This multicenter, randomized, parallel-group study, which included 440
patients with mild to moderate hypertension, compared the efficacy an
d safety of various doses of telmisartan, a specific AT(1)-receptor an
tagonist, with those of enalapril and placebo. Following a 4-week plac
ebo run-in period, eligible patients received one of six treatments: t
elmisartan 40 mg (n = 72), 80 mg (n = 72), 120 mg (n = 73), or 160 mg
(n = 75); placebo (n = 76); or enalapril 20 mg (n = 72). Baseline bloo
d pressure, determined at the end of the placebo run-in, was compared
with trough blood pressure during the 12 weeks of therapy. All doses o
f once-daily telmisartan and enalapril significantly (P<.05) reduced b
oth systolic (SBP) and diastolic (DBP) blood pressure compared with pl
acebo. Final reductions for all telmisartan doses ranged from 10.0-11.
9/8.6-9.7 mm Hg. Final reductions with enalapril were 8.2/7.2 mm Hg. T
elmisartan 40 mg produced a full therapeutic response in terms of the
percentage of patients achieving normalization (DBP <90 mm Hg), with n
early maximal effects by week 4. Compared with enalapril, DBP reductio
ns observed at week 12 either approached or achieved statistical signi
ficance for telmisartan 40 mg (P = .08) and 80 mg (P = .03), as did SE
P reductions for telmisartan 40 mg (P = .06), 80 mg (P = .01), 120 mg
(P = .08), and 160 mg (P = .04). The percentage of patients with treat
ment-related adverse events was somewhat lower for telmisartan (7.5%)
than for either enalapril (13.9%) or placebo (10.5%). Incidences of tr
eatment-related cough were 4.2% with enalapril, 0.3% with telmisartan,
and 1.3% with placebo. One enalapril-treated patient experienced angi
oedema. The antihypertensive efficacy of telmisartan was at least comp
arable to that of enalapril, with tolerability similar to that of plac
ebo.