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The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension.

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 (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, > or = 90 mm Hg) showed similar control of blood pressure, blood glucose and lipid concentrations, and smoking behavior in the nisoldipine group (237 patients) and the enalapril group (233 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 24) than enalapril (total, 4) (risk ratio, 9.5; 95 percent confidence interval, 2.7 to 33.8).

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.

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  • Authors+Show Affiliations

    ,

    Colorado Prevention Center, Division of General Internal Medicine, University of Colorado Health Sciences Center, Denver 80262, USA.

    , , , ,

    Source

    The New England journal of medicine 338:10 1998 Mar 05 pg 645-52

    MeSH

    Adult
    Aged
    Angiotensin-Converting Enzyme Inhibitors
    Calcium Channel Blockers
    Cardiovascular Diseases
    Diabetes Mellitus, Type 2
    Double-Blind Method
    Enalapril
    Female
    Humans
    Hypertension
    Logistic Models
    Male
    Middle Aged
    Myocardial Infarction
    Nisoldipine
    Prospective Studies
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    9486993

    Citation

    Estacio, R O., et al. "The Effect of Nisoldipine as Compared With Enalapril On Cardiovascular Outcomes in Patients With Non-insulin-dependent Diabetes and Hypertension." The New England Journal of Medicine, vol. 338, no. 10, 1998, pp. 645-52.
    Estacio RO, Jeffers BW, Hiatt WR, et al. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med. 1998;338(10):645-52.
    Estacio, R. O., Jeffers, B. W., Hiatt, W. R., Biggerstaff, S. L., Gifford, N., & Schrier, R. W. (1998). The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. The New England Journal of Medicine, 338(10), pp. 645-52.
    Estacio RO, et al. The Effect of Nisoldipine as Compared With Enalapril On Cardiovascular Outcomes in Patients With Non-insulin-dependent Diabetes and Hypertension. N Engl J Med. 1998 Mar 5;338(10):645-52. PubMed PMID: 9486993.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. AU - Estacio,R O, AU - Jeffers,B W, AU - Hiatt,W R, AU - Biggerstaff,S L, AU - Gifford,N, AU - Schrier,R W, PY - 1998/3/5/pubmed PY - 1998/3/5/medline PY - 1998/3/5/entrez SP - 645 EP - 52 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 338 IS - 10 N2 - 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 (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, > or = 90 mm Hg) showed similar control of blood pressure, blood glucose and lipid concentrations, and smoking behavior in the nisoldipine group (237 patients) and the enalapril group (233 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 24) than enalapril (total, 4) (risk ratio, 9.5; 95 percent confidence interval, 2.7 to 33.8). 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. SN - 0028-4793 UR - https://www.unboundmedicine.com/medline/citation/9486993/The_effect_of_nisoldipine_as_compared_with_enalapril_on_cardiovascular_outcomes_in_patients_with_non_insulin_dependent_diabetes_and_hypertension_ L2 - https://www.nejm.org/doi/10.1056/NEJM199803053381003?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -