Yi Lian1, Hui Yin2, Michael N Pollak3, Serge Carrier4, Robert W Platt1, Samy Suissa1, Laurent Azoulay5. 1. Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada. 2. Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. 3. Department of Oncology, McGill University, Montreal, Quebec, Canada. 4. Department of Surgery (Division of Urology), McGill University, Montreal, Quebec, Canada. 5. Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Oncology, McGill University, Montreal, Quebec, Canada. Electronic address: laurent.azoulay@mcgill.ca.
Abstract
BACKGROUND: The association between phosphodiesterase type 5 inhibitors (PDE5-Is), drugs used in the treatment of erectile dysfunction (ED), and melanoma skin cancer is controversial. OBJECTIVE: To assess whether the use of PDE5-Is is associated with an increased risk of melanoma skin cancer. DESIGN, SETTING, AND PARTICIPANTS: Using the UK Clinical Practice Research Datalink, we assembled a cohort of men newly diagnosed with ED between 1998 and 2014 and followed until 2015. PDE5-I exposure was considered as a time-varying variable lagged by 1 yr for latency purposes. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) of incident melanoma associated with PDE5-I use overall and by number of prescriptions and pills received. Identical analyses were conducted for basal and squamous cell carcinoma, two cancers for which PDE5-related pathways are not thought to be involved. RESULTS AND LIMITATIONS: The cohort included 142 983 patients, of whom 440 were newly diagnosed with melanoma during follow-up (rate: 63.0 per 100 000 person-years). Compared with nonuse, PDE5-I use was not associated with an overall increased risk of melanoma (rates: 66.7 vs 54.1 per 100 000 person-years; HR: 1.18; 95% CI, 0.95-1.47). The risk was significantly increased among those who had received seven or more prescriptions and ≥25 pills (HR: 1.30 [95% CI, 1.01-1.69] and 1.34 [95% CI, 1.04-1.72], respectively). In contrast, there was no overall association with basal and squamous cell carcinoma, with an unclear association with numbers of prescriptions and pills received. CONCLUSIONS: The use of PDE5-Is was not associated with an overall increased risk of melanoma skin cancer. The increased risks observed in the highest prescription and pill categories require further validation. PATIENT SUMMARY: In this study, the use of phosphodiesterase type 5 inhibitors was not associated with an increased risk of melanoma skin cancer.
BACKGROUND: The association between phosphodiesterase type 5 inhibitors (PDE5-Is), drugs used in the treatment of erectile dysfunction (ED), and melanoma skin cancer is controversial. OBJECTIVE: To assess whether the use of PDE5-Is is associated with an increased risk of melanoma skin cancer. DESIGN, SETTING, AND PARTICIPANTS: Using the UK Clinical Practice Research Datalink, we assembled a cohort of men newly diagnosed with ED between 1998 and 2014 and followed until 2015. PDE5-I exposure was considered as a time-varying variable lagged by 1 yr for latency purposes. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) of incident melanoma associated with PDE5-I use overall and by number of prescriptions and pills received. Identical analyses were conducted for basal and squamous cell carcinoma, two cancers for which PDE5-related pathways are not thought to be involved. RESULTS AND LIMITATIONS: The cohort included 142 983 patients, of whom 440 were newly diagnosed with melanoma during follow-up (rate: 63.0 per 100 000 person-years). Compared with nonuse, PDE5-I use was not associated with an overall increased risk of melanoma (rates: 66.7 vs 54.1 per 100 000 person-years; HR: 1.18; 95% CI, 0.95-1.47). The risk was significantly increased among those who had received seven or more prescriptions and ≥25 pills (HR: 1.30 [95% CI, 1.01-1.69] and 1.34 [95% CI, 1.04-1.72], respectively). In contrast, there was no overall association with basal and squamous cell carcinoma, with an unclear association with numbers of prescriptions and pills received. CONCLUSIONS: The use of PDE5-Is was not associated with an overall increased risk of melanoma skin cancer. The increased risks observed in the highest prescription and pill categories require further validation. PATIENT SUMMARY: In this study, the use of phosphodiesterase type 5 inhibitors was not associated with an increased risk of melanoma skin cancer.
Authors: Smita Pattanaik; Ravimohan S Mavuduru; Arabind Panda; Joseph L Mathew; Mayank M Agarwal; Eu Chang Hwang; Jennifer A Lyon; Shrawan K Singh; Arup K Mandal Journal: Cochrane Database Syst Rev Date: 2018-11-16
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