THE EFFECT OF NISOLDIPINE AS COMPARED WITH ENALAPRIL ON CARDIOVASCULAR OUTCOMES IN PATIENTS WITH NON-INSULIN-DEPENDENT DIABETES AND HYPERTENSION

Background It has recently been reported that the use of calcium-chann el blockers for hypertension may be associated with an increased risk of cardiovascular complications. Because this issue remains controvers ial, we studied the incidence of such complications in patients with n on-insulin-dependent diabetes mellitus and hypertension who were rando mly assigned to treatment with either the calcium-channel blocker niso ldipine or the angiotensin-converting-enzyme inhibitor enalapril as pa rt of a larger study. Methods The Appropriate Blood Pressure Control i n Diabetes (ABCD) Trial is a prospective, randomized, blinded trial co mparing the effects of moderate control of blood pressure (target dias tolic pressure, 80 to 89 mm Hg) with those of intensive control of blo od pressure (target diastolic pressure, 75 mm Hg) on the incidence and progression of complications of diabetes. The study also compared nis oldipine with enalapril as a first-line antihypertensive agent in term s of the prevention and progression of complications of diabetes. In t he current study, we analyzed data on a secondary end point (the incid ence of myocardial infarction) in the subgroup of patients in the ABCD Trial who had hypertension. Results Analysis of the 470 patients in t he trial who had hypertension (base-line diastolic blood pressure, gre ater than or equal to 90 mm Hg) showed similar control of blood pressu re, blood glucose and lipid concentrations, and smoking behavior in th e nisoldipine group (235 patients) and the enalapril group (235 patien ts) throughout five years of follow-up. Using a multiple logistic-regr ession model with adjustment for cardiac risk factors, we found that n isoldipine was associated with a higher incidence of fatal and nonfata l myocardial infarctions (a total of 25) than enalapril (total, 5) (ri sk ratio, 9.5; 95 percent confidence interval, 2.3 to 21.4). Conclusio ns In this population of patients with diabetes and hypertension, we f ound a significantly higher incidence of fatal and nonfatal myocardial infarction among those assigned to therapy with the calcium-channel b locker nisoldipine than among those assigned to receive enalapril. Sin ce our findings are based on a secondary end point, they will require confirmation. (C) 1998, Massachusetts Medical Society.