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1.
Transpl Infect Dis ; 19(5)2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28599091

RESUMO

BACKGROUND: We investigated the impact of early- (E-CMV) and late onset (L-CMV) cytomegalovirus disease on the probability of graft rejection, graft failure, mortality, and healthcare resource use, following solid organ transplantation (SOT) in France. METHODS: A retrospective analysis of data from the French 'Programme de Médicalisation des Systèmes d'Information' database (2007-2011) was conducted to identify SOT recipients who developed CMV disease in an inpatient setting. Recipients were stratified by time to CMV disease onset: E-CMV (≤3 months), L-CMV-3M (>3-24 months), and L-CMV-6M (>6-24 months). Data were analyzed by comparing recipients with CMV disease or without (controls) in a 1:2 ratio, matched according to age, gender, target organ, and previous/simultaneous occurrence of graft rejection. Graft failure, graft rejection, all-cause in-hospital mortality, and resource utilization (including hospitalization costs) were assessed over 12 months following CMV disease diagnosis. RESULTS: Among 20 473 SOT recipients, 2430 (11.86%) were reported to have CMV disease within 24 months after transplantation. CMV disease was significantly associated with an increased risk of graft rejection and mortality, as indicated by logistic regression analysis. Odd ratios (ORs) for the risk of graft rejection were E-CMV=1.43, L-CMV-3M=1.50, and L-CMV-6M=1.61 (all P<.05), while ORs for mortality were E-CMV=2.85, L-CMV-3M=4.22, and L-CMV-6M=4.77 (all P<.0001). Only L-CMV was significantly correlated with a higher risk of graft failure: E-CMV=1.18 (P=.1906), L-CMV-3M=1.77 (P=.0013), and L-CMV-6M=3.12 (P<.0001). Hospitalization costs increased by €7078 (range €6270-€22 111), €6523 (range €5328-€10 295), and €6311 (range €5295-€9184) in recipients with E-CMV, L-CMV-3M, and L-CMV-6-M, respectively. CONCLUSION: This study, based on French national data, demonstrates the considerable burden of CMV disease in SOT recipients and highlights the importance of developing new strategies to prevent and manage CMV disease and improve clinical outcomes for SOT patients.


Assuntos
Infecções por Citomegalovirus/epidemiologia , Infecções por Citomegalovirus/etiologia , Transplante de Órgãos/efeitos adversos , Transplantados , Estudos de Casos e Controles , Estudos de Coortes , França , Rejeição de Enxerto , Humanos , Incidência , Pacientes Internados , Razão de Chances , Transplante de Órgãos/mortalidade , Fatores de Risco , Análise de Sobrevida
2.
Qual Life Res ; 26(5): 1187-1195, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-27896711

RESUMO

OBJECTIVES: To assess changes in the health status of men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) using the EQ-5D-3L and OAB-5D instruments and to evaluate the sensitivity of the instruments. METHODS: Data were available from a large randomised phase III trial of men with moderate-to-severe storage and voiding LUTS/BPH (NEPTUNE). Men received a fixed-dose combination of solifenacin 6 mg plus oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS, 0.4 mg), TOCAS monotherapy or placebo and completed the EQ-5D-3L and OAB-5D at baseline and weeks 4, 8 and 12. Analysis of covariance was used to estimate changes in EQ-5D-3L Index, EQ-VAS and OAB-5D. Changes in dimension level were summarised using the Paretian Classification of Health Change (PCHC). RESULTS: Improved health-related quality of life from baseline was seen in all treatment arms on EQ-5D-3L and OAB-5D at week 12, although only OAB-5D showed statistically significant differences between active treatment and placebo, both on the index score and using the PCHC approach. Effect sizes in the active treatment groups were large (>0.8) on OAB-5D but small (≈0.2) on EQ-5D-3L. EQ-5D-3L showed a very high ceiling effect (45% of men reported full health at baseline) and a substantial proportion of these men reported improvements at week 12 in several dimensions of OAB-5D. CONCLUSIONS: A large ceiling effect on EQ-5D-3L substantially limited its sensitivity in this population. OAB-5D proved more sensitive to changes in health status and could be considered a complement to ED-5D-3L as a source of utilities for health economic modelling.


Assuntos
Sintomas do Trato Urinário Inferior/psicologia , Hiperplasia Prostática/complicações , Qualidade de Vida/psicologia , Idoso , Nível de Saúde , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/psicologia
3.
Neurourol Urodyn ; 35(8): 987-994, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-26288118

