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Original Investigation
April 7, 2022

Risk of Ocular Adverse Events Associated With Use of Phosphodiesterase 5 Inhibitors in Men in the US

Author Affiliations
  • 1Collaboration for Epidemiology of Ocular Diseases (CEPOD), Department of Ophthalmology and Visual Sciences, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
  • 2Department of Anesthesiology, Pharmacology, and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
  • 3Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
  • 4Department of Ophthalmology, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  • 5Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
JAMA Ophthalmol. 2022;140(5):480-484. doi:10.1001/jamaophthalmol.2022.0663
Key Points

Question  Is regular use of phosphodiesterase type 5 inhibitors (PDE5Is) associated with an increased risk for serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION) in older men?

Findings  This large cohort study of 213 033 men found an increase in the risk of SRD, RVO, and ION associated with the use of PDE5Is in those who regularly used these drugs.

Meaning  Results of this study suggest that individuals who regularly use PDE5Is should be cognizant of ocular adverse events associated with these drugs and alert their physicians if they experience any visual deficits.

Abstract

Importance  A number of case reports and small epidemiologic studies have quantified the risk of ocular adverse events associated with the use of phosphodiesterase type 5 inhibitors (PDE5Is). However, results have been conflicting, and epidemiologic data on the risk of serous retinal detachment (SRD) and retinal vascular occlusion (RVO) are not available.

Objective  To quantify the risk of SRD, RVO, and ischemic optic neuropathy (ION) associated with the use of PDE5Is.

Design, Setting, and Participants  This cohort study with a nested case-control analysis was performed using data obtained from the PharMetrics Plus database (IQVIA) from January 1, 2006, to December 31, 2020. Cohort members were followed up until the first diagnosis of SRD, RVO, or ION or termination of insurance coverage. For each case, 4 controls were matched by age and time of study entry using density-based sampling. Risk for regular users of PDE5Is was compared with that for nonusers, adjusting for potential confounding variables. Cases with diagnoses of SRD, RVO, and ION in the year before the cohort were excluded.

Main Outcomes and Measures  First diagnosis of SRD, RVO, or ION identified by International Classification of Diseases, Ninth Revision or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes. Adjusted incidence rate ratios (IRRs) with 95% CIs were calculated using conditional logistic regression, controlling for hypertension, coronary artery disease, smoking, and diabetes (for all 3 outcomes) as well as sleep apnea for the ION outcome.

Results  The cohort consisted of 213 033 men receiving PDE5Is, including sildenafil, tadalafil, vardenafil, and avanafil. The case-control analysis included a total of 1146 cases of SRD (278), RVO (628), and ION (240) and 4584 controls, and the mean (SD) age in both groups was 64.6 (13.3) years. Patients with SRD, RVO, and ION were more likely to have hypertension, diabetes, coronary artery disease, and sleep apnea. The adjusted IRR for the composite end points of any of the 3 outcomes was 1.85 (95% CI, 1.41-2.42; incidence, 15.5 cases per 10 000 person-years). The adjusted IRR for SRD, RVO, and ION as individual outcomes was 2.58 (95% CI, 1.55-4.30; incidence, 3.8 cases per 10 000 person-years), 1.44 (95% CI, 0.98-2.12; incidence, 8.5 cases per 10 000 person-years), and 2.02 (95% CI, 1.14-3.58; incidence, 3.2 cases per 10 000 person-years), respectively.

Conclusions and Relevance  Findings of this cohort study suggest that regular users of PDE5Is might have an increased risk for SRD, RVO, and ION. Regular users of PDE5Is need to be cognizant of ocular adverse events associated with these drugs and alert their physicians if they experience any visual deficits.

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    1 Comment for this article
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    Warning our Viagra-dependent patients
    Richard Watson, MD | Hackensack Meridian School of Medicine
    This study may suggest the need to warn long-term users of phosphodiesterase 5 inhibitors about the risk of secondary ocular impairment. At a minimum, these patients perhaps should be reminded that some organizations recommend an eye exam in adults at least once every two years and annually for those over 65.

    Perhaps we should be questioning long-term users of phosphodiesterase 5 inhibitors about the onset of new or worsening visual impairment and, of course, documenting if we did so.

    The investigation does emphasize that while the relative risk is high, the actual risk is still quite low.
    The composite incidence for all three conditions is 15.5/10,000 person-years.
    CONFLICT OF INTEREST: None Reported
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