A Sham-Controlled Randomized Trial of Low Intensity Shockwave Therapy for Erectile Dysfunction

INTRODUCTION AND OBJECTIVE: We performed a shamcontrolled, randomized prospective trial in men with ED using an electrohydraulic shockwave device FDA cleared for connective tissue activation and improved blood flow. METHOD(S): This single-blind study was performed in men with ED naive to acoustic wave and shockwave therapy. Patients were randomized to treatment and assigned to active low intensity shockwave therapy (LiSWT) (4 Hz, 0.12 mJ/mm2) or sham treatment, 2:1. Arm 1 consisted of 3 treatments of 5000 shocks every 3 weeks. Arm 2 consisted of 5000, 3000, and 3000 shocks during weeks 1, 2, and 3, respectively, followed by an identical cycle of treatment 3 weeks later. Doppler ultrasound and grayscale imaging with a 15.4 MHz probe were performed under pharmacologic erection at weeks 20 and 32. Subjects completing sham treatment were unblinded and crossed over to the opposite arm for active treatment. Post-treatment end diastolic velocity (EDV) and peak systolic velocity (PSV) were measured, and visual grading scores were used to assess extent of hypoechoic regions in the corpora cavernosa. Data were analyzed by 2-way repeated measures ANOVA with Geisser-Greenhouse correction. Pairwise comparisons were performed to baseline used Dunnett's multiple comparison test. Missing data were imputed by "last observation carried forward". RESULT(S): Although powered for 60, recruitment was limited due to COVID and 36 subjects (22 active, 14 sham) were randomized. Sham treatments showed no significant changes in outcome measures. The number of subjects with improved visual grading scores in the proximal region was consistently higher in active LiSWT vs sham (Arm 1=88.9% vs. 11.1%;Arm 2=40.0% vs. 20.0%, respectively) with statistical significance in Arm 1 at weeks 20 (p=0.005) and 32 (p=0.001). Sham subjects rolled over to active LiSWT also had improved grayscale ratings (Arm 1=33.3% vs. 11.1%;Arm 2=40.0% vs. 20.0%). After LiSWT, greater numbers of patients had higher PSV, lower EDV, or no worsening of blood flow parameters relative to baseline. Decrease in EDV was statistically significant in active treatment Arm 2 at Week 32 (p=0.003). Mean IIEF-EF scores were nominally higher in subjects in active treatment who had improved visual grading scores vs those with no improvement. Adverse events were transient. CONCLUSION(S): Flaccid penile LiSWT appears to be safe and efficacious for treating ED based on statistically significant changes from baseline between sham and active treatments in primary outcome measures.

Treatment and comorbidities of patients with erectile dysfunction before and during COVID-19 in the United States: A real-world data analysis

Introduction Erectile dysfunction (ED) is usually a symptom of another medical condition. People with poor overall health are more likely to develop severe form of coronavirus disease 2019 (COVID-19) and may have unwanted symptoms such as ED. COVID-19-related stress, anxiety, and depression can also impact sexual health and possibly lead to ED. There are various treatment options for patients with ED. However, real-world evidence of the impact of COVID-19 on the treatment and comorbidities of patients with ED is limited. Objectives To estimate the impact of COVID-19 on the treatment and comorbidities of patients with ED in the United States. Methods This retrospective real-world data (RWD) analysis used the IQVIA PharMetrics® Plus claims database, which is a patient-Centric, closed claims database of fully adjudicated pharmacy, hospital and medical claims anonymized at the patient level, that captures the complete patient journey for all services billed to and covered by the patient's health plan. We compared the ED treatment and comorbidities in adult males aged 18+ years with ED in the same 3-month periods before (01March - 31May, 2019) and during (01March – 31May, 2020) the COVID-19 pandemic. ED treatment included any ED-related claims, prescriptions of any and individual phosphodiesterase-5 inhibitor (PDE5i) medications (avanafil, sildenafil, tadalafil and vardenafil). Results See the table below for number of patients having ED-related claims, having any and individual PDE5i prescriptions, number of patients with COVID-19 diagnosis, and percentage of patients with each of the top 10 comorbidities, in the 3-month periods before and during COVID-19. Conclusions RWD showed that ED-related claims significantly decreased during the COVID-19 pandemic, reflecting the pandemic's impact on ED patients’ health. However, the use of PDE5i medications remained stable during the pandemic. Key comorbidities including hypertension, hyperlipidemia, type 2 diabetes mellitus, benign prostatic hyperplasia with lower urinary tract symptoms, testicular hypofunction, and malignant neoplasm of the prostate, during the pandemic, compared with pre-pandemic period, highlighted the impact of the pandemic on ED patients’ health and need for managing their other comorbid chronic diseases. Disclosure Work supported by industry: yes, by Viatris. A consultant, employee (part time or full time) or shareholder is among the authors (Viatris).

COVID-19 and Its Impact on Financial Markets and the Real Economy

The COVID-19 pandemic severely disrupted financial markets and the real economy worldwide. These extraordinary events prompted large monetary and fiscal policy interventions. Recognizing the unusual nature of the shock, the academic community has produced an impressive amount of research during the last year. Macro-finance models have been extended to analyze the impact of epidemics. Empirical papers study the origins and consequences of the disruptions and the impact of policy interventions. New research evaluates the ongoing financial fragility and its relation to previous episodes and regulations. This special issue contains early contributions to this important and rapidly developing literature.(1)

Financial fragility in the COVID-19 crisis: The case of investment funds in corporate bond markets

Using daily microdata, we document major outflows in corporate-bond funds during the COVID-19 crisis. Large outflows were sustained over weeks and most severe for funds with illiquid assets, vulnerable to fire sales, and exposed to sectors hurt by the crisis. By providing a liquidity backstop for their bond holdings, the Federal Reserve bond purchase program helped to reverse outflows especially for the most fragile funds. In turn, the program had spillover effects on primary market issuance and peer funds. The evidence points to a “bond-fund fragility channel” whereby the Fed liquidity backstop transmits to the real economy via funds. © 2021