Avanafil 50mg tablets

Purpose: Erectile dysfunction (ED) contributes to a large burden and impairs the quality of life among males. Avanafil appears to be a promising treatment for ED; however, its efficacy and safety profile remain unclear. This study aimed to evaluate the efficacy and safety of avanafil for the treatment of ED. Patients and Methods: An extensive search of PubMed, ScienceDirect, Web of Science, and Embase databases with 11 publications was performed, with outcomes evaluated are International Index of Erectile Function - Erectile Function (IIEF-EF), Sexual Encounter Profile (SEP), and Treatment-Emergent Adverse Events (TEAE). Statistical parameter Mean Difference (MD) and Risk Ratio (RR) with 95% Confidence Interval (CI) were used to measure effect size. Results: The pooled estimates demonstrated that changes in IIEF-EF function (MD=4.39, 95% CI [3.41, 5.37], p<0.001), SEP-2 (RR=3.43, 95% CI [2.79, 4.22], p<0.001), SEP-3 (RR=2.30, 95% CI [2.01, 2.62], p<0.001), and TEAE (RR=1.49, 95% CI [1.12, 1.96], p=0.005) were significantly higher in the avanafil group than in the placebo group. Moreover, 200 mg avanafil was superior to that mg 100 mg-avanafil, indicated by the IIEF-EF score (MD=-1.15, 95% CI [-1.40, -0.89], p<0.001). In contrary, there were no significant differences in SEP-2 (RR=0.90, 95% CI [0.75, 1.08], p=0.26), SEP-3 (RR=0.92, 95% CI [0.81, 1.05], p=0.21) and TEAE (RR=1.00, 95% CI [0.87, 1.15], p=0.99) for both 100 mg and 200 mg doses. Conclusion: This review highlights the potential use of this drug in ED treatment. Further large-scale Randomized Controlled Trials investigations involving various racial groups are required to confirm these findings.

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<h2>Summary</h2><h3>Background</h3> Phosphodiesterase 5 (PDE5) inhibitors, owing to their mechanism of action, have been gaining recognition as a potential case of drug repurposing and combination therapy for diabetes treatment. We aimed to examine the effect of long and short half-life PDE5 inhibitors have on Haemoglobin A1c (HbA1c) levels. <h3>Methods</h3> A systematic review and meta-analysis was conducted of randomised controlled trials (RCTs) in people with elevated HbA1c (>6%) to assess mean difference in HbA1c levels from baseline versus controls after any PDE5 inhibitor intervention of ≥4 weeks, excluding multiple interventions. Cochrane CENTRAL, PMC Medline, ClinicalTrials.gov, and WHO ICTRP were searched without language restrictions up to September 30, 2024. Summary data from published data were extracted. PRISMA and Cochrane guidelines used to extract and assess data using a random-effects meta-analysis. This study is registered with the Research Registry, reviewregistry1733. <h3>Findings</h3> Among 1096 studies identified, in analysis of 13 studies with 1083 baseline patients, long half-life PDE5 inhibitors (tadalafil, PF-00489791) had decreases in HbA1c while short half-life PDE5 inhibitors (sildenafil, avanafil) had no change. Five (38.5%) studies had a low risk of bias, and eight (61.5%) had some concerns. Long half-life inhibitors had significant mean decrease of −0.40% ([−0.66, −0.14], p = 0.002, I² = 82%, 7.70% baseline HbA1c). Short half-life inhibitors had insignificant mean difference of +0.08% ([−0.16, 0.33], p = 0.51, I² = 40%, 7.73% baseline HbA1c). In ≥8-week trials with participants with type 2 diabetes (T2D) and mean HbA1c ≥ 6.5%, long half-life inhibitors had significant mean decrease of −0.50% ([−0.83, −0.17], I² = 88%, p = 0.003); short half-life inhibitors had significant mean increase of +0.36% ([0.03, 0.68], I² = 3%, p = 0.03). <h3>Interpretation</h3> At the well-controlled HbA1c of the participants, previous literature shows current diabetes treatments have similar HbA1c decreases, so the HbA1c mean difference of long half-life PDE5 inhibitors may indeed be clinically relevant. This suggests future investigation into PDE5 inhibitors as part of combination therapy or as therapy for high HbA1c individuals is needed, especially because of variable risk of biases, homogeneity, and sample sizes in our study. <h3>Funding</h3> None.

