Tadalafil Relieves Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
is accompanied by
Abstract
Purpose:
We assessed the efficacy and safety of tadalafil dosed once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Materials and Methods:
Following a 4-week, single-blind, placebo run-in 281 men were randomly assigned (1:1) to 5 mg tadalafil for 6 weeks, followed by dose escalation to 20 mg for 6 weeks or 12 weeks of placebo.
Results:
Tadalafil significantly improved the mean change from baseline in International Prostate Symptom Score at 6 weeks (5 mg tadalafil −2.8 vs placebo −1.2) and at 12 weeks (5/20 mg tadalafil −3.8 vs placebo −1.7). Larger changes were observed with inclusion of the placebo run-in at 12 weeks (5/20 mg tadalafil −7.1 vs placebo −4.5). Significant improvements were also seen in the International Prostate Symptom Score irritative and obstructive domains, the International Prostate Symptom Score quality of life index, a question about urinary symptom improvement and the Benign Prostatic Hyperplasia Impact Index (significant at 12 weeks) vs placebo. International Prostate Symptom Score and International Index of Erectile Function erectile function domain scores significantly improved in the 56% of men with lower urinary tract symptoms/benign prostatic hyperplasia who were sexually active and had erectile dysfunction. Changes in uroflowmetry parameters were similar in the placebo and tadalafil groups. Commonly reported (2% or greater) treatment emergent adverse events were “erection increased,” dyspepsia, back pain, headache, nasopharyngitis and upper respiratory tract infection (each 5.1% or less). No change in post-void residual volume was seen with tadalafil treatment.
Conclusions:
Tadalafil once daily was well tolerated and demonstrated clinically meaningful and statistically significant symptomatic improvement for lower urinary tract symptoms/benign prostatic hyperplasia. Tadalafil also improved erectile function in men with lower urinary tract symptoms and erectile dysfunction.
References
- 1 : Urologic diseases in America project: benign prostatic hyperplasia. J Urol2005; 173: 1256. Link, Google Scholar
- 2 : Lower urinary tract symptoms and male sexual dysfunction: the Multinational Survey of the Aging Male (MSAM-7). Eur Urol2003; 44: 637. Google Scholar
- 3 American Urological Association (AUA) Clinical guideline on the management of benign prostatic hyperplasia (BPH). Available at http://www.auanet.org/guidelines/bph.cfm. Accessed December 2005. Google Scholar
- 4 : The efficacy and safety of tadalafil: an update. BJU Int2004; 93: 1276. Google Scholar
- 5 : Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol2005; 61: 280. Google Scholar
- 6 : Molecular properties of mammalian proteins that interact with cGMP: protein kinases, cation channels, phosphodiesterases, and multi-drug anion transporters. Front Biosci2005; 10: 2097. Google Scholar
- 7 : Characterization and functional relevance of cyclic nucleotide phosphodiesterase isoenzymes of the human prostate. J Urol2001; 166: 2484. Link, Google Scholar
- 8 : Antiproliferative effect in human prostatic smooth muscle cells by nitric oxide donor. Mol Pharmacol1998; 53: 467. Google Scholar
- 9 : Sildenafil influences lower urinary tract symptoms. BJU Int2002; 90: 836. Google Scholar
- 10 : Novel agents for sexual dysfunction. BJU Int2003; 92: 534. Google Scholar
- 11 : The American Urological Association symptom index for benign prostatic hyperplasia: The Measurement Committee of the American Urological Association. J Urol1992; 148: 1549. Link, Google Scholar
- 12 : Measuring disease-specific health status in men with benign prostatic hyperplasia: Measurement Committee of the American Urological Association. Med Care1995; 33: AS145. Google Scholar
- 13 : The International Index of Erectile Function (I.I.E.F.): a multidimensional scale for the assessment of erectile dysfunction. Urology1997; 49: 822. Google Scholar
- 14 : Efficacy and safety of once-daily alfuzosin in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a randomized, placebo-controlled trial. Urology2001; 58: 953. Google Scholar
- 15 : Evaluation of symptoms and quality of life in men with benign prostatic hyperplasia. Urology2001; 58: 25. Google Scholar
- 16 : Sildenafil improves erectile function and urinary symptoms in men with erectile dysfunction and concomitant lower urinary tract symptoms. J Urol, suppl.2006; 175: 527. abstract 1637. Link, Google Scholar
- 17 : Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients?. J Urol1995; 154: 1770. Link, Google Scholar
- 18 : Increased perfusion in the prostate after administration of PDE-inhibitor sildenafil. J Urol, suppl.2004; 171: 425. abstract 1612. Link, Google Scholar
- 19 : Nitric oxide modulates Ca+2 channels in dorsal root ganglion neurons innervating rat urinary bladder. J Neurophysiol2001; 86: 304. Google Scholar
- 20 : Erectile dysfunction and lower urinary tract symptoms secondary to BPH. Eur Urol2005; 47: 838. Google Scholar
