Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered with and without Water vs ViagraⓇ Film-Coated Tablets in Healthy Male Volunteers.

Background: Orodispersible film (ODF) formulation offers ease of use, convenience of administration, and other advantages, especially for patients who have difficulty in swallowing or are on liquid restriction compared with conventional oral formulations for the treatment of erectile dysfunction. Objectives: These studies compared the bioequivalence of 50 mg sildenafil citrate ODF formulation (test drug) with the marketed 50 mg sildenafil citrate film-coated tablet (FCT) (ViagraⓇ; Pfizer, New York, NY) (reference drug), with and without water in 2 randomized cross-over studies. Methods: Two randomized cross-over studies were conducted. The first study explored the bioequivalence of test drug administered with and without water compared with the reference drug with water. The second study investigated the bioequivalence of test drug, without water, compared with the reference drug with water. Forty-two and 80 healthy male volunteers were recruited in the first and second study, respectively. All volunteers fasted for 10 hours pre-dose. A 1-day washout period between doses was observed. Blood samples were collected at both before (up to 120 minutes before dosing) and after dosing (at different intervals up to 14 hours) stages. Statistical analyses on pharmacokinetic parameters were performed. Safety and tolerability for both the formulations were evaluated. Results: In the first study, bioequivalence was demonstrated for sildenafil citrate ODF administered with water when compared with the ViagraⓇ FCT. The ratios of adjusted geometric means (90% confidence interval (CI)) were maximum plasma concentration: 1.02 (94.91-108.78) and area under the plasma concentration-time curve: 1.09 (104.49-113.21) for sildenafil citrate ODF administered with water vs ViagraⓇ FCT. These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. The pharmacokinetic parameters for the second study also showed bioequivalence for sildenafil citrate ODF (without water) compared with ViagraⓇ FCT. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47-109.36) and area under the plasma concentration-time curve: 1.06 (103.42-108.40) for sildenafil citrate ODF administered without water vs ViagraⓇ FCT. Adverse events in both the studies occurred at similar rates for the 2 formulations and were mild in intensity. Conclusions: These results suggest that the new ODF formulation can be used interchangeably with the marketed FCT formulation. Sildenafil citrate ODF administered with and without water met bioequivalence criteria compared with ViagraⓇ FCT administered with water under fasted conditions in healthy adult male volunteers. The new ODF formulation can be used as a suitable alternative to the conventional oral solid dosage form.

Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update.

BACKGROUND: While phosphodiesterase type-5 inhibitors (PDE5Is) are highly effective for the treatment of erectile dysfunction (ED) and well tolerated, updated data on prescription patterns have been limited in real-world settings. AIM: To describe men in the United States who are prescribed PDE5Is for ED treatment and to evaluate patterns of initiation, switching, and treatment overlap. METHODS: This retrospective claims study used MarketScan Commercial and Medicare Supplement Databases from January 1, 2010, to December 31, 2015, to identify initial PDE5I claims (index date) for sildenafil, tadalafil, and/or vardenafil. Adults aged ≥18 years with ED were identified between July 1, 2010, and December 31, 2014, allowing for a 6-month preindex and 12-month follow-up period from the index date. OUTCOMES: Outcomes included patient demographics and treatment-related patterns after treatment initiation. RESULTS: A total of 106,206 identified patients met all inclusion criteria. Of these, 51,694, 40,193, and 14,319 had initial claims for sildenafil, tadalafil, and vardenafil, respectively. Mean age was 50.35 years, and comorbidities included dyslipidemia (44.17%), hypertension (43.09%), diabetes (15.32%), and depression (10.61%). More patients (48.67%) initiated on sildenafil than tadalafil (37.85%) or vardenafil (13.48%). Rate of switching was lower in the 60 days after the end of day supply of the initial prescription in the sildenafil cohort (2.71%) compared with the tadalafil (2.81%) and vardenafil (3.88%) cohorts (P < .001 for sildenafil vs tadalafil or vardenafil). Treatment overlap was lower in the sildenafil cohort (0.35%) than in the tadalafil (0.75%) and vardenafil (0.62%) groups (P < .001 for sildenafil vs tadalafil or vardenafil). CLINICAL IMPLICATIONS: These findings provide insight into updated patterns of PDE5I prescriptions in the United States and may aid in clinical decision-making. STRENGTHS & LIMITATIONS: Strengths include the large sample size, long data coverage period, and the real-world nature of the study. Limitations include the retrospective study design, use of data collected with a primary focus of claims, and lack of further details regarding reasons that drive switching. Actual rates of ED and impact on prescription patterns may be underestimated because the claims database only captured patients electing to visit a health-care provider. CONCLUSION: Among men with ED in the United States, rates of switching and treatment overlap were low for all PDE5Is but were found to be the lowest for sildenafil compared with tadalafil and vardenafil. Mulhall JP, Chopra I, Patel D, et al. Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update. J Sex Med 2020;17:941-948.

