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.
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 BP. 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.
Ogihara
Toshio
T
Osaka University Graduate School of Medicine, Osaka, Japan.
Saruta
Takao
T
Rakugi
Hiromi
H
Shimamoto
Kazuaki
K
Ito
Sadayoshi
S
Matsuoka
Hiroaki
H
Horiuchi
Masatsugu
M
Imaizumi
Tsutomu
T
Takishita
Shuichi
S
Higaki
Jitsuo
J
Katayama
Shigehiro
S
Saito
Ikuo
I
Shimada
Kazuyuki
K
D000368:Aged; D000369:Aged, 80 and over; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004095:Dihydropyridines / Q000627:therapeutic use; D004232:Diuretics / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D011446:Prospective Studies; D012306:Risk; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D004232:Diuretics; D007093:Imidazoles; D013777:Tetrazoles; C038806:1,4-dihydropyridine; C437965:olmesartan