Combination therapy in patients with benign prostatic hyperplasia
Background: The purpose of observational program of patients with lower urinary tract symptoms (LUTS) because of benign prostatic hyperplasia (BPH) (LUTS/BPH) was to acquire additional pharmaco-epidemiological data on the safety and efficacy of combination therapy with finasteride and tamsulosin.
Methods: Observational program of men with BPH was conducted in urological outpatient clinics in Slovenia from April 2004 until November 2005. In open-label, non-interventional program 1173 patients were observed, who had been treated because of LUTS/BPH with combination therapy with finasteride and tamsulosin, in the framework of common treatment. At baseline and after six months of treatment for each patient the International Prostatic Symptom Score (IPSS) questionnaire and assessment of quality of life (QL) were filled in. In addition, urinary flow rate and prostate volume were determined. Adverse effects of drugs were reported spontaneously. For statistical analysis the Student’s t-test was performed.
Results: Combination therapy with finasteride and tamsulosin was well tolerated. 89 (7.6 %) patients discontinued with medication because of lack of efficacy or because of adverse effects of drugs. Symptom score, assessment of quality of patients’ lives and volume of prostates were significantly lower (p < 0.0001), while urinary flow rate was significantly higher (p < 0.0001) after six months of treatment with finasteride and tamsulosin.
Conclusions: Combination therapy of patients with LUTS/BPH with finasteride and tamsulosin is effective and safe.
Anderson JB, Roehrborn CG, Shalken JA, Emberton M. The progression of benign prostatic hyperplasia: Examining the evidence and determing the risk. Eur Urol 2001; 39: 390–9.
McConnell JD. The pathophysiology of BPH. J Androl 1991; 12: 356–63.
Nickel JC. The overlapping LUTS/BPH and prostatitis. Curr Opin Urol 2006; 16: 5–10.
Roehrborn CG, McConnell JD. Etiology, pathophysiology, epidemiology and natural history of BPH. In: Walsh PC, ed. Campbell’s Urology. 8th ed. Philadelphia: Sounders; 2002. p. 1297–336.
Djavan B. Benign prostatic hyperplasia in the new millenium. Curr Opin Urol 2005; 15: 33–4.
Lepor H. Rule of alpha-adrenergic blockers in the treatment of BPH. Prostate Supp 1990; 3: 75–84.
Roehrborn CG, Oesterling JE, Auerbach S. The Hytrin Community Assessment Trial Study: A one year study of terazosin versus placebo in the treatment of men with symptomatic BPH. Urology 1996; 47: 159–68.
Roehrborn CG, Siegel RL. Safety and efficacy of doxazosin in BPH: A pulled analysis of three double-blind placebo-controlled studies. Urology 1996; 48: 406–15.
Kawabe K. Efficacy and safety of tamsulosin in the treatment of BPH. Br J Urol 1995; 76: 63–7.
Roehrborn CG. Efficacy and safety of once daily alfuzosin in the treatment of LUTS/BHP; A randomized, placebo-controlled trial. Urology 2001; 58: 953–9.
McConnell JD, Bruskewitz R, Walsh P. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with BPH. N Engl J Med 1998; 338: 557–63.
Lepor H, Williford WO, Barry MJ. The efficacy of terazosin, finasteride, or both in BPH. N Engl J Med 1996; 335: 533–9.
Kirby RS, Roehrborn CG, Boyle P. Efficacy and tolerability of doxazosin and finasteride alone or in combination in treatment of symptomatic BPH: The Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Urology 2003; 61: 119–26.
McConnell JD. The long-term effect of doxazosine, finasteride and combination therapy on the clinical progression of BPH. N Engl J Med 2003; 349: 2387–98.
Tršinar B. Tamsulozin – novo zdravilo za zdravljenje benigne hiperplazije prostate. Zdrav Vestn 2000; 69: 733–7.
Tršinar B. Rezultati zdravljenja benigne prostatične obstrukcije s finasteridom. Zdrav Vestn 2001; 70: 733–6.
Marberger MJ. Long-term effects of finasteride of patients with BPH: A double-blind, placebo-controlled, multicentre study. Urology 1998; 51: 677–86.
Michel MC. Protecting bladder function and reducing disease progression. Eur Urol 2003; 2: 13–8.
The Author transfers to the Publisher (Zdravniški vestnik/Slovenian Medical Journal) all economic copyrights following form Article 22 of the Slovene Copyright and Related Rights Act (ZASP), including the right of reproduction, the right of distribution, the rental right, the right of public performance, the right of public transmission, the right of public communication by means of phonograms and videograms, the right of public presentation, the right of broadcasting, the right of rebroadcasting, the right of secondary broadcasting, the right of communication to the public, the right of transformation, the right of audiovisual adaptation and all other rights of the author according to ZASP.
The aforementioned rights are transferred non-exclusively, for an unlimited number of editions, for the term of the statutory
The Author can make use of his work himself or transfer subjective rights to others only after 3 months from date of first publishing in the journal Zdravniški vestnik/Slovenian Medical Journal.
The Publisher (Zdravniški vestnik/Slovenian Medical Journal) has the right to transfer the rights, acquired parties without explicit consent of the Author.
The Author consents that the Article be published under the Creative Commons BY-NC 4.0 (attribution-non-commercial) or comparable licence.