For those patients who have not reached their BP goal on monotherapy...
AVALIDE is indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.
INCLUSIVE studied patients with systolic blood pressure (SBP) uncontrolled on monotherapy
Patients (N=844) included
17:
- 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) included
17:
- ACEIs (34%)
- ARBs (20%)
- CCBs (20%)
- diuretics (14%)
- beta-blockers (11%)
- others (2%)
Primary end point results—significant (>20 mm Hg) SBP reduction
17
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.
Kochar et al: Powerful BP reduction proven in mild-to-moderate hypertensive patients
20
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 weeks
14,15
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).14,15 The most common adverse events were headache, fatigue, and nausea/vomiting.
Download additional study information following the full Prescribing Information
