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
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
收藏
页码:163 / 167
页数:5
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