RESUMO

AIMS: To assess patient-reported outcomes (PROs) in patients with overactive bladder (OAB) receiving the novel ß3 -adrenoceptor agonist mirabegron. METHODS: Data from a randomised, double-blind, controlled phase III trial in 1,987 patients aged ≥18 years with OAB symptoms for ≥3 months were analysed. Patients received placebo, mirabegron 50 or 100 mg/day, or tolterodine extended release (ER) 4 mg orally once daily for 12 weeks after a 2-week placebo run-in. Prespecified analysis of PROs (changes in OAB Questionnaire [OAB-q], Patient Perception of Bladder Condition [PPBC], and Work Productivity and Activity Impairment: Specific Health Problem [WPAI-SHP] instrument) in patients treated with mirabegron 50 mg/day, tolterodine ER 4 mg/day or placebo is reported. Post-hoc analyses of OAB-q, PPBC and the Treatment Satisfaction-Visual Analogue Scale (TS-VAS) in patients who were incontinent at baseline are also reported. RESULTS: Significant improvements over placebo in OAB-q coping and concern from baseline to final visit were observed with mirabegron 50 mg/day. No significant improvements in these parameters were observed with tolterodine ER 4 mg/day. Mirabegron 50 mg/day significantly increased the proportion of patients showing a PPBC improvement over placebo. Mirabegron 50 mg/day also produced greater improvements in WPAI-SHP presenteeism and greater reductions in absenteeism and overall work impairment than placebo or tolterodine ER 4 mg/day. The impact of mirabegron 50 mg/day treatment on PROs in the incontinent population appears to be greater than that in the overall OAB population. CONCLUSIONS: At the approved dose of 50 mg/day, mirabegron significantly improves OAB patients' perception of disease and quality of life, independent of whether they are incontinent at baseline. Neurourol. Urodynam. 35:987-994, 2016. © 2015 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.


Assuntos
Acetanilidas/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Absenteísmo , Idoso , Método Duplo-Cego , Feminino , Humanos , Tampões Absorventes para a Incontinência Urinária/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/uso terapêutico , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Tartarato de Tolterodina/uso terapêutico , Resultado do Tratamento , Bexiga Urinária Hiperativa/complicações , Bexiga Urinária Hiperativa/psicologia
4.
BJU Int ; 117(1): 165-72, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25907003

RESUMO

OBJECTIVE: To evaluate the effect of a fixed-dose combination (FDC) of solifenacin and an oral-controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS) on health-related quality of life (HRQoL) in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: Men with moderate-to-severe storage symptoms and voiding symptoms were treated for 12 weeks with a FDC of solifenacin 6 or 9 mg plus TOCAS (0.4 mg), TOCAS monotherapy (0.4 mg) or placebo in a randomised, double-blind study (NEPTUNE). The co-primary endpoints were Total Urgency Frequency Score (TUFS) and total International Prostate Symptom Score (IPSS). HRQoL was assessed by several secondary endpoints: IPSS QoL index, overactive bladder questionnaire (OAB-q), and Patient Global Impression (PGI) scale. The correlation between symptom improvement (TUFS) and HRQoL was assessed by Spearman rank correlation coefficients. Single and double responder analyses, using subjective and objective measures, were also performed. RESULTS: In the responder analyses, men treated with a FDC of solifenacin 6 mg plus TOCAS consistently had significantly improved outcomes compared with placebo (8/8 responder analyses performed) and TOCAS (6/8 responder analyses performed). There was a significant correlation (P < 0.001) between the reduction in TUFS and the improvement in HRQoL defined by IPSS QoL score, OAB-q symptom bother score, PGI overall bladder symptoms and PGI general health. CONCLUSIONS: In men with LUTS/BPH who have moderate-to-severe storage symptoms and voiding symptoms, the reduction in symptoms with a once-daily FDC of solifenacin and TOCAS was associated with consistent patient-relevant improvements in HRQoL compared with placebo and TOCAS monotherapy.


Assuntos
Sintomas do Trato Urinário Inferior/tratamento farmacológico , Succinato de Solifenacina/uso terapêutico , Sulfonamidas/uso terapêutico , Agentes Urológicos/uso terapêutico , Método Duplo-Cego , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/complicações , Qualidade de Vida , Tansulosina
5.
Value Health ; 18(6): 783-90, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26409605

RESUMO

BACKGROUND: Mirabegron, a first-in-class selective oral ß3-adrenoceptor agonist, has similar efficacy to most antimuscarinic agents and a lower incidence of dry mouth in patients with overactive bladder (OAB). OBJECTIVES: To evaluate the cost-effectiveness of mirabegron 50 mg compared with oral antimuscarinic agents in adults with OAB from a UK National Health Service perspective. METHODS: A Markov model including health states for symptom severity, treatment status, and adverse events was developed. Cycle length was 1 month, and the time horizon was 5 years. Antimuscarinic comparators were tolterodine extended release, solifenacin, fesoterodine, oxybutynin extended release and immediate release (IR), darifenacin, and trospium chloride modified release. Transition probabilities for symptom severity levels and adverse events were estimated from a mirabegron trial and a mixed treatment comparison. Estimates for other inputs were obtained from published literature or expert opinion. Quality-adjusted life-years (QALYs) and total health care costs, including costs of drug acquisition, physician visits, incontinence pad use, and botox injections, were modeled. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Base-case incremental cost-effectiveness ratios ranged from £367 (vs. solifenacin 10 mg) to £15,593 (vs. oxybutynin IR 10 mg) per QALY gained. Probabilistic sensitivity analyses showed that at a willingness-to-pay threshold of £20,000/QALY gained, the probability of mirabegron 50 mg being cost-effective ranged from 70.2% versus oxybutynin IR 10 mg to 97.8% versus darifenacin 15 mg. A limitation of our analysis is the uncertainty due to the lack of direct comparisons of mirabegron with other agents; a mixed treatment comparison using rigorous methodology provided the data for the analysis, but the studies involved showed heterogeneity. CONCLUSIONS: Mirabegron 50 mg appears to be cost-effective compared with standard oral antimuscarinic agents for the treatment of adults with OAB from a UK National Health Service perspective.


