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Posted by ottercritr
New England Journal of Medicine -- March 5, 1998 -- Volume 338, Number 10
The Effect of Nisoldipine as Compared with Enalapril on Cardiovascular Outcomes
in Patients with Non-Insulin-Dependent Diabetes and Hypertension
Raymond O. Estacio, Barrett W. Jeffers, William R. Hiatt, Stacy L. Biggerstaff,
Nancy Gifford, Robert W. Schrier
Abstract:
Background. It has recently been reported that the use of calcium-channel
blockers for hypertension may be associated with an increased risk of
cardiovascular complications. Because this issue remains controversial, we
studied the incidence of such complications in patients with
non-insulin-dependent diabetes mellitus and hypertension who were randomly
assigned to treatment with either the calcium-channel
blocker nisoldipine or the angiotensin-converting-enzyme inhibitor
enalapril as part of a larger study.
Methods. The Appropriate Blood Pressure Control in Diabetes (ABCD) Trial
is a prospective, randomized, blinded trial comparing the effects of
moderate control of blood pressure (target diastolic pressure, 80 to 89
mm Hg) with those of intensive control of blood pressure (target
diastolic pressure, 75 mm Hg) on the incidence and progression of
complications of diabetes. The study also compared nisoldipine with
enalapril as a first-line antihypertensive agent in terms of the
prevention and progression of complications of diabetes. In the current
study, we analyzed data on a secondary end point (the incidence of
myocardial infarction) in the subgroup of patients in the ABCD Trial who
had hypertension.
Results. Analysis of the 470 patients in the trial who had hypertension
(base-line diastolic blood pressure, greater than or equal to 90 mm Hg)
showed similar control of blood pressure, blood glucose and lipid
concentrations, and smoking behavior in the nisoldipine group (235
patients) and the enalapril group (235 patients) throughout five years
of follow-up. Using a multiple logistic-regression model with adjustment
for cardiac risk factors, we found that nisoldipine was associated with
a higher incidence of fatal and nonfatal myocardial infarctions (a total
of 25) than enalapril (total, 5) (risk ratio, 9.5; 95 percent confidence
interval, 2.3 to 21.4).
Conclusions. In this population of patients with diabetes and
hypertension, we found a *significantly higher incidence of fatal and
nonfatal myocardial infarction* among those assigned to therapy with the
calcium-channel blocker nisoldipine than among those assigned to receive
enalapril. Since our findings are based on a secondary end point, they
will require confirmation. (N Engl J Med 1998;338:645-52.)
Source Information:
From the Colorado Prevention Center (R.O.E., B.W.J., W.R.H., S.L.B.,
N.G., R.W.S.); the Division of General Internal Medicine (R.O.E.), the
Division of Renal Diseases and Hypertension (B.W.J., N.G., R.W.S.), the
Divisions of Geriatrics and Cardiology (W.R.H.), Department of Medicine,
and the Section of Vascular Medicine (W.R.H.), University of Colorado
Health Sciences Center; and the Department of Community Health Services,
Denver Health (R.O.E.) -- all in Denver. Address reprint requests to Dr.
Schrier at the Division of Renal Diseases and Hypertension, Department
of Medicine, University of Colorado Health Sciences Center, 4200 E.
Ninth Ave., Box B-178, Denver, CO 80262.