Answers
01/28/1994

<TITLE>CAPTOPRIL APPROVED FOR TREATING DIABETIC KIDNEY DISEASE</TITLE>
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T94-8                                   June Wyman
Jan. 28, 1994                           (301) 443-3285
                                        Home (301) 496-2830

CAPTOPRIL APPROVED FOR TREATING DIABETIC KIDNEY DISEASE

     We have been receiving inquiries about FDA's Jan. 28 approval
of captopril for treating nephropathy (kidney disease) and
preventing kidney failure in Type 1 (juvenile type) insulin-
dependent diabetics.  The following can be used to answer
questions.
     Captopril is the first drug therapy for diabetic nephropathy,
a common and often fatal complication of diabetes.  Until now, the
only treatments were hemodialysis or a kidney transplant.  
     FDA's approval is based largely on results of a double-blind,
placebo-controlled clinical trial that involved 409 patients at 30
centers in the United States and Canada.  Captopril treatment was
associated with a 50 percent reduction in the combined risk of
death or of kidney failure requiring dialysis or a transplant. 
Several smaller studies also showed that captopril could slow
progression of diabetic kidney disease.
     Treatment should be offered to patients with Type 1 diabetes
who have two diagnostic markers for kidney disease:  high protein
levels in the urine and abnormalities in blood vessels of the eye. 
For long-term prevention the recommended dose is 75 mg/day divided
into three doses.  Although serious side effects are unusual, they
can include swelling of the face, tongue, larynx, and other facial 
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                               Page 2, T94-8, Captopril
tissues, low blood pressure and neutropenia, a deficiency of white
blood cells.
     Captopril is already approved for treating high blood pressure
and heart failure.  An added benefit of its use for diabetic
nephropathy is that it lowers hypertension, a major complication of
diabetes.
     Captopril has not been shown to slow kidney disease in non-
insulin-dependent diabetics or in people with adult-onset diabetes. 
Also, the drug should not be taken during pregnancy because of
possible damage to the fetus.
     Of 13 million diabetics in the United States, about 5 percent,
or 650,000, have Type 1 (juvenile-onset) diabetes.  Of these, 35 to
45 percent eventually develop kidney disease and would be
candidates for preventive drug treatment.
     Captopril is marketed under the name Capoten by Bristol-Myers
Squibb Co. of Princeton, N.J.
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