Use of phosphodiesterase 5 inhibitors is not associated with ocular adverse events.

BACKGROUND: Phosphodiesterase 5 inhibitor (PDE5i) use has been linked to a number of ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION). AIM: We investigated the risk for SRD, RVO, and ION in patients using PDE5is. METHODS: We utilized the IBM MarketScan (2007-2021) Commercial and Medicare Supplemental Databases (version 2.0) for this analysis. To estimate overall events risk, Cox proportional hazard models were applied to calculate the hazard ratios (HRs) for erectile dysfunction (ED) diagnosis and the different treatments, adjusting for region, median age, obesity, diabetes mellitus, hyperlipidemia, smoking, hypertension, coronary artery disease, and sleep apnea. Additionally, the same analyses were performed to calculate the HRs for benign prostatic hyperplasia (BPH) diagnosis and the different treatments. OUTCOMES: HRs for SRD, RVO, and ION. RESULTS: In total, 1 938 262 men with an ED diagnosis were observed during the study period. Among them, 615 838 (31.8%) were treated with PDE5is. In total, 2 175 439 men with a BPH diagnosis were observed during the study period. Among them, 175 725 (8.1%) were treated with PDE5is. On adjusted Cox regression analysis, PDE5i use was not associated with SRD, RVO, ION, and any ocular event when compared with ED diagnosis and other ED treatments. Importantly, as the intensity of ED treatment increased, so did the risk of ocular events. In addition, PDE5i use was not associated with SRD and ION when compared with BPH diagnosis and other BPH treatments. In contrast, in patients with BPH, PDE5i use was associated with RVO (HR, 1.14; 95% CI, 1.06-1.23). Importantly, patients with BPH receiving other medical treatment (ie, 5a reductase/alpha blocker; HR, 1.11; 95% CI, 1.06-1.16) or surgical treatment (HR, 1.10; 95% CI, 1.02-1.19) had a higher risk of RVO. CLINICAL IMPLICATIONS: We did not observe any consistent association between PDE5i use and any ocular adverse events (SRD, RVO, and ION). STRENGTHS AND LIMITATIONS: Because we did not have access to the patients' medical records, we recorded outcome definitions using ICD-9 and ICD-10 coding. CONCLUSIONS: Patients using PDE5is for ED or BPH indications did not have an increased risk of ocular events, even when compared with other treatments for ED or BPH.

5-alpha reductase inhibitors (5-ARi) with or without alpha-blockers (α-B) for Benign Prostatic Hyperplasia do NOT lower the risk of incident Bladder Cancer: United States insurance claims data.

BACKGROUND: Chemoprotective effect of 5-alpha reductase inhibitors (5-ARi) on bladder cancer (BCa) risk in men with Benign Prostatic Hyperplasia (BPH) has been explored with conflicting results. We sought to examine the effect of 5-ARi on new BCa diagnoses in a large US database. METHODS: Men ≥ 50 y/o with a prescription for 5-ARi after BPH diagnosis were identified in the IBM® Marketscan® Research de-identified Databases between 2007 and 2016 and matched with paired controls. Incident BCa diagnoses were identified after BPH diagnosis and/or pharmacologic treatment. Multivariable regression modeling adjusting for relevant factors was implemented. Sub-group analyses by exposure risk were performed to explore the association between 5-ARi and BCa over time. Administration of alpha-blockers (α-B) w/o 5-ARi was also examined. RESULTS: In total, n = 24,036 men on 5-ARi, n = 107,086 on 5-ARi plus alpha-blockers, and n = 894,275 without medical therapy for BPH were identified. The percentage of men diagnosed with BCa was 0.8% for the 5-ARi, 1.4% for the 5-ARi + α-B, and 0.6% for the untreated BPH group of incident BCa (adjusted hazard ratio [aHR], 0.90, 95% confidence interval [CI] 0.56 - 1.47), and 1.08, 95%CI 0.89 - 1.30, respectively). This was also true at both shorter (≤ 2 yr) and longer-term (> 2 yr) follow up. In addition, α-B alone had no change in BCa risk (HR 1.06, 0.86-1.30). CONCLUSIONS: We did not find any diminished risk of new BCa in men treated with 5-ARi (i.e., chemoprotective effect). The current report suggests that 5-ARi do not change a man's bladder cancer risk.

