Telmisartan + hydrochlorothiazide versus amlodipine + hydrochlorothiazide in older patients with predominantly systolic hypertension

Sustained blood pressure control is important to reduce cardiovascular and cerebrovascular risk in the elderly. A prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group study was performed in older patients (≥60 years) with systolic blood pressure (SBP) >140 mg, diastolic blood pressure (DBP) ≤95 mmHg, and 24-h mean ambulatory SBP >125 mmHg. After a 2- to 4-week placebo run-in, patients were randomized to treatment with telmisartan (T) 40 mg for 2 weeks, with uptitration to T 80 mg for 6 weeks and then to T 80 mg + hydrochlorothiazide (H) 12.5 mg for 6 weeks or amlodipine (A) 5 mg, with uptitration to A 10 mg for 6 weeks and then to A 10 mg + H 12.5 mg for 6 weeks. Efficacy was determined using 24-h ambulatory blood pressure monitoring. Adverse events (AEs) were monitored. The reduction from baseline adjusted last 6-h mean SBP (primary endpoint) was 18.8±0.6 mmHg for T+H (n=354) and 17.7±0.6 mmHg for A+H (n=329). The difference in favor of T+H versus A+H of −1.1 mmHg (95% CI −2.7, 0.5 mmHg) confirmed that T+H was at least as effective as A+H. Reductions in 24-h mean SBP (p=0.0010), daytime SBP (p=0.0002), and morning mean SBP (p=0.0105) were greater with T+H than with A+H. T+H was also superior to A+H for DBP endpoints. Drug-related AEs occurred in 40 (8.0%) T-group patients and in 168 (33.4%) A-group patients (p<0.0001). The most common AE was peripheral edema, observed in 6 (1.2%) T-group patients and 122 (24.3%) A-group patients (p<0.0001). T 80 mg + H 12.5 mg is statistically superior to A 10 mg + H 12.5 mg during the 24-h dosing interval for both SBP and DBP; with both groups being comparable in the last 6 h, the time of heightened cardiovascular risk. The safety profile of T+H is superior to that of A+H.