Comparative dissolution study on counterfeit medicines of PDE-5 inhibitors

Counterfeit medicines are a growing problem in both developing and industrialised countries. In general the evaluation of these medicines is limited to the identification and the dosage of the active ingredients. In this study in vitro dissolution tests were conducted on two sets of counterfeit medicines containing PDE-5 inhibitors （sildenafil citrate and tadalafil）. The dissolution profiles were statistically compared to the ones of the genuine products using the f2-method and a comparison at each time point using the Cochran test. The results showed low equivalences between counterfeit and genuine products as well as higher variations around the mean dissolution value at the different time points for the counterfeit products.

Incidence rate of prostate cancer in men treated for erectile dysfunction with phosphodiesterase type 5 inhibitors： retrospective analysis

The purpose of this study was to determine the incidence rate of prostate cancer among men with erectile dysfunction （ED） treated with phosphodiesterase type 5 inhibitors （PDE-5i） over a 7-year period vs. men with ED of the same age and with similar risk factors who were not treated with PDE-5i. In a retrospective review of electronic medical records and billing databases between the years 2000 and 2006, men with ED between the ages of 50 and 69 years and no history of prostate cancer prior to 2000 were identified. These individuals were divided into two groups： 2362 men who had treatment with PDE-5i, and 2612 men who did not have treatment. Demographic data in each group were compared. During the study period, 97 （4.1%） men with ED treated with PDE-5i were diagnosed with prostate cancer compared with 258 （9.9%） men with ED in the non-treated group （P〈00001）. A higher percentage of African Americans were treated with PDE-5i vs. those who were not （10.5% vs. 7.1%; P〈O.O001）. The PDE-5i group had lower documented diagnosis of elevated prostate-specific antigen （10.0% vs. 13.1%; P=-0.0008） and higher percentage of benign prostatic hyperplasia （38.4% vs. 35.1%; P=0.0149）. Men with ED treated with PDE-5i tended to have less chance （adjusted odds ratio： 0.4; 95% confidence intervals： 0.3-0.5; P〈0.0001） of having prostate cancer. Our data suggest that men with ED treated with PDE-5i tended to have less of a chance of beine diaenosed with orostate cancer. Further research is warranted.

Combination therapy for erectile dysfunction： an update review

The introduction of oral phosphodiesterase-5 inhibitors （PDE51s） in the late 1990s and early 2000s revolutionized the field of sexual medicine and PDE51s are currently first-line monotherapy for erectile dysfunction （ED）. However, a significant proportion of patients with complex ED will be therapeutic non-responders to PDE51 monotherapy. Combination therapy has recently been adopted for more refractory cases of ED, but a critical evaluation of current combination therapies is lacking. A thorough PubMed and Cochrane Library search was conducted focusing on the effectiveness of combination therapies for ED in therapeutic non-responders to PDE51 therapy. Journal articles spanning the time period between January 1990 and December 2010 were reviewed. Criteria included all pertinent review articles, randomized controlled trials, cohort studies and retrospective analyses. References from retrieved articles were also manually scanned for additional relevant publications. Published combination therapies include PDE51 plus vacuum erectile device （VED）, intraurethral medication, intracavernosal injection （ICI）, androgen supplement, a-blocker or miscellaneous combinations. Based on this review, some of these combination treatments appeared to be quite effective in preliminary testing. Caution must be advised, however, as the majority of combination therapy articles in the last decade have numerous limitations including study biases and small subject size. Regardless of limitations, present combination therapy research provides a solid foundation for future studies in complex ED management.

Management of erectile dysfunction in hypertension:Tips and tricks

Arterial hypertension is a major risk factor for cardiovascular disease and affects approximately one third of the adult population worldwide. The vascular origin of erectile dysfunction is now widely accepted in the vast majority of cases. Erectile dysfunction is frequently encountered in patients with arterial hypertension and greatly affects their quality of life of hypertensive patients and their sexual partners. Therefore, the management of erectile dysfunction in hypertensive patients is of paramount importance. Unfortunately, erectile dysfunction remains under-reported, under-recognized, and under-treated in hypertensive patients, mainly due to the lack of familiarity with this clinical entity by treating physicians. This review aims to discuss the more frequent problems in the management of hypertensive patients with erectile dysfunction and propose ways to overcome these problems in everyday clinical practice.

