Comparison of olmesartan combined with a calcium channel blocker or a diuretic in elderly hypertensive patients (COLM Study): safety and tolerability

被引：13

作者：

Saruta, Takao ^{[1
]}

Ogihara, Toshio ^{[2
]}

Saito, Ikuo ^{[1
]}

Rakugi, Hiromi ^{[3
]}

Shimamoto, Kazuaki ^{[4
]}

Matsuoka, Hiroaki ^{[5
]}

Teramukai, Satoshi ^{[6
]}

Higaki, Jitsuo ^{[7
]}

Ito, Sadayoshi ^{[8
]}

Shimada, Kazuyuki ^{[9
]}

机构：

[1] Keio Univ, Sch Med, Dept Internal Med, Tokyo, Japan

[2] Morinomiya Univ Med Sci, Osaka, Japan

[3] Osaka Univ, Grad Sch Med, Dept Geriatr Med & Nephrol, Osaka, Japan

[4] Sapporo Med Univ, Sch Med, Sapporo, Hokkaido, Japan

[5] Dokkyo Med Univ, Dept Hypertens & Cardiorenal Med, Mibu, Tochigi, Japan

[6] Kyoto Univ, Grad Sch Med, Translat Res Ctr, Dept Clin Trial Design & Management, Shitsukawa, Ehime, Japan

[7] Ehime Univ, Grad Sch Med, Dept Integrated Med & Informat, Div Cardiol, Sendai, Miyagi, Japan

[8] Tohoku Univ, Grad Sch Med, Dept Nephrol Endocrinol & Vasc Med, Sendai, Miyagi 980, Japan

[9] Shin Oyama City Hosp, Dept Cardiol, Oyama, Japan

来源：

HYPERTENSION RESEARCH | 2015年 / 38卷 / 02期

关键词：

adverse event; combination therapy; discontinuation; elderly hypertensive patient; olmesartan; DOSE COMBINATION THERAPY; SERUM URIC-ACID; CARDIOVASCULAR EVENTS; CONTROLLED-TRIAL; BLOOD-PRESSURE; SYSTOLIC HYPERTENSION; DOUBLE-BLIND; HYDROCHLOROTHIAZIDE; RISK; AMLODIPINE;

D O I：

10.1038/hr.2014.141

中图分类号：

R6 [外科学];

学科分类号：

1002 ; 100210 ;

摘要：

The cardiovascular effects of combined therapy with the angiotensin receptor blocker (olmesartan) and a dihydropyridine calcium channel blocker (CCB) or a diuretic were compared in high-risk elderly Japanese hypertensive patients by performing a randomized, open label, blinded-endpoint study of morbidity and mortality (the COLM study). Here we report the results obtained with respect to safety and tolerability. High-risk hypertensive patients aged 65-84 years were enrolled and were randomized to receive olmesartan combined with either a CCB (amlodipine or azelnidipine) or a low-dose diuretic for at least 3 years. The primary endpoint was a composite of fatal and non fatal cardiovascular events, whereas adverse events (AEs) and the percentage of patients who discontinued the allocated treatment were evaluated as secondary endpoints. A total of 5141 patients were randomized. Both combination regimens achieved a similar reduction of cardiovascular morbidity and mortality. The incidences of AEs, serious AEs, drug-related serious AEs and discontinuation due to serious AEs were lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group. Serum levels of uric acid and creatinine were significantly higher in the olmesartan plus diuretic group than in the olmesartan plus CCB group. Olmesartan combined with a CCB was significantly superior to olmesartan plus a diuretic with regard to the frequency of AEs and discontinuation of treatment.

引用

页码：132 / 136

页数：5

共 20 条

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