Patterns of treatment with PDE5 inhibitors in the clinical practice in Italy: longitudinal data from the Erectile Dysfunction Observational Study.
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ABSTRACT:
SUBMITTER: Fusco F
PROVIDER: S-EPMC3735015 | biostudies-other | 2009 Sep
REPOSITORIES: biostudies-other
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Project description:BACKGROUND:Men with diabetes are at greater risk of erectile dysfunction (ED). AIM:To describe the natural history of ED in men with type 1 diabetes. METHODS:We examined up to 30 years of prospectively collected annual ED status and demographic and clinical variables from 600 male participants in the Diabetes Control and Complications Trial (DCCT; 1983-1993) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (1994-present; data in this study are through 2012). OUTCOMES:Yes vs no response to whether the participant had experienced impotence in the past year and whether he had used ED medication. RESULTS:Sixty-one percent of men reported ED at least once during the study. For some men, the initial report of ED was permanent. For others, potency returned and was lost multiple times. Visual display of the data showed four longitudinal ED phenotypes: never (38.7%), isolated (6.7%), intermittent (41.8%), and persistent (12.8%). Men who never reported ED or in only 1 isolated year were younger, had lower body mass index, and better glycemic control than men in the intermittent and persistent groups at DCCT baseline. In a multivariable logistic model comparing men at their first year reporting ED, men who were older had lower odds of remission and men who were in the conventional DCCT treatment group had higher odds of remission. CLINICAL TRANSLATION:If validated in other cohorts, such findings could be used to guide individualized interventions for patients with ED. STRENGTHS AND LIMITATIONS:This is the first examination of ED with repeated measures at an annual resolution, with up to 30 years of responses for each participant. However, the yes vs no response is a limitation because the real phenotype is not binary and the question can be interpreted differently depending on the participant. CONCLUSIONS:Age, glycemic control, and BMI were important longitudinal predictors of ED. We have described a more complex ED phenotype, with variation in remission patterns, which could offer insight into different mechanisms or opportunities for intervention. If validated in other cohorts, such findings could be used to establish more accurate prognostication of outcomes for patients with ED to guide individualized interventions. Palmer MR, Holt SK, Sarma AV, et al. Longitudinal Patterns of Occurrence and Remission of Erectile Dysfunction in Men With Type 1 Diabetes. J Sex Med 2017;14:1187-1194.
| S-EPMC5624836 | biostudies-literature
Project description:Abstract Background: Erectile dysfunction is a disease commonly caused by diabetes mellitus (DMED) and cavernous nerve injury (CNIED). Bioinformatics analyses including differentially expressed genes (DEGs), enriched functions and pathways (EFPs), and protein-protein interaction (PPI) networks were carried out in DMED and CNIED rats in this study. The critical biomarkers that may intervene in nitric oxide synthase (NOS, predominantly nNOS, ancillary eNOS, and iNOS)-cyclic guanosine monophosphate (cGMP)-phosphodiesterase 5 enzyme (PDE5) pathway, an important mechanism in erectile dysfunction treatment, were then explored for potential clinical applications. Methods: GSE2457 and GSE31247 were downloaded. Their DEGs with a |logFC (fold change)| > 0 were screened out. Database for Annotation, Visualization and Integrated Discovery (DAVID) online database was used to analyze the EFPs in Gene Ontology enrichment and Kyoto Encyclopedia of Genes and Genomes networks based on down-regulated and up-regulated DEGs respectively. PPI analysis of 2 datasets was performed in Search Tool for the Retrieval of Interacting Genes/Proteins (STRING) and Cytoscape. Interactions with an average score greater than 0.9 were chosen as the cutoff for statistical significance. Results: From a total of 1710 DEGs in GSE2457, 772 were down-regulated and 938 were up-regulated, in contrast to the 836 DEGs in GSE31247, from which 508 were down-regulated and 328 were up-regulated. The 25 common EFPs such as aging and response to hormone were identified in both models. PPI results showed that the first 10 hub genes in DMED were all different from those in CNIED. Conclusions: The intervention of iNOS with the hub gene complement component 3 in DMED and the aging process in both DMED and CNIED deserves attention.
