Ocular side effects of levitra ® (vardenafil) - results of a double-blind crossover study in healthy male subjects

To determine ocular side effects of vardenafil with special regard to color vision and retinal function. This was a single center, randomized, double-blind, placebo-controlled, twofold crossover study with an administration of a single oral dose of two 20 mg tablets of BAY 38-9456 (vardenafil hydroc...

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Vydané v:	Drug design, development and therapy Ročník 13; s. 37 - 43
Hlavní autori:	Roessler, Gernot, Vobig, Michael, Walter, Peter, Mazinani, Babac AE
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	New Zealand Dove Medical Press Limited 01.01.2019 Taylor & Francis Ltd Dove Medical Press
Predmet:	Acuity Administration, Oral Adolescent Adult BASIC (programming language) Clinical Trial Report Color Color vision Color Vision - drug effects Comparative analysis Cross-Over Studies Diabetic retinopathy Double-Blind Method Double-blind studies Drug dosages Electrocardiography Electroretinography Erectile dysfunction Errors Germany Humans Latency Male Middle Aged ocular side effects Ophthalmology Patient compliance PDE-5-inhibitors Phosphodiesterase 5 Inhibitors - administration & dosage Phosphodiesterase 5 Inhibitors - adverse effects Retina Retina - drug effects Retina - physiopathology retinal function Side effects Tablets Time Factors Vardenafil Dihydrochloride - administration & dosage Vardenafil Dihydrochloride - adverse effects Visual acuity Visual field Visual fields Young Adult Germany electroretinogram phosophodiesterase-5 inhibitor placebo-controlled adverse events color vision retinal function
ISSN:	1177-8881, 1177-8881
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Popis
Shrnutí:	To determine ocular side effects of vardenafil with special regard to color vision and retinal function. This was a single center, randomized, double-blind, placebo-controlled, twofold crossover study with an administration of a single oral dose of two 20 mg tablets of BAY 38-9456 (vardenafil hydrochloride) or corresponding placebo in 24 healthy male subjects. Ocular investigations included Farnsworth-Munsell D100 color vision test, electroretinogram, and basic ophthalmological examinations like visual acuity, visual field, and slit-lamp of anterior segment and fundus. Compared to placebo, administration of vardenafil hydrochloride lead to a temporary significant increase of Farnsworth-Munsell D100 total error score after 1 and 6 hours as well as in error lines 3 and 4 after 1 hour. Twenty-four hours after administration there was no significant alteration of total error score or of any error line. While latency of electroretinogram b-wave remained unaffected, amplitudes showed a significant decrease compared to placebo 1 hour following administration. While other ocular examinations did not reveal any differences in general some mild to moderate but no serious adverse events have been reported. Despite temporary changes in retinal function our study reports good tolerability of vardenafil in regard to ocular side effects.
Bibliografia:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3
ISSN:	1177-8881 1177-8881
DOI:	10.2147/DDDT.S186633