Integrated care for the management of ageing-related non-communicable diseases: current gaps and future directions.

Due to the increase in the older population in Europe and associated rise in the absolute number of persons with Non-Communicable Diseases (NCDs), it is becoming increasingly important to find ways to promote healthy ageing, which is defined as the process of developing and maintaining the functional ability that enables well-being in older age. Older persons with NCDs can have complex care needs due to the increased risk of frailty, multimorbidity, and polypharmacy. However, current health systems in Europe often provide fragmented care for older people with NCDs; many receive disjointed care from numerous specialists or via different levels of care. In the current article, we discuss barriers and challenges in implementing integrated care models in European settings for older NCD patients. Specifically, we discuss the need for greater use of case managers in the care and treatment persons with complex care needs as well as the lack of training and education in healthcare professionals on topics related to multimorbidity, frailty, and polypharmacy. We discuss the limitations that arise from the current focus on disease-specific guidelines and care models that do not take comorbid conditions into account, and the lack of good quality evidence that evaluates the effectiveness of integrated care interventions, especially in European health settings. We highlight the importance of evaluating and monitoring mental health in conjunction with somatic symptoms in NCD patients and discuss the integral role of information and communication technology in healthcare to streamline integrated care processes and help to achieve better outcomes for patients.

National Health and Wellness Survey exploratory cluster analysis of males 40-70 years old focused on erectile dysfunction and associated risk factors across the USA, Italy, Brazil and China.

OBJECTIVES: Prior studies of erectile dysfunction (ED) tend to narrowly focus on relationships with specific comorbidities, rather than evaluating a more comprehensive array of risk factors and assessing naturalistic patterns among them. This study identifies natural clusters of male characteristics from a general population sample per country, quantifies ED dynamics in these profiles and compares profiles across the US, Italy, Brazil and China samples. METHODS: National Health and Wellness Survey 2015 and 2016 patient-reported data on men aged 40-70 years (USA n = 15,652; Italy n = 2,521; Brazil n = 2,822; China n = 5,553) were analysed. Hierarchical agglomerative clustering identified clusters where predictors included demographics, health characteristics/behaviours, ED risk factors and provider visits in the past 6 months. Multinomial logistic regression assessed the independent utility of variables in predicting cluster membership, compared with the healthiest control cluster per country. RESULTS: Different natural clusters were found across countries, with four clusters for the USA, Italy and China and three clusters for Brazil. Age, income, employment, health behaviours and ED risk factors predicted different cluster membership across countries. In the USA, Italy and Brazil, younger clusters were predicted by ED, unhealthy behaviours and ED risk factors. Unique cluster profiles were identified in China, with ED and ED risk factors (aside from hypertension) not predicting cluster membership, while socio-demographics and health behaviours were strongly predictive. CONCLUSIONS: Natural cluster profiles revealed notable ED rates among adult males of age 40-70 in four different countries. Clusters were mainly predicted by unhealthy behaviours, ED risk factors and ED, regardless of level or presence of positive health characteristics and behaviours. This analysis identified meaningful subgroups of men with heightened ED risk factors, which can help healthcare providers to better recognise specific populations with the greatest need for intervention.

The association of erectile dysfunction with productivity and absenteeism in eight countries globally.

