Efficacy, safety and tolerability of aliskiren, a direct renin inhibitor, in women with hypertension: a pooled analysis of eight studies

Abstract

Hypertension is a major risk factor for cardiovascular disease, which is the leading cause of mortality in women in developed countries. This pooled analysis assessed the antihypertensive efficacy, safety and tolerability of monotherapy with the direct renin inhibitor aliskiren (150 mg and 300 mg) over 8-12 weeks in women with mild-to-moderate hypertension (mean sitting diastolic blood pressure (msDBP)X95 and o110 mm Hg) across eight randomized and double-blind trials. Safety and tolerability were assessed in the five placebo-controlled trials in the analysis. In the 1527 women enrolled in these studies, aliskiren 150 mg and 300 mg produced significantly greater blood pressure (BP) reductions (14.1/11.0 and 16.1/12.3 mm Hg, respectively) compared with placebo (7.2/7.6 mm Hg; Po0.0001). BP reductions with aliskiren monotherapy in women were similar to those observed in men, and consistent across subgroups of age, metabolic syndrome and obesity. The overall incidence of adverse events in women was similar with aliskiren treatment (150 mg, 42.3%; 300 mg, 46.0%) and placebo (39.0%); adverse events with aliskiren were more frequent in women than in men, consistent with previous studies of gender differences in drug tolerability. In conclusion, aliskiren monotherapy at 150 mg and 300 mg doses provided effective, dose-dependent BP-lowering in women with mild-to-moderate hypertension, and it was well tolerated.

State of the art paper Aliskiren – an alternative to angiotensin-converting enzyme inhibitors or angiotensin receptor blockers in the therapy of arterial hypertension

“…Comparable hypotensive effects of aliskiren in both sexes (2064 males and 1527 females) were found in Gradman's meta-analysis of 2010. Occurrence of aliskiren adverse effects in females and in the placebo group was similar, but more frequent in comparison with the males given aliskiren [36]. Stanton et al .…”

Beta-blockers for hypertension

“…The rationale for treating hypertension achieved great impetus with the finding that even small reductions in blood pressure can significantly reduce associated morbidity and mortality risks (Collins 1990; Staessen 2003; Thomopoulos 2015). The major classes of drugs for treating hypertension include beta-blockers, calcium-channel blockers (CCBs), diuretics, and renin-angiotensin system (RAS) inhibitors (Wiysonge 2013).…”

Aliskiren in the Management of Hypertension

“…This is important, since the early achievement of BP control has been associated with better outcomes. [61] These and other studies [47,48] have shown that there are no significant differences in the magnitude of BP reduction with aliskiren according to sex or age, or the presence of metabolic syndrome or obesity.…”