01-07-2008 | Adis Drug Profile
Irbesartan/Hydrochlorothiazide
In Moderate to Severe Hypertension
Published in: Drugs | Issue 10/2008
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▲ 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.
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▲ 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.
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▲ 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.
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▲ 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).
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▲ 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.
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▲ Irbesartan/HCTZ combination therapy had a similar tolerability profile to irbesartan and HCTZ monotherapy. Most adverse events were of mild to moderate intensity.