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Accordingly, 135 patients diagnosed with ED were needed to be enrolled and were randomized by simple numbering technique. Any married male patient ≥ 25 years old with regular heterosexual intercourse, 2–3 times/week in the previous 6 months prior to enrollment in the study presenting with mild-to-moderate ED was included. Patients with diabetes, hypertension, metabolic syndrome, malabsorption syndrome, ischemic heart disease, atherosclerosis, vasculitis, major psychological problems, or Peyronie’s disease were excluded from the current study. Those with post-priapism ED, a history of recent penile and/or urethral surgery or trauma, as well as uncorrected hypogonadism and contraindication to PDE5Is were excluded. Finally, patients who tried PDEIs and experienced side effects were also excluded from the study.

Author statement

All patients who fulfilled the inclusion criteria were subjected to the following: medical and surgical histories were obtained from the participants. Furthermore, general and local examinations were done. All subjects answered a copy of the validated Arabic version of IIEF-5 (ArIIEF-5) separately at baseline and after 1 month [16]. Morning serum testosterone and prolactin (before 11 AM), total PSA (only in groups including men above 40 Y), glycosylated hemoglobin, random blood sugar, lipid profile were analyzed, and complete urine analysis was performed. Patients were equally divided into 3 groups according to age where each group included 45 patients. The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Shamloul R, Ghanem H (2013) Erectile dysfunction.

  • Cialis oral strips are a prescription medication in many countries.
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Salama MN, Eid AA, Hatem A, Swidan AK (2020) Prevalence of erectile dysfunction in Egyptian males with metabolic syndrome.

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Zedan H, Hareadei AA, Abdel Sayed AA, Abdel Maguid EM (2010) Cigarette smoking, hypertension and diabetes mellitus as risk factors for erectile dysfunction in upper Egypt. EMHJ-East Mediterr Health J 16(3):281–285 Zedan H, Hareadei AA, cost of cialis 40mg Abdel Sayed AA, Abdel Maguid EM (2010) Cigarette smoking, hypertension and diabetes mellitus as risk factors for erectile dysfunction in upper Egypt.

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Furthermore, the same aforementioned study generic cialis 5 mg conducted by Park et al. (2018) [18] reported no serious adverse events in the study arms, either in oral tablet tadalafil or ODF tadalafil [18], which could also be seen as contradictory to our findings. (2017) [19] revealed that sildenafil ODF exhibited comparable levels of safety and efficacy to the conventional film-coated tablet [19]. However, the aforementioned study revealed that the ODF formulation elicited greater overall satisfaction among the patients [19], which could be seen as similar to our findings. In the same context, the prevalence of headache in ODF decreased, and the duration and intensity of flushing and nasal congestion were lower in a study conducted by De Toni et al.

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(2018) [20] that could be seen in agreement with the current findings. Although both formulations demonstrated comparable efficacy in the current study, yet, the ODF tadalafil 5 mg formulation demonstrated lesser side effects as well as better tolerability. Henceforth, the findings of the current study could be postulated that a rapid ODF pre-gastric absorption resulted in a faster onset of action with subsequent enhanced bioavailability and therapeutic outcomes as well as reduced dosing and adverse effects [21]. Furthermore, the safety profiles could be enhanced by lowering toxic metabolites that resulted from hepatic metabolism since the drug was mostly absorbed from buccal mucosa [14]. The main limitation of the current study was the relatively small sample size per group. EMHJ-East Mediterr Health J 16(3):281–285 Saad HM, GamalEl Din SF, Elbokl OM, Adel A (2022) Predictive factors of erectile dysfunction in Egyptian individuals after contracting COVID-19: a prospective case–control study. Saad HM, GamalEl Din SF, Elbokl OM, Adel A (2022) Predictive factors of erectile dysfunction in Egyptian individuals after contracting COVID-19: a prospective case–control study.

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Kamal EE, Zedan HM, Ismail AA, Hussein K, Zakaria M, Badran AY (2021) Erectile dysfunction in Egyptian patients with chronic obstructive pulmonary disease. Egypt J Dermatol Venerol 41(1):38 Kamal EE, Zedan HM, Ismail AA, Hussein K, Zakaria M, Badran AY (2021) Erectile dysfunction in Egyptian patients with chronic obstructive pulmonary disease.

Frequently Asked Questions

Group A was > 25 to < 40 years, group B was 40 to 55 years, and group C was > 55 years. Within each group, 15 patients received oral tadalafil 5 mg tablet and 15 patients received ODF formulations of tadalafil 5 mg as well as 15 patients received an ODF placebo (hydroxy profile methyl cellulose polymer and starch) for 1 month. Moreover, the efficacy of different forms of tadalafil was assessed by responding affirmatively to the following questions: “Are you satisfied with the effect of treatment on your erections?” and “If yes, has treatment improved your ability to engage in sexual activity?’’ [17]. Finally, all patients were evaluated for the presence of adverse effects such as headache, dizziness, palpitation, gastrointestinal upset, and muscle or back pain on a scale from 1 to 10. Data analysis was conducted using SPSS version 22nd; Qualitative data were presented by number and percentage, and quantitative data were presented by mean, standard deviation, minimum, and maximum.

