Tadalafil (Cialis) for Benign Prostatic Hyperplasia (BPH)
Tadalafil 5mg daily is an effective treatment option for patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the added benefit of improving erectile dysfunction in men who have both conditions. 1
Efficacy for BPH
Tadalafil 5mg daily has demonstrated significant improvement in BPH symptoms as measured by the International Prostate Symptom Score (IPSS):
- FDA-approved studies showed statistically significant improvement in total IPSS compared to placebo 2
- Mean IPSS decreased starting at 4 weeks and remained decreased through 12 weeks 2
- The percentage of treatment responders (defined as ≥3 point improvement in IPSS) showed a relative effect of 1.13 to 1.80 compared to placebo 1
Mechanism of Action
Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor that works through several mechanisms:
- Relaxes smooth muscle in the prostate, bladder neck, and supporting vasculature 3
- Increases blood perfusion to the lower urinary tract 3
- Modulates bladder afferent nerve activity 3
- Improves endothelial function in BPH patients 4
Clinical Considerations
Ideal Candidates
- Men with both BPH and erectile dysfunction will receive dual benefits 2, 5
- Patients with moderate to severe LUTS due to BPH 1
- Those who cannot tolerate or have contraindications to alpha blockers
Important Precautions
- Do not combine tadalafil 5mg with alpha blockers as this combination offers no advantages in symptom improvement over either agent alone and increases risk of hypotension 1
- Maximum urinary flow rate (Qmax) improvements with tadalafil are modest (median 1.1 vs 0.4 ml/sec for placebo) 6
- Effects on Qmax may be more pronounced with larger voided volumes 6
Dosing and Administration
- Standard dose is 5mg once daily 2
- Can be taken with or without food
- No dosage adjustment needed based on timing of sexual activity
Combination Therapy Considerations
When using tadalafil with finasteride (a 5-alpha reductase inhibitor):
- The combination showed statistically significant improvement in BPH symptoms compared to finasteride alone 2
- Benefits were observed as early as 4 weeks 2
- However, the incremental benefit of tadalafil decreased from 1.7 points at week 4 to 1.0 point at week 26 2
- The incremental benefit beyond 26 weeks is unknown 2
Safety Profile
Tadalafil is generally well tolerated:
- Adverse events are typically mild to moderate in intensity 7
- Long-term studies (up to 1 year) have confirmed safety in BPH patients 7, 3
- Improves brachial-ankle pulse wave velocity (baPWV) and ankle brachial index (ABI), suggesting beneficial effects on vascular function 4
Clinical Decision Algorithm
- Initial assessment: Determine if patient has moderate to severe LUTS due to BPH
- Consider comorbidities:
- If patient also has erectile dysfunction → tadalafil 5mg daily is an excellent first-line option
- If patient has enlarged prostate (>30cc) → consider 5-ARI (finasteride/dutasteride) with or without tadalafil
- Evaluate contraindications:
- Current use of nitrates (absolute contraindication)
- Current use of alpha blockers (relative contraindication)
- Monitor response:
- Assess symptom improvement at 4-12 weeks using IPSS
- Continue if beneficial response observed
- Consider alternative therapy if inadequate response after 12 weeks
Tadalafil represents an important treatment option for BPH, particularly valuable for the substantial population of men who suffer from both BPH and erectile dysfunction.