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CARDIOVASCULAR SAFETY OF LEVITRA™ (VARDENAFIL) IN PATIENTS RECEIVING ANTIHYPERTENSIVE MEDICATIONS: ANALYSIS OF PHASE III CLINICAL TRIALS
M Seger, J Zadra, JF Yale
Toronto, Ontario
Erectile dysfunction (ED) is often a co-morbidity in patients with hypertension. PDE5 inhibitor use results in smooth muscle relaxation, and one may expect a potentiating effect on BP reduction when given with antihypertensive medications. This study evaluated the effect of vardenafil, a potent, selective PDE5 inhibitor on BP reduction and CV safety when used with antihypertensives.
Data was extracted from 7 double-blind, Phase III trials in which 3,402 men with ED received vardenafil 5, 10, or 20 mg or placebo prn for
In patients evaluated for safety, ³1 antihypertensive was used by 39%/42% of placebo/vardenafil-treated patients. Mean changes from pre-treatment standing SBP/DBP (mmHg), and HR (bpm) in the subgroup having post-dose data are summarized below.
Vardenafil alone was associated with transient mild BP reductions and small HR increases. Vardenafil given concomitantly with antihypertensives produced slight, incremental reductions in BP which were generally similar across classes (ACE-I, Ca2+ antagonist, a- or b-blockers, diuretic, or ARB). Incidence rates of CV AEs were similar in placebo and vardenafil.
Concomitant use of antihypertensives did not result in BP or HR changes of clinical concern compared to those observed by vardenafil alone.
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