Background Erectile dysfunction (ED) is an adverse effect of many medications. Aim We used a national pharmacovigilance database to assess which medications had the highest reported frequency of ED. Methods The Food and Drug Administration Adverse Event Reporting System (FAERS) was queried to identify medications with the highest frequency of ED adverse event reports from 2010 to 2020. Phosphodiesterase-5 inhibitors and testosterone were excluded because these medications are often used as treatments for men with ED. The 20 medications with the highest frequency of ED were included in the disproportionality analysis. Outcomes Proportional Reporting Ratios (PRRs) and their 95% confidence intervals were calculated. Results The 20 medications accounted for 6,142 reports of ED. 5-α reductase inhibitors (5-ARIs) and neuropsychiatric medications accounted for 2,823 (46%) and 2,442 (40%) of these reports respectively. Seven medications showed significant levels of disproportionate reporting with finasteride and dutasteride having the highest PRRs: 110.03 (103.14–117.39) and 9.40 (7.83–11.05) respectively. The other medications are used in a wide variety of medical fields such as cardiology, dermatology, and immunology. Clinical Implications Physicians should be familiar with these medications and understand their respective mechanisms of action, so that they may counsel patients appropriately and improve their quality of life. Strengths and Limitations The strength of the study is its large sample size and that it captures pharmacologic trends on a national level. Quantitative and comparative “real-world” data is lacking for the most common medications associated with ED. The limitation is that the number of reported events does not establish causality and cannot be used to calculate ED incidence rates. Conclusion In a national pharmacovigilance database, 5-ARIs and neuropsychiatric medications had the highest reports of ED adverse effects. There were many other medications used in a variety of medical fields that were also associated with ED.
This is a multicentre evaluation of prospective databases in men with phi result and MRI-guided targeted and systematic prostate biopsy performed. The additional value of phi to pre-biopsy MRI Prostate Imaging Reporting & Data System(PIRADS) version 2 score was evaluated with multivariate analyses and Cstatistics(AUC). The proportion of unnecessary biopsies that can be avoided are estimated for csPCa(ISUP group !2 PCa).RESULTS: Among the whole cohort of 2014 men without prior PCa diagnosis, 1183 men had pre-biopsy phi results available. The median(interquartile range) age, PSA, Prostate volume(PV), MRI lesion size, highest PIRADS score, targeted and systematic biopsy cores were 67(62-71), 8.0(5.8-11.0)ng/mL, 50.0(36.9-68.0)ml, 11(7-15)mm, 4(3-4), 3(3-4) cores and 12(12-18) cores respectively. Abnormal digital rectal exam(DRE) and Prior negative biopsy was seen in in 20.8% and 36.6% men respectively. PCa and csPCa was diagnosed in 51.3%(607/1183) and 35.3%(417/1181) men. csPCa was diagnosed in 4.7%, 15.5%, 40.1% and 74.2% of PIRADS 2, 3, 4 and 5 lesions respectively. In multivariate analyses, independent predictors for csPCa detection (odd ratio OR, 95%CI) included age(1.06,1.03-1.08), phi(1.04,1.03-1.04), PV(0.97, 0.96-0.98), and PIRADS score(reference PIRADS 2) [PIRADS 3 (3.3, PIRADS 4(8.2, PIRADS 5(21.6,]. AUC of predictors for csPCa were shown in the Table . Using a 5-factor risk score for csPCa in men with PIRADS score 2 or 3, 36.9%(90% sensitivity) and 19.4%(95% sensitivity) biopsies could be avoided. Decision curve analyses showed the 5-factor risk score achieving the best net clinical benefit.CONCLUSIONS: Adding phi test to men with MRI prostate performed improved csPCa prediction, and further reduced unnecessary biopsies using multivariable risk models especially in PIRADS 2 and 3 lesions. The observed benefits were superior to adding PSA density to MRI prostate.
213 Background: In March 2020, the coronavirus disease (COVID-19) spread across New York City. All non-emergent medical care was delayed, and healthcare resources were redirected to COVID-19 patients. Physicians managing prostate cancer faced unprecedented decisions to balance risks of the pandemic against risks of cancer progression. Here we review management of localized prostate cancer at an Urban Cancer Center in New York City during the height of the pandemic. Methods: We examined men with newly diagnosed, localized prostate cancer seen in initial consultation by Urology or Radiation Oncology between January 1 and June 30, 2020 (COVID-19 cohort). We reviewed cancer management, as well as the impact of the pandemic on treatment choice and patterns of care. Chi square and t-test analyses were performed to compare the COVID-19 cohort to a similar cohort managed before the pandemic from July 1, 2019 to December 31, 2019 (pre-COVID-19 cohort). Results: We identified 75 men in the COVID-19 cohort. NCCN risk profile: 20% low risk, 53.4% intermediate, and 26.7% high. During the height of the pandemic, there was 7 week pause in both new radiation therapy (RT) and radical prostatectomy. 11 patients continued previous RT, 1 of which developed a symptomatic covid infection and required a 2 week pause in treatment. During the operating room restart, 11 patients underwent radical prostatectomy including 8 with unfavorable-intermediate or high-risk disease. No surgical patients acquired COVID-19. Compared to the pre-COVID-19 cohort, the COVID-19 cohort had longer time from initial visit to treatment (92.1 days vs 71.0 days, p = 0.045) and a larger percentage of patients who were seen but did not return for management (25.3% vs 14%, p = 0.044). Conclusions: Our cancer center had a coordinated, 7-week cessation in primary RT and surgery for prostate cancer during the height of the COVID-19 pandemic. There were no severe COVID-19 infections among patients finishing RT, or the first cohort of men having surgery during the restart of treatments, suggesting that localized prostate cancer treatments can be safely delivered in the event of a second wave. We identified a substantial number of men who were seen, but did not return for management, highlighting a cohort who need to be reintegrated into the healthcare system. [Table: see text]
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