Comparative Effectiveness of Dalerpen vs. Branded and Other Generic Tadalafil: The “Shift Study”
Background: Phosphodiesterase type 5 inhibitors (PDE5i), particularly tadalafil and sildenafil, are the first-line therapies for erectile dysfunction (ED). After the patent expiration of branded tadalafil in 2017, generic formulations became available. Despite equivalent efficacy, skepticism persists regarding the effectiveness and safety of generics. The SHIFT study aimed to evaluate the non-inferiority of a generic tadalafil (Dalerpen) compared with branded and other generic tadalafil in terms of clinical efficacy and patient satisfaction. Methods: A prospective, multicenter study was conducted involving 247 patients treated with tadalafil (either 5 mg or 20 mg) for ED. Patients switched from branded or other generic tadalafil to Dalerpen. Baseline and follow-up assessments included the International Index of Erectile Function—Erectile Function Domain (IIEF-EF) (primary endpoint), Sexual Encounter Profile (SEP-2 and SEP-3), and International Prostatic Symptom Score (IPSS). A one-month follow-up was performed. Results: A total of 247 patients were included in the final analysis. After switching to Dalerpen, significant improvements were observed in both IIEF-EF (18.8 ± 5.6 vs. 16.7 ± 5.4, p < 0.001) and IPSS scores (10.4 ± 6.7 vs. 11.2 ± 6.3, p < 0.001), though the minimal clinically important difference (MCID) was not reached. SEP-3 scores also significantly increased (3 ± 1.2 vs. 2 ± 1.1, p < 0.001). Multivariate analysis identified baseline IIEF, IPSS scores, and post-treatment IPSS as predictors of IIEF-EF improvement (p < 0.001). Switching to Dalerpen was an independent predictor of both IIEF-EF and IPSS improvement. No new adverse events were reported. Conclusions: The SHIFT study demonstrates that Dalerpen is non-inferior to branded tadalafil in terms of clinical efficacy, offering a reliable and cost-effective therapeutic option. Educating patients on bioequivalence and addressing concerns regarding generic drugs are essential to facilitate therapeutic switches.
- Research Article
4
- 10.1007/s00345-020-03128-9
- Feb 21, 2020
- World Journal of Urology
The current results show that lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are co-prevalent conditions. The objective of this study was to determine which LUTS among seven items on the International Prostate Symptom Scores (IPSS) were related to ED in the general population. The Korean Internet Sexuality Survey was performed in 2006 and 2016. We sent emails and surveyed the panelists registered at an Internet survey agency. The inclusion criteria were sexually active men aged between 20 and 69. Data, including the International Index of Erectile Function-5 (IIEF-5) and IPSS scores were extracted from the surveys. Logistic regression analyses were performed to determine the factors related to 'any degree of ED' (IIEF-5 < 22) or 'more than mild ED' (IIEF-5 < 17). The mean age of 1464 men was 39.2 ± 11.4years. The mean total IPSS and IIEF-5 scores were 7.2 ± 6.5 and 20.8 ± 3.3 points, respectively. The IIEF-5 and total IPSS scores showed significant negative relationships (r = - 0.251, p < 0.001). Among the seven IPSS items, IPSS 5 (weak stream, r = - 0.243, p < 0.001) was most strongly correlated with the IIEF-5 scores. On multivariate analysis, IPSS 3 (intermittency, OR 0.160, 95% CI 1.010-1.333, p = 0.035) and IPSS 7 (nocturia, OR 1.238, 95% CI 1.077-1.423, p = 0.003) were significantly related to 'any degree of ED'. 'More than mild ED' was significantly related to IPSS 5 (weak stream, OR 1.267, 95% CI 1.058-1.518, p = 0.010). Every LUTS listed in the IPSS items was negatively correlated with erectile function. Among the seven IPSS items, IPSS 5 (weak stream) was the most related to 'more than mild ED'.
