LAUSR

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; I2 = 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. Thirty‐nine (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.