Assuntos
Acetanilidas/economia , Acetanilidas/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/economia , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Custos de Medicamentos , Recursos em Saúde/economia , Antagonistas Muscarínicos/economia , Antagonistas Muscarínicos/uso terapêutico , Tiazóis/economia , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária Hiperativa/economia , Acetanilidas/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversos , Adulto , Teorema de Bayes , Pesquisa Comparativa da Efetividade , Simulação por Computador , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Recursos em Saúde/estatística & dados numéricos , Humanos , Cadeias de Markov , Modelos Econômicos , Antagonistas Muscarínicos/efeitos adversos , Seleção de Pacientes , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Índice de Gravidade de Doença , Medicina Estatal/economia , Tiazóis/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Reino Unido , Bexiga Urinária/efeitos dos fármacos , Bexiga Urinária/fisiopatologia , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia
6.
Clin Drug Investig ; 35(2): 83-93, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25491433

RESUMO

BACKGROUND: Overactive bladder (OAB) is highly prevalent and is associated with considerable morbidity and reduced health-related quality of life. ß3-adrenergic receptor (ß3-AR) stimulation is a novel alternative to antimuscarinic therapy for OAB. OBJECTIVE: The objective of this analysis was to assess the cost effectiveness of the ß3-AR agonist mirabegron relative to tolterodine extended release (ER) in patients with OAB from a UK National Health Service (NHS) perspective. METHODS: A Markov model was developed to simulate the management, course of disease, and effect of complications in OAB patients over a period of 5 years. Transition probabilities for symptom severity levels and probabilities of adverse events were estimated from the results of the randomised, double-blind SCORPIO trial in 1,987 patients with OAB. Other model inputs were derived from the literature and on assumptions based on clinical experience. RESULTS: Total 5-year costs per patient were £1,645.62 for mirabegron 50 mg/day and £1,607.75 for tolterodine ER 4 mg/day. Mirabegron was associated with a gain of 0.009 quality-adjusted life-years (QALYs) with an additional cost of £37.88. The resulting incremental cost-effectiveness ratio (ICER) was £4,386/QALY gained. In deterministic sensitivity analyses in the general OAB population and several subgroups, ICERs remained below the generally accepted willingness-to-pay (WTP) threshold of £20,000/QALY gained. The probability of mirabegron 50 mg being cost effective relative to tolterodine ER 4 mg was 89.4 % at the same WTP threshold. CONCLUSIONS: Mirabegron 50 mg/day is likely to be cost effective compared with tolterodine ER 4 mg/day for adult patients with OAB from a UK NHS perspective.


Assuntos
Acetanilidas/economia , Compostos Benzidrílicos/economia , Análise Custo-Benefício , Cresóis/economia , Fenilpropanolamina/economia , Tiazóis/economia , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/economia , Acetanilidas/administração & dosagem , Acetanilidas/uso terapêutico , Adulto , Compostos Benzidrílicos/administração & dosagem , Compostos Benzidrílicos/uso terapêutico , Cresóis/administração & dosagem , Cresóis/uso terapêutico , Método Duplo-Cego , Humanos , Fenilpropanolamina/administração & dosagem , Fenilpropanolamina/uso terapêutico , Qualidade de Vida , Tiazóis/administração & dosagem , Tiazóis/uso terapêutico , Tartarato de Tolterodina , Reino Unido , Bexiga Urinária Hiperativa/fisiopatologia , Agentes Urológicos/administração & dosagem , Agentes Urológicos/uso terapêutico
7.
Curr Med Res Opin ; 31(1): 43-50, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25333647

RESUMO

BACKGROUND: Real-world data on the pharmacological management of men who have lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are limited. OBJECTIVE: To characterize men with LUTS/BPH who had both storage and voiding symptoms and to evaluate treatment patterns in UK primary care. DESIGN, SETTING AND PARTICIPANTS: This was an observational study of men aged ≥45 years with a diagnosis, symptoms or therapies indicative of LUTS/BPH with both storage and voiding components. These men were identified from the large Health Improvement Network (THIN) database between 1 January 2004 and 30 September 2011. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Drug prescriptions and switching/discontinuation patterns for α1-blockers and antimuscarinics. RESULTS AND LIMITATIONS: We identified 8694 men with a median age of 66.0 (interquartile range [IQR], 59.0-74.0) years. Most (7850; 90.3%) received an α1-blocker, and 2167 (24.9%) received antimuscarinic therapy over a median of 2.1 years. The most commonly prescribed α1-blocker was tamsulosin (81.8%); most frequent antimuscarinics were tolterodine (41.0%), oxybutynin (37.2%) and solifenacin (35.7%). Concomitant prescription of α1-blocker and antimuscarinic therapy (within 30 days of each other) was received by 1160 men (14.8% of α1-blocker-treated men). Of α1-blocker recipients, 3024 (38.5%) discontinued during follow-up, while 1149 (53.0%) discontinued antimuscarinic therapy. Of 2167 men who received an antimuscarinic, 476 (22.0%) switched to another antimuscarinic. Of the three most commonly prescribed antimuscarinics, solifenacin had the lowest proportions of discontinuations (43.0%) and switches (15.3%), and the longest median duration of therapy (90 days, IQR 30-300). General practice consultations accounted for most resource use (5307.9 per 1000 patient-years). CONCLUSIONS: This study presents real-world management of men with LUTS/BPH who have both storage and voiding symptoms. The low proportion of men who received concomitant α1-blocker and antimuscarinic therapy suggests that some patients are sub-optimally treated in routine clinical practice.


