Retinal effects of 6 months of daily use of tadalafil or sildenafil.

Publications // Ronald Danis // Apr 01 2009

PubMed ID: 19365010

Author(s): Cordell WH, Maturi RK, Costigan TM, Marmor MF, Weleber RG, Coupland SG, Danis RP, McGettigan JW Jr, Antoszyk AN, Klise S, Sides GD; ERG Testing During Chronic PDE5 Inhibitor Administration (ERG-PDE5i) Consortium. Retinal effects of 6 months of daily use of tadalafil or sildenafil. Arch Ophthalmol. 2009 Apr;127(4):367-73. doi: 10.1001/archophthalmol.2009.36. PMID 19365010

Journal: Archives Of Ophthalmology (Chicago, Ill. : 1960), Volume 127, Issue 4, Apr 2009

OBJECTIVE To assess changes in electroretinography (ERG) and other retinal function parameters during 6 months of daily use of tadalafil, sildenafil citrate, or placebo.

METHODS Subjects were randomized to use of a placebo (n=82), 5 mg of tadalafil (n=85), or 50 mg of sildenafil (n=77) daily for 6 months. Electroretinographs were recorded using the International Society for Clinical Electrophysiology of Vision (ISCEV) protocol and standardized ERG equipment at all 15 study sites. Other tests of ocular anatomy and visual function were performed at each assessment.

MAIN OUTCOME MEASURES The primary outcome was the average mean change for both eyes from baseline to endpoint in ERG b-wave amplitude using dark-adapted combined standard response to a bright ISCEV standard flash. Secondary endpoints were other ERG parameter changes, visual acuity, number of errors in color discrimination testing, mean deviation in automated visual field testing, and intraocular pressure (IOP).

RESULTS No significant differences were found between treatment/placebo groups for the primary outcome, most other ERG variables, visual function, IOP, or anatomic assessments. The medications were well tolerated.

CONCLUSIONS No abnormalities in ERG or visual function and no treatment-related findings suggestive of drug toxicity are associated with daily administration of tadalafil or sildenafil for 6 months.

APPLICATION TO CLINICAL PRACTICE Assessed visual safety of tadalafil/sildenafil administered daily over a prolonged period.

TRIAL REGISTRATION Identifier: NCT00333281.