| S-EPMC8519209 | biostudies-literature
Project description:BackgroundBone marrow mononuclear cells have been successfully utilized for numerous regenerative purposes. In the current study, patients suffering from erectile dysfunction (ED) unresponsive to phosphodiesterase 5 inhibitors were administered autologous bone marrow concentrate delivered intracavernously utilizing a point of care FDA cleared medical device.MethodsA total of 40 patients were treated in the primary trial and 100 in the clinical registry, with the longest follow up of 12 months.ResultsMinimal treatment associated adverse effects where observed related to short term bruising at the site of harvest or injection. No long-term adverse events were noted related to the intervention. Mean improvements in IIEF-5 score were 2 in the Caverstem 1.0 low dose group, 3 in the high dose Caverstem 1.0 group and 9 in the Caverstem 2.0 group. Furthermore, improvements peaked by 3 months and maintained at 6 months follow-up.ConclusionThese data support the safety and efficacy of point of care, minimally to non-manipulated, non-expanded bone marrow concentrate for the treatment of ED. Trial registration Funded by Creative Medical Health, Inc.; Clinicaltrials.gov number: NCT03699943; https://clinicaltrials.gov/ct2/show/NCT03699943?term=caverstem&rank=1; initially registered December 12, 2015.
| S-EPMC6958721 | biostudies-literature
Project description:BackgroundBiologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice.MethodsCHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics.Results399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7-76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7-73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133).ConclusionsThe CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures.
| S-EPMC9464489 | biostudies-literature
Project description:Background: Despite availability of clinical guidelines, underdiagnosis, undertreatment, and poor adherence are still significant concerns in allergic rhinitis (AR) therapeutic management. We investigated clinical practice patterns and prescribing behavior of Italian healthcare professionals (HCPs) specialized in AR.Methods: One-hundred allergologists, 100 ear, nose and throat (ENT) specialists, and 150 general practitioners (GPs) were recruited. The survey assessed: socio-demographic, work experience, monthly caseload, prescription drivers. Next, HCPs were invited to retrospectively recover patients' clinical data to investigate: AR clinical characteristics, therapy management, prescription patterns, patient adherence. Descriptive statistics, Chi square, One-Way analysis of variance, and Two-Way Analysis of Variance were performed.Results: Allergologists visited more AR patients (31% of monthly caseload) than ENTs (21%, p?<?0.001), while GPs' caseload was the lowest (6%). Clinical information of 2823 patients were retrieved of whom 1906 (67.5%) suffered from moderate/severe AR (discomfort score: 7.7?±?1.3) and 917 (32.4%) from mild AR (5.7?±?1.9). About one-third of mild patients had a discomfort score???7. Main prescription drivers were "effective on all symptoms" (54.3% patients) and "quick symptom relief" (47.8%), whereas minor drivers were "affordable price" (13.4%) and "refundable" (8.7%). The most prescribed drugs were antihistamines and intranasal corticosteroids (79% and 55% prescriptions), followed by fixed-dose-combination of intranasal azelastine/fluticasone (19%). Polytherapy was the most common treatment strategy (59.6%). HCPs' believe that the majority of the patients was adherent to treatment (88% with score?>?7).Conclusions: This survey describes the therapeutic approach adopted by Italian physicians to cope with AR and shows that HCPs underestimated AR severity and had a non-realistic perception of patients' adherence. These findings suggest that further efforts are required to improve AR clinical management in Italy.
