14. Data on file, Bristol-Myers Squibb, AVAL001.
15. Howe P et al. Clin Exp Hypertens. 1999;21:1373-1396.
AVALIDE: 8-week, multicenter, randomized, double-blind, placebo-controlled study.
Primary end point results: significant ambulatory DBP reduction vs placebo at Week 8 (13.5 mm Hg vs 3.5 mm Hg, P<.01).
The most common adverse events were headache, fatigue, and nausea/vomiting.
Prompt BP reductions: Antihypertensive effects significant at
2 weeks
13-15
The antihypertensive effect of AVAPRO is apparent after the first dose and is close to its full observed effect at 2 weeks.
13 AVAPRO reductions versus placebo in trough seated diastolic blood pressure (SeDBP) reached statistical significance by Week 2 with 100, 200, and 300 mg irbesartan.
13 The most common adverse events were headache, upper respiratory infection, and musculoskeletal pain.
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.
