Comparison of Azelnidipine and Trichlormethiazide in Japanese Type 2 Diabetic Patients with Hypertension: The COAT Randomized Controlled Trial.
OBJECTIVE
This study compared the efficacy and safety of azelnidipine with that of trichlormethiazide in Japanese type 2 diabetic patients with hypertension.


METHODS
In a multicenter, open-label trial, 240 patients with adequately controlled diabetes (HbA1c ≤ 7.0%) under lifestyle modification and/or administration of hypoglycemic agents and inadequately controlled hypertension (systolic blood pressure [sBP] ≥ 130 mmHg or diastolic blood pressure [dBP] ≥ 80 mmHg) who were being treated with olmesartan were enrolled. Participants were randomly assigned to an azelnidipine group or a trichlormethiazide group and were followed up for 48 weeks. Main outcome measure was the difference in the change in HbA1c levels from the baseline values at 48 weeks between these two groups.


RESULTS
Of the 240 subjects that were enrolled, 209 subjects (azelnidipine group: 103 patients, trichlormethiazide group: 106 patients) completed this trial. At 48 weeks, the following changes were observed in the azelnidipine and trichlormethiazide groups, respectively: HbA1c levels, 0.19 ± 0.52% and 0.19 ± 0.54%; sBP/dBP, -10.7 ± 9.6/-6.6 ± 6.6 mmHg and -7.1 ± 7.7/-3.3 ± 6.1 mmHg (P < 0.001 for both sBP and dBP). In both groups, dizziness (12 patients [11.7%] and 16 patients [15.1%]) and edema (16 patients [15.5%] and 7 patients [6.6%], P = 0.047) were observed during the 48-week follow-up period.


CONCLUSIONS
Azelnidipine was more effective for controlling blood pressure than trichlormethiazide in Japanese type 2 diabetes patients, whereas trichlormethiazide was more effective for reducing albuminuria than azelnidipine. Both of these agents, however, similarly exacerbated glycemic control in type 2 diabetic patients with hypertension.


BACKGROUND
UMIN 000006081.
Department of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Masahiro
M
Takihata
Department of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Akinobu
A
Nakamura
Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, Chigasaki, Kanagawa, Japan.
Yoshinobu
Y
Kondo
Department of Endocrinology and Metabolism, Shonan Fujisawa Tokushukai Hospital, Fujisawa, Kanagawa, Japan.
Satsuki
S
Kawasaki
Department of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Mari
M
Kimura
Department of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Yasuo
Y
Terauchi
D000368:Aged; D001383:Azetidinecarboxylic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy*; D004095:Dihydropyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004232:Diuretics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome; D014237:Trichlormethiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D004232:Diuretics; D001383:Azetidinecarboxylic Acid; C061679:azelnidipine; D014237:Trichlormethiazide