A double-blind, placebo-controlled, randomized clinical study of the effects of vardenafil on human nasal patency.
BACKGROUND
Vardenafil, a selective phosphodiesterase 5 (PDE5) inhibitor, may affect nasal patency because of its adverse-effect profile. This double-blind, placebo-controlled, randomized clinical study sought to assess the effect of vardenafil on nasal patency in patients at a university hospital.


METHODS
Nasal patency was assessed using a visual analog score and by measuring the minimum cross-sectional areas (MCAs) and nasal cavity volumes with acoustic rhinometry in 14 subjects before and after administration of vardenafil. Measurements were repeated after administration of a local decongestant spray.


RESULTS
There was no statistically significant difference between the nasal cavity volumes, MCA, and visual analog scale (VAS) scores before and after the administration of placebo. However, there was a significant increase in the nasal cavity volumes, MCAs, and VAS scores after application of the local decongestant. A significant correlation was found between MCAs and VAS scores (r = 0.96; p < 0.001). After administration of vardenafil, there was a significant increase in the degree of subjective sense of nasal obstruction as measured by VAS scores. Total nasal volumes showed a significant decrease (p < 0.05). The congestion effect induced by the vardenafil was reversed after application of the local decongestant spray, and a significant increase in cross-sectional areas was noted. In the vardenafil group, a significant increase in MCA, total volume, and VAS scores was observed after application of the local decongestant (p < 0.05).


CONCLUSIONS
Objective and subjective nasal obstruction after administration of vardenafil was significantly higher in this study than in previously reported studies. The effect of congestion can be reversed by local decongestants. The role of PDE5 inhibitors in nasal physiology merits additional investigation.
Aydin
Erdinc
E
Department of Otorhinolaryngology Head and Neck Surgery, Baskent University Faculty of Medicine, Baskent University, Ankara, Turkey. erdina@baskent-ank.edu.tr
Hizal
Evren
E
Onay
Ovsen
O
Ozgen
Basak
B
Turhan
Baris
B
Zaimoglu
Murat
M
Peskircioglu
Levent
L
Budakoglu
Isil Irem
II
D000328:Adult; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009296:Nasal Cavity / Q000033:anatomy & histology / Q000187:drug effects / Q000502:physiology; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D023842:Rhinometry, Acoustic; D013450:Sulfones / Q000627:therapeutic use; D014227:Triazines / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride; D014665:Vasodilator Agents / Q000627:therapeutic use*
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D014665:Vasodilator Agents; D000069058:Vardenafil Dihydrochloride