* The fixed-dose combination of
irbesartan/
hydrochlorothiazide (
HCTZ) is approved in the US for use as initial
therapy in patients who are likely to need multiple agents to achieve their blood pressure (BP) goals. * In a 12-week, randomized, double-blind, multicentre trial in 538 patients with moderate
hypertension that was untreated or uncontrolled by monotherapy, the mean reduction from baseline in seated systolic BP (SeSBP) at week 8 (primary endpoint) was significantly greater with
irbesartan/
HCTZ than with either
irbesartan or
HCTZ as monotherapy. * In addition, the proportion of patients with moderate
hypertension achieving controlled BP (SeSBP < 140 mmHg/seated diastolic BP [SeDBP] < 90 mmHg) at 12 weeks was significantly greater with
irbesartan/
HCTZ combination
therapy than with
irbesartan or
HCTZ monotherapy. * In a 7-week, randomized, double-blind, multicentre trial in 697 patients with severe
hypertension that was untreated or uncontrolled by monotherapy, a significantly greater proportion achieved a trough SeDBP of < 90 mmHg following 5 weeks of combination
therapy with
irbesartan/
HCTZ compared with
irbesartan monotherapy (primary endpoint). * Furthermore, the proportion of patients with severe
hypertension achieving controlled BP of < 140/90 mmHg was significantly greater at all timepoints of the trial compared with
irbesartan monotherapy. *
Irbesartan/
HCTZ combination
therapy had a similar tolerability profile to
irbesartan and
HCTZ monotherapy. Most adverse events were of mild to moderate intensity.