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BACKGROUND: Phosphodiesterase type-5 inhibitors (PDE5is) are used for the treatment of erectile dysfunction (ED) and have potential cardioprotective effects. The impacts of PDE5is on cardiovascular parameters, which may be associated with the occurrence and progression of subclinical cardiovascular diseases, remain uncertain. In this study, we evaluated the effects of PDE5is on vascular parameters. METHODS: Randomized controlled trials (RCTs) that compared the effects of PDE5is and placebo on vascular parameters and were published from 1998 to 2022 were identified from PubMed, Scopus and Web of Science. Mean differences (MDs) with 95% confidence intervals (CIs) were pooled. A sensitivity analysis was conducted to confirm the robustness of the pooled results. The keywords that were searched in the databases are as follows: ((systolic blood pressure) OR (SBP) OR (diastolic blood pressure) OR (DBP) OR (mean arterial pressure) OR (MAP) OR (Pulse Wave Velocity) OR (PWV) OR (intima-media thickness) OR (cIMT) OR (augmentation Index) OR (AI) OR (FMD) OR (flow-mediated dilation) OR (reactive hyperemia index) OR (RHI) OR (Endothelial microparticles) OR (EMP) OR (EPCs) OR (Endothelial Progenitor Cells) OR (PSV) OR (peak systolic velocity)) AND ((PDE5 Inhibitors) OR (PDE5i) OR (Sildenafil) OR (Vardenafil) OR (Tadalafil) OR (Lodenafil) OR (Udenafil) OR (Avanafil)). RESULTS: Sixty-three studies involving 3242 subjects were included. Overall, PDE5is decreased systolic blood pressure (MD: -2.80 mmHg, 95% CI: -4.24, -1.37, P < 0.001), diastolic blood pressure (MD: -1.80 mmHg, 95% CI: -2.37, -1.22, P < 0.001), carotid intima‒media thickness (MD: -0.01 mm, 95% CI: -0.02, -0.01, P < 0.001), and pulse wave velocity (MD: -0.75 cm/s, 95% CI: -1.01, -0.49, P < 0.001). In addition, PDE5is increased the peak systolic velocity (MD: 3.70 cm/s, 95% CI: 3.52, 3.88, P < 0.001), flow-mediated dilation (MD: 2.47%, 95% CI: 1.24, 3.71, P < 0.001), concentration of endothelial progenitor cells (MD: 475.29 cells/mL, 95% CI: 51.38, 899.20, P = 0.03), and concentration of endothelial microparticles (MD: 4.86%, 95% CI: 0.65, 9.07, P = 0.02). However, the effects of PDE5is on the augmentation index, brachial artery diameter and reactive hyperemia index were not statistically significant. CONCLUSION: Compared with the placebo, PDE5is improved vascular parameters, indicating the potential of PDE5is for treating subclinical cardiovascular diseases. Further research is needed to confirm the role of the improvement on vascular parameters by PDE5isin preventing and treating cardiovascular diseases. SYSTEMATIC REVIEW REGISTRATION: The present study protocol was reviewed and approved by PROSPERO. The title is "Associations between PDE5is and vascular parameters: A systematic review and meta-analysis" ( https://www.crd.york.ac.uk/PROSPERO/ ) (Reg. No. CRD42023387924).

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The simultaneous assay of duloxetine hydrochloride (DLX) and avanafil (AVN) in their pure forms, synthetic mixtures, and spiked human plasma was achieved using a novel, eco-friendly, sensitive, and specific HPTLC methodology that have been established and validated. Measuring the levels of co-administered antidepressants and sexual stimulants in biological fluids is an important step for individuals with depression and sexual problems. Separation was performed successfully using pre-coated silica gel 60-F254 as a stationary phase and a mobile phase composed of methanol, acetone, and 33% ammonia (8:2:0.05, v/v/v). Compact bands were produced by the optimized mobile phase that was chosen for development (Rf values were 0.23 and 0.75 for DLX and AVN, individually) after dual-wavelength detection for DLX and AVN at 232 and 253 nm, respectively. The results of polynomial regression analysis were exceptional (r = 0.9999 for both medicines) over concentration ranges of 5-800 and 10-800ng/spot for DLX and AVN, respectively. The quantitation limits were 4.69 and 9.53 ng/spot (0.31 and 0.94 µg/mL), whereas the detection limits were 1.55 and 3.15 ng/spot (0.63 and 1.91 µg/mL), for DLX and AVN, respectively. The International Council for Harmonization (ICH) criteria served as the basis for validating the established approach. Moreover, the proposed technique was evaluated in terms of greenness using four contemporary ecological metrics: The Analytical Greenness software (AGREE), the Green Analytical Procedure Index (GAPI), Eco-Scale, and the National Environmental Method Index (NEMI). Additionally, the Blue Applicability Grade Index (BAGI), a newly developed tool for evaluating the practicality (blueness) of procedures, was taken into consideration when evaluating the sustainability levels of the established approach.