- Research Article
140
- 10.1111/j.1743-6109.2006.00259.x
- Jul 1, 2006
- The Journal of Sexual Medicine
Assessment of the Impact of Sildenafil Citrate on Lower Urinary Tract Symptoms in Men with Erectile Dysfunction
- Abstract
3
- 10.1016/j.ijrobp.2007.07.1487
- Sep 27, 2007
- International Journal of Radiation Oncology*Biology*Physics
Urinary Morbidity Following Cs-131 Brachytherapy for Localized Prostate Cancer
- Research Article
307
- 10.1016/j.eururo.2012.02.033
- Feb 24, 2012
- European Urology
A Systematic Review and Meta-analysis on the Use of Phosphodiesterase 5 Inhibitors Alone or in Combination with α-Blockers for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- Research Article
12
- 10.5527/wjn.v4.i1.138
- Jan 1, 2015
- World Journal of Nephrology
To review the efficacy of phosphodiesterase type 5 inhibitors (PDE5-Is) in lower urinary tract symptoms (LUTS) suggestive of benign prostate hyperplasia (LUTS/BPH). A comprehensive research was conducted to identify all publications relating to benign prostate hyperplasia and treatment with sildenafil, vardenafil and tadalafil. To assess the efficacy, the changes in total international prostate symptom score (IPSS), IPSS subscore including voiding, storage and quality of life (QoL), Benign prostatic hyperplasia Impact Index (BII), maximum urinary flow rate (Qmax) and the International Index of Erectile Function (IIEF) were extracted. A meta-analytical technique was used for the analysis of integrated data from the included studies to evaluate the mean difference in the results. Total IPSS score, IIEF and BII showed a significant improvement in trials in which LUTS/BPH with or without erectile dysfunction (ED) were compared with the placebo. For LUTS/BPH, the mean differences of total IPSS score, IIEF and BII are -2.17, 4.88 and -0.43, P < 0.00001, respectively. For LUTS/BPH with comorbid ED, the mean difference are -1.97, 4.54 and -0.52, P < 0.00001, respectively. PDE5-Is appear to improve IPSS storage, voiding and QoL subscore (mean difference = -0.71, -1.23 and -0.33, P < 0.00001, respectively). Although four doses of tadalafil (2.5, 5, 10 and 20 mg) failed to reach significance in Qmax (mean difference = 0.22, P = 0.10), the 5 mg dose of tadalafil significantly improved the Qmax (mean difference = 0.33, P = 0.03). PED5-Is demonstrated efficacy for improving LUTS in BPH patients with or without ED and could be considered to be the first line treatment for LUTS/BPH.
- Research Article
120
- 10.1111/j.1743-6109.2008.01109.x
- Feb 1, 2009
- The Journal of Sexual Medicine
Efficacy and Safety of Combined Oral Therapy with Tadalafil and Alfuzosin: An Integrated Approach to the Management of Patients with Lower Urinary Tract Symptoms and Erectile Dysfunction. Preliminary Report
- Research Article
3
- 10.1111/j.1442-2042.2010.02561.x
- Jul 22, 2010
- International Journal of Urology
Preface Currently, there are many wellestablished therapeutic options for early prostate cancer, and therefore, it is difficult for both urologists and patients to choose the optimal treatment. It is essential for urologists to counsel their patients according to reliable information about the advantages and disadvantages of each therapeutic option. We picked the topic for this issue, “Characteristics and management of erectile dysfunction after various treatments for prostate cancer,” because erectile dysfunction (ED) is one of the most frequent adverse events encountered in the management of prostate cancer. We invited six specialists to review each therapeutic option: radical prostatectomy, laparoscopic radical prostatectomy, robot-assisted laparoscopic radical prostatectomy, external beam radiotherapy, brachytherapy, and androgen deprivation therapy (ADT). Among these modalities, surgical interventions tend to induce a quick drop in erectile function with slow postoperative recovery. Early postoperative rehabilitation has been introduced, aiming at the early recovery of ED. On the contrary, radiation therapy tends to maintain the patient’s erectile function for a while after treatment but it gradually decreases. ADT may compromise not only the erectile function but also the libido level, and may result in significant deterioration of the patient’s quality of life. We hope these reviews will help urologists to counsel their patients with regards to decision-making in the management of early prostate cancer.
- Research Article
20
- 10.1038/aja.2010.177
- May 23, 2011
- Asian Journal of Andrology
This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction (ED) and lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH/LUTS). The trial was conducted in hospitals in Beijing, Shanghai, Changsha, Wuhan and Guangzhou, five major cities in China. A total of 250 patients diagnosed with ED and BPH/LUTS aged 50-75 years, and who had International Index of Erection Function-5 (IIEF-5) scores ≤21 and International Prostate Symptom Score (IPSS) ≥10 points, were enrolled and randomly divided into Group A (168 cases; doxazosin GITS 4 mg once daily plus sildenafil 25-100 mg on demand) and Group B (82 cases; sildenafil 25-100 mg on demand). Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life (QoL) questionnaire, and adverse effects were evaluated during the treatment period. There were no statistically significant differences in mean age, and IIEF-5, IPSS and QoL scores pre-treatment between the two groups. After treatment, IIEF-5, IPSS and QoL scores were significantly improved in Group A, while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment. There were no significant differences in side effects between the two groups. The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy.
