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Diabetics exposed to telmisartan and enalapril - DETAIL
Description:
The goal of the trial was to compare the ACE inhibitor enalapril with the angiotensin-receptor blocker (ARB) telmisartan for noninferiority in renoprotection as assessed by the glomerular filtration rate (GFR) at five years in patients with type 2 diabetes, hypertension, and early nephropathy.
Study Design
Study Design:
Patients Enrolled: 250
Mean Follow Up: Five years
Mean Patient Age: Mean age 60 years
Female: 27
Patient Populations:
Age 35-80 years, type 2 diabetes, ACE inhibitor use in the three months prior to enrollment, mild to moderate hypertension (blood pressure ≤180/95), and early stage nephropathy (GFR ≥70 ml/min/1.73 m2)
Primary Endpoints:
GFR at five years
Secondary Endpoints:
GFR at years 1, 2, 3, 4
All-cause mortality
Safety
Drug/Procedures Used:
Patients were randomized to either the ACE inhibitor enalapril (n=130; 40 mg for one month followed by 80 mg for 59 months) or the ARB telmisartan (n=120; 10 mg for one month followed by 20 mg for 59 months). GFR was assessed at years 1, 2, 3, 4, and 5. The trial was designed to test for noninferiority.
Principal Findings:
At five years, 82 patients in the telmisartan arm (68%) and 86 patients in the enalapril arm (66%) had follow-up data available.
Change from GFR at baseline to five years was -17.9 ml/min/1.73 m2 in the telmisartan group and -14.9 ml/min/1.73 m2 in the enalapril group (p=NS), meeting the criteria for noninferiority. The largest drop in both groups in GFR was from the baseline to one-year period. Serum creatinine increased by 0.10 mg/dl in both groups (p=NS). Urinary albumin excretion rate decreased by 1,03 in the telmisartan group and by 0.99 in the enalapril group (p=NS). Blood pressure dropped in both groups, with no difference by treatment. The frequency of serious adverse events was similar in both groups (49.3% for telmisartan vs. 43.8% for enalapril, p=NS), with discontinuation of study drug due to an adverse event reported in 20 and 30 patients, respectively.
There was no difference in clinical events between the telmisartan group and enalapril group, including mortality (5.0% vs. 4.6%), myocardial infarction (7.5% vs. 4.6%), stroke (5.0% vs. 4.6%), and heart failure (7.5% vs. 5.4%). No patients in the study needed dialysis.
Interpretation:
Among patients with type 2 diabetes, hypertension, and early nephropathy, treatment with the ACE inhibitor enalapril compared with the ARB telmisartan were noninferior for the primary endpoint of renoprotection as assessed by the GFR at five years.
Diabetic nephropathy is the most common cause of chronic renal failure, need for dialysis, and increased cardiovascular mortality in diabetic patients. Both ACE inhibitors and ARBs protect the kidney by blocking the renin angiotensin system, but do so by different mechanisms. Although the trial was small and follow-up through five years was low, the presenters noted that the present study was the first long-term study to compare an ARB with an ACE inhibitor for renoprotection in this patient population, and suggested that the data support use of either study drug as first-line therapy in patients with diabetic nephropathy and hypertension.
References:
Barnett AH, et al. Angiotensin-Receptor Blockade versus Converting–Enzyme Inhibition in Type 2 Diabetes and Nephropathy. N Engl J Med 2004;351:1952-61.
Barnett A. DETAIL: Diabetics exposed to telmisartan and enalapril. Paper presented at the European Society of Cardiology Congress 2004, 29 August-1 September, Munich, Germany.
Keywords: Myocardial Infarction, Stroke, Enalapril, Follow-Up Studies, Kidney Failure, Chronic, Diabetes Mellitus, Type 2, Renin-Angiotensin System, Blood Pressure, Diabetic Nephropathies, Creatinine, Benzoates, Renal Dialysis, Angiotensin II Type 1 Receptor Blockers, Benzimidazoles, Heart Failure, Glomerular Filtration Rate, Hypertension
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