Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics
Status:
Unknown status
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
People with both hypertension and diabetes have a higher chance of developing heart and
arterial problems that could be reduced with anti-coagulant therapy. Valsartan (Diovan), an
FDA approved angiotensin-II receptor antagonist (blocker) clinically indicated for the
treatment of essential hypertension is known to inhibit platelet activity in both an in vitro
and ex vivo setting. Aliskiren (Tekturna) is a recently FDA-approved potent direct renin
inhibitor which is also an effective anti-hypertensive agent in patients with
mild-to-moderate hypertension and which, in vitro, modulates antithrombin III in plasma.
Therefore, in addition to being clinically approved anti-hypertensive medications, combining
these two agents will potentially target both primary hemostasis (platelets) and
anticoagulant (antithrombin-III is a cornerstone substrate for heparin) properties to exert
their anti-thrombotic efficacy simultaneously. This combination strategy may not only improve
hypertension management, but also improve vascular outcomes in high-risk diabetic population
via favorable effects on anti-thrombotic activity. Importantly, there have been no
significant additional safety concerns of using the combination of aliskiren and valsartan.
The investigators hypothesis is that valsartan 160 mg/daily in combination with aliskiren
150-300 mg/daily for 4 weeks will favorably affect blood levels of
platelet/coagulation/fibrinolytic biomarkers (ie, diminish platelet activity, and enhance
antithrombin III potency) when compared with monotherapy with aliskiren 150mg/daily in
hypertensive patients with type 2 diabetes mellitus.