On 1 August 2011 dutasteride-with-tamsulosin fixed-dose combination (Duodart; 0.5 mg dutasteride/0.4 mg tamsulosin hydrochloride) was listed on the Pharmaceutical Benefits Scheme for men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).1
The streamlined authority listing requires treatment to be initiated by a urologist but can be continued by a general practitioner or nurse practitioner.
The Pharmaceutical Benefits Advisory Committee recommended subsidy of the dutasteride with tamsulosin combination product on a cost-minimisation basis — that is, similar efficacy and cost — compared with a combination of dutasteride and prazosin.1 Tamsulosin is as effective as prazosin — the only PBS-listed alpha blocker — but may be better tolerated.2,3
Dutasteride co-administered with tamsulosin improves urinary flow, and reduces the incidence of acute urinary retention and prostate surgery compared with dutasteride monotherapy or tamsulosin monotherapy at 4 years.4,5
Guidelines recommend combination therapy with a 5-alpha-reductase inhibitor (dutasteride or finasteride) and an alpha blocker (tamsulosin, alfuzosin, prazosin or terazosin) for men with moderate or severe urinary symptoms, a prostate volume > 30 mL and PSA > 1.4 ng/mL, who are considered at increased risk of disease progression.6,7,8
The recent NPS RADAR review of dutasteride (Avodart) has been updated to include information on the fixed dose combination of dutasteride with tamsulosin.
- Australian Department of Health and Ageing. November 2010 PBAC outcomes: positive recommendations. 2010. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-nov10-positive (accessed 16 February 2011).
- Rossi S, ed. Australian Medicines Handbook 2011. Adelaide: Australian Medicines Handbook Pty Ltd.
- Wilt TJ, Mac Donald R, Rutks I. Tamsulosin for benign prostatic hyperplasia. Cochrane Database Syst Rev 2003:CD002081. [PubMed]
- Roehrborn CG, Siami P, Barkin J, et al. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol 2008;179:616–21. [PubMed]
- Roehrborn CG, Siami P, Barkin J, et al. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 2010;57:123–31. [PubMed]
- European Association of Urology. Guidelines on conservative treatment of non-neurogenic male LUTS. 2010. http://www.uroweb.org/gls/pdf/BPH%202010.pdf (accessed 16 December 2010).
- National Institute for Health and Clinical Excellence. Lower urinary tract symptoms. The management of lower urinary tract symptoms in men. NICE clinical guideline 97, Issue date: May 2010.
- Andrology Australia. Prostate Disease. BPH and prostatitis — diagnosis and management. Clinical Summary Guide 7. May 2010. http://www.andrologyaustralia.org/docs/clinical-summary-guide07_May2010.pdf (accessed 4 January 2011).