Skip to main content. Skip to left menu.

AVALIDE: Powerful BP Efficacy Across All Stages of Hypertensive Risk

  • More power for more patients than ever before across all stages of hypertension
Primary end point results—significant (>20 mm Hg) SBP reduction
*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
  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
  Patients without comorbid diseases (patients with comorbid disease have a BP goal of <130/80 mm Hg).
 
Primary end point results—significant (>20 mm Hg) SBP reduction
  • 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
  # 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
  7-week, randomized, double-blind, active-controlled, parallel-group, multicenter trial.21
  Patients without comorbid diseases (patients with comorbid disease have a BP goal of <130/80 mm Hg).
 
Primary end point results—significant (>20 mm Hg) SBP reduction

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
  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.
Primary end point results—significant (>20 mm Hg) SBP reduction
  • 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: Click Here
With AVALIDE:
  • Prompt treatment of hypertension is clinically relevant
    Patients with Stage 2 (severe or moderate) hypertension are at relatively high risk for:
  • Cardiovascular events (such as strokes, heart attacks, and heart failure)
  • Kidney failure
  • Vision problems
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.


WARNING: USE IN PREGNANCY
When pregnancy is detected, discontinue AVAPRO or AVALIDE as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [See Warnings and Precautions: Fetal/Neonatal Morbidity and Mortality in the full Prescribing Information.]