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The Pearson Chi2 test was used to compare categorical variables between groups. Quantitative variables were presented in mean, standard deviation, minimum, and maximum. The Kruskal–Wallis test was used to compare quantitative variables between study groups. Socio-demographic characteristics are presented in Table 1. Groups A, B, and C showed a statistically significant improvement in the ArIIEF-5 scores after treatment with tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to ODF placebo (p < 0.001) (Table 2, Fig. Egypt J Dermatol Venerol 41(1):38 McMahon CG (2019) Current diagnosis and management of erectile dysfunction.

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Med J Aust 210(10):469–476 McMahon CG (2019) Current diagnosis and management of erectile dysfunction.

  • Always consult a healthcare provider before starting Cialis oral strips.
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Med J Aust 210(10):469–476 Brock GB, McMahon CG, Chen KK et al (2002) Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol 168(4 Pt 1):1332–1336 Brock GB, McMahon CG, Chen KK et al (2002) Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses.

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Also, the inability to measure the serum levels of both formulations to evaluate the pharmacokinetic properties can be added as a limitation. Finally, exclusion of patients with serious medical comorbidities which might have interfered with the effectiveness of each drug formulation can be regarded as another limitation. However, it should be emphasized that we did not need to monitor any potential side effects from both formulations of tadalafil 5 mg administration especially cardiovascular complications since patients with severe ED and associated serious comorbidities were excluded from the study as mentioned in the previous limitation. Furthermore, it is worth mentioning that proper diagnosis and treatment of ED as well as its risk factors optimize control and management of any associated comorbidity with ED [22]. Eventually, large prospective studies should be conducted to assess the prevalence and severity of adverse events of tadalafil tablets compared to ODF and to assess the difference of tadalafil tablets among patients with organic ED due to medical comorbidities, metabolic and malabsorption syndromes. J Urol 168(4 Pt 1):1332–1336 Coward RM, Carson CC (2008) Tadalafil in the treatment of erectile dysfunction. Ther Clin Risk Manag 4(6):1315–1330 Coward RM, Carson CC (2008) Tadalafil in the treatment of erectile dysfunction.

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The efficacy of ODF tadalafil 5 mg and tadalafil 5 mg tablet was markedly higher compared to placebo (p < 0.001). Improvement in both formulations was reported in all patients compared liquid cialis buy to placebo across all groups. Compliance was significantly higher among patients on ODF tadalafil 5 mg compared to tadalafil 5 mg tablet in groups B and C, respectively (p < 0.001) (Table 2). Regarding adverse effects, muscle and back pains were significantly higher among patients receiving tadalafil 5 mg tablet compared to other formulations in group A (p = 0.040) (Table 2). While headache, gastrointestinal (GIT) upset, and muscle and back pains were significantly reported among patients receiving tadalafil 5 mg tablet compared to other formulations in group B (p < 0.001, < 0.001, and 0.012, respectively) (Table 2).

Arch. Ital. Urol. Androl.

Finally, GIT upset was significantly reported among patients receiving tadalafil 5 mg tablet compared to other formulations in group C (p < 0.001) (Table 2). The core findings of the current study were that participants across all groups showed a statistically significant improvement in the ArIIEF-5 scores after tadalafil 5 mg tablet and ODF tadalafil 5 mg compared to ODF placebo. Furthermore, post hoc analysis showed that improvement after tadalafil 5 mg tablet and ODF tadalafil 5 mg was mainly significant compared to placebo, and both formulations were comparable in efficacy. Patients who received ODF tadalafil 5 mg were significantly more compliant to treatment compared to tadalafil 5 mg tablet. (2018) stated that safety and tolerability features of the ODF formulation were found to be comparable to those of the film-coated tablet formulation [18]. Ther Clin Risk Manag 4(6):1315–1330 Hoffmann EM, Breitenbach A, Breitkreutz J (2011) Advances in orodispersible films for drug delivery. Expert Opin Drug Deliv 8(3):299–316 Hoffmann EM, Breitenbach A, Breitkreutz J (2011) Advances in orodispersible films for drug delivery.

Condition Recommended Range Notes
Temperature 15°C to 30°C Keep away from heat and moisture
Humidity Below 70% To prevent deterioration
Light exposure Store in a dark place Protect from sunlight
Shelf life 2 years from manufacturing date Check expiry date