| S-EPMC7640419 | biostudies-literature
Project description:Erectile dysfunction is a multidimensional but common male sexual dysfunction that involves an alteration in any of the components of the erectile response, including organic, relational and psychological. Roles for nonendocrine (neurogenic, vasculogenic and iatrogenic) and endocrine pathways have been proposed. Owing to its strong association with metabolic syndrome and cardiovascular disease, cardiac assessment may be warranted in men with symptoms of erectile dysfunction. Minimally invasive interventions to relieve the symptoms of erectile dysfunction include lifestyle modifications, oral drugs, injected vasodilator agents and vacuum erection devices. Surgical therapies are reserved for the subset of patients who have contraindications to these nonsurgical interventions, those who experience adverse effects from (or are refractory to) medical therapy and those who also have penile fibrosis or penile vascular insufficiency. Erectile dysfunction can have deleterious effects on a man's quality of life; most patients have symptoms of depression and anxiety related to sexual performance. These symptoms, in turn, affect his partner's sexual experience and the couple's quality of life. This Primer highlights numerous aspects of erectile dysfunction, summarizes new treatment targets and ongoing preclinical studies that evaluate new pharmacotherapies, and covers the topic of regenerative medicine, which represents the future of sexual medicine.
| S-EPMC5027992 | biostudies-literature
Project description:BackgroundFollowing metoidioplasty, transmen (TM) experience sexual function challenges including erectile dysfunction, which is typically treated in cisgender men with phosphodiesterase-5 inhibitors (PDE5i) and intracavernosal injections (ICI).AimWe aim to evaluate sexual function post-metoidioplasty and explore attitudes toward using PDE5i and ICI as potential erectile aids METHODS: All patients who had metoidioplasty completed at the Gender Surgery Program in Vancouver, British Columbia were contacted. Participants completed an electronically accessible self-constructed questionnaire consisting of 39 items on erectile function, orgasm, and penetrative intercourse which also captured Erection Hardness Scores (EHS). Data were analyzed via t-test and 1-way ANOVA.OutcomesOur outcomes were the importance of erectile function, ability to orgasm, penetrative intercourse, and attitudes towards using PDE5i and ICI post-metoidioplasty.ResultsFifteen out of 22 patients completed the survey (median age 32 years). Most had metoidioplasty within the past 2 years. The participants ranked the ability to orgasm and to achieve or maintain erections significantly higher than penetrative intercourse (P <.001, P =.005 respectively). Most participants reported facing challenges with penetrative intercourse (87%) and erectile function (80%). In contrast, a smaller proportion reported challenges with orgasm (33%). With regards to EHS, 83% of participants described their erections as either "larger but not hard," or "hard but not hard enough for penetration." A total of 47% of the participants had previously tried PDE5i, but none had used ICI. Although 87% were willing to use PDE5i, only 40% were willing to try ICI to improve their erections. Patients reported lack of knowledge and understanding among primary care physicians as barriers to accessing treatment for sexual dysfunction.Clinical translationThe results of this study can facilitate decision making for TM undergoing genital gender-affirmation surgery and provide potential options for improving erectile function post surgery.Strengths & limitationsThis study represents the first assessment of sexual function and use of erectile aids in post-metoidioplasty patients. The results of this study are limited by the small sample size and enrolment from a single surgical center.ConclusionMetoidioplasty patients surveyed fail to achieve a fully rigid erection without treatment, typically retain the ability to orgasm, and are generally willing to try PDE5i. Khorrami A, Kumar S, Bertin E, et al. The Sexual Goals of Metoidioplasty Patients and Their Attitudes Toward Using PDE5 Inhibitors and Intracavernosal Injections as Erectile Aids. Sex Med 2022;10:100505.
