Comparison of the effects of aliskiren/valsartan in combination versus valsartan
alone in patients with stage 2 hypertension.
Author(s): Flack JM, Yadao AM, Purkayastha D, Samuel R, White WB.
Affiliation(s): Department of Medicine, Division of Translational Research and Clinical
Epidemiology, Wayne State University School of Medicine, Detroit, MI, USA.
jflack@med.wayne.edu
Publication date & source: 2012, J Am Soc Hypertens. , 6(2):142-51
The extent to which the combination of a renin inhibitor with an angiotensin
receptor blocker (ARB) lowers clinic and ambulatory blood pressure (BP) versus an
ARB alone in stage 2 hypertension is not well known. Hence, we performed an
8-week, randomized, double-blind study in 451 patients with stage 2 hypertension
to compare the efficacy of the combination of aliskiren/valsartan 300/320 mg
versus valsartan 320 mg. The primary endpoint was change in seated systolic BP
from baseline to week 8 analyzed on the intent-to-treat (ITT) population using
the last-observation-carried-forward (LOCF) approach; patients completing the
entire treatment period (per-protocol completers) were similarly analyzed. For
the predefined primary analysis, systolic BP reductions for aliskiren/valsartan
(n = 230) and valsartan (n = 217) were -22.1 and -20.5 mm Hg, respectively (P =
.295). In per-protocol completers, aliskiren/valsartan (n = 201) lowered BP
significantly greater than valsartan (n = 196); -23.7 mm Hg versus -20.3 mm Hg,
respectively (P = .028). Although limited by a small sample size (n = 76) using
ambulatory BP monitoring, aliskiren/valsartan lowered the 24-hour BP
significantly more than valsartan alone (-14.6/-9.0 mm Hg versus -5.9/-4.2 mm Hg;
P < .01). Safety and tolerability were similar for the two treatment groups.
These data demonstrate the importance of multiple modalities to assess BP changes
in clinical trials of antihypertensive therapies, particularly in stage 2
hypertension.
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