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NICE LUTS Clinical Guideline 2010

NICE LUTS Clinical Guideline 2010. Lower Urinary Tract Symptoms (LUTS) in men. NICE Clinical Guideline 97 (2010) Available on www.nice.org.uk/guidance/CG97 Published 19 th May 2010 . Prescribing information can be found on the final slide UK/DUTT/0061j/10/ Date of preparation: April 2012.

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NICE LUTS Clinical Guideline 2010

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  1. NICE LUTS Clinical Guideline 2010 Lower Urinary Tract Symptoms (LUTS) in men. NICE Clinical Guideline 97 (2010) Available on www.nice.org.uk/guidance/CG97 Published 19th May 2010 Prescribing information can be found on the final slide UK/DUTT/0061j/10/ Date of preparation: April 2012

  2. Content • Executive summary – 10 key priorities for implementation • Guideline Development Group members • Male ‘LUTS’ • Recommendations on diagnosis • Recommendations on treatment • Recommendations on referral to secondary care UK/DUTT/0061j/10/ Date of preparation: April 2012

  3. Summary: NICE 10 Key Priorities for Implementation - Initial Assessment- • At initial assessment, offer men with LUTS an assessment of their general medical history to identify possible causes of LUTS, and associated comorbidities. Review current medication, including herbal and over-the-counter medicines, to identify drugs that may be contributing to the problem. • 1 • At initial assessment, offer men with LUTS a physical examination guided by urological symptoms and other medical conditions, an examination of the abdomen and external genitalia, and a digital rectal examination (DRE). • 2 • At initial assessment, ask men with bothersome LUTS to complete a urinary frequency volume chart. • 3 • Refer men for specialist assessment if they have LUTS complicated by recurrent or persistent urinary tract infection, retention, renal impairment that is suspected to be caused by lower urinary tract dysfunction, or suspected urological cancer. • 4 UK/DUTT/0061j/10/ Date of preparation: April 2012 • http://guidance.nice.org.uk/CG97/QuickRefGuide Accessed 20th May 2010

  4. Summary: NICE 10 Key Priorities for Implementation- Conservative Management - • Offer men with storage LUTS (particularly urinary incontinence) temporary containment products (for example, pads or collecting devices) to achieve social continence until a diagnosis and management plan have been discussed. • 5 • Offer men with storage LUTS suggestive of overactive bladder (OAB) supervised bladder training, advice on fluid intake, lifestyle advice and, if needed, containment products. • 6 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  5. Summary: NICE 10 Key Priorities for Implementation- Surgery for Voiding Symptoms- • If offering surgery for managing voiding LUTS presumed secondary to BPE, offer monopolar or bipolar transurethral resection of the prostate (TURP), monopolar transurethral vaporisation of the prostate (TUVP) or holmium laser enucleation of the prostate (HoLEP). Perform HoLEP at a centre specialising in the technique, or with mentorship arrangements in place. • 7 If offering surgery for managing voiding LUTS presumed secondary to BPE, do not offer minimally invasive treatments (including transurethral needle ablation [TUNA], transurethral microwave thermotherapy [TUMT], high-intensity focused ultrasound [HIFU], transurethral ethanol ablation of the prostate [TEAP] and laser coagulation) as an alternative to TURP, TUVP or HoLEP (see above recommendation). • 8 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  6. Summary: NICE 10 Key Priorities for Implementation- Providing information - • Make sure men with LUTS have access to care that can help with their emotional and physical conditions and relevant physical, emotional, psychological, sexual and social issues. • 9 • Provide men with storage LUTS (particularly incontinence) containment products at point of need, and advice about relevant support groups. • 10 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  7. Guideline Development Group Formed 2007, Guideline published 2010 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  8. Male ‘LUTS’ Lower urinary tract symptoms (LUTS) are storage, voiding and postmicturition symptoms affecting the lower urinary tract. Bothersome LUTS may occur in up to 30% of men older than 65 years. Post Micturition dribbling Voiding (previously ‘obstructive’) weak or intermittent urinary stream straining hesitancy terminal dribbling incomplete emptying Storage (previously ‘irritative’) urgency frequency incontinence Nocturia http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010 http://www.nice.org.uk/nicemedia/live/12984/48554/48554.pdf Accessed 20th May 2010 UK/DUTT/0061j/10/ Date of preparation: April 2012