AIM: To evaluate the association of erectile dysfunction (ED) with work productivity loss, activity impairment and health-related quality of life (HRQoL) across Brazil, China, France, Germany, Italy, Spain, the UK and the US. METHODS: This cross-sectional observational study used data from adult men (40-70 years old; N = 52 697) from the 2015 and 2016 National Health and Wellness Surveys. ED assessment was based on self-reported difficulty in achieving or maintaining an erection in the past 6 months. Impairment to work and non-work activities and HRQoL were assessed for each country and compared against the US. Multivariable models tested interactions between ED status and country for each outcome. RESULTS: Overall ED prevalence was reported as 49.7%, with Italy reporting the highest rate (54.7%). Men with ED reported significantly higher absenteeism (7.1% vs 3.2%), presenteeism (22.5% vs 10.1%), overall work productivity impairment (24.8% vs 11.2%), activity impairment (28.6% vs 14.5%) and significantly lower Mental Component Summary scores (MCS; 46.7 vs 51.2), Physical Component Summary scores (PCS; 48.3 vs 53.0), and health state utilities (SF-6D: 0.693 vs 0.778; all, P < 0.001) than men with no ED. After adjusting for covariates, compared with the US, the association of ED status with overall work productivity impairment was greatest in the UK (26% higher; P < 0.05), and with MCS, PCS and SF-6D scores was greatest in China (-2.67, -1.58, and -0.043 points, respectively; all, P < 0.001). Greater ED severity was significantly associated with higher impairment to work and non-work activities and lower HRQoL, with China reporting the highest burden, compared with the US (most P < 0.05). CONCLUSION: ED poses a significant burden with respect to work productivity and HRQoL, with greater severity associated with worse outcomes. Better management and earlier detection may help reduce this burden, especially in countries reporting a strong association between ED and poor economic and health outcomes.

Information and communication technology for increasing healthy ageing in people with non-communicable diseases: identifying challenges and further areas for development.

Information and communication technology (ICT) within healthcare covers a range of technologies that aim to improve disease management or help modify health behaviors. We discuss clinical practice and system-related ICT challenges in Europe in relation to healthy ageing in people with non-communicable diseases (NCD). Although ICT use within healthcare is increasing, several challenges remain, including: (i) variations in ICT use within Europe; (ii) under-use of electronic health records; (iii) frequent use of single domain outcomes; (iv) shortage of clinical trials on current technologies; (v) lack of involvement of patients in ICT development; (vii) need to develop and adapt ICTs for people with cognitive or sensory impairment; and (viii) need to use longitudinal big data better. Close collaboration between key stakeholders (academia, biopharmaceutical and technology industries, healthcare, policy makers, patients, and caregivers) should foster both technological innovation and innovative models to facilitate more cost-effective approaches, ultimately leading to increased healthy ageing.

The 2018 Revision to the Process of Care Model for Management of Erectile Dysfunction.

INTRODUCTION: Erectile dysfunction (ED) is a common condition the treatment of which over the years has expanded from specialty care settings to various other clinical settings. A Process of Care Model was developed in 1999 to provide primary care physicians with guidance in the diagnosis and management of ED. AIM: This update to the Process of Care Model aims to reflect current ED management practices, because the study of ED has changed since 1999. METHODS: Updates to the Process of Care Model were developed during a meeting of international experts from diverse disciplines. The updated model is data-driven, evidence-based, and relevant to a wide range of healthcare providers. MAIN OUTCOME MEASURES: This article summarizes the results of the expert meeting and focuses on ED management. The evaluation of ED is discussed in a separate article. RESULTS: The updated model presents modification of risk factors and correction of comorbidities frequently associated with ED as critical parts of patient management. Patients should be encouraged to make positive lifestyle changes such as improving diet and increasing physical exercise. Lifestyle changes may be accompanied by the first-line medical therapies of sexual counseling and therapy, which takes into consideration patient sexual dynamics and pharmacotherapy with phosphodiesterase 5 inhibitors (PDE5Is). CLINICAL IMPLICATIONS: The updated model provides guidance regarding risk factors associated with ED, their modification, sexual counseling, and PDE5I selection, dosing, and patient education. STRENGTHS AND LIMITATIONS: This update leverages the extensive clinical expertise and experience of the authors to provide updated, comprehensive guidance for ED management. The model reflects the views and experiences of a limited number of contributors; however, these authors draw upon a diverse array of clinical specialties and are regarded as experts in their fields. Additionally, no meta-analyses were performed to further support the ED evaluation guidelines presented. CONCLUSION: Effective management of ED may be achieved through a combination of patient risk factor modification and first-line therapy, taking into consideration any patient comorbidities known to be associated with ED. Treatment goals should be individualized to restore sexual satisfaction to the patient and/or couple and improve quality of life based on the patient's expressed needs and desires. Mulhall JP, Giraldi A, Hackett G, et al. The 2018 Revision to the Process of Care Model for Management of Erectile Dysfunction. J Sex Med 2018;15:1434-1445.