Assuntos
Antagonistas de Receptores Adrenérgicos alfa 1/uso terapêutico , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Sintomas do Trato Urinário Inferior/etiologia , Antagonistas Muscarínicos/uso terapêutico , Atenção Primária à Saúde , Hiperplasia Prostática/complicações , Idoso , Compostos Benzidrílicos/uso terapêutico , Cresóis/uso terapêutico , Medicina de Família e Comunidade , Humanos , Masculino , Ácidos Mandélicos/uso terapêutico , Pessoa de Meia-Idade , Fenilpropanolamina/uso terapêutico , Hiperplasia Prostática/tratamento farmacológico , Quinuclidinas/uso terapêutico , Estudos Retrospectivos , Succinato de Solifenacina , Sulfonamidas/uso terapêutico , Tansulosina , Tetra-Hidroisoquinolinas/uso terapêutico , Tartarato de Tolterodina , Reino Unido
8.
J Med Econ ; 18(5): 390-7, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25488631

RESUMO

OBJECTIVE: To evaluate the costs and outcomes associated with different sequences of oral anti-muscarinic agents and the selective ß(3)-adrenoceptor agonist, mirabegron, for the treatment of overactive bladder (OAB). METHODS: A Markov model with monthly cycle length and time horizon up to 3 years was designed to compare two different sequences of up to three lines of oral therapy for OAB. Patients who discontinued one oral medication could switch to another oral medication or could discontinue treatment. Patients whose symptoms were not controlled were considered for botulinum toxin or sacral nerve stimulation. Outcomes were measured by (a) number of patients with controlled symptoms (no incontinence episodes and <8 micturitions per 24 h); (b) patients with no incontinence episodes per 24 hours; and (c) patients with <8 micturitions per 24 h. RESULTS: Including a third-line oral medication before considering other treatment options improved all patient outcomes, irrespective of the specific drugs used. A three-line sequence including two generic (oxybutynin first line and tolterodine extended-release second line) and one branded drug (solifenacin 5 mg third line) resulted in inferior patient outcomes at costs similar to a sequence of branded drugs (mirabegron first line, solifenacin 5 mg second line, solifenacin 10 mg third line): controlled patients (generic 29.6/1000 vs branded 38.7/1000); patients with no incontinence episodes (103.6/1000 vs 123.7/1000); patients with <8 micturitions (228.7/1000 vs 262.1/1000). Annual treatment costs per patient were similar (generic £1299 vs branded £1385). CONCLUSIONS: In the treatment of OAB, low-cost generic treatments are not necessarily more cost-effective than branded drugs, primarily because a better efficacy and tolerability balance improves both symptom control and persistence.


Assuntos
Acetanilidas/economia , Agonistas de Receptores Adrenérgicos beta 3/economia , Antagonistas Muscarínicos/economia , Tiazóis/economia , Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/economia , Acetanilidas/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Análise Custo-Benefício , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Cadeias de Markov , Antagonistas Muscarínicos/uso terapêutico , Programas Nacionais de Saúde , Tiazóis/uso terapêutico , Reino Unido , Agentes Urológicos/uso terapêutico
9.
Value Health ; 17(8): 823-9, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25498777

RESUMO

OBJECTIVE: To assess the reliability and validity of scores derived from the Patient Perception of Intensity of Urgency Scale (PPIUS) in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: A post hoc analysis of the phase II Solifenacin and Tamsulosin in Males with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia trial (NCT00510406), a 12-week clinical trial in men with LUTS associated with BPH, assessed the measurement properties of six PPIUS-derived scores: mean score; maximum urgency score; total urgency and frequency score (TUFS; average sum of urgency scores over 3 days); and numbers of urgency episodes, urgency episodes of grade 3 or 4, and urgency incontinence episodes. Test-retest reliability, presence of floor/ceiling effects, responsiveness to change, known-group validity, and concurrent validity were assessed for each score. RESULTS: A total of 901 patients had at least one valid PPIUS assessment after baseline. TUFS demonstrated good test-retest reliability (intraclass correlation coefficient >0.8), discriminated between groups defined based on International Prostate Symptom Score storage score severity (known-groups validity), had high concurrent validity, and had high responsiveness to change (Guyatt's responsiveness statistic 0.88), with an absence of floor or ceiling effects. The psychometric properties of other PPIUS-derived scores were not as consistently robust and showed either low-to-moderate responsiveness, presence of a floor or ceiling effect, or low-to-moderate test-retest reliability. CONCLUSIONS: This study shows that the PPIUS is reliable and valid in patients with LUTS associated with BPH. TUFS provided the best combination of psychometric properties of the six scores derived from the PPIUS and appeared to be an appropriate measure of urgency and frequency.


