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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

Not for distribution to US media

Issued – Tuesday 22 April 2008, London, UK

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 (Q_max)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. 

About benign prostatic hyperplasia

Benign prostatic hyperplasia (BPH) is a common, progressive non-cancerous growth of the prostate, that may cause lower urinary tract symptoms (LUTS), such as a hesitant, interrupted and weak flow of urine, urge to urinate, leaking or dribbling, and more frequent urination, especially at night.⁸

Symptoms may worsen over time, particularly in patients with an enlarged prostate and/or increased prostate-specific antigen (PSA) levels. If left untreated, there is a risk of acute urinary retention (AUR) and the need for BPH-related surgery, and less frequently, potential bladder and kidney damage.^7-9

More than 1 in 4 men in their 50s and nearly half of all men aged 80 years or older suffer from moderate-to-severe LUTS.⁸

About Avodart^®

Avodart^®is the only BPH treatment that inhibits both type 1 and type 2 5α-reductase isoenzymes, blocking the conversion of testosterone into the primary male hormone, dihydrotestosterone (responsible for prostate growth and BPH development), providing long-term symptom improvement, and reducing the risk of BPH complications (AUR and surgery).^{10, 11}

About tamsulosin

Tamsulosin is a widely prescribed α-blocker, which provides a rapid onset of urinary symptom relief by reducing the smooth muscle tone in the prostate and bladder neck, although other mechanisms of action might also exist.¹²

About CombAT

The CombAT (Combination of Avodart^®and Tamsulosin) trial is an ongoing 4 year, randomised, double-blind, multicentre (446 investigators in 35 countries), parallel group study investigating the efficacy and safety of the dual 5α-reductase inhibitor dutasteride (0.5mg), and the a-blocker tamsulosin(0.4 mg), separately and in combination, in 4844 men with moderate-to-severe BPH symptoms (IPSS ≥ 12), a prostate volume ≥ 30 cc and serum PSA ≥1.5 ng/mL. The two-year CombAT results demonstrated that the combination therapy provided significantly superior and sustained improvement in symptoms, urinary flow and quality of life than either monotherapy over 2 years.^1,2   The CombAT study, still ongoing, will also evaluate, at four years, the efficacy of dutasteride and tamsulosin combination therapy versus each monotherapy alone in reducing the risk of AUR and BPH-related surgery. At two years, the profile of adverse events for combination therapy was consistent with those reported for either monotherapy. Although drug-related adverse events (mainly sexually related) were more common with combination therapy, rates of withdrawal from the study due to adverse events were low (≤ 5%) across all treatment groups.¹

About GSK

GSK is one of the world’s leading research-based pharmaceutical and healthcare companies. GSK is committed to researching and developing treatments for urological conditions to enable healthcare professionals to meet the needs of patients.

GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.

Avodart^® can be administered alone or in combination with the a-blocker tamsulosin.

Avodart^® is a registered trademark of the GlaxoSmithKline group of companies. 

Enquiries 

UK Media enquiries:	Philip Thomson	(020) 8047 5502
	Alice Hunt	(020) 8047 5502
	Gwenan White	(020) 8047 5502
European Analyst/Investor enquiries:	David Mawdsley	(020) 8047 5564
	Sally Ferguson	(020) 8047 5543
	Gary Davies	(020) 8047 5503

References

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). http://www.uroweb.org/nc/professional-resources/guidelines/online/

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.