Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction

Yafi, Faysal A.; Sharlip, Ira D.; Becher, Edgardo

doi:10.1016/j.sxmr.2017.08.001

Cited by 81 publications

(60 citation statements)

References 78 publications

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“…Sildenafil was evaluated in 1 high‐quality, positive study and is considered “ efficacious ” for the treatment of ED in PD, and the practice implication is “ clinically useful .” There is a lack of safety data for sildenafil in PD patients. Taking into account the data available in the general population, sildenafil is considered to pose an “ acceptable risk without specialized monitoring .” OH is common in PD and consequences of sildenafil treatment in this population have not been widely explored. Cautious use is advised therefore in parkinsonian patients with OH.…”

Section: Results and Conclusionmentioning

confidence: 99%

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

et al. 2019

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Objective To update evidence‐based medicine recommendations for treating nonmotor symptoms in Parkinson's disease (PD). Background The International Parkinson and Movement Disorder Society Evidence‐Based Medicine Committee's recommendations for treatments of PD were first published in 2002, updated in 2011, and now updated again through December 31, 2016. Methods Level I studies testing pharmacological, surgical, or nonpharmacological interventions for the treatment of nonmotor symptoms in PD were reviewed. Criteria for inclusion and quality scoring were as previously reported. The disorders covered were a range of neuropsychiatric symptoms, autonomic dysfunction, disorders of sleep and wakefulness, pain, fatigue, impaired olfaction, and ophthalmologic dysfunction. Clinical efficacy, implications for clinical practice, and safety conclusions are reported. Results A total of 37 new studies qualified for review. There were no randomized controlled trials that met inclusion criteria for the treatment of anxiety disorders, rapid eye movement sleep behavior disorder, excessive sweating, impaired olfaction, or ophthalmologic dysfunction. We identified clinically useful or possibly useful interventions for the treatment of depression, apathy, impulse control and related disorders, dementia, psychosis, insomnia, daytime sleepiness, drooling, orthostatic hypotension, gastrointestinal dysfunction, urinary dysfunction, erectile dysfunction, fatigue, and pain. There were no clinically useful interventions identified to treat non‐dementia‐level cognitive impairment. Conclusions The evidence base for treating a range of nonmotor symptoms in PD has grown substantially in recent years. However, treatment options overall remain limited given the high prevalence and adverse impact of these disorders, so the development and testing of new treatments for nonmotor symptoms in PD remains a top priority. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

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Section: Results and Conclusionmentioning

confidence: 99%

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

et al. 2019

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“…Common mild adverse events include transient headache, dizziness, and blurred vision; however, some rare ocular complications can occur, leading to serious harm to patients’ visual acuity. 4 Non-arteritic anterior ischemic optic neuropathy (NAION) has been linked to PDE5-I use. These patients often complain of unilateral, sudden, and painless loss of vision when awakening.…”

Section: Introductionmentioning

confidence: 99%

The Association Between Phosphodiesterase Type 5 Inhibitor Use and Risk of Non-Arteritic Anterior Ischemic Optic Neuropathy: A Systematic Review and Meta-Analysis

et al. 2018

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IntroductionPhosphodiesterase type 5 inhibitors (PDE5-Is) are first-line drugs for erectile dysfunction. Non-arteritic anterior ischemic optic neuropathy (NAION) has been linked with PDE5-I use. However, no meta-analysis or conclusive review has explored the association between NAION and PDE5-I use.AimTo investigate the association between PDE5-I use and risk of NAION.MethodsA comprehensive literature search was conducted using online databases in October 2017 to obtain studies researching the association between PDE5-I application and occurrence of NAION. Summarized unadjusted risk ratios (RRs) with 95% CIs were calculated for the strength of this association. This study was conducted in accordance to Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines and registered in PROSPERO under number CRD42017080865.Main Outcome MeasuresThe strength of association between PDE5-I use and risk of NAION was assessed through pooled unadjusted RRs and 95% CIs.Results5 original articles with 6 clinical observations were included in the meta-analysis. No significant higher risk of NAION was observed after the use of PDE5-Is within a 1-month period (RR = 1.16, 95% CI = 0.98-1.39, P = .09). Subgroup analyses indicated 2 PDE5-Is were significantly related to NAION (tadalafil: RR = 2.14, 95% CI = 1.20–3.84, P = .01; sildenafil: RR = 2.25, 95% CI = 1.29–3.94, P = .004).ConclusionsAlthough we found no association between NAION and PDE5-I use, our results should be interpreted cautiously because we included only observational studies and could not control for potential confounders. Because NAION is a rare ocular disease and difficult to diagnose, this association should be confirmed in prospective comparative studies with larger samples and more rigorous designs.Liu B, Zhu L, Zhong J, et al. The Association Between Phosphodiesterase Type 5 Inhibitor Use and Risk of Non-Arteritic Anterior Ischemic Optic Neuropathy: A Systematic Review and Meta-Analysis. Sex Med 2018;6:185−192.

