Tadalafil

(Cialis®)

Tadalafil

Drug updated on 9/4/2024

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).

Latest News

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Summary
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  • Cialis (tadalafil) is indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and the combined conditions of ED and BPH.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Esophageal Motility Disorders: PDE-5 inhibitors, including sildenafil, significantly reduced lower esophageal sphincter pressure (SMD -1.69, 95% CI: -2.39 to -0.99) and amplitude of contractions (SMD -2.04, 95% CI: -2.97 to -1.11), with no significant difference in residual pressure compared to placebo (SMD -0.24, 95% CI: -1.20 to 0.72).
  • Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH): Combination therapy of tamsulosin plus tadalafil significantly improved IPSS (p < .0001), quality of life (p = .003), maximum urine flow rate (p < .00001), and IIEF (p < .00001) compared to tamsulosin alone. Tadalafil monotherapy also showed significant improvement in LUTS/BPH outcomes, including total IPSS (MD: -1.97, 95% CI: -2.24 to -1.70, p < 0.00001) compared to placebo.
  • Male Infertility: PDE-5 inhibitors, including tadalafil, significantly improved sperm concentration (MD=1.96, 95% CI=1.70-2.21, p < 0.001), straight progressive motility (Grade A) (MD=3.71, 95% CI=2.21-5.20, p < 0.001), overall sperm motility (MD=8.09, 95% CI=7.83-8.36, p < 0.001), and other sperm parameters.
  • LUTS/BPH: Combination therapy of tamsulosin plus tadalafil had a higher incidence of pain symptoms (p < .0001) compared to monotherapy, but similar rates of discontinuation due to adverse events. Tadalafil monotherapy showed no significant difference in serious adverse events compared to placebo (risk ratio: 1.27, 95% CI: 0.80-2.01, p = 0.31), though the incidence of adverse events was higher in the tadalafil group.
  • Erectile Dysfunction: Mirodenafil 150 mg caused the most adverse events, particularly flushing and headaches. Sildenafil 100 mg was associated with more visual disorders, and vardenafil and udenafil caused more nasal congestion.
  • The evidence reviewed highlights that studies on esophageal motility disorders focused on individuals with conditions like achalasia, LUTS/BPH studies involved geriatric males and those with erectile dysfunction, research on Multiple Sclerosis (PwMS) addressed sexual dysfunction, and male infertility studies targeted males with infertility issues. Notably, tadalafil is particularly effective for patients with LUTS associated with erectile dysfunction, and PDE-5 inhibitors show significant potential in improving sperm quality in males with infertility. Further research is needed for sexual dysfunction in PwMS.

Product Monograph / Prescribing Information

Document TitleYearSource
Cialis (tadalafil) Prescribing Information.2023Lilly USA, LLC., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Phosphodiesterase 5 (PDE-5) inhibitors (sildenafil, tadalafil, and vardenafil) effects on esophageal motility: a systematic review2023BMC Gastroenterology
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 hyperplasia.2023American Journal of Men’s Health
Sexual dysfunction therapeutic approaches in patients with multiple sclerosis: a systematic review.2023Neurological Sciences
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-analysis.2022International Journal of Clinical Practice
Effect of phosphodiesterase-5 inhibitors on the treatment of male infertility: a systematic review and meta-analysis. 2021The World Journal of Men's Health
Efficacy and safety of oral phosphodiesterase 5 inhibitors for erectile dysfunction: a network meta-analysis and multicriteria decision analysis. 2021World Journal of Urology
Efficacy and safety of 12-week monotherapy with once daily 5 mg tadalafil for lower urinary tract symptoms of benign prostatic hyperplasia: Evidence-based analysis.2021Frontiers in Medicine
Comparative effectiveness of tadalafil versus tamsulosin in treating lower urinary tract symptoms suggestive of benign prostate hyperplasia: a meta-analysis of randomized controlled trials.2020Medical Science Monitor
Meta-analysis of efficacy and safety of tadalafil plus tamsulosin compared with tadalafil alone in treating men with benign prostatic hyperplasia and erectile dysfunction.2019American Journal of Men’s Health

Clinical Practice Guidelines