Tadalafil

(Cialis®)

Tadalafil

Drug updated on 11/1/2024

Dosage FormTablet (oral: 2.5 mg, 5 mg, 10 mg, 20 mg)
Drug ClassPhosphodiesterase 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).

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Summary
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  • 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 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. 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 TitleYearSource
Cialis (tadalafil) Prescribing Information.2023Eli Lilly and Company, Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Sildenafil for congenital heart diseases induced pulmonary hypertension, a meta-analysis of randomized controlled trials2023Bmc Pediatrics
A Systematic Review and Meta-Analysis of the Efficacy and Safety of Tamsulosin Plus Tadalafil Compared With Tamsulosin Alone in Treating Males With Lower Urinary Tract Symptoms Secondary to Benign Prostrate Hyperplasia2023American Journal of Men's Health
Sexual dysfunction therapeutic approaches in patients with multiple sclerosis: a systematic review2023Neurological Sciences : Official Journal of the Italian Neurological Society and
Discontinuation Rates of Tadalafil Alone and in Combination with a-Blockers in the Treatment of Male Lower Urinary Tract Symptoms with or without Coexisting Erectile Dysfunction: A Systematic Review and Meta-Analysis2022International Journal of Clinical Practice
Beta 3 Adrenoreceptor Agonist for the Management of Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia: A Systematic Review2021International Neurourology Journal
Serum Folic Acid and Erectile Dysfunction: A Systematic Review and Meta-Analysis2021Sexual Medicine
Effect of Phosphodiesterase-5 Inhibitors on the Treatment of Male Infertility: A Systematic Review and Meta-Analysis2021The World Journal of Men's Health
Assessment of Combination Therapies vs Monotherapy for Erectile Dysfunction: A Systematic Review and Meta-analysis2021Jama Network Open
Current Concepts on the Reno-Protective Effects of Phosphodiesterase 5 Inhibitors in Acute Kidney Injury: Systematic Search and Review2020Journal of Clinical Medicine
Comparative Effectiveness of Tadalafil versus Tamsulosin in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostate Hyperplasia: A Meta-Analysis of Randomized Controlled Trials2020Medical Science Monitor : International Medical Journal of Experimental and
Chinese herbal medicine combined with tadalafil for erectile dysfunction: a systematic review and meta-analysis2020Andrology

Clinical Practice Guidelines