Hypertension Clinical Trial
Official title:
Effect of Nebivolol Compared With Metoprolol in Hypertensive Patients With Peripheral Arterial Disease
This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral artery disease, hypertension, and at least moderate risk for coronary artery disease.
Peripheral arterial disease (PAD) affects up to an estimated 16-29% of men and women over
age 50, and is associated with increased cardiovascular morbidity and mortality.
Beta-blockers have been shown to reduce the risk of myocardial infarction and death in
patients with coronary artery disease (CAD) and are indicated for the treatment of
hypertension in patients with PAD. However, there is a theoretical risk that
antihypertensive therapy may decrease limb perfusion pressure and therefore exacerbate
symptoms of claudication or limb ischemia. Patients with CAD and concomitant PAD are less
likely to be prescribed beta-blockers, even though most patients are able to tolerate
antihypertensive therapy without worsening of symptoms.
The third generation beta-blocker, nebivolol, has vasodilating properties in addition to
beta-adrenergic blockade. This vasodilatory effect is mediated through the L-arginine-nitric
oxide-dependent pathway. Nitric oxide is a critical modulator of vascular disease with
effects that lead to vasodilatation, endothelial regeneration, inhibition of leukocyte
chemotaxis and inhibition of platelet adhesion. This combination of beta-blockade and nitric
oxide-dependent vasodilation may enhance effectiveness and tolerability of nebivolol versus
other beta-blockers in patients with hypertension, CAD or high-risk state, and PAD.
This study will be a pilot comparative effectiveness study to examine the effect of
nebivolol versus metoprolol succinate in patients with lower-extremity PAD and at least
moderate risk for CAD on PAD symptoms as measured by both functional and quality of life
measures.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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