From Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton,
NJ.
Abstract—Results of eight
multicenter, randomized, placebo-controlled, double-blind,
parallel-group studies were pooled to assess the efficacy of the
angiotensin II–receptor blocker irbesartan over the dose
range of 1 to 900 mg. A total of 2955 adults with a seated
diastolic blood pressure of 95 to 110 mm Hg were
randomized to treatment with oral irbesartan once daily or placebo for
6 to 8 weeks. Office blood pressure was measured at trough (24±3 hours
after the last dose) and peak (3±1 hours after the last dose) by
mercury sphygmomanometry. Demographic characteristics (mean blood
pressure; 151/101 mm Hg; mean age, 54 years; 63% male; and 82%
white) were similar across all dose groups. After the groups were
pooled, antihypertensive efficacy was assessed by therapeutic response
(trough seated diastolic blood pressure <90 mm Hg or
a reduction from baseline of
© 1998 American Heart Association, Inc.
Scientific Contributions
Dose-Related Efficacy of Irbesartan for Hypertension
An Integrated Analysis
10 mm Hg) and by modeling of the
maximum reductions in trough and peak seated diastolic and
systolic blood pressure. Antihypertensive effects increased
with increasing doses and reached a plateau at 300 mg. Irbesartan 150
mg provided placebo-subtracted reductions in trough seated
systolic and diastolic blood pressure of 
8 and
5 mm Hg, respectively, with 56% of patients displaying a
favorable response. In conclusion, irbesartan provides clinically
significant blood pressure lowering, with a clear relationship between
(log) dose and antihypertensive effect.
Key Words: irbesartan • dose response • randomized controlled trials • placebo
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