Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 50 mg, 100 mg, 200 mg) |
Drug Class | Phosphodiesterase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of erectile dysfunction.
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Summary
- Stendra (avanafil) is indicated for the treatment of erectile dysfunction.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Avanafil significantly improved IIEF-EF scores compared to placebo, with a mean difference of 4.39 (95% CI [3.41, 5.37], p<0.001), and 200 mg avanafil was more effective than 100 mg (MD=-1.15, 95% CI [-1.40, -0.89], p<0.001).
- In SEP outcomes, avanafil showed significant improvements compared to placebo, with RR=3.43 (95% CI [2.79, 4.22], p<0.001) for SEP-2 and RR=2.30 (95% CI [2.01, 2.62], p<0.001) for SEP-3. No significant differences were found between 100 mg and 200 mg doses in these outcomes.
- Avanafil was less effective overall compared to other PDE5Is, with sildenafil 25 mg and 50 mg and tadalafil 10 mg and 20 mg showing superior profiles in enhancing IIEF scores. However, avanafil 200 mg had the highest probability of being the best intervention for ED following nerve-sparing radical prostatectomy.
- Avanafil was associated with a significantly higher incidence of treatment-emergent adverse events (TEAEs) compared to placebo (RR=1.49, 95% CI [1.12, 1.96], p=0.005), with no significant differences in TEAEs observed between 100 mg and 200 mg doses (RR=1.00, 95% CI [0.87, 1.15], p=0.99).
- Mirodenafil 150 mg had more adverse events, particularly flushing and headaches, sildenafil 100 mg was more associated with visual disorders, and vardenafil and udenafil were more likely to cause nasal congestion.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Stendra (avanafil) Prescribing Information. | 2022 | Metuchen Pharmaceuticals LLC, Freehold, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Pharmacological treatment and inappropriate prescriptions for patients with erectile dysfunction. | 2020 | International Journal of Clinical Pharmacy |
Practical guidelines for the treatment of erectile dysfunction and Peyronie’s disease. | 2020 | Urologic Principles and Practice |
Current diagnosis and management of erectile dysfunction. | 2019 | Australian Centre for Sexual Health, Sydney, NSW |