To investigate the impact of treatment on cardiovascular mortality and morbidity, we assessed outcomes in patients with
hypertension and diabetes who received
co-amilozide or
nifedipine in the International
Nifedipine GITS Study: Intervention as a Goal in
Hypertension. Participants had to be 55 to 80 years of age, with
hypertension (> or =150/95 or > or =160 mm Hg) and at least one additional cardiovascular risk factor. Patients received 30 mg
nifedipine once daily or
co-amilozide (25 mg
hydrochlorothiazide and 2.5 mg
amiloride) daily. Doses were doubled if target blood pressures (<140/90 mm Hg) were not achieved. Primary (composite of cardiovascular death,
myocardial infarction,
heart failure, and
stroke) and secondary outcomes (composite of primary outcomes, including all-cause mortality and death from vascular and nonvascular causes) were assessed by means of intent-to-treat analyses. There was no significant difference in the incidence of primary outcomes between
nifedipine-treated and
co-amilozide-treated patients with diabetes at baseline (n=1302) (8.3% versus 8.4%; relative risk, 0.99, 95% CI, 0.69 to 1.42; P=1.00). A significant benefit for
nifedipine-treated patients was seen for the composite secondary outcome (14.2% versus 18.7%; relative risk, 0.76, 95% CI, 0.59 to 0.97; P=0.03). Among patients without diabetes at baseline (n=5019), there was a significant difference in the incidence of new diabetes (
nifedipine 4.3% versus
co-amilozide 5.6%, P=0.023).
Nifedipine GITS once daily is as effective as
diuretic therapy in reducing cardiovascular complications in hypertensive diabetics.
Nifedipine-treated patients were also less likely to have diabetes or have secondary events (a composite of all-cause mortality, death from a vascular cause, and death from a nonvascular cause) than
co-amilozide recipients. Our results suggest that
nifedipine could be considered as first-line
therapy for hypertensive diabetics.