  9. NICE Recommendations on Initial Assessment Offer • Assessment of general medical history, including a review of current medication • General ‘focused’ physical examination • Abdominal examination and external genitalia and digital rectal examination (DRE) Investigations Offer • Urine dipstick • Bothersome LUTS – request patient completes frequency volume chart • PSA test –Offer men information, advice and time to decide if they wish to have prostate specific antigen (PSA) testing if their LUTS are suggestive of bladder outlet obstruction secondary to BPE or their prostate feels abnormal on DRE or they are concerned about prostate cancer • Serum creatinine – only if indications of renal impairment • Offer men considering treatment for LUTS an assessment of their baseline symptoms with a validated symptom score (for example, the IPSS). UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  10. NICE Recommendations on Initial Assessment Do not routinely offer: Cystoscopy to men with no evidence of bladder abnormality Imaging of the upper urinary tract to men with no evidence of bladder abnormality Flow-rate measurement Post void residual volume measurement UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  11. NICE Recommendations on management of mild or moderate LUTS Bothersome or to the patient, or complicated? Yes No Active surveillance? Give reassurance, offer advice on lifestyle interventions and information on their condition. Offer review if symptoms change. Active intervention Conservative management / drug treatment or surgery Offer baseline assessment (eg IPSS) UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  12. NICE RecommendationsConservative management – storage symptoms Storage symptoms • OAB Offer • supervised bladder training • advice on fluid intake • lifestyle advice • containment products (if needed) • Stress incontinence caused by prostatectomy • Offer supervised pelvic floor muscle training Offer containment products as appropriate Do not offer penile clamps UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  13. NICE RecommendationsConservative management – voiding symptoms Voiding symptoms Offer intermittent bladder catheterisation before indwelling urethral or suprapubic catheterisation if LUTS cannot be corrected by less invasive measures. Tell men with proven bladder outlet obstruction that bladder training is less effective than surgery. Explain to men with post micturition dribble how to perform urethral milking. UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  14. NICE RecommendationsDrug Treatment - LUTS Offer an alpha blocker Moderate to severe LUTS LUTS and a prostate estimated to be larger than 30g or PSA greater than 1.4 ng/ml, and high risk of progression Offer a 5-Alpha reductase inhibitor (5ARI) Consider combination treatment with an alpha blocker and a 5ARI Bothersome moderate to severe LUTS, and a prostate estimated to be larger than 30g or PSA greater than 1.4 ng/ml 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010 UK/DUTT/0061j/10/ Date of preparation: April 2012

  15. NICE RecommendationsDrug treatment – storage symptoms Offer an anticholinergic OAB Storage symptoms despite treatment with an alpha blocker alone Consider adding an anticholinergic 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010 UK/DUTT/0061j/10/ Date of preparation: April 2012

  16. NICE recommendations for drug treatment review Review men taking drug treatments to assess symptoms, the effect of the drugs on the patient’s quality of life and to ask about any adverse effects from treatment (consider IPSS for baseline and subsequent assessments). Alpha - blockers Review at 4-6 weeks and then every 6-12 months Review at 3-6 months and then every 6-12 months 5ARI Anticholinergic Review at 4–6 weeks until stable, then every 6–12 months 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010 UK/DUTT/0061j/10/ Date of preparation: April 2012

  17. Risk factors for progressive disease • Age over 70 with LUTS • Moderate to severe symptoms i.e. IPSS > 7 • PSA > 1.4 ng/ml • Prostate volume over 30ccs (i.e. feels enlarged on DRE) • Flow rate <12 ml/sec • http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010 • http://www.nice.org.uk/nicemedia/live/12984/48554/48554.pdf Accessed 20th May 2010 • Roehrborn CG et al. J Urol 2000; 163(1):13–20 • Emberton M et al. Urology 2003; 61: 267-273 UK/DUTT/0061j/10/ Date of preparation: April 2012

