734: Cardiovascular Safety of the Combination of Vardenafil and Alpha-Blockers: A Subgroup Analysis of the Post Marketing Surveillance Study ‘Real Life Safety and Efficacy of Vardenafil (Realise)

Medical therapy options for aging men with benign prostatic hyperplasia: focus on alfuzosin 10 mg once daily

“…In an open-label study of men with BPH who were treated with alfuzosin 10 mg once daily and tadalafil 20 mg (as needed, but no more than twice weekly), no significant change in blood pressure measurements or the side effect profile was observed over a 1-month period when compared with either monotherapy (Yassin and Diede 2003). Preliminary results of a post-marketing surveillance study of men with ED who were treated with vardenafil indicated that the type and incidence of side effects were similar in those taking and those not taking alfuzosin (Van Ahlen et al 2005). Current US labeling for sildenafil, tadalafil, and vardenafil states that these phosphodiesterase type 5 inhibitors should be started at the lowest recommended dose for patients stabilized on α-blocker therapy, whereas α-blocker therapy should be started at the lowest recommended dose for patients already taking sildenafil, tadalafil, or vardenafil (Cialis ® 2005; Levitra ® 2005; Viagra ® 2006).…”

Diagnosis and management of erectile dysfunction in the primary care setting

“…In addition, data from controlled clinical trials show that there is no increase in MI or mortality rates in patients taking any of the currently available PDE‐5 inhibitors (75–80). Additionally, retrospective and postmarketing data show no short‐term acute risk for MI and no significant increase in MI, stroke or syncope following sexual intercourse in men treated with PDE‐5 inhibitors (81–84). A number of recent clinical safety findings with respect to the use of PDE‐5 inhibitors potentially may have implications on their use in the management of ED.…”

“…This Prescribing Information change was based on data from studies that demonstrated the CV safety profile of the concomitant use of PDE‐5 inhibitors with stable alpha‐blocker therapy. A phase 1 study with vardenafil showed that concomitant alpha‐blocker therapy did not induce clinically significant hypotension in men with BPH (88) and a subgroup analysis from a postmarketing study (81,82) showed the favourable CV safety profile of vardenafil in the treatment of men with ED while on alpha blockers for comorbid conditions, including BPH and hypertension. The CV safety of tadalafil when administered in combination with either doxazosin or tamsulosin was evaluated in a trial of healthy, normotensive men (89).…”

Current safety and tolerability issues in men with erectile dysfunction receiving PDE5 inhibitors

“…The data from PDE5 inhibitor clinical trials in men with ED who had concomitant comorbidities, including hypertension (36–44), dyslipidaemia (36–50) and diabetes (51–58), showed comparable safety profiles with these agents when used in the general ED patient population. The most commonly reported AEs according to product labelling for sildenafil include headache (16%), flushing (10%), dyspepsia (7%), nasal congestion (4%), urinary tract infection (3%), mild and transient abnormal vision (3%), diarrhoea (3%), dizziness (2%), and rash (2%) (30).…”