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CAPTOPRIL USE IN DIABETIC NEPHROPATHY COULD SAVE MEDICARE $2.6 BIL

Executive Summary

CAPTOPRIL USE IN DIABETIC NEPHROPATHY COULD SAVE MEDICARE $2.6 BIL over a 10-year period, Edmund (9 Lewis, MD, Rush Presbyterian-St. Luke's Medical Center, estimated at a Nov. 10 press conference reporting on a study published in the Nov. 11 issue of The New England Journal of Medicine. Lewis, the study's lead investigator, based his estimate on the $7.2 bil. in current annual Medicare spending on end-stage renal disease (ESRD) and study findings that therapy with Bristol- Myers Squibb's angiotensin-converting enzyme inhibitor Capoten (captopril) in diabetic patients with kidney failure showed a 50% reduction in patients' risk of dying or requiring dialysis or a kidney transplant for ESRD. In contrast, the cost of captopril therapy would be about $700 annually per patient, Lewis said. Of the 14 mil. people in the U.S. who have diabetes, about 30%-40% will develop kidney disease, Lewis said. There are approximately 200,000 people with ESRD in the U.S. and diabetes accounts for almost 35% of the new cases each year. Based on these numbers, the cost of treating all diabetic ESRD patients with captopril would be approximately $49 mil. annually. National Institute of Diabetes and Digestive and Kidney Diseases" Gary Striker, MD, pointed to Lewis' study as an example of preventive care that is consistent with the goals of health care reform. He also asserted that the study, funded by NIDDK and Bristol-Myers Squibb, heralds a new era of government and industry collaboration that can "shorten the time from basic research to clinical practice." BMS donated $5 mil. in funding for the trial and NIDDK provided $2 mil. The NEJM study followed an initial cohort of 409 diabetic nephropathy patients for an average of three years. In the study, 207 patients were treated with captopril 25 mg t.i.d. and 202 received placebo. In the group treated with captopril, 11% died or required dialysis or transplantation compared to 21% of the patients who had received placebo. Captopril also reduced the number of patients who had a doubling of their serum creatinine levels by almost half. The benefit from captopril was independent of its blood pressure lowering effect and the drug worked to delay progression of disease regardless of patients" initial degree of kidney impairment. FDA's Cardiovascular & Renal Drugs Advisory Committee recommended Oct. 28 that captopril be approved for the treatment of diabetic nephropathy in patients fitting the criteria of those enrolled in the Lewis study ("The Pink Sheet" Nov. 1, T&G-7). Those criteria were: Type I insulin-dependent diabetics with overt nephropathy defined as having at least 500 mg of urinary protein excretion per 24 hours and a serum creatinine </= 2.5 mg per decaliter. The patients also had to have developed diabetes before the age of 30. Lewis suggested, however, that captopril could be used in patients with incipient nephropathy, who have only traces of proteinuria and in people with Type II non-insulin-dependent diabetic nophropathy. "A diabetic patient with any evidence of nephropathy should be placed on captopril [therapy]," Lewis asserted. The Rush researcher said that a study is being planned to test captopril therapy in Type II diabetics. Asked if the effect of captopril diabetic nephropathy could be considered a class effect of ACE inhibitors, Lewis commented that not all ACE inhibitors should be considered equal until the studies have been conducted. "They will have to be studied head- to-head [with captopril]," he remarked. Merck is conducting trials with Vasotec (enalapril) for congestive heart failure in hypertensive patients with diabetes and kidney dysfunction.
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