The 2018 Revision to the Process of Care Model for Evaluation of Erectile Dysfunction.

BACKGROUND: Erectile dysfunction (ED) is a common condition that may affect men of all ages; in 1999, a Process of Care Model was developed to provide clinicians with recommendations regarding the evaluation and management of ED. AIM: To reflect the evolution of the study of ED since 1999, this update to the process of care model presents health care providers with a tool kit to facilitate patient interactions, comprehensive evaluation, and counseling for ED. METHODS: A cross-disciplinary panel of international experts met to propose updates to the 1999 process of care model from a global perspective. The updated model was designed to be evidence-based, data-driven, and accessible to a wide range of health care providers. OUTCOMES: This article summarizes the resulting discussion of the expert meeting and focuses on ED evaluation. The management of ED is discussed in an article by Muhall et al (J Sex Med 2018;15:1280-1292). RESULTS: A comprehensive approach to the evaluation of ED is warranted because ED may involve both psychological and organic components. The updated process of care model for evaluation was divided into core and optional components and now focuses on the combination of first-line pharmacotherapy and counseling in consideration of patient sexual dynamics. CLINICAL IMPLICATIONS: Patient evaluation for ED should encompass a variety of aspects, including medical history, sexual history, physical examination, psychological evaluation, laboratory testing, and possibly adjunctive testing. STRENGTHS & LIMITATIONS: This update draws on author expertise and experience to provide multi-faceted guidance for the evaluation of ED in a modern context. Although a limited number of contributors provided input on the update, these experts represent diverse fields that encounter patients with ED. Additionally, no meta-analyses were performed to further support the ED evaluation guidelines presented. CONCLUSION: Comprehensive evaluation of ED affords health care providers an opportunity to address medical, psychological/psycho-social, and sexual issues associated with ED, with the ultimate goal being effective management and possibly resolution of ED. While some or all techniques described in the updated model may be needed for each patient, evaluation should in all cases be thorough. Mulhall JP, Giraldi A, Hackett G, et al. The 2018 Revision to the Process of Care Model for Evaluation of Erectile Dysfunction. J Sex Med 2018;15:1280-1292.

Sexual habits of men with ED who take phosphodiesterase 5 inhibitors: a survey conducted in 7 countries.

INTRODUCTION: Western cultural perceptions that favour spontaneous sex may create unrealistic expectations for erectile dysfunction (ED) treatment. Little is known about how users of phosphodiesterase type 5 inhibitors (PDE5Is) plan sexual activity and timing of their preactivity PDE5I ingestion. Because various PDE5Is vary in their duration of action and dosage regimen, this may be an important consideration in selecting the optimal agent for the ED patient. AIM: To better understand the sexual habits of PDE5I users. METHODS: Men from 7 countries (Brazil, China, Italy, Japan, Russia, Taiwan, Turkey) were screened online for age, self-reported comorbidities and ED medication use in the prior 3 months. After screening, eligible participants were asked to complete a 7-question, self-administered online survey containing questions regarding sexual habits and behaviours. MAIN OUTCOME MEASURES: Survey questions focused primarily on advanced planning of sexual intercourse and timing of PDE5I ingestion but also addressed the frequency of sexual intercourse and ED medication use. RESULTS: Of the 1458 respondents (response rate: 48%; median age: 48 years [interquartile range (IQR), 44-55]), 83% always/sometimes planned a specific time for intercourse in advance; 72% planned a specific time for sexual intercourse up to several hours in advance. Of respondents who planned in advance, more than half planned specific days of the week (55%) and times of the day (60%) for sexual intercourse. The time to sexual intercourse after dosing was ≤1 hour for 70% and ≤4 hours for 96% of men. The median frequency of sexual intercourse was 6 times/month (IQR, 4-10), with ED medication taken a median of 5 times/month (IQR, 3-8). CONCLUSIONS: Sexual activity is usually planned by ED medication users several hours in advance, and the vast majority are attempting activity within a short time after ingestion of the agent. These data should aid clinicians in the selection of the optimal PDE5I.

