Takihata Masahiro, Nakamura Akinobu, Kondo Yoshinobu, Kawasaki Satsuki, Kimura Mari, Terauchi Yasuo
Department of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan.
Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, Chigasaki, Kanagawa, Japan.
PLoS One. 2015 May 4;10(5):e0125519. doi: 10.1371/journal.pone.0125519. eCollection 2015.
This study compared the efficacy and safety of azelnidipine with that of trichlormethiazide in Japanese type 2 diabetic patients with hypertension.
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.
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.
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.
UMIN 000006081.
本研究比较了阿折地平与三氯噻嗪对日本2型糖尿病合并高血压患者的疗效和安全性。
在一项多中心、开放标签试验中，纳入了240例在生活方式干预和/或使用降糖药物治疗下糖尿病得到充分控制（糖化血红蛋白≤7.0%）但高血压控制不佳（收缩压≥130 mmHg或舒张压≥80 mmHg）且正在接受奥美沙坦治疗的患者。参与者被随机分配至阿折地平组或三氯噻嗪组，并随访48周。主要结局指标是两组在48周时糖化血红蛋白水平相对于基线值变化的差异。
在纳入的240名受试者中，209名受试者（阿折地平组：103例患者，三氯噻嗪组：106例患者）完成了本试验。在48周时，阿折地平组和三氯噻嗪组分别观察到以下变化：糖化血红蛋白水平，分别为0.19±0.52%和0.19±0.54%；收缩压/舒张压，分别为-10.7±9.6/-6.6±6.6 mmHg和-7.1±7.7/-3.3±6.1 mmHg（收缩压和舒张压P均<0.001）。在48周的随访期内，两组均观察到头晕（分别为12例患者[11.7%]和16例患者[15.1%]）和水肿（分别为16例患者[15.5%]和7例患者[6.6%]，P = 0.047）。
在日本2型糖尿病患者中，阿折地平在控制血压方面比三氯噻嗪更有效，而三氯噻嗪在降低蛋白尿方面比阿折地平更有效。然而，这两种药物对2型糖尿病合并高血压患者的血糖控制同样有不良影响。
UMIN 000006081。