  18. NICE Recommendations on referral for specialist assessment Offer referral for specialist assessment if: Bothersome LUTS have not responded to conservative management or drug treatment • Refer men for specialist assessment if they have: • LUTS complicated by recurrent or persistent urinary tract infection, or • retention, or • renal impairment you suspect is caused by lower urinary tract dysfunction or • suspected urological cancer or • stress urinary incontinence UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  19. NICE Recommendations on managing acute urinary retention Immediately catheterise men with acute retention Offer an alpha blocker to men before withdrawing the catheter UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  20. NICE Recommendations on managing chronic urinary retention* * Defined as residual volume of greater than 1 litre or presence of a palpable/percussable bladder UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  21. NICE Recommendations on surgery for voiding symptoms Only offer surgery if: Voiding symptoms are severe, or drug treatment and conservative management options have been unsuccessful or are not appropriate. Discuss the alternatives to and outcomes from surgery. UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  22. NICE Recommendations on surgery for storage symptoms Only consider in patients whose symptoms have not responded to conservative management and drug treatment Discuss the alternatives of containment or surgery. Inform men that effectiveness, side effects and long-term risks of surgery are uncertain. UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  23. Back up slides for further information UK/DUTT/0061j/10/ Date of preparation: April 2012

  24. Digital rectal examination General overview of DRE • A digital rectal examination (DRE) is essential to assess the prostate. • The symmetry, size, firmness, surface smoothness, tenderness and the midline groove should all be assessed. • Training and experience will teach the difference between a soft smoothly enlarged benign feeling prostate and the hard, woody irregular carcinoma. • The rectum and pelvis should also be assessed. Faecal loading or impaction, rectal tumours and other pelvic masses may all be palpated when present. • NICE Guideline recommends a DRE as part of initial assessment1 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  25. Urinalysis General Overview • Urinalysis is used as a first line investigation in any setting to identify haematuria, glycosuria, proteinuria, pyuria, and the presence of urinary nitrites and leucocytes • A dipstick test whilst suggestive of pathology, is useful as a screening test and abnormal findings need to be confirmed by an MSU sent for microscopy and culture (and if any growth, sensitivities). • Microscopy may reveal bacteria, blood cells (leucocytes and erythrocytes) and cellular casts (always abnormal and suggestive of renal disease. • NICE Guideline Recommends: • At initial assessment, offer men with LUTS a urine dipstick test to detect blood, glucose, protein, leucocytes and nitrites1 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  26. PSA testing General Overview • Offer men information, advice and time to decide if they wish to have a PSA test if their: • LUTS are suggestive of bladder outlet obstruction secondary to BPE or • Prostate feels abnormal on DRE or • Concern is about prostate cancer • NICE Guideline Recommends: Manage suspected prostate cancer in men with LUTS in line with ‘Prostate cancer: diagnosis and management’ (NICE clinical guideline 58) and ‘Referral guidelines for suspected cancer’ (NICE clinical guideline 27) 1 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  27. Frequency Volume Charts • Voiding diaries are simple, non-invasive tools that are frequently part of the initial evaluation of patients complaining of LUTS, particularly those who have storage symptoms such as increased urinary frequency and incontinence. • These diaries give an indication of the voiding pattern, the severity of symptoms and they add objectivity to the history. • NICE Guideline recommends: At initial and specialist assessment and on specialist referral, ask men with bothersome LUTS to complete a urinary frequency volume chart1 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  28. International Prostate Symptom Score (IPSS) • Mild symptoms 0 - 7 • Moderate 8 – 19 • Severe 20-35 Example of IPSS A copy of the IPSS score pad as a pdf can be downloaded from www.health.gsk.co.uk • NICE Guideline recommends: Offer men considering any treatment for LUTS an assessment of their baseline symptoms to allow assessment of subsequent symptom change1 UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  29. A copy of the IPSS score pad as a pdf can be downloaded from www.health.gsk.co.uk UK/DUTT/0061j/10/ Date of preparation: April 2012

