Combination of
OLMesartan and a
calcium channel blocker or a
diuretic in Japanese elderly hypertensive patients (COLM) trial demonstrated that
olmesartan combinations with a CCB or
diuretic have similar effects on reducing cardiovascular risk in elderly hypertensive patients. However, the safety profiles suggest that
olmesartan combined with CCB may be preferable to
olmesartan combined with
diuretic. In this subgroup analysis, we further evaluated the effects and safety of these combinations in elderly (65-74 years old (y.o.)) and very elderly (75-84 y.o.) hypertensive patients. In the COLM trial, 5141 patients (2918 elderly and 2223 very elderly) were randomly assigned to receive
olmesartan-based
therapy with either CCB or
diuretic. The hazard ratios and 95% confidence intervals, respectively, in the elderly age group and in the very elderly group were: 1.04 (0.72-1.50;
olmesartan plus CCB vs.
olmesartan plus
diuretic, P = 0.85) and 0.71 (0.51-0.99, P = 0.045) for the primary composite end point, and 1.07 (0.67-1.72, P = 0.77) and 0.64 (0.42-0.98, P = 0.036) for the composite of hard end points. The hazard ratios for
stroke (fatal and non-fatal) were 1.48 (0.88-2.48;
olmesartan plus CCB vs.
olmesartan plus
diuretic, P = 0.13) and 0.63 (0.39-1.02, P = 0.059) (interaction-P = 0.019). Withdrawal rates from the trial, withdrawal due to serious adverse event and the incidence of any adverse event were higher in the
olmesartan plus
diuretic group than in the
olmesartan plus CCB group in both age groups. In conclusion,
angiotensin receptor blocker (ARB) and CCB combination may be preferable to an ARB and
diuretic combination in the very elderly hypertensive patients for the reduction of cardiovascular risk, particularly for the reduction in
stroke risk.