Meta-Analysis of the Association between Phosphodiesterase Inhibitors (PDE5Is) and Risk of Melanoma

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Abstract

The US Food and Drug Administration recently announced the need to evaluate the association between PDE5is and melanoma. We performed a meta-analysis on the association between PDE5i and melanoma using random effects models and examined whether it met Hill's criteria for causality. A systematic search of Medline, EMBASE, and the Cochrane Library from 1998 to 2016 identified three case-control studies and two cohort studies, including a total of 866 049 men, of whom 41 874 were diagnosed with melanoma. We found a summary estimate indicating an increased risk of melanoma in PDE5i users (relative risk = 1.11, 95% confidence interval = 1.02 to 1.22). However, the association was only statistically significant among men with low PDE5i exposure (not high exposure) and with low-stage melanoma (not high stage), indicating a lack of dose response and biological gradient. PDE5i use was also associated with basal cell cancer, suggesting a lack of specificity and likely confounding by ultraviolet exposure. Thus, although this meta-analysis found a statistically significant association between PDE5i and melanoma, it did not satisfy Hill's criteria for causality.

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Loeb, S., Ventimiglia, E., Salonia, A., Folkvaljon, Y., & Stattin, P. (2017). Meta-Analysis of the Association between Phosphodiesterase Inhibitors (PDE5Is) and Risk of Melanoma. Journal of the National Cancer Institute, 109(8). https://doi.org/10.1093/jnci/djx086

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