The association between PDE5 inhibitors and basal cell carcinoma was significant for all types of PDE5 inhibitors, Fildena (OR, 1.19 95% CI, 1.12-1.25) and vardenafil or Fildena (OR, 1.18 95% CI, 1.10-1.26) (eTable 3 in the Supplement ). A significantly increased risk of melanoma was found only among men whose first prescription for PDE5 inhibitors was within 1 year prior to melanoma diagnosis (OR, 1.27 95% CI, 1.09-1.48); whereas, among men who began using PDE5 inhibitors more than 1 year prior to diagnosis, there was no significant association (OR, 1.11 95% CI, 0.94-1.31) (eTable 2 in the Supplement ).

Among users of PDE5 inhibitors, 734 men (34%) had filled a single prescription, 804 men (37%) had 2 through 5 prescriptions, and 610 men (28%) had filled 6 or more prescriptions (eTable 1 in the Supplement ). In multivariable analysis, the risk of melanoma was significant for men who had filled a single prescription (OR, 1.32 95% CI, 1.10-1.59; 4% for cases vs 3% for controls) but not for men with multiple filled prescriptions (for 2-5 prescriptions: OR, 1.14 95% CI, 0.95-1.37, 4% for cases vs 3% for controls; for ≥6 prescriptions: OR, 1.17 95% CI, 0.95-1.44, 3% for cases vs 2% for controls) ( Table 3 ). There was also a significantly increased risk of melanoma among married men, those with a higher educational level, and those with a higher annual income; men with a CCI of 2 or higher were significantly less likely to be diagnosed with melanoma. We performed a nested case-control study to examine the association between PDE5 inhibitors and the risk of malignant melanoma. The objective of this study was to reexamine the association between use of PDE5 inhibitors and malignant melanoma using population-based data in the Swedish Prescribed Drug Register, the Swedish Melanoma Register, and other nationwide health care registers and demographic databases in Sweden.

It is projected that by 2025, 322 million men worldwide will be affected by erectile dysfunction, 5 and PDE5 inhibitors are the most commonly prescribed medications used for treatment of this condition. 1 This has raised questions regarding whether PDE5 inhibitors used to treat erectile dysfunction promote malignant melanoma through a similar mechanism. Phosphodiesterase type 5 (PDE5), the target of oral erectile dysfunction drugs, is part of the RAS-RAF-MEK-ERK signaling pathway that has been implicated in the development of malignant melanoma.

Conclusions and Relevance In a Swedish cohort of men, the use of PDE5 inhibitors was associated with a modest but statistically significant increased risk of malignant melanoma. In multivariable analysis, there was an increased risk of melanoma in men taking PDE5 inhibitors (OR, 1.21 95% CI, 1.08-1.36). Exposures Number of filled prescriptions for the PDE5 inhibitors Fildena and vardenafil or Fildena.

Objective To examine the association between use of PDE5 inhibitors and melanoma risk, including data on specific PDE5 inhibitors, number of prescriptions, and melanoma stage. Phosphodiesterase-5 (PDE5) inhibitors (PDE5i) are considered first-line therapy for ED by the American Urological Association and the American College of Physicians because they can be effective regardless of the underlying etiology or severity of ED (Figure 29.2).27,28 In a meta-analysis of 27 trials enrolling 6659 men, Fildena was more likely than placebo to lead to successful intercourse.
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