Drug updated on 12/11/2024
Dosage Form | Tablet (oral: 2.5 mg, 5 mg, 10 mg, 20 mg) |
Drug Class | Phosphodiesterase-5 (PDE-5) inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of erectile dysfunction (ED)
- Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
- Indicated for or the treatment of ED and the signs and symptoms of BPH (ED/BPH).
Latest News
Summary
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- In the treatment of erectile dysfunction (ED), combination therapies that include tadalafil and additional agents like folic acid, low-intensity shockwave therapy, or Traditional Chinese Medicine (TCM) significantly improved International Index of Erectile Function (IIEF) scores compared to monotherapy, indicating enhanced effectiveness.
- Tadalafil alone or combined with alpha-blockers showed a low discontinuation rate, supporting its tolerability and sustained use in ED management.
- For lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), combining tadalafil with tamsulosin or a B3AR agonist led to notable improvements in International Prostate Symptom Score (IPSS), quality of life, and urine flow rate versus monotherapies. Additionally, tadalafil alone provided similar LUTS management effectiveness as tamsulosin, with superior IIEF scores for patients experiencing both LUTS and ED.
- In male infertility, tadalafil and other phosphodiesterase-5 (PDE5) inhibitors were associated with improvements in sperm concentration, motility, and morphology, suggesting potential benefits for fertility outcomes.
- For erectile dysfunction, combination therapies involving tadalafil, including daily use or adjuncts like shockwave therapy or Traditional Chinese Medicine, did not lead to an increase in adverse events compared to monotherapy. The discontinuation rate due to adverse events for tadalafil alone or combined with alpha-blockers was 4.56%, suggesting a favorable safety profile.
- In managing lower urinary tract symptoms and benign prostatic hyperplasia, combination therapy with tamsulosin and tadalafil showed similar rates of discontinuation due to adverse events as tamsulosin alone, though there was a higher incidence of pain-related symptoms in the combination group. Beta-3 adrenoceptor (B3AR) agonist combined with tadalafil also did not increase the adverse event rate compared to monotherapy.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Cialis (tadalafil) Prescribing Information. | 2023 | Eli Lilly and Company, Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical practice guideline for transurethral plasmakinetic resection of prostate for benign prostatic hyperplasia (2021 Edition). | 2021 | Military Medical Research |