Shiga Yuhei, Miura Shin-ichiro, Morii Joji, Kuwano Takashi, Mitsutake Ryoko, Uehara Yoshinari, Inoue Asao, Saku Keijiro
Department of Cardiology, Fukuoka University School of Medicine, Japan.
Intern Med. 2011;50(21):2477-83. doi: 10.2169/internalmedicine.50.5939. Epub 2011 Nov 1.
We analyzed the efficacy and safety of Preminent(®) [losartan (50 mg/day)/HCTZ (12.5 mg/day)] compared to CodioMD(®) [valsartan (80 mg/day)/HCTZ (6.25 mg/day)].
In this study, 31 hypertensive patients after receiving 3 months of Preminent(®) (Stage A) were enrolled. We applied a changeover with switching from Preminent(®) to CodioMD(®) (Stage B). We then applied another changeover with switching from CodioMD(®) to Preminent(®) after 3 months (Stage C).
Average values of 24-h blood pressure (BP), daytime BP and nighttime BP using ambulatory BP monitoring (ABPM) significantly increased from Stage A to B [4/3 mmHg, 5/3 mmHg and 3/3 mmHg, respectively]. Average values of 24-h BP, morning BP, daytime BP, nighttime BP significantly decreased from the end of Stage B to C [-5/-5 mmHg, -4/-6 mmHg, -5/-5 mmHg and -6/-4 mmHg, respectively]. Interestingly, the serum levels of uric acid and the urinary albumin/creatinine ratio showed a significant increase after the change to CodioMD(®). Since these adverse effects did not disappear after the return to Preminent(®) at the end of Stage C, we performed an additional 3-month follow-up (extended stage). These adverse effects finally disappeared at the end of this extended stage.
Single-pill fixed-dose combination therapy using Preminent(®) showed significant 24-h BP-lowering effects and was safe when compared with CodioMD(®).
我们分析了卓越（®）[氯沙坦（50毫克/天）/氢氯噻嗪（12.5毫克/天）]与科迪欧MD（®）[缬沙坦（80毫克/天）/氢氯噻嗪（6.25毫克/天）]相比的疗效和安全性。
在本研究中，招募了31名接受了3个月卓越（®）治疗（A阶段）的高血压患者。我们进行了从卓越（®）转换为科迪欧MD（®）的换药（B阶段）。然后在3个月后进行了从科迪欧MD（®）转换回卓越（®）的另一次换药（C阶段）。
使用动态血压监测（ABPM）测得的24小时血压（BP）、日间血压和夜间血压的平均值从A阶段到B阶段显著升高[分别为4/3毫米汞柱、5/3毫米汞柱和3/3毫米汞柱]。从B阶段结束到C阶段，24小时血压、清晨血压、日间血压、夜间血压的平均值显著下降[分别为-5/-5毫米汞柱、-4/-6毫米汞柱、-5/-5毫米汞柱和-6/-4毫米汞柱]。有趣的是，转换为科迪欧MD（®）后，尿酸水平和尿白蛋白/肌酐比值显著升高。由于这些不良反应在C阶段结束恢复使用卓越（®）后并未消失，我们又进行了3个月的随访（延长阶段）。这些不良反应最终在这个延长阶段结束时消失。
与科迪欧MD（®）相比，使用卓越（®）的单片固定剂量联合治疗显示出显著的24小时降压效果且安全。