  30. NICE Recommendations on surgery for voiding LUTS presumed secondary to BPE UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  31. NICE Recommendations on surgery for storage symptoms If considering offering surgery for storage LUTS, refer men to a urologist to discuss: – the surgical and non-surgical options appropriate for their circumstances and – the potential benefits and limitations of each option, particularly long-term results. Do not offer myectomy to manage detrusor overactivity. 6 At the time of publication (May 2010), botulinum toxin did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented. UK/DUTT/0061j/10/ Date of preparation: April 2012 1. http://guidance.nice.org.uk/CG97/QuickRefGuide/pdf/English. Accessed 20th May 2010

  32. Some common comparisons to help assess prostate size Not to scale • A DRE typically underestimates the prostate size as verified by transrectal ultrasound (TRUS) by up to 55%, with the degree of underestimation increasing with increasing prostate size.1 Roehborn CG, Sech S, Montoya J et al. Interexaminer reliability and validity of a three dimensional model to assess prostate volume by digital rectal examination. Urology 2001; 56(6): 1087-1092. UK/DUTT/0061j/10/ Date of preparation: April 2012

  33. Prescribing Information (PI) (Please refer to the full Summary of Product Characteristics before prescribing). Combodart®▼0.5 mg/0.4 mg hard capsules (dutasteride 0.5 mg/ tamsulosinhydrochloride 0.4 mg) Uses - The treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. Dosage and administration (adults including elderly) - The recommended dose of Combodart is one capsule (0.5 mg/0.4 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. No dose adjustment is necessary in the elderly. Caution in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of Combodart is contraindicated. Where appropriate, Combodart may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to Combodart may be considered. Contra-indications-Use in women, children and adolescents. Known hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including tamsulosin induced angio-edema), soya, peanut or any of the other excipients. Patients with a history of orthostatic hypotension. Patients with severe hepatic impairment. Special Warnings and Precautions - Combination therapy should be prescribed after careful benefit: risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies. In two 4-year clinical studies, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was higher among subjects taking the combination of dutasteride and an alpha blocker, primarily tamsulosin, than it was among subjects not taking the combination. In these two studies, the incidence of cardiac failure was low (≤1%). Digital rectal examination, must be performed on patients prior to initiating therapy with Combodart and periodically thereafter. Women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water. Use with caution in patients with mild to moderate hepatic impairment. Combodart causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Combodart should have a new PSA baseline established after 6 months of treatment with Combodart. It is recommended to monitor PSA values regularly thereafter. Any confirmed increases from lowest PSA level while on Combodart may signal the presence of prostate cancer (particularly high grade cancer) or noncompliance to therapy and should be carefully evaluated. Treatment with Combodart does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Combodart. If electing to use percent free PSA as aid to prostate cancer detection in men undergoing Combodart therapy, no adjustment to its value appears necessary. Results of one clinical study in men at increase risk of prostate cancer (REDUCE), revealed a higher incidence of Gleason 8 – 10 prostate cancers in dutasteride treated men compared to placebo. The relationship between dutasteride and high grade prostate cancer is not clear. Men taking Combodart should be regularly evaluated for prostate cancer risk including PSA testing. Treatment of severely renally impaired patients should be approached with caution as these patients have not been studied. As with other alpha-blockers, a reduction in blood pressure can occur during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Combodart should be cautioned to sit or lie down at the first signs of orthostatic hypotension until the symptoms have resolved. Intraoperative Floppy Iris Syndrome has been observed during cataract surgery in some patients on or previously treated with tamsulosin. This may lead to increased procedural complications during the operation. The initiation of therapy with Combodart in patients for whom cataract surgery is scheduled is therefore not recommended. Breast cancer has