Assuntos
Sintomas do Trato Urinário Inferior/psicologia , Hiperplasia Prostática/psicologia , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Humanos , Sintomas do Trato Urinário Inferior/complicações , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/complicações , Hiperplasia Prostática/tratamento farmacológico , Psicometria , Quinuclidinas/uso terapêutico , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Succinato de Solifenacina , Sulfonamidas/uso terapêutico , Inquéritos e Questionários , Tansulosina , Tetra-Hidroisoquinolinas/uso terapêutico , Agentes Urológicos/uso terapêutico
10.
J Antimicrob Chemother ; 69(11): 2901-12, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25096079

RESUMO

OBJECTIVES: Fidaxomicin was non-inferior to vancomycin with respect to clinical cure rates in the treatment of Clostridium difficile infections (CDIs) in two Phase III trials, but was associated with significantly fewer recurrences than vancomycin. This economic analysis investigated the cost-effectiveness of fidaxomicin compared with vancomycin in patients with severe CDI and in patients with their first CDI recurrence. METHODS: A 1 year time horizon Markov model with seven health states was developed from the perspective of Scottish public healthcare providers. Model inputs for effectiveness, resource use, direct costs and utilities were obtained from published sources and a Scottish expert panel. The main model outcome was the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY), for fidaxomicin versus vancomycin; ICERs were interpreted using willingness-to-pay thresholds of £20,000/QALY and £30,000/QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS: Total costs were similar with fidaxomicin and vancomycin in patients with severe CDI (£14,515 and £14,344, respectively) and in patients with a first recurrence (£16,535 and £16,926, respectively). Improvements in clinical outcomes with fidaxomicin resulted in small QALY gains versus vancomycin (severe CDI, +0.010; patients with first recurrence, +0.019). Fidaxomicin was cost-effective in severe CDI (ICER £16,529/QALY) and dominant (i.e. more effective and less costly) in patients with a first recurrence. The probability that fidaxomicin was cost-effective at a willingness-to-pay threshold of £30,000/QALY was 60% for severe CDI and 68% in a first recurrence. CONCLUSIONS: Fidaxomicin is cost-effective in patients with severe CDI and in patients with a first CDI recurrence versus vancomycin.


Assuntos
Aminoglicosídeos/economia , Antibacterianos/economia , Infecções por Clostridium/economia , Clostridium difficile , Análise Custo-Benefício/métodos , Vancomicina/economia , Aminoglicosídeos/farmacologia , Aminoglicosídeos/uso terapêutico , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Infecções por Clostridium/tratamento farmacológico , Clostridium difficile/efeitos dos fármacos , Fidaxomicina , Humanos , Cadeias de Markov , Vancomicina/farmacologia , Vancomicina/uso terapêutico
11.
J Antimicrob Chemother ; 69(11): 2892-900, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25074856

RESUMO

OBJECTIVES: To evaluate the efficacy of fidaxomicin treatment, which has a limited effect on the normal gut flora, compared with vancomycin and metronidazole treatment in Clostridium difficile infections (CDIs). METHODS: A systematic literature review was conducted in July to August 2011 and updated in July 2013. For fidaxomicin versus vancomycin, efficacy was evaluated using meta-analysis of data from two Phase III direct comparative studies (n = 1164). As there were no studies comparing fidaxomicin and metronidazole, an indirect comparison was made using data from three vancomycin versus metronidazole studies (n = 345), using the methodology of Bucher et al. (J Clin Epidemiol 1997; 50: 683-91). This provides an OR for the indirect comparison of fidaxomicin versus metronidazole when direct evidence of fidaxomicin versus vancomycin and vancomycin versus metronidazole is available. RESULTS: Clinical cure rates were similar for fidaxomicin and vancomycin; the OR (95% CI) was 1.17 (0.82, 1.66). Recurrence [0.47 (0.34, 0.65)] was significantly lower and sustained cure rates [1.75 (1.35, 2.27)] significantly higher for fidaxomicin than vancomycin. Similar results were obtained in patient subgroups with severe CDI and with non-severe CDI. From the indirect comparison, the likelihood of recurrence [0.42 (0.18, 0.96)] and sustained cure [2.55 (1.44, 4.51)] were significantly improved for fidaxomicin versus metronidazole. Again, similar results were obtained in those with severe and non-severe CDI. CONCLUSIONS: Fidaxomicin provides improved sustained cure rates in patients with CDI compared with vancomycin. An indirect comparison indicates that the same is also true for fidaxomicin versus metronidazole. In view of these data, fidaxomicin may be considered as first-line therapy for CDI.


