Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients with erectile dysfunction and arterial hypertension treated with multiple anti hypertensives

Klinikum Osnabrück, Osnabrück, Germany.
Journal of Sexual Medicine (Impact Factor: 3.15). 12/2005; 2(6):856-64. DOI: 10.1111/j.1743-6109.2005.00150.x
Source: PubMed

ABSTRACT Vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, was evaluated in a prospective trial in the primary care setting involving hypertensive men with ED who were receiving at least one antihypertensive medication.
To investigate the safety and efficacy of flexible-dose vardenafil therapy compared with placebo in PDE5 inhibitor-naïve subjects with arterial hypertension and ED.
In this multicenter, randomized, double-blind, placebo-controlled study, 354 patients received placebo or vardenafil (5-20 mg) for 12 weeks. Primary efficacy measures were diary responses to the Sexual Encounter Profile (SEP) questions 2 (vaginal insertion) and 3 (maintenance of erection). Additional efficacy measures included positive responses to the Global Assessment Question (GAQ).
Compared with placebo, vardenafil significantly improved mean SEP2 and SEP3 success rates over the 12-week study period (intention-to-treat [ITT] and last observation carried forward [LOCF]) analysis). For LOCF, SEP2 and SEP3 were 83% for vardenafil vs. 58% for placebo and 67% for vardenafil vs. 35% for placebo, respectively (P<0.0001 vs. placebo). Improved erections (GAQ) were experienced by 80% of vardenafil-treated patients at study end, compared with 40% for placebo (P<0.0001, LOCF). The most commonly reported treatment-emerging adverse events were headache (3.1%) and flushing (1.6%), which were mild-to-moderate and transient in nature. Importantly, there were no significant changes in systolic and diastolic blood pressure or heart rate between the vardenafil and placebo groups. The average number of antihypertensives used per patient was 1.5 and 1.4 in the vardenafil and placebo groups, respectively. Both the incidence of adverse events and the ability to maintain an erection were unaffected by stratification into distinct subsets according to the class of antihypertensive medication being received.
Vardenafil significantly improves EF in hypertensive men treated with concomitant antihypertensive medication, is well tolerated, and does not significantly affect blood pressure.

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    • "In a randomised, doubleblind , placebo-controlled study with 395 participants , aged 18–64 years with ED for >6 months, vardenafil was clearly superior over placebo with regard to scores of vaginal penetration and completion of intercourse [22]. A great range of studies attest to the safety of vardenafil [15] [16] [20] [21] [23]. In conclusion: the efficacy and safety of vardenafil have now been demonstrated in numerous studies worldwide in men with ED and underlying cardiovascular conditions. "
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    ABSTRACT: The introduction in 1998 of the phosphodiesterase type 5 (PDE-5) inhibitors has changed the landscape of diagnosis and, in particular, the treatment of erectile dysfunction (ED). It has paved the road for a more profound insight into ED. ED and other ailments of elderly men, such as atherosclerosis, hypertension, diabetes mellitus and lower urinary tract symptoms were usually regarded as distinct diagnostic/therapeutic entities, but there is growing evidence that they are interrelated and are factors in ED. To optimise the treatment of ED, an integral approach to the health of the ageing male is required. There is an interdependence between the metabolic syndrome, ED and patterns of testosterone in ageing men. The main features of the metabolic syndrome are abdominal obesity, insulin resistance, hypertension and dyslipidaemia, significant factors in the aetiology of erectile function. The metabolic syndrome is associated with lower-than-normal testosterone levels. Testosterone is a determinant of glucose homeostasis and lipid metabolism. Testosterone is not only a factor in libido but also exerts essential effects on the anatomical and physiological substrate of penile erection. With these recent insights, the health problems of elderly men must be placed in a context that allows an integral approach. While PDE-5 inhibitors are the mainstay of treatment of men with ED, treatment of testosterone deficiency is becoming part and parcel of a new approach to both ED and the metabolic syndrome. The diagnostic work-up of ED should comprise measurement of plasma testosterone. If proven deficient, treatment with testosterone is indicated.
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