20 Aug Angiotensin II receptor antagonist telmisartan in isolated systolic hypertension (ARAMIS) study: efficacy and safety of telmisartan 20, 40 or 80 mg versus hydrochlorothiazide 12.5 mg or placebo
Athanasios J. Manolisa, John L. Reidb, Dick de Zeeuwc, Michael B. Murphyd, Elke Seewaldt-Beckere and Ju¨ rgen Ko¨ sterf on behalf of the ARAMIS Study Group
Objective: To identify telmisartan doses that are more effective than placebo and non-inferior to hydrochlorothiazide (HCTZ) 12.5 mg, and are well tolerated, in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH).
Patients and methods: A 2-4-week single-blind placebo run-in was followed by randomization of 1039 patients (age 36-84 years) with ISH [seated SBP 150-179 mmHg and seated diastolic blood pressure (DBP) < 90 mmHg] to once-daily double-blind treatment with telmisartan 20, 40 or 80 mg, HCTZ 12.5 mg, or placebo. The change in seated trough SBP after 6 weeks compared with baseline was the primary end point. Secondary end points were the percentage achieving the target fall in SBP and the change from baseline in seated trough DBP. Incidence and severity of adverse events and physical examination and laboratory parameters were monitored for the safety evaluation.
Results: Baseline demographics in telmisartan 20 mg (n 206), 40 mg (n 210), 80 mg (n 207), HCTZ 12.5 mg (n 205) and placebo (n 211) treatment groups were comparable: (mean 6 SD) age, 63.0 6 10.9 years; SBP, 162.9 6 8.1 mmHg; and DBP 83.4 6 5.0 mmHg. No previous antihypertensive therapy had been received by 66% of the patients. Mean reductions in seated trough SBP (adjusted for baseline and country) were: telmisartan 20 mg, 15.6 mmHg (n 204); 40 mg, 17.9 mmHg (n 209); and 80 mg, 16.9 mmHg (n 205), compared with placebo, 11.4 mmHg (n 208), and HCTZ 12.5 mg, 15.7 mmHg (n 204). The target fall in seated trough SBP (< 140 mmHg or reduction by > 20 mmHg) was achieved