Assuntos
Aminoglicosídeos/uso terapêutico , Antibacterianos/uso terapêutico , Infecções por Clostridium/tratamento farmacológico , Clostridium difficile/efeitos dos fármacos , Metronidazol/uso terapêutico , Vancomicina/uso terapêutico , Ensaios Clínicos Fase III como Assunto/métodos , Infecções por Clostridium/diagnóstico , Enterocolite Pseudomembranosa/diagnóstico , Enterocolite Pseudomembranosa/tratamento farmacológico , Fidaxomicina , Humanos , Resultado do Tratamento
12.
Int J Equity Health ; 13: 20, 2014 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-24559409

RESUMO

BACKGROUND: Nigeria has included a regulated community-based health insurance (CBHI) model within its National Health Insurance Scheme (NHIS). Uptake to date has been disappointing, however. The aim of this study is to review the present status of CBHI in SSA in general to highlight the issues that affect its successful integration within the NHIS of Nigeria and more widely in developing countries. METHODS: A literature survey using PubMed and EconLit was carried out to identify and review studies that report factors affecting implementation of CBHI in SSA with a focus on Nigeria. RESULTS: CBHI schemes with a variety of designs have been introduced across SSA but with generally disappointing results so far. Two exceptions are Ghana and Rwanda, both of which have introduced schemes with effective government control and support coupled with intensive implementation programmes. Poor support for CBHI is repeatedly linked elsewhere with failure to engage and account for the 'real world' needs of beneficiaries, lack of clear legislative and regulatory frameworks, inadequate financial support, and unrealistic enrolment requirements. Nigeria's CBHI-type schemes for the informal sectors of its NHIS have been set up under an appropriate legislative framework, but work is needed to eliminate regressive financing, to involve scheme members in the setting up and management of programmes, to inform and educate more effectively, to eliminate lack of confidence in the schemes, and to address inequity in provision. Targeted subsidies should also be considered. CONCLUSIONS: Disappointing uptake of CBHI-type NHIS elements in Nigeria can be addressed through closer integration of informal and formal programmes under the NHIS umbrella, with increasing involvement of beneficiaries in scheme design and management, improved communication and education, and targeted financial assistance.


Assuntos
Acesso aos Serviços de Saúde , Seguro Saúde , Programas Nacionais de Saúde , Avaliação de Programas e Projetos de Saúde , Necessidades e Demandas de Serviços de Saúde , Humanos , Nigéria
13.
J Med Econ ; 16(11): 1344-56, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24003830

RESUMO

BACKGROUND: Systemic Candida infections (SCI) occur predominantly in intensive care unit patients and are a common cause of morbidity and mortality. Recently, changes in Candida epidemiology with an increasing prevalence of SCI caused by Candida non-albicans species have been reported. Resistance to fluconazole and azoles in general is not uncommon for non-albicans species. Despite guidelines recommending initial treatment with broad-spectrum antifungals such as echinocandins with subsequent switch to fluconazole if isolates are sensitive (de-escalation strategy), fluconazole is still the preferred first-line antifungal (escalation) in many clinical practice settings. After diagnosis of the pathogen, the initial therapy with fluconazole is switched to a broad-spectrum antifungal if a non-albicans is identified. METHODS: The cost-effectiveness of initial treatment with micafungin (de-escalation) vs fluconazole (escalation) in patients with SCI was estimated using decision analysis based on clinical and microbiological data from pertinent studies. The model horizon was 42 days, and was extrapolated to cover a lifetime horizon. All costs were analyzed from the UK NHS perspective. Several assumptions were taken to address uncertainties; the limitations of these assumptions are discussed in the article. RESULTS: In patients with fluconazole-resistant isolates, initial treatment with micafungin avoids 30% more deaths and successfully treats 23% more patients than initial treatment with fluconazole, with cost savings of £1621 per treated patient. In the overall SCI population, de-escalation results in 1.2% fewer deaths at a marginal cost of £740 per patient. Over a lifetime horizon, the incremental cost-effectiveness of de-escalation vs escalation was £15,522 per life-year and £25,673 per QALY. CONCLUSIONS: De-escalation from micafungin may improve clinical outcomes and overall survival, particularly among patients with fluconazole-resistant Candida strains. De-escalation from initial treatment with micafungin is a cost-effective alternative to escalation from a UK NHS perspective, with a differential cost per QALY below the 'willingness-to-pay' threshold of £30,000.


Assuntos
Antifúngicos/economia , Antifúngicos/uso terapêutico , Candidíase/tratamento farmacológico , Equinocandinas/economia , Equinocandinas/uso terapêutico , Lipopeptídeos/economia , Lipopeptídeos/uso terapêutico , Antifúngicos/administração & dosagem , Candidíase/economia , Candidíase/mortalidade , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Equinocandinas/administração & dosagem , Fluconazol/economia , Fluconazol/uso terapêutico , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Expectativa de Vida , Lipopeptídeos/administração & dosagem , Micafungina , Testes de Sensibilidade Microbiana , Anos de Vida Ajustados por Qualidade de Vida
14.
Int J Equity Health ; 12: 9, 2013 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-23339606

