systolic blood pressure (SBP) by ambulatory BP monitoring (ABPM). Other endpoints were trough sitting clinic SBP, ABPM and clinic diastolic BP (DBP), response rates (BP <140/90 mm Hg and/or reduction of 20/10 mm Hg or more from baseline), and adverse events.Results: The patients' mean age was 58 years (51% men). Baseline BPs were similar (Table). AZL-M 40 and 80 mg þ AML significantly lowered 24-hour SBP/DBP versus placebo þ AML (all P < 0.001). AZL-M 40 and 80 mg þ AML produced significant placebo-adjusted changes in 24-hour SBP and clinic SBP (Table). Response rates were 43%, 66%, and 69% for AML þ placebo, AZL-M 40 mg, and AZL-M 80 mg, respectively. Peripheral edema occurred in 9 (4.9%) patients taking placebo and 4 (2.1%) in each AZL-M arm.Conclusions: AZL-M þ AML 5 mg provided powerful antihypertensive efficacy and meaningful BP responses in most patients with stage 2 hypertension. Peripheral edema rates suggested that AZL-M attenuated edematous effects of AML.
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