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ABCD
Appropriate Blood pressure Control in Diabetes
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Author(s) |
(a) Savage S, Nagel NJ, Estacio RO, Feig PU, MacCarthy EP, Lukken NJ, Ziegler R, Schrier RW
(b) Estacio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Schrier RW
(c) Estacio RO, Schrier RW
(d) Schrier RW, Estacio RO
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Title(s) |
(a) The ABCD (Appropriate Blood pressure Control in Diabetes) trial. Rationale and design of a trial of hypertension control (moderate or intensive) in type II diabetes
(b) The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension
(c) Antihypertensive therapy in type 2 diabetes: implications of the Appropriate Blood Pressure Control in Diabetes (ABCD) trial
(d) Additional follow-up from the ABCD trial in patients with type 2 diabetes and hypertension |
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Reference(s) |
(a) Online J Curr Clin Trials 1993 (doc no 104)
(b) N Engl J Med 1998;338:645–52
(c) Am J Cardiol 1998;82:9R–14R
(d) N Engl J Med 2000;343:1969
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Disease |
Type 2 diabetes with/without hypertension
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Purpose |
To determine the efficacy of intensive vs moderate BP control on the outcome of type 2 diabetic end-organ complications in normotensive and hypertensive populations, and to compare enalapril and nisoldipine as first-line antihypertensives in terms of prevention and progression of diabetic complications
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Study design |
Randomised, double-blind, placebo-controlled (normotensive cohort), parallel-group
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Follow-up |
5 years |
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Patients |
950 patients (480 normotensive, 470 hypertensive), aged 40–74 years, with type 2 diabetes and DBP ≥ 80 mm Hg |
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Treatment regimen |
Normotensive cohort: intensive therapy with nisoldipine, 10 mg/day increasing stepwise to 60 mg/day, plus enalapril placebo, or enalapril, 5 mg/day increasing stepwise to 40 mg/day, plus nisoldipine placebo, to target DBP 75 mm Hg, or moderate therapy with placebo only to target DBP 80–89 mm Hg
Hypertensive cohort: nisoldipine, 10 mg/day increasing stepwise to 60 mg/day, plus enalapril placebo, or enalapril, 5 mg/day increasing stepwise to 40 mg/day, plus nisoldipine placebo, to target DBP 75 mm Hg, or moderate therapy with the same agents to target DBP 80–89 mm Hg
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Concomitant therapy |
Open therapy with antihypertensives (including metoprolol and hydrochlorothiazide but not calcium antagonists or ACE inhibitors) at the discretion of the physician to reach target DBP
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Results |
In the hypertensive cohort, control of BP, blood glucose and lipid levels were similar in the nisoldipine and enalapril groups. Adjusting for cardiac risk factors, the incidence of fatal and nonfatal MI was significantly higher in the nisoldipine group than in the enalapril group (25 vs 5 events, p = 0.001)
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Comments |
The trial was terminated in the hypertensive cohort after 67 months when interim analysis showed a significant difference in cardiovascular event rates between groups |
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