RESUMO

BACKGROUND: Nigeria and Ghana have recently introduced a National Health Insurance Scheme (NHIS) with the aim of moving towards universal health care using more equitable financing mechanisms. This study compares health and economic indicators, describes the structure of each country's NHIS within the wider healthcare system, and analyses impacts on equity in financing and access to health care. METHODS: The World Bank and other sources were used to provide comparative health and economic data. Pubmed, Embase and EconLit were searched to locate studies providing descriptions of each NHIS and empirical evidence regarding equity in financing and access to health care. A diagrammatical representation of revenue-raising, pooling, purchasing and provision was produced in order to analyse the two countries' systems. RESULTS: Over the period 2000-2010, Ghana maintained a marked advantage in life expectancy, infant mortality, under-5 year mortality, and has a lower burden of major diseases. Health care expenditure is about 5% of GDP in both countries but public expenditure in 2010 was 38% of total expenditure in Nigeria and 60% in Ghana. Financing and access are less equitable in Nigeria as, inter alia, private out-of-pocket expenditure has fallen from 80% to 66% of total spending in Ghana since the introduction of its NHIS but has remained at over 90% in Nigeria; NHIS membership in Nigeria and Ghana is approximately 3.5% and 65%, respectively; Nigeria offers a variable benefits package depending on membership category while Ghana has uniform benefits across all beneficiaries. Both countries exhibit improvements in equity but there is a pro-rich and pro-urban bias in membership. CONCLUSIONS: Major health indicators are more favourable in Ghana and overall equity in financing and access are weaker in Nigeria. Nigeria is taking steps to expand NHIS membership and has potential to expand its public spending to achieve greater equity. However, heavy burdens of poverty, disease and remote settings make this a substantial challenge. Ghana's relative success has to be tempered by the high number of exemptions through taxation and the threat of moral hazard. The results and methods are anticipated to be informative for policy makers and researchers in both countries and other developing countries more widely.


Assuntos
Acesso aos Serviços de Saúde/normas , Disparidades em Assistência à Saúde , Seguro Saúde/organização & administração , Programas Nacionais de Saúde/organização & administração , Gana , Gastos em Saúde , Acesso aos Serviços de Saúde/economia , Acesso aos Serviços de Saúde/organização & administração , Humanos , Expectativa de Vida , Programas Nacionais de Saúde/economia , Nigéria
15.
Drug Discov Today ; 17(11-12): 615-22, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22366662

RESUMO

Healthcare decision makers who determine funding for new medical technologies depend on manufacturers to provide evidence of the technology's efficacy, safety and cost-effectiveness. Constrained budgets and increasing reliance on formal health technology assessment (HTA) have created an abundance of external hurdles that manufacturers must navigate to ensure successful product commercialization. These demands have pushed pharmaceutical companies to adjust their internal structures to coordinate generation of appropriate evidence. In this article we summarize internal and external opportunities for manufacturers to establish a foundation of evidence for successful market access, starting in Phase I of development and continuing throughout the post-approval product lifecycle.


Assuntos
Biofarmácia/economia , Pesquisa Comparativa da Efetividade , Descoberta de Drogas/economia , Reembolso de Seguro de Saúde , Marketing/economia , Avaliação da Tecnologia Biomédica/economia , Análise Custo-Benefício , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Curr Med Res Opin ; 25(1): 239-50, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19210155

RESUMO

BACKGROUND: The objective of this study was to model the economic impact of optimal dosing of immune tolerance induction (ITI) in haemophilia patients with inhibitors. Evidence based research suggests that, in the right patient population characterised by ITI risk status, the use of high-dose ITI regimen in 'poor risk' patients, and the low-dose regimen in 'good risk' patients, would be the cost effective strategy. The model also explored the impact of anamnestic response (AR), a phenomenon which worsens patients' ITI risks. METHOD: A cost-minimisation technique was used to compare the cost of managing inhibitor patients whose bleeds were managed pre-ITI with an immunogenic bypassing agent, activated prothrombin complex concentrate (APCC), with patients previously on a non-immunogenic product, recombinant activated factor VII (rFVIIa). Patients were subsequently offered a low-dose or high-dose ITI regime depending on their ITI risk status. The study perspective was that of the United Kingdom NHS, hence, all resources used were based on UK costs. RESULTS: The model estimated the mean cost of managing inhibitor patients from detection of titres through ITI to be 959,250.39 pound sterling and 770,834.17 pound sterling in the APCC and rFVIIa treatment options, respectively. Meanwhile, the costs per effectively tolerised patients were 1,505,279 pound sterling and 1,196,706 pound sterling for APCC and rFVIIa treated patients, respectively. Of the incremental cost in the APCC-treated patients in the model, 129,367 pound sterling (68%) represents additional ITI cost attributable to anamnestic response to earlier treatment with an immunogenic bypassing agent (APCC). CONCLUSION: The study concludes that decreasing factor VIII usage during ITI, through the identification and management of 'good risk' ITI patients with low-dose protocol, while managing 'poor risk' patients with high-dose regimen, will significantly lower the cost of ITI. Furthermore, avoiding AR prior to ITI by using non-immunogenic bypassing agents to manage spontaneous bleeds also has the potential for significant cost savings.