been reported in men taking dutasteride in clinical studies and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of dutasteride. In the double blind 2 year monotheraphy clinical studies and the 2 year open label extension, there were 2 cases of breast cancer reported in dutasteride-treated patients and 1 case in a patient who received placebo. In the 4 year CombAT and REDUCE clinical studies there were no cases of breast cancer reported in any treatment groups. Interactions - There have been no drug interaction studies for Combodart.Dutasteride:In vitro studies: Dutasteride mainly eliminated via metabolism by CYP3A4 and CYP3A5. Long-term combination of dutasteride with potent inhibitors of CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of dutasteride. No effect on the pharmacokinetics of warfarin, digoxin, tamsulosin or terazosin. Tamsulosin:. Concomitant administration of tamsulosin hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Dutasteride-tamsulosin should not be used in combination with other alpha-1 adrenergic blockers. Caution should be used when dutasteride-tamsulosin is used in combination with cimetidine. Caution should be exercised with concomitant administration of warfarin and tamsulosin hydrochloride. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of tamsulosin. Pregnancy and lactation -Combodart is contraindicated in women. There have been no studies to investigate the effect of Combodart on pregnancy, lactation and fertility. Fertility:Dutasteride:Reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. Possibility of reduced male fertility cannot be excluded. Tamsulosin:. Effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated. Pregnancy:Dutasteride:Small amounts of dutasteride have been found in semen of subjects receiving dutasteride 0.5 mg. As with all 5-alpha reductase inhibitors, a condom is recommended for use in patients when their partner is or may potentially become pregnant to avoid exposure to semen. Tamsulosin:Administration of tamsulosin hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm. Lactation: Not known whether dutasteride or tamsulosin is excreted in human milk. Effects on ability to drive and use machines- No studies on the effects of Combodart on the ability to drive and use machines have been performed. However, patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking Combodart. Side effects - There have been no therapeutic clinical studies conducted with Combodart; however bioequivalence of Combodart with co-administered dutasteride and tamsulosin has been demonstrated. A 30% reduction on Cmax was observed for the tamsulosin component in the fed state compared to the fasted state. Food had no effect on AUC of tamsulosin. Dutasteridemonotherapy clinical studies: Higher incidence with dutasteride than placebo groups: Impotence, altered (decreased) libido, ejaculation disorders, breast disorders (including breast enlargement and/or breast tenderness). Post marketing reports: Allergic reactions including rash, pruritus, urticaria, localised oedema and angioedema. Alopecia (primarily body hair loss), hypertrichosis. Dutasteridein combination with the alpha blocker tamsulosin - 4 year clinical data (CombAT): Higher incidence in the combination therapy group in the first year of treatment due to higher incidence of reproductive disorders, specifically ejaculation disorders. Other reproductive disorders: Impotence, altered (decreased) libido, breast disorders (includes enlargement and/or tenderness), dizziness. Cardiac failure: Dutasteride in combination with the alpha blocker tamsulosin– 4 year clinical data (CombAT): the incidence of the composite term cardiac failure in the combination group (14/1610, 0.9%) was higher than in either monotherapy group: dutasteride, (4/1623, 0.2%) and tamsulosin, (10/1611, 0.6%). In a separate 4-year study in 8231 men aged 50 to 75, there was a higher incidence of the composite term cardiac failure in subjects taking dutasteride 0.5 mg once daily (30/4105, 0.7%) compared to subjects taking placebo (16/4126, 0.4%). Legal category: POM. Presentation and Basic NHS cost Combodart0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (hard capsules) £19.80 per 30 capsule pack. Product licence number19494/0046 Product licence holder GlaxoSmithKline UK Ltd, Stockley Park West, Middlesex, UB11 1BT. Prescribing information updated: March 2012. UK/DUTT/0003/12 Adverse events should be reported. Reporting forms and information can be found at:- http://www.mhra.gov.uk/yellowcardAdverse events should also be reported to GlaxoSmithKline on 0800 221 441. Combodart is a registered trademark of the GlaxoSmithKline group of companies UK/DUTT/0061j/10/ Date of preparation: April 2012

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