospitalization from heart failure.
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Result

Losartan significantly reduced the risk for the primary composite end point in the RENAAL Asian population by 35% as compared to placebo.

The risk of renal outcomes of ESRD or DsCr was 36% lower with losartan compared to placebo.

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The risk of renal outcomes of ESRD or DsCr was 36% lower with losartan compared to placebo. The rate of decrease in renal function was reduced by 30.7% with losartan as compared to placebo.

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Conclusion

The risk of developing the primary end point of double creatinine levels and ESRD and all cause mortality was significantly reduced with losartan treatment in the Asian patients. Losartan was found to reduce proteinuria and progression of renal disease and was also well tolerated.

In the Asian population of the RENAAL study, losartan was found to reduce proteinuria and progression of renal disease and was also well tolerated.

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