Assuntos
Fator VIIa/uso terapêutico , Custos de Cuidados de Saúde , Hemofilia A/tratamento farmacológico , Tolerância Imunológica , Protrombina/uso terapêutico , Hemofilia A/imunologia , Humanos , Proteínas Recombinantes/uso terapêutico
17.
BJU Int ; 97(6): 1267-72, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16686724

RESUMO

OBJECTIVE: To evaluate the impact of the overactive bladder (OAB) on quality of life and health-related utility. PATIENTS AND METHODS: In a study conducted in Cardiff and Vale NHS Trust, patients were identified from an academic urology unit inpatient database for admissions and sent a postal survey. The survey pack comprised questionnaires on demography, urological functioning, health utility (EQ5D(index)), and health-related quality of life (Short Form-36, SF36). Respondents were classified according to general urinary status, frequency, urgency, and stress incontinence. RESULTS: Of 2193 surveys dispatched, 609 (27.8%) were returned; of these patients, 52% had incontinence, of whom 83% had both frequency and urgency, and 60% stress incontinence. Patients with stress incontinence reported a mean (sd) EQ5D(index) of 0.578 (0.331), compared to 0.714 (0.281) for all other patients (P < 0.001). From the SF36, respondents scored lowest in the role physical domain and highest in the mental domain, with mean scores of 33.8 and 72.1, respectively. Multivariate analysis of SF36 and EQ5D(index) scores, controlling for age, gender and body mass index, showed that incontinence was associated with a notable reduction in the EQ5D(index) and SF36 scores across all domains. CONCLUSION: This study showed a significant reduction in quality of life for all patient groups with OAB; in particular, stress incontinence had the greatest impact.


Assuntos
Qualidade de Vida , Incontinência Urinária/psicologia , Idoso , Índice de Massa Corporal , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Inquéritos e Questionários
18.
Eur Urol ; 49(3): 519-27, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16413656

RESUMO

OBJECTIVE(S): This study aimed to assess the resource utilisation, health benefits and cost-effectiveness of intra-detrusor injections of botulinum neurotoxin-A (BoNT/A) in patients with overactive bladder (OAB). METHODS: 101 patients with urodynamically-proven detrusor overactivity of either neurogenic (NDO; n = 63) or idiopathic (IDO; n = 38) origin received intra-detrusor injections of 200-300 units of BoNT/A in 20-30 ml saline as part of a research protocol. Twenty-nine patients received repeat injections after 7-26 months. Symptom severity and urodynamic parameters were assessed at 0, 4 and 16 weeks. The cost of therapy was quantified based on the NHS resources used by typical patients and was used to calculate the cost-effectiveness of BoNT/A compared with standard care from the perspective of the UK NHS. RESULTS: In an intent-to-treat analysis, 82% of patients showed a 25% or greater improvement in at least two out of five parameters (urinary frequency, urgency, urgency incontinence episodes, maximum cystometric capacity and maximum detrusor pressure) four weeks after treatment, reducing to 65% after 16 weeks. A 50% or greater improvement in the frequency of micturition, urgency or urgency incontinence was seen in 73% of patients at four weeks and 54% at 16 weeks. There were no significant differences between IDO and NDO patients in the proportion meeting these endpoints. Therapy cost pounds 826 per patient, with a cost-effectiveness ratio of pounds 617 per patient-year with > or = 25% clinical improvement. CONCLUSION(S): This study demonstrates that intra-detrusor BoNT/A is an effective treatment for OAB that is highly likely to be cost-effective in both idiopathic and neurogenic disease.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Fármacos Neuromusculares/uso terapêutico , Incontinência Urinária/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/economia , Análise Custo-Benefício , Feminino , Humanos , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Músculo Liso/efeitos dos fármacos , Reino Unido , Incontinência Urinária/economia
19.
Health Policy ; 77(3): 352-67, 2006 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16213624

RESUMO

The National Institute for Health and Clinical Excellence (NICE) issues mandatory guidance on health technologies to the UK NHS, based on clinical evidence, cost-effectiveness and other considerations. However, the exact factors considered, their relative importance and tradeoffs between them are not made explicit. Previous research modelled NICE decisions as a binary choice (accept/reject) dependent on cost-effectiveness, amongst other variables. This paper proposes and tests an alternative model of decision-making that may better represent the "yes, but..." nature of many NICE decisions. Decisions were categorised as "recommended for routine use", "recommended for restricted use" or "not recommended". The NICE appraisal process was modelled as a single decision between the three categories. Multinomial logistic regression techniques were used to evaluate the impact of: quantity/quality of clinical evidence; cost-effectiveness; decision date; existence of alternative treatments; budget impact; technology type. Results suggest that interventions supported by more randomised trials are more likely to be recommended and endorsed for routine use. Higher cost-effectiveness ratios increased the likelihood of interventions being rejected rather than recommended for restricted use but did not significantly affect the decision between routine and restricted use. Pharmaceuticals, interventions appraised early in the NICE programme and those with more systematic reviews were also less likely to be rejected, while patient group submissions made a recommendation for routine rather than restricted use more likely. The presence of factors affecting the decision between routine and restricted use but not that between routine use and rejection suggests that modelling these three outcomes reflects NICE decision-making more closely than binary-choice analyses.


Assuntos
Técnicas de Apoio para a Decisão , Avaliação da Tecnologia Biomédica/organização & administração , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicina Estatal , Reino Unido
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