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AVALIDE: Power for Patients Who Need Added BP Efficacy*

For those patients who have not reached their BP goal on monotherapy...

*AVALIDE is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.
INCLUSIVE studied patients with systolic blood pressure (SBP) uncontrolled on monotherapy

Patients (N=844) included16:
  • Women (52%)
  • Patients with metabolic syndrome (46%)
  • Patients with type 2 diabetes mellitus (30%)
  • Elderly (25%)
  • African Americans (23%)
  • Hispanic/Latinos (14%)§
Previous monotherapies (N=844) included16:
  • ACEIs (34%)
  • ARBs (20%)
  • CCBs (20%)
  • diuretics (14%)
  • beta-blockers (11%)
  • others (2%)
Primary end point results—significant (>20 mm Hg) SBP reduction16
Primary end point results—significant (>20 mm Hg) SBP reduction

18-week, prospective, open-label, single-arm study.
Primary end point: reduction in mean SBP at Week 18 compared with baseline.

To qualify for metabolic syndrome, a patient needed to have at least 3 of the following NCEP criteria: waist circumference as follows: men >102 cm (>40 in); women >88 cm (>35 in); triglycerides >150 mg/dL; HDL cholesterol as follows: men <40 mg/dL; women <50 mg/dL; BP >130/85 mm Hg; and fasting glucose >110 mg/dL.

Type 2 diabetes defined by the presence of either (1) fasting glucose >126 mg/dL or (2) taking antidiabetic medication, except insulin.

§Patients could be classified in multiple groups; mean age 57.3 years.


The most common drug-related adverse event was dizziness, which occurred in 3% of patients.

Download additional study information following the full Prescribing Information

Kochar et al: Powerful BP reduction proven in mild-to-moderate hypertensive patients19
AVALIDE demonstrated significant SBP and DBP reduction vs placebo at 8 weeks

8-week, multicenter, randomized, double-blind, placebo-controlled study.
Primary end point: mean change from baseline in SeDBP to Week 8.
Mean age, 55 years; 65% male; 85% Caucasian.


The most common drug-related adverse events were headache, dizziness, and fatigue.

Download additional study information following the full Prescribing Information

Howe et al: Prompt, significant BP reduction at 2 weeks13,14
AVALIDE was shown to produce powerful BP reduction within 2 weeks. In an 8-week, multicenter, randomized, double-blind, placebo-controlled study, significant systolic blood pressure (SBP) reductions were seen with AVALIDE at starting doses compared with placebo at 2 weeks (20.5 mm Hg versus 7.7 mm Hg; P<0.01).13,14 The most common adverse events were headache, fatigue, and nausea/vomiting.
Avalide vs Placebo

*Primary End Point

13. Data on file, Bristol-Myers Squibb, AVAL001.
14. Howe P et al. Clin Exp Hypertens. 1999;21:1373-1396.


Download additional study information following the full Prescribing Information


As soon as pregnancy is detected, discontinue AVAPRO or AVALIDE (please see boxed WARNING regarding Use in Pregnancy in the full Prescribing Information).