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GlaxoSmithKline gains approval for co-administration of Avodart® (dutasteride) with tamsulosin for the treatment of benign prostatic hyperplasia under the European Mutual Recognition Procedure


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GlaxoSmithKline (GSK) announced today that regulatory approval has been granted in Sweden for its 5α-reductase inhibitor (5ARI) Avodart®, the only dual acting 5ARI, in combination with tamsulosin, a widely prescribed a-blocker, for the treatment of patients with moderate-to-severe benign prostatic hyperplasia (BPH) symptoms. Approval was granted through the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State. Further approvals are anticipated in the coming months across a further 26 European countries.

The approval was based on positive two year results from the ongoing Combination of Avodart® and Tamsulosin (CombAT) study, which showed that combination therapy with dutasteride and tamsulosin provides significantly superior and sustained improvements over two years in symptoms1, peak urinary flow (Qmax)1 and quality-of-life2 versus either monotherapy, in men with moderate-to-severe BPH symptoms.

The combination of dutasteride and tamsulosin has also been shown to provide significantly superior and sustained improvements in BPH symptoms versus dutasteride alone from month 3 and versus tamsulosin alone from month 9.1 This is the first time combination therapy has been shown to provide superior BPH symptom improvement versus both monotherapies in less than 1 year.1, 3-7

“For patients with BPH whose disease is worsening and whose symptoms are moderate-to-severe, the co-administration of Avodart®and tamsulosin offers the benefits of both medicines, and provides doctors with an effective treatment option”, said Dr Alastair Benbow, Vice President and European Medical Director, GSK.
Avodart® is a registered trademark of the GlaxoSmithKline group of companies.

1. 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;179:616-621; discussion 621.

2. Barkin J, Haillot O, Chantada V, Roehrborn C, Castro R, Morrill B, Black L, Montorsi F, on behalf of the CombAT Study Group. Improvements in patient-reported quality of life with dutasteride, tamsulosin and the combination: 2-year results from the Combination of Avodart and Tamsulosin (Combat) trial. European Urol Supplements 2008; 7(3): 95 [abstract number 99].

3. Lepor H, Williford WO, Barry MJ, et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. N Engl J Med. 1996;335:533-539.

4. Lepor H, Williford WO, Barry MJ, Haakenson C, Jones K. The impact of medical therapy on bother due to symptoms, quality of life and global outcome, and factors predicting response. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. J Urol. 1998;160:1358-1367.

5. Debruyne FM, Jardin A, Colloi D, et al. Sustained-release alfuzosin, finasteride and the combination of both in the treatment of benign prostatic hyperplasia. European ALFIN Study Group. Eur Urol. 1998;34:169-175.

6. Kirby RS, Roehrborn C, Boyle P, et al. Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Urology. 2003;61:119-126.

7. McConnell, J.D., Roehrborn, C.G., Bautista, O.M., et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349:2387-98.

8. McVary KT. BPH: epidemiology and co morbidities. Am J Manag Care 2006;12:S122-128

9. de la Rosette JJ, Madersbacher S, Alivizatos G, Sanz CR, Nordling J, Emberton M. Guidelines on benign prostatic hyperplasia. European Association of Urology. 2006 (2004 update).

10. Debruyne F, Barkin J, van Erps P, Reis M, Tammela TL, Roehrborn C. Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur Urol. 2004;46:488-494; discussion 495.

11. Roehrborn CG, Boyle P, Nickel JC, Hoefner K, Andriole G. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology. 2002;60:434-441.

12. Michel MC, Vrydag W. Alpha1-, alpha2- and beta-adrenoceptors in the urinary bladder, urethra and prostate. Br J Pharmacol. 2006;147 Suppl 2:S88-119.


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