Unsatisfactory outcomes of prolonged ischemic priapism without early surgical^shunts： our clinical experience and a review of the literature

Ischemic priapism is a rare occurrence which can cause severe erectile dysfunction （ED） without timely treatment. This retrospective study reports our experience in treating prolonged ischemic priapism and proposes our further considerations. In this paper, a total of nine patients with prolonged ischemic priapism underwent one to three types of surgical shunts, including nine Winter shunts, two AI-Ghorab shunts and one Grayhack shunt. During the follow-up visit （after a mean of 21.11 months）, all patients＇ postoperative characters were recorded, except one patient lost for death. Six postoperative patients accepted a 25-mg oral administration of sildenafil citrate. The erectile function of the patients was evaluated by their postoperative 5-item version of International Index of Erectile Function Questionnaire （IIEF-5）, which were later compared with their premorbid scores. All patients had complete resolutions, and none relapsed. The resolution rate was 100%. Seven patients were resolved with Winter shunts, one with an AI-Ghorab shunt and one with a Grayhack shunt. The mean hospital stay was 8.22 days. There was only one urethral fistula, and the incidence of postoperative ED was 66.67%. Four patients with more than a 72-h duration of priapism had no response to the long-term phosphodiesterase type 5 （PDE-5） inhibitor treatment. These results suggest that surgical shunts are an efficient approach to make the penis flaccid after prolonged priapism. However, the severe ED caused by prolonged duration is irreversible, and long-term PDE-5 inhibitor treatments are ineffective. Thus, we recommend early penile prosthesis surgeries for these patients.

Update summarising the conclusions of the international consultation on male lower urinary tract symptoms

The International Consultation on Urological Disease have recently published comprehensive conclusions, based on evidence reviewed by eight committees, on aspects of male lower urinary tract symptoms(LUTS). In this review, we summarise the conclusions from fourof the committees, namely, the evidence regarding the epidemiology of male LUTS, patient assessment, nocturia and medical management. It is indisputable that with an expanding and ageing global population the prevalence of male LUTS is likely to increase. Therefore symptom prevention and preservation of quality of life(Qo L) feature highly in the guidelines. There are now a number of different medical options, proven to lead to significant improvements in symptom scores, flow rate and Qo L available to men with LUTS. Metaanalyses have shown the benefits for alpha blockers, antimuscarinics, 5-α reductase and phosphodiesterase-5 inhibitors. High level evidence also exists for combinations of all of the above with alpha blockers and so men with concomitant storage symptoms, prostate volume > 30 mL, PSA > 1.4 or erectile dysfunction may be considered for combination treatment of an alpha blocker with an antimuscarinic, 5-α reductase inhibitor or phosphodiesterase-5 inhibitor respectively. In an era of personalised medicine, appropriate patient selection is likely to provide the key to the most effective clinical management strategy.

Erectile dysfunction in chronic kidney disease:From pathophysiology to management

Chronic kidney disease(CKD) is encountered in millions of people worldwide,with continuously rising incidence during the past decades,affecting their quality of life despite the increase of life expectancy in these patients.Disturbance of sexual function is common among men with CKD,as both conditions share common pathophysiological causes,such as vascular or hormonal abnormalities and are both affected by similar coexisting comorbid conditions such as cardiovascular disease,hypertension and diabetes mellitus.The estimated prevalence of erectile dysfunction reaches 70% in end stage renal disease patients.Nevertheless,sexual dysfunction remains under-recognized and under-treated in a high proportion of these patients,a fact which should raise awareness among clinicians.A multifactorial approach in management and treatment is undoubtedly required in order to improve patients' quality of life and cardiovascular outcomes.

