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The long-term antihypertensive activity and tolerability of irbesartan with hydrochlorothiazide
Insights
Long-term irbesartan/hydrochlorothiazide (HCTZ) therapy is safe and effective for hypertension management. Over 80% of patients maintained normalized blood pressure with good tolerability.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Hypertension Research
Background:
- Hypertension remains a significant global health concern, necessitating effective and safe long-term treatment strategies.
- Combination therapy is often required to achieve target blood pressure goals in hypertensive patients.
Purpose of the Study:
- To evaluate the long-term safety, tolerability, and antihypertensive efficacy of irbesartan/hydrochlorothiazide (HCTZ) combination therapy.
- To assess the durability of blood pressure control achieved with irbesartan/HCTZ over one year.
Main Methods:
- A 1-year open-label study involving 1098 hypertensive patients who completed prior randomized trials.
- Sequential dose titration of irbesartan/HCTZ (starting at 75 mg/12.5 mg) was employed to reach target blood pressure (<140/90 mm Hg).
- Adjunctive therapies were permitted if target blood pressure was not achieved with irbesartan/HCTZ alone.
Main Results:
- Mean reductions in trough seated systolic/diastolic blood pressure were -20.6/-15.6 mm Hg at 12 months.
- Blood pressure normalization (SeDBP <90 mm Hg) was achieved in 75-85% of patients, with responder rates (SeDBP reduction ≥10 mm Hg) of 81-91%.
- The majority of patients (≥87%) were treated with irbesartan/HCTZ alone, and only 7.5% discontinued due to adverse events, with no serious drug-related events reported.
Conclusions:
- Long-term treatment with irbesartan/HCTZ is safe and well-tolerated in patients with hypertension.
- This combination therapy effectively maintains normalized blood pressure in a high percentage of patients over one year.
- Irbesartan/HCTZ demonstrates sustained antihypertensive effects, supporting its use for chronic hypertension management.
Abstract:
The long-term safety, tolerability, and antihypertensive effects of irbesartan/hydrochlorothiazide (HCTZ) were assessed in hypertensive patients (seated diastolic blood pressure [SeDBP] 95-110 mm Hg). Patients (n = 1098) completing two randomised, double-blind trials of irbesartan alone, HCTZ alone, irbesartan/HCTZ combinations, or placebo, took 1 year of open-label therapy starting with irbesartan 75 mg/HCTZ 12.5 mg once daily. If target blood pressure (BP) (<140/<90 mm Hg) was not achieved, the dose was titrated sequentially at 2- to 4-week intervals to irbesartan 150 mg/HCTZ 12. 5 mg, then to irbesartan 300 mg/HCTZ 25 mg. If necessary, adjunctive therapies were added. Mean changes in trough seated systolic BP/SeDBP at months 2, 6, and 12 were -19.1/-14.2 mm Hg (n = 941), -20.7/ -15.7 mm Hg (n = 948), and -20.6/-15.6 mm Hg (n = 898), respectively. From months 2 to 12, normalisation rates (trough SeDBP <90 mm Hg) ranged from 75-85% and total responder rates (normalised or >/=10 mm Hg trough SeDBP reduction) ranged from 81-91%, while target BP was achieved in 65-75% of patients. At all time-points, most patients (>/=87%) were receiving irbesartan/HCTZ alone. Eighty-two patients (7.5%) discontinued the study due to adverse events, with half of these events considered unrelated to study medication. There were no reports of serious adverse events related to study medication. Long-term therapy with irbesartan/HCTZ is safe, well tolerated, and maintains normalised BP in >80% of patients.