Clinical Practice Management of Primary Open-Angle Glaucoma in the United States: An Analysis of Real-World Evidence.

Purpose: To investigate clinical management of primary open-angle glaucoma (POAG) in the United States using real-world evidence and to examine healthcare resource utilization (HCRU), medication adherence/persistence, and procedure use. Design: A cross-sectional, retrospective analysis of Optum's de-identified Market Clarity Dataset (July 1, 2013-December 31, 2019). Patients and Methods: Patients ≥18 years with POAG diagnosis and continuous enrollment for 1-year pre- and post-index were eligible and categorized into four mutually exclusive cohorts: CH1, treated with antiglaucoma medication(s) only; CH2, underwent glaucoma procedure(s) only; CH3, treated with antiglaucoma medication(s) and underwent procedure(s); and CH4, received no treatment for POAG. Adherence and persistence with antiglaucoma medications, and disease-specific HCRU were analyzed. Pairwise two-sample comparisons and multivariate regressions were conducted. Results: Examined 232,572 eligible patients (CH1=60,895; CH2=4330; CH3=6027; CH4=161,320). Prostaglandin analogs were most prescribed antiglaucoma medications (CH1: 69.7%; CH3: 62.7%), of which latanoprost was most common (CH1: 51.3%; CH3: 46.1%). Disease-specific office visits occurred in 26.3%, 78.2%, 75.0%, 23.8%, and surgical services visits occurred in 3.8%, 36.3%, 42.5%, 3.3%, in CH1-CH4, respectively. Adherence was higher (medication possession ratio: 47.1% vs 39.4%; P<0.0001), and more patients remained persistent across 1-year post-index period in CH1 vs CH3 (25.4% vs 16.1%; P<0.0001). Positive predictors of medication persistence included being female, ≥55 years, and history of dyslipidemia or thyroid disease (all P≤0.0003). Conclusion: Overall, 70% POAG patients might not have received antiglaucoma treatment. Since POAG is a slowly progressive blinding disease, the lack of antiglaucoma treatment and suboptimal adherence/persistence with medications are of major concerns. Targeted screening and educational approaches are needed to improve POAG management.

New Strategies to Improve Patient Adherence to Medications for Noncommunicable Diseases During and After the COVID-19 Era Identified via a Literature Review.

Noncommunicable diseases (NCDs) place a huge burden on healthcare systems and society as a whole. Relatively early in the coronavirus disease 2019 (COVID-19) pandemic, clinicians became aware that in individuals infected with COVID-19, those with preexisting NCDs such as diabetes mellitus and cardiovascular disease (CVD) were at a greater risk of poor outcomes and mortality than those without. The importance of adherence to medications and lifestyle changes to control and prevent NCDs has been a major focus for many years, but with limited success - the proportion of patients adherent and persistent to their medications remains very low. There are many facets to adherence and persistence. Recent evidence suggests that a patient-centric approach is important, and ensuring that a patient is both motivated and empowered is critical to improving adherence/persistence. The COVID-19 pandemic has brought many changes to the way in which patients with NCDs are managed, with telemedicine and ehealth becoming more common. Changes have also occurred in the way in which patients can gain access to medications during the pandemic. The potential for these changes forms the basis of improving the management of patients with NCDs both during and after the pandemic. Over the coming months, a huge amount of work will be put into initiatives to promote adherence to COVID-19 vaccination programs. Those at highest risk of severe COVID-19, such as people aged 80 years and older, are likely to receive the vaccine first in some parts of world. Finally, social determinants of health are critical elements that can impact not just the likelihood of having an NCD or becoming infected with COVID-19, but also access to healthcare, and a patient's adherence and persistence with their treatments.

