Effects of sildenafil on blue-on-yellow and white-on-white Humphrey perimetry in 3 months regular use.

Dundar SO, Topalo Gcaron Lu A, Dundar M, Kocak I.

Eye. 2005 Jul 29.

1Department of Ophthalmology, Faculty of Medicine, Adnan Menderes University, Aydin, Turkey.

Purpose:  To assess the effects of sildenafil on blue-on-yellow (B/Y) and white-on-white (W/W) Humphrey perimetry in a group of men with erectile dysfunction in 3 months regular use.MethodsIn this prospective study, 14 patients with erectile dysfunction received 50 mg doses of sildenafil (Viagra, Pfizer) two times per week regularly for 3 months. Patients underwent best-corrected visual acuity (BCVA), colour vision, anterior segment and fundus examination, and B/Y and W/W Humphrey perimetry in each eye before and after sildenafil treatment. Changes in mean deviations (MD) were compared separately for both eyes. 

Results:  No significant changes from baseline were observed in BCVA and colour vision after sildenafil treatment. The anterior segment and fundus examinations revealed no abnormalities. There was no change on B/Y and W/W Humphrey visual field. MD values of B/Y and W/W Humphrey perimetry remained nonsignificant for both eyes after 3 months regular use of sildenafil (P=0.133, and 0.092, respectively, for right, and P=0.221 and 0.925, respectively, for left eyes).  ConclusionOral sildenafil used regularly for 3 months produced no effect on B/Y and W/W Humphrey perimetry.  Eye advance online publication, 29 July 2005; doi:10.1038/sj.eye.6702017.

PMID: 16052253 [PubMed - as supplied by publisher]

Ocular safety of Viagra, (sildenafil citrate).

Laties AM, Fraunfelder FT.

Scheie Eye Institute, Philadelphia, USA.

To date, sildenafil citrate (Viagra) gives every evidence of being a safe drug for the eye despite a series of expressed concerns. A review of how its ocular safety profile has been identified offers insights into the strengths and weaknesses of present systems and resources for judging the ocular safety of Viagra or, for that matter, of any new drug. Such insights include: The great value of careful, informed assessment of preclinical information gleaned from laboratory experiments. By and large, such assessments point the way toward appropriate clinical evaluation. For Viagra, early in its development it was noted that besides exerting a major inhibitory effect on the intended target, the vascular-associated enzyme phosphodiesterase 5 (PDE5), the drug also exerts a lesser but definite inhibitory effect on the closely related PDE6, located in the retina. For this reason, preclinical evaluation of the drug included electroretinography plus postmortem histology. In addition, an extended eye examination was incorporated into clinical protocols. The often chaotic but invaluable information stream that becomes available once marketing approval has been gained and large populations begin to use a drug. False alarms, misattribution, and erroneous information are the order of the day. Nevertheless, as information accumulates, patterns of response clarify and the true nature of special susceptibility for subpopulations, if any, becomes apparent. A role for the astute clinician remains: Subtle changes or unusual risks for subpopulations can be missed entirely for long periods of time. A manifest need for improvement in evaluation of postmarketing side-effects. This need has led to the establishment of a new discipline: pharmacoepidemiology. In ophthalmology, the National Registry of Drug Induced Ocular Side-Effects maintains a constant and invaluable surveillance. Examples are supplied to illustrate each of these major points: Our presentation will include data gleaned from clinical trials plus postmarketing information on the incidence, duration, and type of color vision defects observed at different doses of Viagra.

More studies

Int Ophthalmol. 2004 Mar;25(2):69-72.

Acute effects of sildenafil on Humphrey visual field and intraocular pressure.

Ermis SS, Inan UU, Samli M, Ozturk F.

CONCLUSIONS: No significant effect of sildenafil was seen on visual field and intraocular pressure in healthy subjects.

Am J Ophthalmol. 2004 May;137(5):842-9.

Visual short-term effects of Viagra: double-blind study in healthy young subjects.

Jagle H, Jagle C, Serey L, Yu A, Rilk A, Sadowski B, Besch D, Zrenner E, Sharpe LT.

Although rod amplitudes of the ERG recordings tended to be higher and cone amplitudes lower in the sildenafil group after drug ingestion, the differences were nonsignificant.

OTHER STUDIES CONFIRMED THIS CONCLUSION & ITS SAFE FOR THE HEART!

Efficacy and safety of sildenafil citrate in the treatment of erectile dysfunction in patients with ischemic heart disease.

Conti CR, Pepine CJ, Sweeney M.

‘Erectile dysfunction is a common condition in men with cardiovascular disease, probably as a result of shared factors that impair hemodynamic mechanisms in the penile and ischemic vasculature. Sildenafil citrate, an orally active, selective inhibitor of phosphodiesterase type 5 (PDE5), has demonstrated excellent efficacy and safety profiles in men with erectile dysfunction of various etiologies. Sildenafil administration is contraindicated in patients who are taking nitrates or nitric oxide donors. This retrospective subanalysis of data from double-blind, placebo-controlled studies assessed the efficacy (9 studies) and safety (11 studies) of sildenafil in patients with erectile dysfunction and ischemic heart disease who were not taking nitrates. Of 3,672 patients randomized to receive sildenafil (5-200 mg) or placebo for 4-24 weeks in 11 double-blind, placebo-controlled studies, 357 (10%) reported a history (past or present) of ischemic heart disease and were not taking nitrates. Efficacy was assessed using end-of-treatment responses to Question 3 (ability to achieve an erection) and Question 4 (ability to maintain an erection) of the International Index of Erectile Function (IIEF), scores for the 5 domains of male sexual function assessed by the IIEF (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), and responses to a global efficacy question ("Did the treatment improve your erections?"). The responses to the 2 IIEF questions were graded on a scale of 1 (almost never or never) to 5 (almost always or always), with a score of 0 indicating no attempt at sexual intercourse. At the end of treatment, the mean scores for Question 3 and Question 4 of the IIEF for patients with erectile dysfunction and ischemic heart disease were significantly higher for the sildenafil group than for the placebo group (p <0.0001). Mean end-of-treatment scores for the IIEF domains also demonstrated significant increases for sildenafil-treated patients compared with those receiving placebo (p <0.05). At the end of treatment, improved erections were reported by 70% of patients who received sildenafil and by 20% of those in the placebo group p <0.0001). For the sildenafil group, the incidences of the most common adverse events (headache 25%, flushing 14%, and dyspepsia 12%) for patients with ischemic heart disease were similar to those in patients without this concomitant illness (21%, 15%, and 10%, respectively). Moreover, the overall incidence of cardiovascular adverse events other than flushing was comparable in patients with and without ischemic heart disease for both treatment groups. Since there is a degree of cardiac risk associated with sexual activity, clinicians should consider the patient's cardiovascular status before initiating any treatment for erectile dysfunction. Physicians should be aware that patients with underlying cardiovascular disease could be adversely affected by the vasodilator effects of sildenafil, especially in combination with sexual activity. The results of the present subanalysis indicate that oral sildenafil significantly improves erectile function and is well tolerated in patients with erectile dysfunction and ischemic heart disease who are not taking nitrate therapy.

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(Today, the Food and Drug Administration (FDA) is warning consumers not to purchase or consume the following products: SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin, manufactured by NVE, Inc., in Newton, N.J. and distributed by Hi-Tech in Norcross, Ga. These products, which are being marketed as dietary supplements, actually contain a prescription drug ingredient that poses possible health risks. The products are being sold over-the-counter and are claiming to increase stamina, confidence and performance.)