Department of Urology, Stanford University School of Medicine, Stanford, CA, USA.
Department of Urology, Stanford University School of Medicine, Stanford, CA, USA; Department of Dermatology, Stanford University School of Medicine, Stanford, CA, USA.
J Sex Med. 2018 Jul;15(7):982-989. doi: 10.1016/j.jsxm.2018.05.002. Epub 2018 Jun 5.
Phosphodiesterase type 5 inhibitors (PDE5is), a treatment for erectile dysfunction, pulmonary hypertension (pHTN), and lower urinary tract symptoms (LUTS), have been implicated in melanoma development.
We sought to determine the association between PDE5i use and melanoma development among patients with erectile dysfunction, pHTN, and LUTS.
This was a retrospective cohort study of subjects contained within the Truven Health MarketScan claims database, which provides information on insurance claims in the United States for privately insured individuals, from 2007-2015. Individuals taking PDE5i were identified through pharmacy claims. A comparison group of men diagnosed with conditions for which PDE5i are prescribed was assembled.
Cox proportional hazard models were used to estimate the hazard ratio (HR) (95% CI) of incident melanoma, basal cell carcinoma, and squamous cell carcinoma.
Of 610,881 subjects prescribed PDE5i, 636 developed melanoma (0.10%). The control group had 8,711 diagnoses of melanoma. There was an association between increased PDE5i tablet use and melanoma (HR 1.05, 95% CI 1.05-1.09). This association was also present between PDE5i use and basal cell carcinoma (HR 1.04, 95% CI 1.02-1.07) and squamous cell carcinoma (HR 1.04, 95% CI 1.01-1.07). In patients with pHTN and LUTS prescribed PDE5is, there was no relationship between exposure and melanoma incidence (HR 0.74, 95% CI 0.48-1.13; and HR 1.03, 95% CI 0.97-1.10, respectively).
There is little evidence for a clinically relevant association between PDE5i use and melanoma incidence.
STRENGTHS & LIMITATIONS: Our current work represents the largest study to date evaluating the relationship between PDE5i use and melanoma risk, and the first to examine all current indications of PDE5i use among men and women. Limitations include a patient population limited to commercially insured individuals, unknown patient medication compliance, and lack of information on patient skin type, lifestyle, and sun-exposure habits.
There is a slight association between higher-volume PDE5i use and development of melanoma, basal cell carcinoma, and squamous cell carcinoma. This association among all skin cancers implies that confounding may account for the observed association. Shkolyar E, Li S, Tang J, et al. Risk of Melanoma With Phosphodiesterase Type 5 Inhibitor Use Among Patients With Erectile Dysfunction, Pulmonary Hypertension, and Lower Urinary Tract Symptoms. J Sex Med 2018;15:982-989.
磷酸二酯酶 5 抑制剂（PDE5i）是治疗勃起功能障碍、肺动脉高压（pHTN）和下尿路症状（LUTS）的药物，其与黑色素瘤的发展有关。
我们旨在确定勃起功能障碍、pHTN 和 LUTS 患者使用 PDE5i 与黑色素瘤发展之间的关联。
这是一项回顾性队列研究，研究对象来自 Truven Health MarketScan 索赔数据库，该数据库提供了美国私人保险个人的保险索赔信息，时间范围为 2007-2015 年。通过药房索赔确定使用 PDE5i 的患者。还组建了一个患有 PDE5i 处方适应证的男性对照组。
在接受 PDE5i 治疗的 610881 名患者中，有 636 名患者发生黑色素瘤（0.10%）。对照组有 8711 例黑色素瘤诊断。PDE5i 片用量增加与黑色素瘤（HR 1.05，95%CI 1.05-1.09）之间存在关联。这种关联也存在于 PDE5i 使用与基底细胞癌（HR 1.04，95%CI 1.02-1.07）和鳞状细胞癌（HR 1.04，95%CI 1.01-1.07）之间。在接受 PDE5i 治疗的 pHTN 和 LUTS 患者中，暴露与黑色素瘤发生率之间没有关系（HR 0.74，95%CI 0.48-1.13；HR 1.03，95%CI 0.97-1.10）。
目前，关于 PDE5i 使用与黑色素瘤发病率之间的关系，几乎没有证据表明存在临床相关的关联。
我们目前的工作代表了迄今为止评估 PDE5i 使用与黑色素瘤风险之间关系的最大规模研究，也是第一个检查男性和女性所有当前 PDE5i 使用适应证的研究。局限性包括患者人群仅限于商业保险人群、未知患者的药物依从性以及缺乏患者皮肤类型、生活方式和阳光暴露习惯的信息。
高剂量 PDE5i 使用与黑色素瘤、基底细胞癌和鳞状细胞癌的发展之间存在轻微关联。所有皮肤癌之间的这种关联表明，混杂因素可能导致了观察到的关联。
