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.
Publication types
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Aged
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Aged, 80 and over
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Angiotensin II Type 1 Receptor Blockers / adverse effects
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Angiotensin II Type 1 Receptor Blockers / therapeutic use*
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Antihypertensive Agents / adverse effects
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Antihypertensive Agents / therapeutic use*
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Calcium Channel Blockers / adverse effects
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Calcium Channel Blockers / therapeutic use*
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Dihydropyridines / therapeutic use
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Diuretics / adverse effects
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Diuretics / therapeutic use*
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Double-Blind Method
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Drug Therapy, Combination
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Endpoint Determination
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Female
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Humans
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Hypertension / complications
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Hypertension / drug therapy*
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Imidazoles / adverse effects
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Imidazoles / therapeutic use*
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Japan
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Male
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Prospective Studies
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Risk
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Tetrazoles / adverse effects
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Tetrazoles / therapeutic use*
Substances
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Angiotensin II Type 1 Receptor Blockers
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Antihypertensive Agents
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Calcium Channel Blockers
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Dihydropyridines
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Diuretics
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Imidazoles
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Tetrazoles
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1,4-dihydropyridine
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olmesartan