DETAIL
Background/Rationale: Hypertensive patients with type 2 diabetes often develop diabetic nephropathy, which puts them at an even higher risk for cardiovascular events and and end-stage renal disease.
Objective:
- The objective of the DETAIL study was to compare the effect of Pritor®/Kinzalmono® and enalapril on the change in the glomerular filtration rate in hypertensive patients with type 2 diabetes and albuminuria over a five-year period.
- The DETAIL study was designed to demonstrate that the renoprotective effect of Pritor®/Kinzalmono® was similar (non-inferior) to that of enalapril.
Study Design: The DETAIL study was a prospective, multicentre, randomised, double-blind, double-dummy, parallel-group, forced-titration, 5-year study in 250 hypertensive patients with type 2 diabetes and albuminuria.
Barnett et al. N Engl J Med 2004;351:1952-61.
Study Endpoints:
- Primary endpoint: Change in glomerular filtration rate (GFR) after 5 years.
- Secondary endpoint were the annual changes in the glomerularfiltration rate, urinary albumin excretion, the serum creatinine level, and blood pressure; the rates of clinical events (end-stage renal disease,myocardial infarction, stroke, and congestive heart failure); the rate of death from all causes; the rate of adverse events; and laboratory abnormalities.
Results:
- Pritor®/Kinzalmono® provides long-term renoprotective effects comparable to enalapril in patients with type 2 diabetes and early nephropathy.
- Pritor®/Kinzalmono® reduced the decline in GFR consistently year after year in patients with type 2 diabetes and early nephropathy.
Schmieder RE et al. - Diabetes Care 2007; 30:1351–6.
Conclusion:
- The renoprotective effect of Pritor®/Kinzalmono® , measured in terms of the annual decline in glomerular filtration rate, is comparable to that achieved with other ARBs in 3 long-term studies: IRMA 2, RENAAL and IDNT
- The DETAIL study demonstrated that Pritor®/Kinzalmono® is similar to enalapril in preventing the progression of renal disease in hypertensive patients with type 2 diabetes and early nephropathy.
