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Stakeholder Opinions: Urinary Tract Infections Growing resistance rates bring opportunities for both new and old drugs
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*Learn about the significance of UTIs as a an indication for antibacterial compounds *Understand and capitalize on clinical unmet needs in the market through new product development in therapy and diagnosis *Discover optimal ways to communicate with physicians by supporting efforts to address gaps in diagnosis, treatment and guideline adherence 126 seiten | |||||||||||
| Inhalt der Studie: |
Urinary tract infections (UTIs) include infections of the kidneys, ureters, and bladder. Escherichia coli is the major UTI pathogen, with emerging extended-spectrum beta-lactamase (ESBL)-producing str.....
Urinary tract infections (UTIs) include infections of the kidneys, ureters, and bladder. Escherichia coli is the major UTI pathogen, with emerging extended-spectrum beta-lactamase (ESBL)-producing strains proving particularly difficult to treat. Bacterial resistance to the most commonly used UTI drugs is growing, highlighting the unmet need and opportunity for novel therapies. Report Highlights UTIs are a major driver of ambulatory care utilization. US statistics point to more than 10 million visits to ambulatory care settings for UTIs per year. From 1995 to 2006, the incidence of cystitis and UTI in unspecified sites in the US increased by 10.7%. Bacterial resistance is the most important factor affecting UTI treatment options and varies both nationally and locally. Resistance rates as low as 10% are deemed to be of concern with regards to efficacy of empiric therapy. Levels of resistance to some older drugs may reach 40-50% in some areas, rendering these drugs ineffective. Two old drugs, nitrofurantoin and fosfomycin, have remarkably favorable resistance profiles and good efficacy for the treatment of cystitis, and therefore may provide highly useful future treatment options. Given these compounds' age, they are not widely prescribed, requiring physician education to improve familiarity and improve their uptake. [Studien Infos ausblenden] |
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ABOUT DATAMONITOR HEALTHCARE 2 About the Infectious Diseases and Respiratory pharmaceutical analysis team 2 CHAPTER 1 EXECUTIVE SUMMARY 4 Scope of the analysis 4 Datamonitor insight into the urinary tract infections market 4 Contributing experts 5 Related reports 6 Upcoming related reports 6 CHAPTER 2 EPIDEMIOLOGY AND DISEASE BACKGROUND 8 Etiology and symptoms 9 Types of urinary tract infections 9 Urethritis 9 Cystitis 10 Pyelonephritis 10 Asymptomatic bacteriuria 10 Acute urethral syndrome 11 Complicated and uncomplicated urinary tract infections 11 Pathogens 12 Escherichia coli is the major UTI pathogen, although its role is less prominent in the hospital setting 12 Data suggest that Escherichia coli is responsible for approximately half of all hospital UTI cases in the US and Canada 13 Italian data suggest a slightly less prominent role for Escherichia coli in community-acquired disease 14 Japanese data collected over a 20-year period suggest a less prominent role for Escherichia coli in Japan compared to Europe 16 Risk groups 17 General risk factors for urinary tract infection 17 Risk factors specific to women 17 Risk factors specific to men 18 Recurrent UTI 18 UTIs in children 18 Hospital-acquired UTIs 18 Epidemiological trends 19 150 million estimated cases of urinary tract infection worldwide each year 19 US 20 Robust data indicate over 10 million cases of UTI in the US in 2000 20 Differences in classification of urinary tract infection diagnoses across studies provides variation in estimated incidence 21 UTI incidence in the US has increased by 10.7% between 1995 and 2006 22 Women of all ages in the US face a considerable risk of UTI, although incidence is highest in young women 24 Study suggests over 11 million women in the US suffer from UTI each year 24 Nosocomial UTI contributes significantly to the burden of UTI in the US 25 Europe 25 Nosocomial UTI represents a major problem in European hospitals 25 UK 26 UK data suggest a higher incidence of UTI in older women 26 Low diagnosis rates may lead to conservative estimates of UTI incidence in the UK 27 Nosocomial UTI represents a substantial problem in the UK 27 Germany 27 Each year over 150,000 UTIs are contracted in German hospitals 27 France 28 UTI incidence rate in France is comparable to the US and UK 28 Italy 28 Nosocomial UTI prevalence data in Italy is comparable