What does the medical literature show regarding the efficacy of Cialis (Tadalafil) in treating benign prostatic hyperplasia (BPH)?

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Last updated: February 7, 2025 • View editorial policy

From the Guidelines

Cialis (Tadalafil) is effective in treating benign prostatic hyperplasia (BPH), with studies showing a small reduction in International Prostate Symptom Score (IPSS) compared to placebo 1.

Efficacy of Tadalafil in BPH

  • Tadalafil 5 mg is the only phosphodiesterase 5 inhibitor (PDE5I) licensed for the treatment of male lower urinary tract symptoms (MLUTS) 1.
  • A Cochrane review found that PDE5Is, including Tadalafil, may result in a small reduction in IPSS compared with placebo 1.
  • Meta-analyses have reported improvements in IPSS and International Index of Erectile Function (IIEF) score with Tadalafil treatment 1.
  • However, Tadalafil has not been shown to improve maximum urinary flow rate (Qmax) 1.

Combination Therapy

  • Combining Tadalafil with alpha-1 blockers has been shown to significantly improve IPSS score, IIEF score, and Qmax compared to alpha-1 blocker monotherapy 1.

Safety Considerations

  • Common adverse events associated with Tadalafil include flushing, gastro-oesophageal reflux, headache, dyspepsia, back pain, and nasal congestion 1.
  • Tadalafil is contraindicated in patients with certain medical conditions, including cardiac disease, hypotension, and significant hepatic or renal insufficiency 1.

From the FDA Drug Label

The efficacy and safety of tadalafil for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization In each of these 2 trials, tadalafil 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks

The medical literature shows that tadalafil (Cialis) is effective in treating benign prostatic hyperplasia (BPH), as evidenced by statistically significant improvements in the International Prostate Symptom Score (IPSS) compared to placebo in two 12-week studies 2. The treatment effect was observed as early as 4 weeks and persisted through 12 weeks. Key benefits of tadalafil for BPH include:

  • Statistically significant improvement in total IPSS
  • Decrease in IPSS starting at 4 weeks and remaining decreased through 12 weeks
  • Effective in patients with moderate to severe BPH symptoms
  • Can be used in combination with finasteride for up to 26 weeks 3

From the Research

Efficacy of Cialis (Tadalafil) in Treating BPH

The medical literature shows that Cialis (Tadalafil) is effective in treating benign prostatic hyperplasia (BPH) symptoms. Key findings include:

  • Tadalafil improves International Prostate Symptom Score (IPSS) and quality of life in patients with BPH 4, 5, 6, 7, 8
  • Tadalafil is effective in treating both erectile dysfunction (ED) and BPH symptoms 5, 7, 8
  • The efficacy of tadalafil is maintained over a 1-year period 6, 7

Dosage and Administration

Studies have investigated the efficacy of different tadalafil dosages, including:

  • 2.5 mg, 5 mg, 10 mg, and 20 mg once daily 5
  • 5 mg once daily is the approved dosage for treating BPH symptoms 6, 7, 8

Safety Profile

The safety profile of tadalafil in patients with BPH is well established, with:

  • Most adverse events being mild or moderate in severity 6, 7
  • No new or unexpected adverse events reported in BPH studies compared to ED studies 8

Comparison to Other Treatments

Tadalafil is a new treatment alternative to other established drugs for BPH, such as:

  • α-adrenergic antagonists
  • 5α-reductase inhibitors
  • Tadalafil has the advantage of treating both ED and BPH symptoms simultaneously, without the sexual adverse events associated with other drugs 8

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.