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• A green, sensitive micelle-enhanced spectrofluorimetric method was developed for Avanafil quantification. • SDS significantly enhanced the weak native fluorescence of Avanafil, improving detection sensitivity. • The method is successfully applied to pharmaceutical dosage forms with high accuracy and precision. • Sustainability assessments (Eco-Scale and WAC) confirmed superior greenness and analytical efficiency compared to reported methods. A simple, rapid, eco-friendly, and highly sensitive micelle-enhanced spectrofluorimetric method was developed for the determination of Avanafil (AVA) in pharmaceutical formulations. The method is based on the enhancement of AVA native fluorescence through micelle formation with the anionic surfactant sodium dodecyl sulfate (SDS). The fluorescence intensity significantly increased upon micellar interaction, and measurements were recorded at 385 nm following excitation at 310 nm. The method was carefully optimized with respect to critical parameters, including the pH of the system, the volume of SDS, and the type of diluting solvent to achieve maximum sensitivity and reproducibility. A linear response was obtained over the concentration range of 100–1200 ng mL -1 , with a detection limit of 20 ng mL -1 and a quantitation limit of 70 ng mL -1 . The developed method was applied for the determination of the drug in spiked human plasma samples with an average percent recovery of 98.65%. Therefore, it is suitable for pharmacokinetic studies and therapeutic monitoring of AVA. The proposed method was validated according to ICH guidelines, demonstrating excellent linearity, accuracy, precision, and robustness. Statistical comparison with a previously reported HPLC method revealed no significant differences in accuracy or precision, confirming the reliability of the proposed approach. Additionally, the greenness and whiteness of the method were evaluated using established assessment tools, highlighting its environmental sustainability compared to other reported methods.

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Background: Avanafil is a second-generation phosphodiesterase type 5 (PDE5) inhibitor, and offers a rapid onset of action (15 minutes). Its real-world data, including treatment satisfaction, are still lacking. Aim: The study sought to investigate the treatment outcomes of avanafil and the factors impacting treatment satisfaction in a real-world setting. Methods: Between November 2021 and February 2023, erectile dysfunction (ED) patients prescribed avanafil were consecutively enrolled in this phase 4, open-label, cross-sectional, observational study. At each follow-up visit (4-week intervals), participants completed a questionnaire for assessing the use and treatment-emergent adverse events of avanafil, ED severity, and treatment satisfaction. Outcomes: The outcome measures included the Sexual Health Inventory for Men (SHIM), and Erectile Dysfunction Inventory of Treatment Satisfaction. Results: < .001). Of the patients treated with avanafil, 71.4% (n = 80 of 112) reported a >4-point improvement in the SHIM total score, and 33.1% (n = 37 of 112) reported normal erectile function. The proportion of patients satisfied with avanafil treatment (defined as Erectile Dysfunction Inventory of Treatment Satisfaction index score ≥60) was 87.5%. Several physical factors (younger age, lower waist circumference, and lower level of low-density lipoprotein), and sexual function factors (shorter duration of ED, higher SHIM total score at baseline, PDE5 inhibitor treatment naive, and acquired premature ejaculation) tended to contribute to satisfaction with avanafil treatment. Treatment-emergent adverse events occurred in 41.1% of patients, and all were mild in severity. Clinical Implications: This study identifies the factors associated with treatment satisfaction of avanafil, which may ultimately lead to better treatment outcomes. Strengths and Limitations: This is the first study to provide real-world evidence of avanafil for ED treatment, and validated questionnaires were used to assess erectile function and treatment satisfaction. However, the limitations of this study include single-center observational study design, small sample size, and short-term follow-up. Conclusion: Avanafil is an effective treatment for ED, and satisfaction rate is high in an outpatient setting. The awareness of identified factors related to patient satisfaction may improve treatment outcomes.

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