with that of the UK 28 No incidence data have been published for Japan or Spain 28 Economic burden of urinary tract infections 29 US expenditure on urinary tract infection up by 30% between 1994 and 2000 29 Inflation and population growth must be considered when considering UTI expenditure trends 29 Expensive therapies may drive increasing expenditure for UTI in the US 31 UTI contributes significantly to private healthcare costs 33 CHAPTER 3 PRESENTATION, DIAGNOSIS AND REFERRAL OPTIONS 34 Overview 35 Presentation 35 Diagnosis 36 Urine culture is the gold standard in the diagnosis, although most physicians rely on the presence of risk factors and/or dipstick testing 36 Diagnosis of UTI can be challenging in the elderly and children 37 Guidelines for the diagnosis and management of urinary tract infections are targeted at physicians across the seven major markets 37 Physicians have different perceptions of the level of bacteriuria that is clinically significant 39 Cost and time to results limits the use of urine culture to complicated urinary tract infection cases only 40 Physical examination 40 Urine samples 40 Urine appearance 40 Urine dipstick testing 41 Microscopy 42 Gram stain 42 Urine culture 42 Imaging techniques 44 Ultrasound 44 Nuclear scans 44 Magnetic resonance imaging or computed tomography 44 X-rays 45 Cystoscopy 45 Referral 45 Primary care physicians treat most urinary tract infections, although a referral may be made in complicated or recurrent cases 45 Suggestion of complicated urinary tract infection or an underlying urologic problem typically lead to hospitalization 46 Nosocomial urinary tract infections are treated by the attending physician 47 US organizations are working to educate both patients and physicians on urinary tract infections 47 CHAPTER 4 CURRENT TREATMENT OPTIONS AND TRENDS 49 Market overview 50 Treatment guidelines 54 Treatment options 55 Penicillins 55 Amoxicillin 55 Co-amoxiclav 56 Fluoroquinolones 56 Ciprofloxacin 56 Levofloxacin 57 Ofloxacin 57 Norfloxacin 57 Gatifloxacin 58 Trimethoprim products 58 Trimethoprim 58 Trimethoprim-sulfamethoxazole 59 Carbapenems 59 Imipenem and cilastatin 59 Doripenem 59 Older drugs 60 Nitrofurantoin 60 Fosfomycin 60 FDA notification of tendinitis and tendon rupture risk for fluoroquinolones 60 Resistance of bacterial pathogens to urinary tract infection therapies 61 Growing levels of bacterial resistance have rendered a number of leading urinary tract infection drugs ineffective in many regions 61 Increasing fluoroquinolone resistance threatens effectiveness of therapies and future treatment choices 63 Rapidly decreasing fluoroquinolone susceptibilities threaten first-line treatment choices for UTI across the five major EU markets 65 Resistance data suggest that aminopenicillins are an ineffective treatment option for UTIs across the five major EU markets 66 Falling fluoroquinolone susceptibility for Escherichia coli bacteria is a significant problem across the five major EU markets 68 Third generation cephalosporins remain effective in treating Escherichia coli across the five major EU markets, although their role for UTIs remains small 69 Up to a quarter of Escherichia coli isolates in hospitals in some areas of the US and Canada are resistant to fluoroquinolones 71 Japanese study suggests similar problems with Escherichia coli resistance to fluoroquinolones as identified in the US and Europe 72 Susceptibility and resistance data suggests more prominent future roles for nitrofurantoin and fosfomycin 72 French data highlight the problems of prescribing amoxicillin and trimethoprim-sulfamethoxazole and the potential usefulness of fosfomycin 74 Spanish data highlight the potential efficacy of nitrofurantoin and fosfomycin in the treatment of ESBL-producing strains of Escherichia coli 75 Emerging pathogens 77 Extended-spectrum beta-lactamase-producing Escherichia coli and methicillin-resistant Staphylococcus aureus pose an increasingly potent risk for UTIs 77 Treatment choice 80 Efficacy against pathogens is highly influential in treatment choice for urinary tract infections, although safety and cost also play a role 80 Treatment by site of infection 84 Cystitis 84 Urethritis 85 Pyelonephritis 86 CHAPTER 5 UNMET NEEDS AND NEW DEVELOPMENTS 89 Recently approved therapies and drugs in development for urinary tract infections 90 New drug approvals for uncomplicated urinary tract infections have been sparse over the past 5 years as the impact of generics grows 90 Doripenem 90 Sitafloxacin 91 Prulifloxacin 91 Higher dose, short-course regimen of Levofloxacin has