Trends in testosterone prescription amongst medical specialties: a 5-year CMS data analysis.

Testosterone Therapy (TTh) trends have changed as a result of clinical research and market forces over the past several years. Understanding the trends or preferences regarding testosterone prescriptions remains unknown. Our objective was to assess both regional and national trends in TTh prescriptions amongst medical specialties within the United States between 2013 and 2017. Publicly available data from the Center for Medicare and Medicaid Services (CMS) Part D Prescriber database with regards to TTh prescriptions across a 5-year span (January 1, 2013-December 31, 2017) were analyzed. TTh therapies were consolidated into four categories: Topical, Oral, Injection and Pellet. Statistical analysis utilizing R 4.0.2 was performed on the resulting data. Trends in prescription modality claim count and cost were plotted over the study period while statistical analysis evaluated associations between TTh modality and medical specialist. We found that Endocrinologists and Urologists prescribed topical testosterone more than all other specialties (60.4% and 53.5%, respectively), while Family and Internal medicine physicians were more likely to prescribe injections (59.82% and 50.69%, respectively). Oral and pellet testosterone were rarely prescribed across all specialties. In conclusion, the wide variation in modalities of testosterone prescriptions illustrates an opportunity for treatment guidelines to be streamlined across all specialists to improve patient outcomes.

Practice Comparison and Cost Analysis of Direct-to-Consumer Telemedicine Platforms Offering Testosterone Therapy.

BACKGROUND: Direct-to-consumer telemedicine platforms have expanded their reach to include services for the evaluation and treatment of testosterone deficiency. AIM: We aim to (i) evaluate the treatment practices and costs associated with receiving testosterone therapy through direct-to-consumer telemedicine platforms; (ii) compare these practices to the American Urological Association guidelines; and (iii) compare the cost of receiving similar care at a tertiary center. METHODS: Google was queried to identify telemedicine platforms offing testosterone therapy. Websites were analyzed for information regarding the initial consultation, initial laboratory evaluation, follow up, treatment monitoring regimen, and associated costs of receiving testosterone therapy. The costs for similar services at a tertiary care center were estimated using a single institution's online cost estimator for a patient with no insurance, private insurance, or Medicare. OUTCOMES: Evaluation and treatment practices of each platform were compared to the American Urological Association guidelines, and a cost analysis was completed for the cost of (i) undergoing an initial evaluation, and (ii) receiving 12 months of treatment through each platform and at a tertiary center. RESULTS: Three online platforms met inclusion criteria: Hone, Regenex Health, and TRT Nation. The initial evaluation and follow up of patients on TTh were similar between the online platforms and practice guidelines. The costs of the initial consultation were lowest for the patient with Medicare at a tertiary center and via the telemedicine platforms. Conversely, the cost of 12 months of intramuscular testosterone treatment was highest via the telemedicine platforms, ranging from $1,586 to $4,200, as compared to the tertiary center, which ranged from $134.01 to $1,333.04 with varying insurance models. Costs of ongoing treatment with transdermal testosterone are similarly higher via DTC platforms. CLINICAL IMPLICATIONS: Patients with private insurance or Medicare should be counseled that ongoing treatment through telemedicine platforms will likely incur a greater cost than receiving such care at a tertiary center that can utilize insurance coverage. STRENGTHS & LIMITATIONS: Practice and cost comparisons include accurate, up-to-date information based on each platform's website. Limitations include the analysis of only three telemedicine platforms, and the ability to describe only the information provided on each website. In addition, cost estimates for the tertiary center only include a single type of private and public insurance, limiting generalizability. CONCLUSION: This observational study indicates that direct-to-consumer telemedicine platforms are largely following practice guidelines in the evaluation and treatment of testosterone, however, there is a high cost associated with ongoing treatment. Jesse E, Sellke N, Rivero M-J, et al. Practice Comparison and Cost Analysis of Direct-to-Consumer Telemedicine Platforms Offering Testosterone Therapy. J Sex Med 2022;19:1608-1615.