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Clinical Trials |

Retinal Effects of 6 Months of Daily Use of Tadalafil or Sildenafil

William H. Cordell, MD; Raj K. Maturi, MD; Timothy M. Costigan, PhD; Michael F. Marmor, MD; Richard G. Weleber, MD; Stuart G. Coupland, PhD; Ronald P. Danis, MD; John W. McGettigan Jr, MD; Andrew N. Antoszyk, MD; Suzanne Klise, BS; Gregory D. Sides, MD; ERG Testing During Chronic PDE5 Inhibitor Administration (ERG-PDE5i) Consortium
Arch Ophthalmol. 2009;127(4):367-373. doi:10.1001/archophthalmol.2009.36.
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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  clinicaltrials.gov Identifier: NCT00333281

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Figures

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Figure 1.

Study design. ERG indicates electroretinography. Comprehensive ophthalmologic examination included ERG unless otherwise noted.

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Figure 2.

Subject disposition and derivation of the 2 data analysis sets. Numbers in parentheses and dotted lines represent discontinuations and/or deletions from the 2 analysis sets. Of the 244 randomized subjects, 194 completed 6 months of treatment. Reasons for discontinuation prior to completing 6 months of drug therapy are as follows by group: 9 placebo, 5 tadalafil, and 2 sildenafil subjects had a personal conflict or other subject decision; 2 placebo, 1 tadalafil, and 0 sildenafil subjects had protocol violations; 5 placebo, 3 tadalafil, and 4 sildenafil subjects had entry criterion violations; 2 placebo, 2 tadalafil, and 3 sildenafil subjects could not be contacted; 2 placebo, 1 tadalafil, and 6 sildenafil subjects had an adverse event; 1 tadalafil subject was given the incorrect drug; and 2 sildenafil subjects were unmasked.

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