Headaches and Erectile Dysfunction Medications at UTH-Kara (Togo)

Introduction: Headaches are a common symptom affecting individuals worldwide, including in the tropical zone, and have been extensively studied in Togo. Phosphodiesterase-5 inhibitors, commonly prescribed for erectile dysfunction, are known to induce headaches, yet there is a lack of research on this topic in sub-Saharan Africa and Togo. Methods: A cross-sectional study conducted from February 1st to June 30th, 2023, including adult patients seeking erectile dysfunction treatment and prescribed PDE-5 inhibitors. Results: A total of 28 patients were included in the study, with an average age of 34.46 ± 7.5 years. The age group of 30 - 39 years was the most represented (53.57%). Among the participants, 67.86% had a history of chronic headaches. During the intake of PDE-5 inhibitors, 71.43% reported the onset of headaches. Among the 19 patients with chronic headaches, 68.42% developed headaches following PDE-5 inhibitor use (RR = 0.88, 95% CI: 0.55 - 1.40, p = 0.484). The characteristics of the induced headaches were similar to the patients’ pre-existing headaches in 78.95% of cases. Additional symptoms included nasal congestion (36.84%) and an urge to have a bowel movement (26.32%). Sildenafil (75.00%) and Tadalafil (25.00%) were the primarily prescribed PDE-5 inhibitors. The incidence of headaches did not significantly differ between the two groups (RR = 1.33, 95% CI: 0.67 - 2.64, p = 0.306). Treatment for the induced headaches involved self-medication with paracetamol (65.00%) and nonsteroidal anti-inflammatory drugs (NSAIDs) (35.00%). Conclusion: Headaches induced by PDE-5 inhibitors are a well-established reality, emphasizing the need for caution and warning in patients with pre-existing headache conditions, while individualized approaches are necessary to address the potential interplay between migraine medications and erectile dysfunction treatments.

Audiovisual Sexual Stimulation and RigiScan Test for the Diagnosis of Erectile Dysfunction

Background： Currently available evaluation criteria lbr penile tumescence and rigidity have been fraught with controversy. In tiffs study, we sought to establish normative Chinese evaluation criteria lbr penile tumescence and rigidity by utilizing audiovisual sexual stimulation and RigiScanTM test （AVSS-Rigiscan test） with the administration of phosphodiesterase-5 inhibitor. Methods： A total of 1169 patients （aged 18-67 years） complained of erectile dysfunction （ED） underwent AVSS-RigiScan test with the administration of phosphodiesterase-5 inhibitor. A total of 1078 patients whose final etiological diagnosis was accurate by means of history, endocrine, vascular, and neurological diagnosis, International Index of Erectile Function 5 questionnaire, and erection hardness score were included in the research. Logistic regression model and receiver operating characteristic curve analysis were performed to determine the cutoffvalue of the RigiScanTM data. Then, the multivariable logistic analysis was used in the selected variables. Results： A normal restllt is defined as one erection with basal rigidity over 60% sustained for at least 8.75 rain, average event rigidity of tip at least 43.5% and base at least 50.5%, average maximum rigidity of tip at least 62.5% and base at least 67.5%, △tumescence （increase of tumescence or maxinaum-mininaum tumescence） of tip at least 1.75 cm and base at least 1.95 cm, total tumescence time at least 29.75 rain, and times of total tumescence at least once. Most importantly, basal rigidity over 60% sustained for at least 8.75 min, average event rigidity of tip at least 43.5%, and base at least 50.5% would be the new normative Chinese evaluation criteria for penile tumescence and rigidity. By multivariable logistic regression analysis, six significant RigiScanTM parameters including times of total tumescence, duration of erectile episodes over 60%, average event rigidity of tip, Atumescence of tip, average event rigidity of base, and Atunaescence of base contribute to the risk model of ED. In logistic regression equation, predict value P 〈 0.303 was considered as psychogenic ED. The sensitivity and specificity of the AVSS-RigiScan test with the administration ofphosphodiesterase-5 inhibitor in discriminating psychogenic from organic ED was 87.7% and 93.4%,, respectively. Conclusions： This study suggests that AVSS-RigiScan test with oral phosphodiesterase-5 inhibitors can objectively assess penile tumescence and rigidity and seems to be a better modality in differentiating psychogenic from organic ED. ttowever, due to the limited sample size, bias cannot be totally excluded.