received FDA approval 91 Pipeline drugs in late-stage development 91 NXL104/ceftazidime 91 Finafloxacin 93 Unmet needs and future developments 93 Treatment satisfaction 93 Variation in resistance patterns may be highly influential in the levels of UTI treatment satisfaction expressed by physicians 93 Unmet needs in the diagnosis of urinary tract infections 95 Education of physicians remains an issue despite widespread guideline publication 95 Unmet needs in the treatment of urinary tract infections 96 Surveillance of antimicrobial resistance patterns and development of novel therapies are paramount to maintaining effective treatment options for UTIs 96 Future developments 99 Researchers at UCLA are developing point-of-care technology for the detection of urinary tract bacterial pathogens 99 US researchers have recently suggested strategies for developing new virulence-targeted urinary tract infection therapies 100 BIBLIOGRAPHY 102 Journal papers 102 Websites 109 Other 115 APPENDIX A 116 Contributing experts 116 APPENDIX B 117 About Datamonitor 117 About Datamonitor Healthcare 117 About the Infectious Diseases and Respiratory pharmaceutical analysis team 118 Disclaimer 119 [Inhaltsverzeichnis ausblenden] |
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Table 1: Pathogens responsible for urinary tract infections in the community and hospital setting 13 Table 2: Pathogens isolated most frequently among community outpatients with a urinary tract infection in Brescia, Italy, 2002-05 14 Table 3: Pathogens isolated from urine of patients with a catheter-associated urinary tract infection in Brescia, Italy, 2002-05 15 Table 4: Pathogens most frequently isolated among hospital inpatients with a urinary tract infection in Brescia, Italy 16 Table 5: Estimated number of visits to physicians for UTI in the US, 2000 21 Table 6: Number of physician visits for urinary tract infection (site not specified) in the US, 1995-2006 23 Table 7: Number of physician visits for cystitis and other disorders of the bladder in the US, 1995-2006 23 Table 8: Number of physician visits for urinary tract infection (site not specified) and cystitis and other bladder disorders in the US, 1995-2006 24 Table 9: Annual incidence of urinary tract infection in the UK 27 Table 10: US expenditure on urinary tract infection, 1994-2000 30 Table 11: Expenditure on female and male urinary tract infection in the US and share of costs by site of service, 2000 30 Table 12: Average annual spending and use of outpatient prescription drugs for treatment of UTI (male and female), 1996-98 32 Table 13: Volume sales (standard units, 000s) for drugs used to treat urinary tract infections (UTIs) in the US and five major EU markets, 2007 52 Table 14: Value sales ($000s) for drugs used to treat urinary tract infections (UTIs) in the US and five major EU markets, 2007 53 Table 15: Aminopenicillin susceptibility results for Escherichia coli isolates in the five major EU markets, 2002-07 67 Table 16: Fluoroquinolone susceptibility results for Escherichia coli isolates in the five major EU markets, 2002-07 68 Table 17: Third generation cephalosporin susceptibility results for E. coli isolates in the five major EU markets, 2002-07 70 Table 18: Resistance rates of outpatient Escherichia coli isolates to urinary tract infection drugs in the US and Canada, April 2003-June 2004 72 Table 19: Antimicrobial resistance of Escherichia coli isolates from women with community and hospital acquired urinary tract infections in Rennes, France 75 Table 20: Antimicrobial susceptibility of Escherichia coli in 15 laboratories across nine regions in Spain, March-July 2002 76 Table 21: Antimicrobial resistance rates of Escherichia coli isolates in 15 laboratories across nine regions in Spain, February-June 2006 77 Figure 1: US expenditure on urinary tract infection (UTI), 1994-2000 31 Figure 2: Volume sales (standard units, 000s) for drugs used to treat urinary tract infections (UTIs) in the US and five major EU markets, 2007 52 Figure 3: Value sales ($000s) for drugs used to treat urinary tract infections (UTIs) in the US and five major EU markets, 2007 53 Figure 4: Aminopenicillin susceptibility results for Escherichia coli isolates in the five major EU markets, 2002-07 67 Figure 5: Fluoroquinolone susceptibility results for Escherichia coli isolates in the five major EU markets, 2002-07 69 Figure 6: Third generation cephalosporin susceptibility results for E. coli isolates in the five major EU markets, 2002-07 70 [Tabellenverzeichnis ausblenden] |
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