- More power for more patients than ever before across all stages of hypertension
*Nephropathy is defined as elevated serum creatinine and proteinuria (>300 mg/day).
- JNC 7 guidelines state CVD risk doubles with each 20/10 mm Hg BP increment starting at 115/75 mm Hg1
In a severe hypertension study with AVALIDE (mean baseline BP 172/113 mm Hg):
- Rapid (Week 1) and powerful (Week 7) BP reductions to help patients reach JNC 7 BP goal of <140/90 mm Hg†1,21-22
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Primary end point: proportion of patients who achieved SeDBP <90 mm Hg at 5 weeks. Initial study regimens were AVALIDE 150/12.5-mg and AVAPRO 150-mg and at Week 1 increased to AVALIDE 300/25-mg and AVAPRO 300-mg.21
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7-week, randomized, double-blind, active-controlled, parallel-group, multicenter trial.21
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Patients without comorbid diseases (patients with comorbid disease have a BP goal of <130/80 mm Hg).
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- The incidences of pre-specified adverse events on AVALIDE vs irbesartan were syncope (0% vs 0%), hypotension (0.6% vs 0%), dizziness (3.6% vs 4.0%), headache (4.3% vs 6.6%), hyperkalemia (0.2% vs 0%), and hypokalemia (0.6% vs 0.4%)
In a moderate hypertension study with AVALIDE (mean baseline BP 162/98 mm Hg):
- Significant SBP and DBP reductions to help patients reach JNC 7 BP goal of <140/90 mm Hg†23,24
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Primary end point: mean change from baseline SeSBP at 8 weeks. Initial study regimens were AVALIDE 150/12.5-mg, AVAPRO 150-mg, and HCTZ 12.5 mg and increased at Week 2 to AVALIDE 300/25-mg, AVAPRO 300-mg, and HCTZ 25 mg.23
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7-week, randomized, double-blind, active-controlled, parallel-group, multicenter trial.21
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Patients without comorbid diseases (patients with comorbid disease have a BP goal of <130/80 mm Hg).
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The incidences of pre-specified adverse events on AVALIDE vs irbesartan or hydrochlorothiazide (HCTZ) monotherapy were hypotension (0.9% vs 0% and 0%), dizziness (3.0% vs 3.8% and 1.0%), headache (5.5% vs 3.8% and 4.8%), hyperkalemia (1.2% vs 0% and 1.0%), and hypokalemia (0.9% vs 0% and 0%); there were no reported events of syncope in the AVALIDE treatment group and there was one reported event in the HCTZ treatment group
In a severe hypertension study with AVALIDE (mean baseline BP 172/113 mm Hg):
- Rapid response as early as Week 122
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Primary end point: proportion of patients who achieved SeDBP <90 mm Hg at 5 weeks. Initial study regimens were AVALIDE 150/12.5-mg and AVAPRO 150-mg and at Week 1 increased to AVALIDE 300/25-mg and AVAPRO 300-mg.21 7-week, randomized, double-blind, active-controlled, parallel-group, multicenter trial. 21
*SBP ≥180 mm Hg or DBP ≥110 mm Hg.
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- The incidences of pre-specified adverse events on AVALIDE vs irbesartan were syncope (0% vs 0%), hypotension (0.6% vs 0%), dizziness (3.6% vs 4.0%), headache (4.3% vs 6.6%), hyperkalemia (0.2% vs 0%), and hypokalemia (0.6% vs 0.4%)
To decide whether AVALIDE should be used for initial therapy, approximate the likelihood of reaching targeted blood pressure goals with probability charts:
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With AVALIDE:
- Prompt treatment of hypertension is clinically relevant
Severe Study—Neutel JM et al:
Objective
- To evaluate whether AVALIDE (irbesartan-hydrochlorothiazide) as initial therapy would achieve BP control to seated diastolic blood pressure (SeDBP) <90 mm Hg over 5 weeks in a greater proportion of severe hypertensive patients than treatment with irbesartan monotherapy
Design
- 7-week, randomized, double-blind, active-controlled, parallel-group, multicenter trial
- 697* patients with severe hypertension SeDBP >110 mm Hg (untreated) or currently receiving antihypertensive monotherapy with SeDBP >100 mm Hg
— Patients with SeDBP >110 mm Hg after placebo lead-in were randomized
- Initial doses of AVALIDE 150/12.5-mg and AVAPRO® (irbesartan) 150-mg were increased at 1 week to AVALIDE 300/25-mg and AVAPRO 300-mg
- Primary end point: proportion of patients who achieved SeDBP <90 mm Hg at 5 weeks
*Two patients in the irbesartan treatment group did not receive double-blind treatment.