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Randomized Controlled Trial
. 2014 Oct;32(10):2054-63; discussiom 2063.
doi: 10.1097/HJH.0000000000000281.

Combinations of olmesartan and a calcium channel blocker or a diuretic in elderly hypertensive patients: a randomized, controlled trial

Toshio Ogihara  1 , Takao Saruta, Hiromi Rakugi, Ikuo Saito, Kazuaki Shimamoto, Hiroaki Matsuoka, Kazuyuki Shimada, Sadayoshi Ito, Masatsugu Horiuchi, Tsutomu Imaizumi, Shuichi Takishita, Jitsuo Higaki, Shigehiro Katayama, Genjiroh Kimura, Satoshi Umemura, Nobuyuki Ura, Koichi Hayashi, Masato Odawara, Norio Tanahashi, Toshihiko Ishimitsu, Naoki Kashihara, Satoshi Morita, Satoshi Teramukai; COLM Investigators
Collaborators, Affiliations
Free PMC article
Randomized Controlled Trial

Combinations of olmesartan and a calcium channel blocker or a diuretic in elderly hypertensive patients: a randomized, controlled trial

Toshio Ogihara et al. J Hypertens. 2014 Oct.
Free PMC article

Abstract

Objective: The aim of the present study was to compare the cardiovascular effects of olmesartan, an angiotensin II receptor blocker, combined with a calcium channel blocker (CCB) or a diuretic, in a prospective, randomized, open-label, blinded endpoint trial.

Methods: Japanese hypertensive patients aged at least 65 to less than 85 years with SBP at least 140 mmHg and/or DBP at least 90 mmHg with antihypertensive treatment, or SBP at least 160 mmHg and/or DBP at least 100 mmHg without antihypertensive treatment were randomized to receive olmesartan with either a dihydropyridine CCB or a low-dose diuretic. If SBP and/or DBP remained at least 140 and/or at least 90 mmHg, the other antihypertensive drug was added. The primary endpoint was a composite of fatal and nonfatal cardiovascular events. The median follow-up time was 3.3 years.

Results: Blood pressure decreased similarly in both groups. The primary endpoint occurred in 116/2568 patients (4.5%) in the olmesartan plus CCB group and in 135/2573 patients (5.3%) in the olmesartan plus diuretic group [hazard ratio 0.83, 95% confidence interval (CI) 0.65-1.07, P = 0.16]. Rates of all-cause death and cardiovascular deaths were similar. Among patients aged at least 75 years, the incidence of stroke tended to be lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group (hazard ratio 0.63, 95% CI 0.38-1.02, P = 0.059, interaction P = 0.019). Fewer patients in the olmesartan plus CCB group (8.2%, 211/2568) than in the olmesartan plus diuretic group (9.8%, 253/2573; P = 0.046) experienced serious adverse events.

Conclusion: Despite no significant difference in cardiovascular events, the different safety profiles suggest that the combination of olmesartan and CCB may be preferable to that of olmesartan and diuretic.

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Figures

FIGURE 1
FIGURE 1
Patient disposition.
FIGURE 2
FIGURE 2
Time-course of changes in blood pressure.
FIGURE 3
FIGURE 3
Kaplan–Meier curves for the primary composite endpoint of fatal and nonfatal cardiovascular events.
FIGURE 4
FIGURE 4
Incidence rates and hazard ratios of the primary composite endpoint, of individual components of the primary endpoint, and of the secondary endpoints. The hazard ratios and 95% CIs were determined using a stratified Cox proportional hazards model taking into account sex, age, and baseline cardiovascular disease. The P-values were derived from a log-rank test, stratified by sex, age, and baseline cardiovascular disease. CCB, calcium channel blocker; CI, confidence interval.
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