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Published on: May 26, 2022
Irbesartan/Hydrochlorothiazide : in moderate to severe hypertension
Jamie D Croxtall1, Gillian M Keating
1Wolters Kluwer Health | Adis, Auckland, New Zealand. demail@adis.co.nz
Insights
Fixed-dose irbesartan/hydrochlorothiazide combination therapy effectively lowers blood pressure in patients with moderate to severe hypertension. This combination demonstrated superior efficacy compared to monotherapy, with a comparable safety profile.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Hypertension remains a significant global health concern requiring effective therapeutic strategies.
- Current guidelines recommend combination therapy for patients not achieving blood pressure goals with monotherapy.
Purpose of the Study:
- To evaluate the efficacy and tolerability of fixed-dose irbesartan/hydrochlorothiazide (HCTZ) combination therapy.
- To compare irbesartan/HCTZ with irbesartan or HCTZ monotherapy in patients with moderate and severe hypertension.
Main Methods:
- Two randomized, double-blind, multicentre trials were conducted.
- Trial 1: 538 patients with moderate hypertension, assessing efficacy at 8 and 12 weeks.
- Trial 2: 697 patients with severe hypertension, assessing efficacy at 5 and 7 weeks.
Main Results:
- Irbesartan/HCTZ significantly reduced seated systolic blood pressure (SeSBP) more than monotherapy in moderate hypertension.
- A greater proportion of patients achieved controlled blood pressure (< 140/90 mmHg) with irbesartan/HCTZ in both moderate and severe hypertension trials.
- Combination therapy showed similar tolerability to monotherapy, with mostly mild to moderate adverse events.
Conclusions:
- Fixed-dose irbesartan/HCTZ is an effective initial therapy for patients likely to require multiple agents for blood pressure control.
- The combination therapy offers a statistically significant improvement in achieving blood pressure goals compared to monotherapy.
- Irbesartan/HCTZ provides a favorable benefit-risk profile for managing hypertension.
Abstract:
* 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.
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