title: 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.
abstract: 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.
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Ogihara
authors.forename: Takao
authors.initials: T
authors.lastname: Saruta
authors.forename: Hiromi
authors.initials: H
authors.lastname: Rakugi
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Shimamoto
authors.forename: Sadayoshi
authors.initials: S
authors.lastname: Ito
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Matsuoka
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Horiuchi
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Imaizumi
authors.forename: Shuichi
authors.initials: S
authors.lastname: Takishita
authors.forename: Jitsuo
authors.initials: J
authors.lastname: Higaki
authors.forename: Shigehiro
authors.initials: S
authors.lastname: Katayama
authors.forename: Ikuo
authors.initials: I
authors.lastname: Saito
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
mesh_terms: 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*
chemical_list: 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