Ogihara Toshio, Saruta Takao, Rakugi Hiromi, Saito Ikuo, Shimamoto Kazuaki, Matsuoka Hiroaki, Shimada Kazuyuki, Ito Sadayoshi, Horiuchi Masatsugu, Imaizumi Tsutomu, Takishita Shuichi, Higaki Jitsuo, Katayama Shigehiro, Kimura Genjiroh, Umemura Satoshi, Ura Nobuyuki, Hayashi Koichi, Odawara Masato, Tanahashi Norio, Ishimitsu Toshihiko, Kashihara Naoki, Morita Satoshi, Teramukai Satoshi
aMorinomiya University of Medical Sciences, Osaka bKeio University, Tokyo cOsaka University Graduate School of Medicine, Osaka dSapporo Medical University, Hokkaido eDokkyo Medical University fShin-Oyama City Hospital, Tochigi gTohoku University Graduate School of Medicine, Miyagi hEhime University Graduate School of Medicine, Ehime iKurume University School of Medicine, Fukuoka jUniversity of the Ryukyus School of Medicine, Okinawa kSaitama Medical University, Saitama lAsahi Rousai Hospital, Aichi mYokohama City University Graduate School of Medicine, Kanagawa nSapporo Nishimaruyama Hospital, Hokkaido oTokyo Medical University, Tokyo pKawasaki Medical School, Okayama qKanazawa University Hospital, Ishikawa, Japan.
J Hypertens. 2014 Oct;32(10):2054-63; discussiom 2063. doi: 10.1097/HJH.0000000000000281.
The aim of the present study was to compare the cardiovascular effects of olmesartan, an angiotensin II receptor blocker, combined with a calcium channel blocker (CCB) or a diuretic, in a prospective, randomized, open-label, blinded endpoint trial.
Japanese hypertensive patients aged at least 65 to less than 85 years with SBP at least 140 mmHg and/or DBP at least 90 mmHg with antihypertensive treatment, or SBP at least 160 mmHg and/or DBP at least 100 mmHg without antihypertensive treatment were randomized to receive olmesartan with either a dihydropyridine CCB or a low-dose diuretic. If SBP and/or DBP remained at least 140 and/or at least 90 mmHg, the other antihypertensive drug was added. The primary endpoint was a composite of fatal and nonfatal cardiovascular events. The median follow-up time was 3.3 years.
Blood pressure decreased similarly in both groups. The primary endpoint occurred in 116/2568 patients (4.5%) in the olmesartan plus CCB group and in 135/2573 patients (5.3%) in the olmesartan plus diuretic group [hazard ratio 0.83, 95% confidence interval (CI) 0.65-1.07, P = 0.16]. Rates of all-cause death and cardiovascular deaths were similar. Among patients aged at least 75 years, the incidence of stroke tended to be lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group (hazard ratio 0.63, 95% CI 0.38-1.02, P = 0.059, interaction P = 0.019). Fewer patients in the olmesartan plus CCB group (8.2%, 211/2568) than in the olmesartan plus diuretic group (9.8%, 253/2573; P = 0.046) experienced serious adverse events.
Despite no significant difference in cardiovascular events, the different safety profiles suggest that the combination of olmesartan and CCB may be preferable to that of olmesartan and diuretic.
本研究旨在通过一项前瞻性、随机、开放标签、盲终点试验，比较血管紧张素II受体阻滞剂奥美沙坦与钙通道阻滞剂（CCB）或利尿剂联合使用时的心血管效应。
年龄在65岁及以上至85岁以下、接受抗高血压治疗且收缩压至少为140 mmHg和/或舒张压至少为90 mmHg，或未接受抗高血压治疗且收缩压至少为160 mmHg和/或舒张压至少为100 mmHg的日本高血压患者被随机分组，分别接受奥美沙坦与二氢吡啶类CCB或低剂量利尿剂联合治疗。如果收缩压和/或舒张压仍至少为140和/或至少为90 mmHg，则加用另一种抗高血压药物。主要终点为致命和非致命心血管事件的复合终点。中位随访时间为3.3年。
两组血压下降情况相似。奥美沙坦加CCB组2568例患者中有116例（4.5%）发生主要终点事件，奥美沙坦加利尿剂组2573例患者中有135例（5.3%）发生主要终点事件[风险比0.83，95%置信区间（CI）0.65 - 1.07，P = 0.16]。全因死亡和心血管死亡发生率相似。在年龄至少75岁的患者中，奥美沙坦加CCB组的卒中发生率倾向于低于奥美沙坦加利尿剂组（风险比0.63，95% CI 0.38 - 1.02，P = 0.059，交互作用P = 0.019）。奥美沙坦加CCB组发生严重不良事件的患者（8.2%，211/2568）少于奥美沙坦加利尿剂组（9.8%，253/[2573；P = 0.046]）。
尽管心血管事件无显著差异，但不同的安全性表明奥美沙坦与CCB联合使用可能优于奥美沙坦与利尿剂联合使用。