Epidemiology Update of Erectile Dysfunction in Eight Countries with High Burden.

INTRODUCTION: Prior epidemiology studies on erectile dysfunction (ED) have varied in geography/place, time period, and methodology. Due to this variability, comparisons of data across studies are greatly limited. Additionally, little is known about the rates of comorbid ED and benign prostatic hyperplasia (BPH). AIM: To update the prevalence of ED and patient characteristics using a single methodology in 8 countries: Brazil, China, France, Germany, Italy, Spain, the United Kingdom, and the United States. METHODS: This retrospective cross-sectional study included men (≥18 years) who self-reported experiencing difficulty in achieving or maintaing an erection in the past 6 months in the 2015 and 2016 National Health and Wellness Surveys (N = 97,159). Pairwise comparisons between the United States and each of the other countries were performed among respondents with ED and no BPH, aged ≥18 years, and within the subset of men aged 40-70 years. MAIN OUTCOME MEASURES: ED prevalence (with BPH, with no BPH, and overall), health characteristics, and ED risk factors were assessed. RESULTS: ED with BPH was found to be < 6.0% in all countries. ED prevalence overall varied from 37.2% (Brazil) to 48.6% (Italy). Similar patterns were observed for the subset of men aged 40-70 years. Patients in Brazil were younger (aged ≥18: 43.85 vs. 52.35; aged 40-70: 52.94 vs. 56.76 years; for both, P < .05) than those in the United States. ED-related comorbidities were more common in European countries, comparatively. CONCLUSION: This study provides an important update and outlook to ED epidemiology in Brazil, China, France, Germany, Italy, Spain, the United Kingdom, and the United States. Overall, ED prevalence is high, relative to some previous estimates. Findings from this study highlight the continued burden ED plays in the lives of men in these countries. Goldstein I, Goren A, Li VW, et al. Epidemiology Update of Erectile Dysfunction in Eight Countries with High Burden. Sex Med Rev 2020;8:48-58.

Real-World Assessment of the Impact of Erectile Dysfunction on Sexual Planning Behavior and Health- and Treatment-Related Outcomes Among Men in 8 Countries.

INTRODUCTION: The effect of erectile dysfunction (ED) on sexual planning behaviors and outcomes in men taking phosphodiesterase type 5 inhibitors (PDE5Is) is not well studied. AIMS: To assess sexual habits, behaviors, and treatment-related outcomes of PDE5I-treated men with ED. METHODS: This cross-sectional observational study recruited men aged 30 to 70 years with mild-to-severe ED from 8 diverse countries (the United States, the United Kingdom, Italy, Russia, Turkey, Israel, China, and Japan) to complete an approximately 15-minute survey. Differences were evaluated using bivariate analyses, and data were summarized using descriptive statistics. MAIN OUTCOME MEASURES: Self-reported data were collected for demographics, health characteristics, treatment, sexual habits, ED severity, ED-specific quality of life, and treatment satisfaction. RESULTS: The survey was completed by 1,575 men. Mean frequency of sexual intercourse was 5.7 times/month. Overall, 87.1% of men always, often, or sometimes planned for sexual activity. Of those planning in advance, 32.8% and 40.6% agreed or strongly agreed that they plan for specific days of the week and times of day, respectively. Sexual planning habits were similar for patients taking short-acting vs long-acting PDE5Is. The most commonly cited reasons for planning sexual activity were needing time to take medication (48.4%), needing to make sure medication has taken effect (43.4%), convenient time for sexual activity (34.9%), and needing the partner's agreement (33.4%). Mean Self-Esteem and Relationship Questionnaire total score was 56.4. CONCLUSIONS: The differences in ED burden and sexual planning behavior observed across countries were not influenced by the type of PDE5I being taken, suggesting that cultural differences are an important factor when considering types of ED treatment. These findings provide a better understanding of burden, sexual habits, planning behaviors, quality of life, and treatment-related outcomes among PDE5I-treated men with ED in 8 Western and non-Western countries and may aid healthcare providers in selecting optimal treatments. Goldstein I, Giraldi A, Maculaitis MC, Real-World Assessment of the Impact of Erectile Dysfunction on Sexual Planning Behavior and Health- and Treatment-Related Outcomes Among Men in 8 Countries. J Sex Med 2020;8:338-349.

