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Angiotensin-receptor blockade versus converting-enzyme inhibition in type 2 diabetes and nephropathy
Anthony H Barnett1, Stephen C Bain, Paul Bouter
1Division of Medical Sciences, University of Birmingham and Birmingham Heartlands and Solihull National Health Service Trust (Teaching), Birmingham, United Kingdom. anthony.barnett@heartsol.wmids.nhs.uk
Background:
Few studies have directly compared the renoprotective effects of angiotensin II-receptor blockers and angiotensin-converting-enzyme (ACE) inhibitors in persons with type 2 diabetes.
Methods:
In this prospective, multicenter, double-blind, five-year study, we randomly assigned 250 subjects with type 2 diabetes and early nephropathy to receive either the angiotensin II-receptor blocker telmisartan (80 mg daily, in 120 subjects) or the ACE inhibitor enalapril (20 mg daily, in 130 subjects). The primary end point was the change in the glomerular filtration rate (determined by measuring the plasma clearance of iohexol) between the baseline value and the last available value during the five-year treatment period. Secondary end points included the annual changes in the glomerular filtration rate, serum creatinine level, urinary albumin excretion, and blood pressure; the rates of end-stage renal disease and cardiovascular events; and the rate of death from all causes.
Results:
After five years, the change in the glomerular filtration rate was -17.5 ml per minute per 1.73 m2 (where the minus sign denotes a decrement) in the telmisartan-treated subjects, as compared with -15.0 ml per minute per 1.73 m2 in the enalapril-treated subjects; the treatment difference was thus -2.6 ml per minute per 1.73 m2 (95 percent confidence interval, -7.1 to 2.0 ml per minute per 1.73 m2)[corrected] The lower boundary of the confidence interval, in favor of enalapril, was greater than the predefined margin of -10.0 ml per minute per 1.73 m2, indicating that telmisartan was not inferior to enalapril. The effects of the two agents on the secondary end points were not significantly different after five years.
Conclusions:
Telmisartan is not inferior to enalapril in providing long-term renoprotection in persons with type 2 diabetes. These findings do not necessarily apply to persons with more advanced nephropathy, but they support the clinical equivalence of angiotensin II-receptor blockers and ACE inhibitors in persons with conditions that place them at high risk for cardiovascular events.
Insights
Telmisartan and enalapril show similar long-term kidney protection in type 2 diabetes patients with early nephropathy. This study confirms the clinical equivalence of angiotensin II-receptor blockers and ACE inhibitors for renoprotection.
Area of Science:
- Nephrology
- Endocrinology
- Cardiovascular Medicine
Background:
- Limited comparative data exists on the renoprotective effects of angiotensin II-receptor blockers (ARBs) versus angiotensin-converting-enzyme (ACE) inhibitors in type 2 diabetes patients.
- Early nephropathy in type 2 diabetes is a significant risk factor for progressive kidney disease and cardiovascular events.
Purpose of the Study:
- To compare the long-term renoprotective efficacy of telmisartan (an ARB) against enalapril (an ACE inhibitor) in patients with type 2 diabetes and early nephropathy.
- To assess the non-inferiority of telmisartan compared to enalapril in preserving kidney function over a five-year period.
Main Methods:
- A prospective, multicenter, double-blind, five-year study involving 250 patients with type 2 diabetes and early nephropathy.
- Participants were randomized to receive either telmisartan (80 mg daily) or enalapril (20 mg daily).
- The primary endpoint was the change in glomerular filtration rate (GFR) over five years, with secondary endpoints including serum creatinine, albuminuria, blood pressure, and clinical outcomes.
Main Results:
- After five years, the mean decrement in GFR was -17.5 ml/min/1.73 m² for telmisartan and -15.0 ml/min/1.73 m² for enalapril.
- Telmisartan was found to be non-inferior to enalapril, as the difference (-2.6 ml/min/1.73 m²) did not exceed the predefined non-inferiority margin.
- No significant differences were observed between the two groups in secondary endpoints, including changes in serum creatinine, albuminuria, blood pressure, and rates of end-stage renal disease or cardiovascular events.
Conclusions:
- Telmisartan demonstrates non-inferiority to enalapril in providing long-term renoprotection for patients with type 2 diabetes and early nephropathy.
- The findings support the clinical equivalence of ARBs and ACE inhibitors in this patient population, particularly those at high cardiovascular risk.
- Results may not directly apply to patients with more advanced diabetic nephropathy.
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