Rationale, study design and implementation of the COLM study: the combination of OLMesartan and calcium channel blocker or diuretic in high-risk elderly hypertensive patients

被引：19

作者：

Ogihara, Toshio ^{[1
]}

Saruta, Takao ^{[2
]}

Rakugi, Hiromi ^{[1
]}

Shimamoto, Kazuaki ^{[3
]}

Ito, Sadayoshi ^{[4
]}

Matsuoka, Hiroaki ^{[5
]}

Horiuchi, Masatsugu ^{[6
]}

Imaizumi, Tsutomu ^{[7
]}

Takishita, Shuichi ^{[8
]}

Higaki, Jitsuo ^{[6
]}

Katayama, Shigehiro ^{[9
]}

Saito, Ikuo ^{[2
]}

Shimada, Kazuyuki ^{[10
]}

机构：

[1] Osaka Univ, Grad Sch Med, Dept Geriatr Med & Nephrol, Suita, Osaka 5650871, Japan

[2] Keio Univ, Osaka, Japan

[3] Sapporo Med Univ, Sch Med, Osaka, Japan

[4] Tohoku Univ, Sch Med, Sendai, Japan

[5] Dokkyo Med Univ, Osaka, Japan

[6] Ehime Univ, Grad Sch Med, Osaka, Japan

[7] Kurume Univ, Sch Med, Osaka, Japan

[8] Univ Ryukyus, Sch Med, Osaka, Japan

[9] Saitama Med Univ, Osaka, Japan

[10] Jichi Med Univ, Osaka, Japan

来源：

HYPERTENSION RESEARCH | 2009年 / 32卷 / 02期

关键词：

clinical trial; combination therapy; olmesartan; BLOOD-PRESSURE; CARDIOVASCULAR EVENTS; TRIAL; AMLODIPINE; MEDOXOMIL; EFFICACY; OUTCOMES;

D O I：

10.1038/hr.2008.31

中图分类号：

R6 [外科学];

学科分类号：

1002 ; 100210 ;

摘要：

The COLM study is an investigator-initiated trial comparing the combination therapy using an angiotensin II receptor blocker (ARB), olmesartan, and a calcium channel blocker (CCB) with that using an ARB and a diuretic in high-risk elderly hypertensive patients. Here we describe the rationale and study design. Olmesartan was administered concomitantly with a long-acting dihydropyridine CCB (ARB/CCB group) or with a low-dose diuretic (ARB/diuretic group) to elderly hypertensive patients with a history of or risk factors for cardiovascular disease. Cardiovascular morbidity and mortality as a primary end point were compared between the two groups, with the target blood pressure (BP) being < 140 mm Hg for systolic BP and < 90 mm Hg for diastolic BR Safety and tolerability will also be investigated. A total of more than 4000 patients were recruited and will be followed up for at least 3 years.

引用

页码：163 / 167

页数：5

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