Diabetes, Vol 45, Issue 2 216-222, Copyright © 1996 by American Diabetes Association
Effects of cilazapril and amlodipine on kidney function in hypertensive NIDDM patients
M Velussi, E Brocco, F Frigato, M Zolli, B Muollo, M Maioli, A Carraro, G Tonolo, P Fresu, AM Cernigoi, P Fioretto and R Nosadini
Centro Antidiabetico di Monfalcone, Gorizia, Italy.
Contrasting information has been reported concerning the course of renal
function in NIDDM with hypertension alone or in association with renal
damage. The aim of the present study was to elucidate the course of the
glomerular filtration rate (GFR) in hypertensive NIDDM patients during
antihypertensive therapy. Furthermore, we compared the effects of ACE
inhibitors (cilazapril, Inibace, Roche, Milan, Italy) and Ca(2+)-channel
blockers (amlodipine, Norvasc, Pfizer, Rome, Italy). Of the hypertensive
NIDDM patients attending the outpatient's clinic of the internal medicine
departments of the University of Padova and Sassari, 44 participated in the
present study. Of these patients, 26 were normoalbuminuric and 18
microalbuminuric. They were randomly treated with either cilazapril or
amlodipine. The target of antihypertensive treatment was a value < 140
mmHg for systolic and 85 mmHg for diastolic blood pressure (BP).
Microalbuminuria was defined as an albumin excretion rate (AER) between 20
and 200 micrograms/min. GFR was measured by plasma clearance of
51Cr-labeled EDTA at baseline and every 6-12 months during a 3-year
follow-up interval. A significant decrease was observed in the values of
GFR, AER, and systolic and diastolic BP in normoalbuminuric and
microalbuminuric patients during antihypertensive therapy. The GFR fall in
the overall population of NIDDM patients was significantly and inversely
related to the decrease of mean BP (diastolic + 1/3 pulse pressure) (r =
-0.80, P < 0.0001) but not to that of HbA1c, triglycerides, and BMI. The
GFR decline (mean +/- SE) per year in the normoalbuminuric patient was 2.03
+/- 0.66 ml.min-1 x 1.73 m-2 (95% CI 0.92-3.17) during cilazapril and 2.01
+/- 0.71 ml.min-1 x 1.73 m-2 (95% CI 0.82-3.11) during amlodipine therapy.
The GFR decline per year in the microalbuminuric patient was 2.15 +/- 0.69
ml.min-1 x 1.73 m-2 (95% CI 0.86-3.89) during cilazapril and 2.33 +/- 0.83
ml.min-1 x 1.73 m-2 per year (95% CI 1.03-3.67) during amlodipine therapy.
Cilazapril and amlodipine lowered AER to a similar extent in
normoalbuminuric and microalbuminuric patients. No significant changes were
observed concerning other clinical and biochemical features between the two
antihypertensive therapies and particularly HbA1c, BMI, triglycerides, and
cholesterol plasma values. These results support the tenet that arterial
hypertension plays a pivotal role in contributing to renal damage in NIDDM,
even when AER is normal. However, the degree of BP control, with both
cilazapril and amlodipine, can successfully delay the slope of GFR decline
in hypertensive NIDDM patients with or without incipient nephropathy.