Avanafil 100mg tablets

PurposeErectile 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 methodsAn 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.ResultsThe pooled estimates demonstrated that changes in IIEF-EF function (MD=4.39, 95% CI [3.41, 5.37], pConclusionThis 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.

Abstract licence: CC BY-NC 3.0

IntroductionErectile dysfunction (ED) is a multifactorial condition with psychological, vascular, hormonal, neurological, and systemic risk factors. Four phosphodiesterase-5 inhibitors (PDE5is), sildenafil, tadalafil, vardenafil, and avanafil, have been approved by the United States Food and Drug Administration and the European Medicines Agency for the management of ED.ObjectivesWhile several meta-analyses have assessed the efficacy of PDE5is in the management of ED, none have focused on dose-specific outcomes. Hence, the study was conducted to compare the dose-dependent efficacy and safety of four FDA/EMA-approved PDE5is in the treatment of ED using on-demand dosages.MethodsA comprehensive literature search identified randomized, double-blind, placebo-controlled trials. Only on-demand doses of PDE5is were included in the network meta-analysis (NMA), which focused on primary outcomes such as the proportion of participants achieving satisfactory erectile function (EF), defined as an International Index of Erectile Function (IIEF) domain score > 26. A threshold analysis was conducted to evaluate the robustness of treatment recommendations derived from the NMA.ResultsA total of 83 studies with 6029 participants (treatment group: 3457 participants; placebo group: 2572 participants) were included. This dose-response network meta-analysis highlighted better efficacy with sildenafil (sildenafil 100 mg: odds ratio [OR] 9.06, sildenafil 50 mg: OR 7.90) in improving EF compared to that with placebo, followed by tadalafil (tadalafil 20 mg: OR 7.13, tadalafil 10 mg: OR 3.14), vardenafil (vardenafil 10 mg: OR 7.78), and avanafil (avanafil 200 mg: OR 3.42, avanafil 100 mg: OR 1.75). Threshold analysis showed a statistically significant improvement in ED with sildenafil 100 mg [OR 2.20; 95% confidence interval (CI) 1.78-2.63] and 50 mg (OR 2.10; 95% CI 1.69-2.50) compared to placebo. This indicated the robustness of the results, with moderate variations unlikely to alter their comparative ranking within the NMA. The odds of treatment-related adverse events were highest for vardenafil, followed by avanafil and sildenafil, and lowest for tadalafil compared to placebo. However, in some instances, the wide CI showed higher variability and potential uncertainty in effect estimates.ConclusionPDE5is are highly effective, with sildenafil showing a significantly greater efficacy compared with the other PDE5is.

Abstract licence: CC BY-NC

Purpose: Male infertility is a worldwide problem with limitations in the treatment. Phosphodiesterase-5 inhibitors (PDE5is) is the first choice for the treatment of erectile dysfunction, more and more studies show that it has a certain effect on male infertility in recent years. But there was currently no high quality of systematic review to evaluate the effects of PDE5is on semen quality. Materials and Methods: We retrieved the electronic databases of MEDLINE, PubMed, Web of Science, EMBASE, etc. Related randomized controlled trials (RCTs) were collected and selected up to May 20, 2020. We have searched literature with terms “male infertility”, “phosphodiesterase-5 inhibitors”, “PDE5i”, “Tadalafil”, “Sildenafil”, “Vardenafil”, “Udenafil”, “Avanafil”, “semen”, and “sperm”. Mean value and its standard deviation were used to perform quantitative analysis. All statistical analyses were conducted by RevMan 5.3 and Stata software. Results: There were a total of 1,121 participants in the nine included studies. There was a statistically significant improvement treated with PDE5is compared with sham therapy, which including sperm concentration (mean difference [MD]=1.96, 95% confidence interval [CI]=1.70–2.21, p<0.001; MD=3.22, 95% CI=1.96–4.48, p<0.001), straight progressive motility (%) Grade A (MD=3.71, 95% CI=2.21–5.20, p<0.001), sperm motility (MD=8.09, 95% CI=7.83–8.36, p<0.001), morphologically normal spermatozoa (%) (MD=0.67, 95% CI=0.20–1.15, p=0.005; MD=1.27, 95% CI=0.02–2.52, p=0.05), sperm abnormalities (%) (MD=-0.64, 95% CI=-0.81–-0.47, p<0.001), and progressive motile sperm (MD=5.34, 95% CI=3.87–6.81, p<0.001). Conclusions: In this meta-analysis of nine RCTs, treatment with PDE5is could improve some indicators of male sperm.

