AMADEO
Background/Rationale:
- In patients with type 2 diabetes and renal disease, lowering blood pressure and urinary albumin is effective in reducing the risk of end-stage renal disease and myocardial infarction.
- Reductions in proteinuria >30% at six months strongly correlate with slowed progression to end-stage renal disease (ESRD) in renal outcome trials.
Objective: The objective of the AMADEO study was to assess whether Pritor®/Kinzalmono® and losartan, an ARB with an indication to slow diabetic nephropathy progression, had different effects on proteinuria and if these differences translate into greater and more persistent reduction in proteinuria over time.
Study Design: The AMADEO study was a 1-year prospective, randomised, double-blind, double-dummy, multi-centre, parallel group trial in 860 hypertensive patients with type 2 diabetes and overt nephropathy.
Bakris G et al. - Results of the AMADEO study.
American Society of Hypertension 2007 Scientific Sessions; May 21, 2007; Chicago, IL.
American Society of Hypertension 2007 Scientific Sessions; May 21, 2007; Chicago, IL.
Study Endpoints:
- Primary endpoint: change in proteinuria after 1 year of treatment
Results:
- Pritor®/Kinzalmono® provides significantly greater reductions in proteinuria than losartan in hypertensive patients with type 2 diabetes and overt nephropathy despite similar BP control.
- Pritor®/Kinzalmono® provides a lower incidence of overall and CV composite endpoints than losartan in hypertensive patients with type 2 diabetes and overt nephropathy.
- Pritor®/Kinzalmono®’s antiproteinuric effect was sustained for 2 months after both drugs were stopped
Bakris G et al. - Results of the AMADEO study.
American Society of Hypertension 2007 Scientific Sessions; May 21, 2007; Chicago, IL.
American Society of Hypertension 2007 Scientific Sessions; May 21, 2007; Chicago, IL.
Conclusion:
- In hypertensive patients with type 2 diabetes and overt nephropathy, Pritor®/Kinzalmono®:
- Provided significantly greater reductions in proteinuria than losartan
- Resulted in a lower incidence of overall and CV composite endpoints than losartan - The longer-acting, higher-binding Pritor®/Kinzalmono® may provide greater end-organ and cardiovascular protection than losartan.
