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Executive Summary

SQUIBB RESEARCH ON CAPTOPRIL FOR DIABETIC THERAPY will begin in February, according to the firm. A study comparing the effects of captopril to hydrochlorothiazide on proteinuria (protein in the urine) is being designed to evaluate captopril's usefulness in slowing the progression of chronic renal disease, a consequence of diabetes. The planned Squibb study will follow a Dec. 26, 1985 New England Journal of Medicine report by a Japanese medical team which found that "the inhibition of angiotensin-converting enzyme by captopril relieves intrarenal hypertension . . . ]which[ decreased urinary protein excretion." Though "the follow-up period in ]the[ study was not long enough" to determine whether captopril could delay the need for dialysis, the researchers from Sendai Shakaihoken Hospital, Japan, concluded that, "many advantages can be obtained if serious proteinuria can be improved promptly by the administration of captopril." The diabetic study on Capoten (captopril) could be particularly interesting in light of the drug's initial labeling. When the product was originally approved by FDA, the agency expressed concern about high proteinuria. Capoten labeling contains a warning about proteinuria and advises that urinary protein estimates be obtained prior to therapy.

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