Drug updated on 9/4/2024
Dosage Form | Tablet (oral: 2.5 mg, 5 mg, 10 mg, 20 mg) |
Drug Class | Phosphodiesterase 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
- 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 Title | Year | Source |
---|---|---|
Cialis (tadalafil) Prescribing Information. | 2023 | Lilly USA, LLC., 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 |