Comparison of Azelnidipine and Trichlormethiazide in Japanese Type 2 Diabetic Patients with Hypertension: The COAT Randomized Controlled Trial.

Abstract

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.

TRIAL REGISTRATION:

UMIN 000006081.

• Authors: Masahiro Takihata, Akinobu Nakamura, Yoshinobu Kondo, Satsuki Kawasaki, Mari Kimura, Yasuo Terauchi
• Journal: PloS one (PLoS One) Vol. 10 Issue 5 Pg. e0125519 ( 2015) ISSN: 1932-6203 [Electronic] United States
• PMID: 25938807 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcium Channel Blockers
• Dihydropyridines
• Diuretics
• Azetidinecarboxylic Acid
• azelnidipine
• Trichlormethiazide

Topics

• Aged
• Azetidinecarboxylic Acid (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Blood Pressure (drug effects)
• Calcium Channel Blockers (administration & dosage, adverse effects, therapeutic use)
• Diabetes Mellitus, Type 2 (complications, drug therapy)
• Dihydropyridines (administration & dosage, adverse effects, therapeutic use)
• Diuretics (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Hypertension (complications, drug therapy)
• Japan
• Male
• Middle Aged
• Risk Factors
• Treatment Outcome
• Trichlormethiazide (administration & dosage, adverse effects, therapeutic use)