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ARTICLE | Clinical News

Aliskiren: Phase III data

September 9, 2013 7:00 AM UTC

Data from 458 evaluable patients in the double-blind, international Phase III AQUARIUS trial showed that once-daily 300 mg aliskiren given for >=72 weeks missed the primary endpoint of reducing the progression of coronary atherosclerosis, defined by the change from baseline in PAV, vs. placebo. Specifically, aliskiren reduced PAV by 0.33% vs. a 0.11% increase for placebo (p=0.08). Aliskiren also missed the secondary endpoint of reducing TAV from baseline vs. placebo (4 vs. 2.1 mm 3, p=0.18). Additionally, aliskiren non-significantly improved the proportion of patients with regression of PAV (56.9% vs. 48.9%, p=0.09) and TAV (64.4% vs. 57.5%, p=0.13) vs. placebo. PAV and TAV were measured using intravascular ultrasound (IVUS) and higher values correlate with disease progression. ...