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| |  ESH: Irbesartan Delays Nephropathy In Diabetic Patients By Bruce Wilson Special to DG News
MILAN, ITALY -- June 17, 2001 -- Irbesartan, an angiotensin AT1 receptor blocker (ARB), delays the development of nephropathy in patients with type 2 diabetes, according to the results of a study announced today at the 11th European Society of Hypertension meeting. Speaking on behalf of his colleagues in the PRIME (Program for Irbesartan Mortality and Morbidity Evaluations) initiative, Dr. Lawrence G. Hunsicker, Professor of Internal Medicine (Nephrology), University of Iowa College of Medicine, Iowa City, Iowa, said the results of this trial represent "striking and clear evidence" for the use of irbesartan in this patient population. The IDNT (Irbesartan Diabetic Nephropathy Trial), was a multicentre, randomized, double-blind, placebo-controlled study in 1715 type 2 diabetic patients aged 30 to 70, who had 24-hour urinary protein excretion greater than 900 mg and a serum creatinine of 90 to 265 µmol/L (1.0 to 3.0 mg/dL) in women and 110 to 265 µmol/L (1.2 to 3.0 mg/dL) in men. Patients were randomized to receive irbesartan titrated to 300 mg/day single dose, the calcium channel blocker (CCB) amlodipine titrated to 10 mg/day single dose, or placebo. Blood pressure was controlled in each arm to the identical goal of 135/85 mm Hg or less, using adjunctive agents other than ACE inhibitors, ARBs, or CCBs, as needed. The primary outcome measure was time to event to the composite end point of doubling of serum creatinine, end-stage renal disease (ESRD), or death. The secondary outcome measure was time to composite end point of fatal or nonfatal cardiovascular events. The average length of patient follow-up was 36 months. According to Dr. Hunsicker, "irbesartan did substantially better than either amlodipine and placebo on the primary end point." Specifically, irbesartan was associated with a 20 percent relative risk reduction (p=0.024) of progression to the composite of doubling of serum creatinine, ESRD, and death, compared to placebo, whereas amlodipine did not differ from placebo on this measure. Dr. Hunsicker said that the results on the composite end point were primarily driven by the positive effect of irbesartan on serum creatinine, although irbesartan was clearly significantly better than both amlodipine and placebo on all components. Interestingly, both active treatments were equivalent at lowering blood pressure, indicating that something other than blood pressure lowering is at the basis of irbesartan’s renal benefits. Addressing the clinical significance of these results, Dr. Hunsicker said, "there are about 550,000 patients in the US with type 2 diabetes fulfilling IDNT criteria. If they were treated with irbesartan, we would expect to avoid ESRD in about 35,000 patients. This would results in a savings of $2.5 billion over the next three years, and that is just for dialysis care alone."
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