- Abstract
- 10.1016/j.ijrobp.2012.07.1742
- Oct 25, 2012
- International Journal of Radiation Oncology*Biology*Physics
The Impact of Cystoscopy on the Quality of Life in Men Undergoing Permanent Prostate Brachytherapy
- Research Article
7
- 10.1007/s11255-013-0474-3
- May 24, 2013
- International Urology and Nephrology
Although different factors may affect prostate-specific antigen (PSA) reduction after transurethral resection of prostate, an approximate 70 % decrease from baseline is expected. We hereby undertook a prospective study to analyze changes in serum PSA (S-PSA) after transurethral resection of the prostate (TURP) and its correlation with the residual prostatic weight and clinical symptom score improvement. Seventy patients who underwent TURP for bladder outlet obstruction were included in the study. Patient's evaluation included history, International Prostate Symptom Score (IPSS), S-PSA, Qmax, post-void residual urine and prostate size. On follow-up, trans-rectal ultrasonography, S-PSA and IPSS score were calculated. Patients were analyzed in three groups based on the amount of tissue resected: less than 40, 40-60 and more than 60 % tissue resected. Preoperative prostate size, IPSS, Qmax and S-PSA were 62.56 ml, 23.84, 11.68 ml/sec and 3.3 ng/ml. There was a significant decrease in the IPSS score, prostate size and S-PSA levels after TURP in all the three groups. There was a significant positive correlation of the amount of tissue resected with change in S-PSA levels, change in IPSS score and postoperative IPSS score. Reduction in IPSS score significantly correlated with patient's satisfaction. The amount of tissue resected in TURP has a direct bearing on the S-PSA levels, change in symptom score and residual prostate volume. It is the percentage change in IPSS score and not the absolute value of IPSS, which has a direct bearing with the patient satisfaction and with the amount of tissue resected. Percentage fall in S-PSA by 70 % was found to be predictor of more than 60 % resection.
- Abstract
- 10.1016/j.jsxm.2022.03.370
- May 1, 2022
- The Journal of Sexual Medicine
The brachial-ankle pulse wave velocity is a predictive factor for erectile dysfunction in patients with benign prostate hyperplasia
- Research Article
8
- 10.1016/j.jcjd.2013.01.041
- Mar 26, 2013
- Canadian Journal of Diabetes
Erectile Dysfunction
- Research Article
16
- 10.1007/s11255-006-9153-y
- Jan 16, 2007
- International Urology and Nephrology
To investigate the relationship among the International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS), and Aging Males' Symptoms (AMS) scale scores in various age groups of males. A total of 307 male patients enrolled in the study. Mean age was 52.3 (range 21-77) years. Group 1 consisted of 51 (< or =39 years), Group 2 consisted of 160 (40-59 years), and Group 3 consisted of 96 (> or =60 years) patients. First five and 15th questions of the IIEF, IPSS, and AMS scale were replied by all the patients. The patients were assessed based on the IIEF for erectile dysfunction (ED), IPSS for lower urinary tract symptoms (LUTS), and AMS scale for Symptomatic Late-Onset Hypogonadism (SLOH). ED, LUTS, and SLOH symptoms were detected in 236 (76.8%), 162 (52.8%), and 184 (59.9%) patients. Except for total AMS scores, IIEF and IPSS scores were significantly different among the groups (p (AMS) = 0.320, p (IIEF) = 0.000, p (IPSS) = 0.000). In the comparisons of the IIEF scores between the each group, significant differences were observed (p (Group1-Group2) = 0.000, p (Group1-Group3) = 0.000, p (Group2-Group3) = 0.000). Nevertheless, IPSS score was significantly lower in the patients with age < or =39 years than the other age groups (p = 0.000). In the present study, ED ratio and LUTS severity significantly increased in older men. We did not find significant relationship between aging and SLOH symptoms. In the light of our results, LUTS seems to be an important risk factor on erectile function.
- Research Article
7
- 10.1080/21681805.2016.1250810
- Nov 14, 2016
- Scandinavian Journal of Urology
Objective: This study aimed to assess the role of tadalafil, a phosphodiesterase type 5 inhibitor (PDE5-I), in recovery of lower urinary tract symptoms (LUTS) after robot-assisted radical prostatectomy (RARP).Materials and methods: All patients treated with RARP between October 2010 and August 2013 were enrolled in this retrospective study on prospectively collected data. Patients were retrospectively divided into groups according to postoperative treatment: patients taking tadalafil twice weekly from 1 month to 6 months after RARP, and patients not taking tadalafil. The International Prostate Symptom Score (IPSS), the Overactive Bladder Symptom Score (OABSS) and urinary continence (UC) were assessed preoperatively (2 days before RARP) and at 1, 3, 6, 9 and 12 months after RARP.Results: There was no difference in the overall IPSS score between the groups. At 6 and 9 months, the IPSS storage symptom scores were significantly lower in patients taking tadalafil than in patients not taking tadalafil. In patients with overactive bladder (OAB) before RARP (n = 22), no differences in the total scores of OABSS were seen between patients taking tadalafil and patients not taking tadalafil. On the other hand, in non-OAB patients before RARP (n = 68), at 3, 6 and 9 months, the total scores of OABSS were significantly lower in patients taking tadalafil than in patients not taking tadalafil. No differences in UC rates after surgery were seen between the groups.Conclusion: Postoperative tadalafil treatment may be temporarily effective for the recovery of the IPSS storage symptom scores and OABSS.
- Research Article
282
- 10.1016/j.eururo.2008.01.075
- Feb 4, 2008
- European Urology
A Randomised, Placebo-Controlled Study to Assess the Efficacy of Twice-Daily Vardenafil in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
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