Effect of captopril or imidapril on the progression of diabetic nephropathy in Japanese with type 1 diabetes mellitus: a randomized controlled study (JAPAN-IDDM).
OBJECTIVE
to clarify and confirm the renoprotective effects of ACEIs in Japanese type 1 diabetics.


METHODS
a double-blind randomized study using two ACEIs, imidapril (a prodrug of imdaprilat without an SH-residue) and captopril as well as placebo was performed. Seventy-nine eligible cases were randomized to receive captopril 37.5 mg (n=26), imidapril 5 mg (n=26) or their placebos (n=27) daily in a double-blind manner.


RESULTS
urinary albumin excretion (UAE), determined every half year, was significantly decreased by the ACEIs (placebo vs. ACEIs F=11.316, P=0.001, placebo vs. captopril F=4.260, P=0.043, placebo vs. imidapril F=14.341, P<0.001) during the study period (the mean; 1.48 years). Although the HbA(1C) levels and systolic blood pressure (BP) between the three groups were not different, glycemic and BP control significantly affected UAE. Systolic BP in the placebo group tended to be higher by 7-10 mmHg throughout the study.


CONCLUSIONS
these results suggest that the ACE inhibitors, imidapril and captopril, prevent the increase in UAE in micro and macroalbuminuric patients with type 1 diabetes mellitus and that the target BP might be less than 130/80 mmHg.
Katayama
Shigehiro
S
Fourth Department of Medicine, Saitama Medical School, 38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japan. skataya@saitama-med.ac.jp
Kikkawa
Ryuichi
R
Isogai
Syo
S
Sasaki
Nozomu
N
Matsuura
Nobuo
N
Tajima
Naoko
N
Urakami
Tatsuhiko
T
Uchigata
Yasuko
Y
Ohashi
Yasuo
Y
D000328:Adult; D000419:Albuminuria; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure; D002216:Captopril / Q000627:therapeutic use*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000188:drug therapy / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D048289:Imidazolidines; D008297:Male; D010919:Placebos
D000806:Angiotensin-Converting Enzyme Inhibitors; D001786:Blood Glucose; D002216:Captopril; D006442:Glycated Hemoglobin; D007093:Imidazoles; D048289:Imidazolidines; D010919:Placebos; C065166:imidapril