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“…Other reviews also collect case reports describing the development of NAION after PDE 5 inhibitors administration (Danesh-Meyer & Levin 2007;Thurtell & Tomsak 2008;Laties 2009;Azzouni & Abu samra 2011;Yafi et al 2018). Limitations on the type of evidence found, on the information described in each case report, and on the small number of case reports suggested that there are lack of evidence to support the association between PDE 5 inhibitors use and the development of NAION (Danesh-Meyer & Levin 2007;Thurtell & Tomsak 2008;Laties 2009;Azzouni & Abu samra 2011;Yafi et al 2018). However, some reviews noted that despite the benefit-risk relation was not affected, some precautions should be considered in the prescription of a PDE 5 inhibitor, namely to patients with risk factors for the development of NAION, such as vascular diseases and anomalies in the optic nerve (Thurtell & Tomsak 2008;Yafi et al 2018).…”

Section: Comparison With Other Researchmentioning

confidence: 99%

Risk of nonarteritic ischaemic optic neuropathy with phosphodiesterase type 5 inhibitors: a systematic review and meta‐analysis

Penedones

Marques

2019

Acta Ophthalmologica

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The development of nonarteritic anterior ischaemic optic neuropathy has been described to phosphodiesterase type 5 inhibitors. The aim of this systematic review and meta-analysis was to assess the risk of nonarteritic anterior ischaemic optic neuropathy associated with phosphodiesterase type 5 inhibitors exposure. A literature search was performed at MEDLINE, EMBASE, Toxline and VigiBase. Randomized controlled trials, observational studies, case reports and spontaneous reports describing nonarteritic anterior ischaemic optic neuropathy associated with phosphodiesterase type 5 inhibitors exposure were included. The risk of bias was assessed according to Centre for Reviews and Dissemination's (CRD) guidance. Data were analysed using descriptive statistics and meta-analysis. Four observational studies, 50 case reports and 608 spontaneous reports were identified. All observational studies evaluated males treated for erectile dysfunction. Treatment with phosphodiesterase type 5 inhibitors is not associated with an increased risk of definitive nonarteritic anterior ischaemic optic neuropathy [odds ratio (OR) 1.16; 95% CI 0.89, 1.52, p = 0.046; I 2 = 62.6%]. The methodological quality was assessed as good for three studies. Among case reports, 12 (23%) patients did not have risk factors to develop nonarteritic anterior ischaemic optic neuropathy. Thirtynine (78%) patients were treated for erectile dysfunction. A regular administration of phosphodiesterase type 5 inhibitors was observed in 24 (48%) case reports. All case reports were assessed as higher risk of bias. According to the available evidence, the treatment with phosphodiesterase type 5 inhibitors was not found to be associated with nonarteritic anterior ischaemic optic neuropathy. Further research is needed to study such association, including possible confounding factors.Key words: drug-related side effects and adverse reactions -ischaemic optic neuropathy -metaanalysis -ophthalmology -pharmacovigilance -phosphodiesterase 5 Inhibitors -systematic review Acta Ophthalmol. 2020: 98: 22-31

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Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction

Cited by 81 publications

References 78 publications

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

The Association Between Phosphodiesterase Type 5 Inhibitor Use and Risk of Non-Arteritic Anterior Ischemic Optic Neuropathy: A Systematic Review and Meta-Analysis

Risk of nonarteritic ischaemic optic neuropathy with phosphodiesterase type 5 inhibitors: a systematic review and meta‐analysis

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