Degree of Planning of Sexual Intercourse Among Men From China, Japan, and Taiwan Taking Medication for Erectile Dysfunction: Findings of an Observational, Cross-Sectional Survey.

INTRODUCTION: Management of erectile dysfunction (ED) is beset with assumptions around spontaneity of sexual intercourse, requiring candor between the physician and patient if appropriate treatment is to be implemented. AIM: To evaluate the degree to which men who take ED medications plan for and have sex. METHODS: Men from China, Japan, and Taiwan aged 40-70 years who had taken ED medications within the past 3 months were invited to participate anonymously in an online, self-administered survey that enquired about frequency and advance planning of sex, time between taking ED medication and intercourse, and treatment satisfaction. Data were analyzed using descriptive statistics. MAIN OUTCOME MEASURE: Frequency of planning of sexual intercourse, planning and ED medication dosing interval, and frequency of ED medication use. RESULTS: Data from 604 respondents (mean age 50.8 years) from China (n = 254), Japan (n = 250), and Taiwan (n = 100) were collected. Men used ED medications a median of ≤4 times per month in all 3 territories. 76% who used ED medication during the past 3 months planned for sex on specific occasions, with 59% and 52% agreeing that they plan for sex on specific days of the week and times of the day, respectively. Most commonly, men planned for sex up to several hours to a day beforehand, with 94% taking ED medication within 4 hours of sex. Satisfaction with ED medication was generally high and related to erection rigidity, speed of onset, and safety. CONCLUSION: Knowledge of the degree to which individuals with ED plan for sex may have important implications for the appropriate prescription of ED medication. The high degree of planning around sexual activities exhibited by men taking ED medication suggests there is a need for appropriate counseling to ensure that treatment is aligned with patient behavior. Jiann B-P, Nakajima K, Dighe S, et al. Degree of planning of sexual intercourse among men from China, Japan, and Taiwan taking medication for erectile dysfunction: Findings of an observational, cross-sectional survey. Sex Med 2019;7:54-60.

Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction: Pharmacology and Clinical Impact of the Sildenafil Citrate Orodispersible Tablet Formulation.

PURPOSE: The purpose of this review is to provide an overview of the pharmacology, tolerability, and efficacy of the different phosphodiesterase type 5 (PDE5) inhibitors available for the treatment of erectile dysfunction (ED), with a special focus on the sildenafil orodispersible tablet (ODT) formulation. METHODS: A literature search was performed in PubMed, EMBASE, and Cochrane Reviews using the terms erectile dysfunction, patient preference, sildenafil, and PDE5 inhibitors to identify articles published in English between May 1, 2006, and November 18, 2016. A total of 29 studies were included in this review. FINDINGS: There are substantial data in the literature on the use of PDE5 inhibitors for the treatment of ED. Oral PDE5 inhibitors have been found to be efficacious in the treatment of ED based on results from standard tools used to assess treatment outcomes, such as the Global Assessment Questionnaire 1. In addition, PDE5 inhibitors are defined as well tolerated because of the low occurrence of serious adverse effects or discomfort. Mild adverse reactions, compared with a placebo, include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Both the film-coated tablet and ODT formulations of sildenafil with or without water have equivalent systemic exposure. However, use of a sildenafil ODT formulation offers a convenient alternative method of administration that would be advantageous for patients with ED. IMPLICATIONS: According to the published literature, the PDE5 inhibitors are considered an effective and well-tolerated option for the treatment of ED as determined by data generated from standard instruments used in the assessment of treatment outcomes in ED and reported types and severity of adverse effects. The sildenafil ODT formulation, which disintegrates rapidly in the mouth, is an alternative to the solid film-coated tablet formulation that offers administration benefit with the potential to improve treatment adherence, thereby enhancing the sexual health and sense of psychological well-being of patients and their partners.

The centrality of the patient role in the management of insulin dependent diabetes mellitus.

Full text is available as a scanned copy of the original print version.