| S-EPMC9177887 | biostudies-literature
Project description:Male sexual arousal (SA) has been known as a multidimensional experience involving closely interrelated and coordinated neurobehavioral components that rely on widespread brain regions. Recent functional neuroimaging studies have shown relation between abnormal/altered dynamics in these circuits and male sexual dysfunction. However, alterations in the topological organization of structural brain networks in male sexual dysfunction are still unclear. Here, we used graph theory to investigate the topological properties of large-scale structural brain networks, which were constructed using inter-regional correlations of cortical thickness between 78 cortical regions in 40 patients with psychogenic erectile dysfunction (pED) and 39 normal controls. Compared with normal controls, pED patients exhibited a less optimal global topological organization with reduced global and increased local efficiencies. Our results suggest disrupted neural integration among distant brain regions in pED patients, consistent with previous reports of impaired white matter structure and abnormal functional integrity in pED. Additionally, disrupted global network topology in pED was observed to be primarily relevant to altered subnetwork and nodal properties within the networks mediating the cognitive, motivational and inhibitory processes of male SA, possibly indicating disrupted integration of these networks in the whole brain networks and might account for pED patients' abnormal cognitive, motivational and inhibitory processes for male SA. In total, our findings provide evidence for disrupted integrity in large-scale brain networks underlying the neurobehavioral processes of male SA in pED and provide new insights into the understanding of the pathophysiological mechanisms of pED.
| S-EPMC4683194 | biostudies-literature
Project description:BACKGROUND: There are many recent observational studies on smoking and risk of erectile dysfunction (ED) and whether smoking increases the risk of ED is still inconclusive. The objective of this meta-analysis was to synthesize evidence from studies that evaluated the association between smoking and the risk of ED. METHODS: We searched PubMed, Embase, Web of Science, and Scopus in January 2013 to identify cohort and case-control studies that evaluated the association between smoking and ED. Study quality of included studies was assessed by the Newcastle-Ottawa scale. Random-effects meta-analyses were used to combine the results of included studies. RESULTS: Four prospective cohort studies and four case-control studies involving 28, 586 participants were included. Because of significant heterogeneity after including case-control studies in meta-analysis, the consistent results of prospective cohort studies were considered more accurate, Because of significant heterogeneity after including case-control studies in meta-analysis, the consistent results of prospective cohort studies were considered more accurate, Compared with non-smokers, the overall odd ratio of ED in prospective cohort studies was 1.51(95% CI: 1.34 to 1.71) for current smokers, and it was 1.29 (95% CI: 1.07 to 1.47) for former smokers. Evidence of publication bias was not found. CONCLUSION: Evidence from epidemiological studies suggests that smoking, especially current smoking, may significantly increase the risk of ED.
| S-EPMC3616119 | biostudies-literature
Project description:BackgroundSeveral studies have shown that erectile dysfunction (ED) influences the risk of cardiovascular events (CV events). However, a meta-analysis of the overall risk of CV events associated with ED in patients with diabetes has not been performed.Methodology/principal findingsWe searched MEDLINE and the Cochrane Library for pertinent articles (including references) published between 1951 and April 22, 2012. English language reports of original observational cohort studies and cross-sectional studies were included. Pooled effect estimates were obtained by random effects meta-analysis. A total of 3,791 CV events were reported in 3 cohort studies and 9 cross-sectional studies (covering 22,586 subjects). Across the cohort studies, the overall odds ratio (OR) of diabetic men with ED versus those without ED was 1.74 (95% confidence interval [CI]: 1.34-2.27; P<0.001) for CV events and 1.72 (95% CI: 1.5-1.98; P<0.001) for coronary heart disease (CHD). The funnel plot, Begg's test, and Egger's test did not show evidence of publication bias (all P>0.05). Moreover, meta-regression analysis found no relationship between the method used to assess ED (questionnaire or interview), mean age, mean hemoglobin A(1c), mean body mass index, or mean duration of diabetes and the risk of CV events or CHD. In the cross-sectional studies, the OR of diabetic men with ED versus those without ED was 3.39 (95% CI: 2.58-4.44; P<0.001) for CV events (N = 9), 3.43 (95% CI: 2.46-4.77; P<0.001) for CHD (N = 7), and 2.63 (95% CI: 1.41-4.91; P = 0.002) for peripheral vascular disease (N = 5).Conclusion/significanceED was associated with an increased risk of CV events in diabetic patients. Prevention and early detection of cardiovascular disease are important in the management of diabetes, especially in view of the rapid increase in its prevalence.
| S-EPMC3433443 | biostudies-literature