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Preventing Microalbuminuria in Type 2 Diabetes


Preventing Microalbuminuria in Type 2 Diabetes -- Posted by Gumbo on 11-16-04 20:32


Preventing Microalbuminuria in Type 2 Diabetes
on Tuesday, November 09 @ 15:48:09 EST

In subjects with type 2 diabetes and hypertension but with normoalbuminuria,
the use of trandolapril plus verapamil and trandolapril alone decreased the
incidence of microalbuminuria.

The multicenter double-blind, randomized Bergamo Nephrologic Diabetes
Complications Trial (BENEDICT) was designed to assess whether
angiotensin-converting-enzyme inhibitors and non-dihydropyridine
calcium-channel blockers, alone or in combination, prevent microalbuminuria
in subjects with hypertension, type 2 diabetes mellitus, and normal urinary
albumin excretion.

They studied 1204 subjects, who were randomly assigned to receive at least
three years of treatment with trandolapril (at a dose of 2 mg per day) plus
verapamil (sustained-release formulation, 180 mg per day), trandolapril
alone (2 mg per day), verapamil alone (sustained-release formulation, 240 mg
per day), or placebo. The target blood pressure was 120/80 mm Hg. The
primary end point was the development of persistent microalbuminuria
(overnight albumin excretion, >/=20 microg per minute at two consecutive
visits).

The results showed that the primary outcome was reached in 5.7 percent of
the subjects receiving trandolapril plus verapamil, 6.0 percent of the
subjects receiving trandolapril, 11.9 percent of the subjects receiving
verapamil, and 10.0 percent of control subjects receiving placebo. The
estimated acceleration factor (which quantifies the effect of one treatment
relative to another in accelerating or slowing disease progression) adjusted
for predefined baseline characteristics was 0.39 for the comparison between
verapamil plus trandolapril and placebo , 0.47 for the comparison between
trandolapril and placebo , and 0.83 for the comparison between verapamil and
placebo.

Trandolapril plus verapamil and trandolapril alone delayed the onset of
microalbuminuria by factors of 2.6 and 2.1, respectively. Serious adverse
events were similar in all treatment groups.

From the results it was concluded that, in subjects with type 2 diabetes and
hypertension but with normoalbuminuria, the use of trandolapril plus
verapamil and trandolapril alone decreased the incidence of microalbuminuria
to a similar extent. The effect of verapamil alone was similar to that of
placebo.

N Engl J Med. 2004 Oct 31




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