Abstract licence: CC BY-NC

ObjectiveTo compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction.MethodsIt was a prospective, randomized, double‐blind, two‐arm, active‐controlled, parallel, multicenter, non‐inferiority clinical study carried out in patients with erectile dysfunction for at least 3 months and International Index of Erectile Function – Erectile Function domain score of <26 at enrolment.ResultsA total of 220 patients were randomized to receive either avanafil tablets 100 mg or sildenafil tablets 50 mg in 1:1 ratio. After 4 weeks of treatment, 40.0% of patients in the avanafil group and 45.6% of patients in the sildenafil group required dose escalation to a high dose (avanafil 200 mg/sildenafil 100 mg). The difference in the mean change of International Index of Erectile Function – Erectile Function score from baseline in the two groups increased from week 4 (1.1, 95% confidence interval −0.2 to 2.5) to week 8 (1.4, 95% confidence interval 0.1–2.7) and week 12 (2.1, 95% confidence interval 0.8–3.5), showing non‐inferiority at week 4, and superiority at week 8 and week 12. Avanafil showed a faster onset of action as shown by a significantly better response to modified Sexual Encounter Profile 1 in the avanafil group (84.8%) as compared with that in the sildenafil group (28.2%; P < 0.001). Both avanafil and sildenafil were well tolerated by all the patients in the study; the most common adverse event reported during the study was headache in both the groups.ConclusionAvanafil is superior to sildenafil in improving the International Index of Erectile Function – Erectile Function domain score at the end of 12 weeks of treatment with the added advantage of faster onset of action.

Abstract licence: CC BY-NC-ND 4.0

Abstract Introduction The incidence of erectile dysfunction (ED) increases with age in mainland China and phosphodiesterase 5 inhibitors (PDE5i) are the major drugs used for its treatment. Aim To determine the efficacy and safety of Chinese developed avanafil as therapy for ED in China. Methods This phase III trial was carried out in 7 medical centers in China. Eligible subjects suffering from ED were allocated randomly into 3 groups (ratio 1:1:1) and orally received a placebo, 100 or 200 mg avanafil for a total of 12 weeks. Main Outcome Measures The primary endpoint was changes in erectile function (EF) domain scores according to the International Index of EF (IIEF) questionnaire from baseline to week 12 of therapy. Secondary endpoints assessments were changes in the response rates of SEP, Q2 and Q3; changes in IIEF other domain scores. Safety evaluation monitored treatment-emergent adverse events (TEAEs), serious TEAEs, laboratory test results, vital signs and electrocardiographs. Results Of 218 randomized ED subjects, 182 (83.5%) completed the study. After 12-week therapy, alterations from baseline of the mean IIEF-EF domain scores in the 100 mg and 200 mg groups were greater than for the placebo (all P < .05) group. The changes in mean SEP Q2 response rates from baseline to week 12 in the placebo, 100 mg and 200 mg groups were 5.4%, 22.3% and 22.1%, and SEP Q3 response rate were 22.7%, 42.6% and 38.1%, respectively. Avanafil treatment (regardless of dose) improved EF vs placebo for most of other secondary efficacy endpoints studied (all P < .05). No differences were detected in efficacy endpoints between the 100 and 200 mg dosage groups (all P > .05) or in the incidence of TEAEs and drug-related TEAEs among the 3 groups (all P > .05). Conclusion Avanafil (100 or 200 mg) was effective and generally well tolerated in Chinese subjects with ED.

Abstract licence: CC BY-NC-ND 4.0