Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction.
BACKGROUND
Erectile dysfunction (ED) affects up to 70% of men with diabetes, occurring with a higher prevalence in those with type 1 diabetes than with type 2 diabetes. Studies investigating treatment of ED in men with diabetes have largely been conducted in a total male population with diabetes. Limited data are available on the efficacy and safety of the potent oral phosphodiesterase-5 inhibitor vardenafil in men with ED and type 1 diabetes.


OBJECTIVE
To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-naïve subjects with type 1 diabetes and ED.


METHODS
In this multicenter, double-blind, placebo-controlled clinical trial, phosphodiesterase-5 inhibitor-naïve patients were randomized to receive placebo (N = 149) or flexible-dose (5-20 mg) (N = 153) vardenafil.


METHODS
Sexual Encounter Profile diary questions 2 and 3, concerning success rates of vaginal insertion and maintenance of erection to allow successful intercourse, respectively.


RESULTS
Vardenafil significantly improved mean success rates for Sexual Encounter Profile 2 and 3 compared with baseline and placebo at 4, 8, and 12 weeks (P < 0.0001, intention to treat and last observation carried forward). These rates were unaffected by stratification into distinct subsets according to the level of HbA(1c) (HbA(1c) < 7%, good glycemic control; HbA(1c) >7- < or = 8%, moderate glycemic control; and HbA(1c) > 8%, poor glycemic control). Vardenafil treatment also significantly improved the Erectile Function domain score (P < 0.0001) of the International Index of Erectile Function compared with placebo, in addition to scores for the other individual domains of the International Index of Erectile Function. The most commonly reported treatment-emergent adverse events were headache (3.1%) and flushing (2.5%), which were mild to moderate and transient in nature.


CONCLUSIONS
These data suggest that vardenafil significantly improves erectile function in men with type 1 diabetes and is well tolerated, regardless of the level of glycemic control.
Ziegler
Dan
D
Deutsche Diabetes-Klinik, Deutsches-Diabetes-Zentrum, Leibniz-Institut an der Heinrich-Heine Universität, Düsseldorf, Germany.
Merfort
Frank
F
Diabetologic Office, Grevenbroich, Germany.
Van Ahlen
Hermann
H
Klinikum Osnabrück, Osnabrück, Germany.
Yassin
Aksam
A
Office Norderstedt, Noderstedt, Germany.
Reblin
Tjark
T
GlaxoSmithKline, Munich, Germany. Electronic address: tjark.reblin@gsk.com.
Neureither
Marcus
M
Aachen, Germany.
D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D011788:Quality of Life; D012725:Sexual Behavior / Q000187:drug effects*; D013450:Sulfones / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride