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1.
Drug Discov Today ; 2020 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-32344040

RESUMO

To maintain orphan drug status at the time of market authorization, orphan medicinal products (OMPs) need to be assessed for all criteria, including significant benefit, by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). Subsequently, health technology assessment (HTA) organizations evaluate the same OMPs in their relative effectiveness assessments (REAs). This review investigates the similarities and differences between the two frameworks for six HTA organizations, including the European Network for HTA. We discuss differences between both assessment frameworks within five domains (clinical evidence used, patient population, intervention, comparators, and outcome measures) for all drugs. Five illustrative cases studies were selected for a qualitative review.

2.
Clin Pharmacol Ther ; 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-32236959

RESUMO

Assessments of clinical evidence vary between regulators and health technology assessment bodies, but precise differences remain unclear. To compare uncertainties raised on the clinical evidence of approved drugs, we analyzed assessments of regulators and health technology assessment (HTA) bodies in the United States and Europe. We found that US and European regulators report uncertainties related to safety for almost all drugs (85-94%), whereas HTA bodies reported these less (53-59%). By contrast, HTA bodies raised uncertainties related to effects against relevant comparators for almost all drugs (88-100%), whereas this was infrequently addressed by regulators (12-32%). Regulators as well as HTA bodies reported uncertainties related to the patient population for 60-95% of drugs. The patterns of regulator-HTA misalignment were comparable between the United States and Europe. Our results indicate that increased coordination between these complementary organizations is necessary to facilitate the collection of necessary evidence in an efficient and timely manner.

3.
Br J Clin Pharmacol ; 2020 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-32034790

RESUMO

AIMS: There is a trend for more flexibility in timing of evidence generation in relation to marketing authorization, including the option to complete phase III trials after authorization or not at all. This paper investigated the relation between phase II and III clinical trial efficacy in oncology. METHODS: All oncology drugs approved by the European Medicines Agency (2007-2016) were included. Phase II and phase III trials were matched based on indication and treatment and patient characteristics. Reported objective response rates (ORR), median progression-free survival (PFS) and median overall survival (OS) were analysed through weighted mixed-effects regression with previous treatment, treatment regimen, blinding, randomization, marketing authorization type and cancer type as covariates. RESULTS: A total of 81 phase II-III matches were identified including 252 trials. Mean (standard deviation) weighted difference (phase III minus II) was -4.2% (17.4) for ORR, 2.1 (6.7) months for PFS and -0.3 (5.1) months for OS, indicating very small average differences between phases. Differences varied substantially between individual indications: from -46.6% to 47.3% for ORR, from -5.3 to 35.9 months for PFS and from -13.3 to 10.8 months for OS. All covariates except blinding were associated with differences in effect sizes for at least 1 outcome. CONCLUSIONS: The lack of marked average differences between phases may encourage decision-makers to regard the quality of design and total body of evidence instead of differentiating between phases of clinical development. The large variability emphasizes that replication of study findings remains essential to confirm efficacy of oncology drugs and discern variables associated with demonstrated effects.

4.
Value Health ; 23(1): 10-16, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31952664

RESUMO

BACKGROUND: Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices. OBJECTIVE: To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs. METHODS: HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests. RESULTS: The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P<.01) and Scotland (from 21% to 71%, P<.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/Wales (from 50% to 14%, P<.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P<.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size. CONCLUSION: Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.

5.
Value Health ; 22(11): 1275-1282, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31708064

RESUMO

BACKGROUND: Despite increasing informal and formal use of unmet medical need (UMN) in drug development, regulation, and assessment, there is no insight into its definitions in use. This study aims to provide insight into the current definitions in use and to provide a starting point for a multi-stakeholder discussion on alignment. METHODS: A scoping and a gray literature review were performed to locate definitions of UMN in literature and on stakeholder websites. These definitions were categorized and then discussed among the multi-stakeholder author group via semistructured group discussions and open session workshops with a broader stakeholder audience. Issues with the formation of a common definition and mechanisms for use were discussed. RESULTS: The reviews yielded 16 definitions. Differences were evident, but all included 1 or more of the following elements: (adequacy of) available treatments (16 of 16: 100%), disease severity or burden (6 of 16: 38%), and patient population size (1 of 16: 6%). The stakeholder discussions led to a suggestion for a definition including the first 2 items and, depending on context, population size. The discussions also showed that quantification of UMN is highly dependent on the scope and the value framework in which it is used based on different stakeholder preferences and responsibilities. CONCLUSION: We encourage stakeholders that want to promote alignment on the concept of UMN to prospectively discuss the scope in which they want to apply the concept, what elements they find important for consideration in each case, and how they would measure UMN within the broader regulatory or value framework applicable.

6.
Appl Health Econ Health Policy ; 17(6): 883-893, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31317510

RESUMO

OBJECTIVES: The objective of this study was to construct an early economic evaluation for acalabrutinib for relapsed chronic lymphocytic leukaemia (CLL) to assist early reimbursement decision making. Scenarios were assessed to find the relative impact of critical parameters on incremental costs and quality-adjusted life-years (QALYs). METHODS: A partitioned survival model was constructed comparing acalabrutinib and ibrutinib from a UK national health service perspective. This model included states for progression-free survival (PFS), post-progression survival (PPS) and death. PFS and overall survival (OS) were parametrically extrapolated from ibrutinib publications and a preliminary hazard ratio based on phase I/II data was applied for acalabrutinib. Deterministic and probabilistic sensitivity analyses were performed, and 1296 scenarios were assessed. RESULTS: The base-case incremental cost-effectiveness ratio (ICER) was £61,941/QALY, with 3.44 incremental QALYs and incremental costs of £213,339. Deterministic sensitivity analysis indicated that survival estimates, utilities and treatment costs of ibrutinib and acalabrutinib and resource use during PFS have the greatest influence on the ICER. Probabilistic results under different development scenarios indicated that greater efficacy of acalabrutinib would decrease the likelihood of cost effectiveness (from 63% at no effect to 2% at maximum efficacy). Scenario analyses showed that a reduction in PFS did not lead to great QALY differences (- 8 to - 14% incremental QALYs) although it did greatly affect costs (- 47 to - 122% incremental pounds). For OS, the opposite was true (- 89 to - 93% QALYs and - 7 to - 39% pounds). CONCLUSIONS: Acalabrutinib is not likely to be cost effective compared with ibrutinib under current development scenarios. The conflicting effects of OS, PFS, drug costs and utility during PFS show that determining the cost effectiveness of acalabrutinib without insight into all parameters complicates health technology assessment decision making. Early assessment of the cost effectiveness of new products can support development choices and reimbursement processes through effective early dialogues between stakeholders.

7.
Clin Pharmacol Ther ; 105(3): 684-691, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30300938

RESUMO

This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access.


Assuntos
Aprovação de Drogas/métodos , Medicina Baseada em Evidências/métodos , Reembolso de Seguro de Saúde , Avaliação da Tecnologia Biomédica/métodos , Europa (Continente) , Medicina Baseada em Evidências/normas , Humanos , Reembolso de Seguro de Saúde/normas , Estudos Retrospectivos , Avaliação da Tecnologia Biomédica/normas
8.
JMIR Cancer ; 4(1): e11, 2018 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-29884607

RESUMO

BACKGROUND: An element of health technology assessment constitutes assessing the clinical effectiveness of drugs, generally called relative effectiveness assessment. Little real-world evidence is available directly after market access, therefore randomized controlled trials are used to obtain information for relative effectiveness assessment. However, there is growing interest in using real-world data for relative effectiveness assessment. Social media may provide a source of real-world data. OBJECTIVE: We assessed the extent to which social media-generated health data has provided insights for relative effectiveness assessment. METHODS: An explorative literature review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify examples in oncology where health data were collected using social media. Scientific and grey literature published between January 2010 and June 2016 was identified by four reviewers, who independently screened studies for eligibility and extracted data. A descriptive qualitative analysis was performed. RESULTS: Of 1032 articles identified, eight were included: four articles identified adverse events in response to cancer treatment, three articles disseminated quality of life surveys, and one study assessed the occurrence of disease-specific symptoms. Several strengths of social media-generated health data were highlighted in the articles, such as efficient collection of patient experiences and recruiting patients with rare diseases. Conversely, limitations included validation of authenticity and presence of information and selection bias. CONCLUSIONS: Social media may provide a potential source of real-world data for relative effectiveness assessment, particularly on aspects such as adverse events, symptom occurrence, quality of life, and adherence behavior. This potential has not yet been fully realized and the degree of usefulness for relative effectiveness assessment should be further explored.

9.
Qual Life Res ; 26(9): 2479-2488, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28401419

RESUMO

PURPOSE: The aim of this study is to investigate the role of health-related quality-of-life (QoL) data in relative effectiveness assessments (REAs) of new anti-cancer drugs across European jurisdictions, during health technology assessment procedures. METHODS: Comparative analysis of guidelines and publicly available REAs in six European jurisdictions of anti-cancer drugs approved by EMA between 2011 and 2013. RESULTS: Fourteen anti-cancer drugs were included, adding up to 79 REAs. Whilst all guidelines state that QoL is a relevant endpoint to determine the relative effectiveness of new cancer drugs, QoL data were included in only 54% of the 79 reports and their impact on the recommendations was limited. CONCLUSIONS: Whilst national guidelines recognize the relevance of QoL to determine the relative effectiveness of new anti-cancer drugs, this is not well-reflected in current assessments. Developing and implementing into REAs specific evidence requirements for QoL data would improve the use of this patient-centred outcome in future reimbursement and pricing decisions.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias/tratamento farmacológico , Qualidade de Vida/psicologia , Antineoplásicos/farmacologia , Estudos Transversais , Europa (Continente) , Humanos , Neoplasias/patologia , Neoplasias/psicologia , Estudos Retrospectivos
10.
Value Health ; 18(5): 663-72, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26297095

RESUMO

BACKGROUND: In many European jurisdictions, relative effectiveness assessments (REAs) of pharmaceuticals are performed during the reimbursement decision-making process. International collaboration in the production of these assessments may prevent the duplication of information in various jurisdictions. A first pilot of a joint REA (pazopanib for the treatment of renal cell carcinoma) was published in 2011. OBJECTIVE: The objective was to investigate how well the methods used in the joint REA match the methods used in the national/local assessments on the same topic. METHODS: National/local assessments from European jurisdictions, available in English language, were identified through a literature search and an e-mail request to health technology assessment organizations. Data were abstracted from joint and national/local assessments using a structured data abstraction form. Results were compared for differences and similarities. RESULTS: In total, five national/local reports were included (Belgium, England/Wales, France, The Netherlands, and Scotland). The general methods (indication, main comparator, main end points, main trial) were similar. The details of the assessment (e.g., exact wording of indication, additional comparators, additional trials included, and method of indirect comparison), however, varied. Despite these differences, the joint REA included nearly all comparators, end points, trials, and methods of analysis that were used in national/local REA reports. CONCLUSIONS: This study has shown overlap in the methods national/local REA bodies in Europe have chosen for a pazopanib REA for renal cell carcinoma, except for the use and methods of indirect comparisons. Although some additional comparators and outcomes differed between national/local REAs, they can be captured in a comprehensive joint REA.


Assuntos
Inibidores da Angiogênese/economia , Inibidores da Angiogênese/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/economia , Custos de Medicamentos , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/economia , Pirimidinas/economia , Pirimidinas/uso terapêutico , Sulfonamidas/economia , Sulfonamidas/uso terapêutico , Inibidores da Angiogênese/efeitos adversos , Carcinoma de Células Renais/diagnóstico , Pesquisa Comparativa da Efetividade , Comportamento Cooperativo , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Europa (Continente) , Humanos , Reembolso de Seguro de Saúde , Cooperação Internacional , Neoplasias Renais/diagnóstico , Modelos Econômicos , Pirimidinas/efeitos adversos , Sulfonamidas/efeitos adversos , Resultado do Tratamento
12.
Int J Technol Assess Health Care ; 30(5): 488-96, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25747557

RESUMO

OBJECTIVES: Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals. METHODS: Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model. RESULTS: The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report. CONCLUSIONS: The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.


Assuntos
Cooperação Internacional , Preparações Farmacêuticas/normas , Avaliação da Tecnologia Biomédica/normas , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Bases de Dados Factuais , Europa (Continente) , Humanos , Modelos Organizacionais , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Controle de Qualidade , Tecnologia Farmacêutica
13.
Int J Technol Assess Health Care ; 30(5): 521-9, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25747562

RESUMO

BACKGROUND: This article describes the lessons learned from an international pilot assessment using the first version of the HTA Core Model® and Guidelines for rapid Relative Effectiveness Assessment (REA) of pharmaceuticals based on input from three different perspectives: the assessors, the users (health technology assessment organisations) and the marketing authorisation holder. METHODS: A pilot assessment was performed of pazopanib for the treatment of advanced or metastatic renal cell carcinoma for which 54 individuals from 22 EUnetHTA member organisations from 16 European countries gave their contribution. The work was divided in eight domain teams. Subsequently, results of these domain teams were synthesised in one pilot report. Feedback on the outcomes of the pilot was gathered throughout the project and through structured surveys. RESULTS: The first version of the assessment was produced in six months and consisted of 55 question and answer pairs, 8 domain reports and a synthesis section that combined the results from the different domains. The organisation of the pilot required intense coordination. Main points of criticism on the assessment were the lengthiness of the document and overlap of information throughout the assessment. CONCLUSIONS: A reduction in the number of authoring organisations and individuals participating is necessary to avoid information overlap and increase efficiency in undertaking the assessment. Involving several organisations (e.g. five) in an in-depth review could still ensure the benefit of broad participation from various countries. The focus of a rapid REA should be on the first four domains of the Model.


Assuntos
Inibidores da Angiogênese/farmacologia , Cooperação Internacional , Pirimidinas/farmacologia , Sulfonamidas/farmacologia , Avaliação da Tecnologia Biomédica/organização & administração , Carcinoma de Células Renais/tratamento farmacológico , Pesquisa Comparativa da Efetividade , Europa (Continente) , Humanos , Neoplasias Renais/tratamento farmacológico , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Inquéritos e Questionários
14.
Value Health ; 15(6): 954-60, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22999147

RESUMO

OBJECTIVE: Assessment of the effectiveness compared with alternative treatment(s) plays an important role in many jurisdictions in determining the reimbursement status of pharmaceuticals. This type of assessment is often referred to as a relative effectiveness assessment (REA) and is carried out by many jurisdictions. Increased sharing of information across jurisdictions may save costs and reduce duplication. The objective of this study was to explore the main similarities and differences in the major methodological aspects of REA in multiple jurisdictions. METHODS: Data were gathered with a standardized data extraction form by searching publicly available information and by eliciting information from representatives at relevant organizations. RESULTS: Of the initially included 35 jurisdictions, data were gathered for 29 jurisdictions. There seem to be substantial similarities on the choice of the comparator, the role of indirect comparisons, and preferred end points in REAs (except for the use of health state utilities). Jurisdictions, however, differ in whether effectiveness (usual circumstances of health care practice) is estimated in case no (comparative) effectiveness data are available and how this is done. CONCLUSION: Some important methodological aspects for REA are approached in a similar way in many jurisdictions, indicating that collaboration on assessments may be feasible. Enhanced collaboration in the development of methods and best practices for REA between jurisdictions will be a necessary first step. Important topics for developing best practice are indirect comparisons and how to handle the gap between efficacy and effectiveness data in case good quality comparative effectiveness data are not yet available at the time of reimbursement decisions.


Assuntos
Conduta do Tratamento Medicamentoso , Pesquisa Comparativa da Efetividade/métodos , Mineração de Dados , Europa (Continente) , Humanos , Pesquisa Qualitativa , Eficiência Biológica Relativa
15.
Value Health ; 14(5): 777-84, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21839418

RESUMO

OBJECTIVE: Health technology assessments (HTAs) intend to inform real-world decisions. They often draw on data from explanatory trials and hence are not always applicable to the decision problem. HTAs may therefore not meet the needs of decision makers. Our objective was to develop and apply a checklist to: 1) systematically frame HTAs in a way that they are applicable to the decision problem; and 2) assess if a decision problem can be informed by an available HTA. METHODS: We reviewed published literature to identify factors that should be considered when framing HTAs for resource allocation decisions. The checklist was finalized in collaboration with clinicians and policy makers. We applied the checklist to the economic evaluation of trastuzumab in early breast cancer. We defined a reference case and for each study, retrieved through a systematic review, we examined if each factor was explicitly considered. RESULTS: A checklist was developed with 11 factors (e.g., clinical practice, consequences, and patient use). In the case of trastuzumab, most factors were considered by the 11 retrieved economic evaluations. Two factors, being the inclusion of all relevant comparators and professional use, were considered by none of the studies. CONCLUSIONS: We developed a comprehensive checklist with 11 factors to frame HTAs and to assess the applicability of HTAs to resource allocation decisions. Economic evaluations on trastuzumab considered some of these factors, but overlooked others. The proposed checklist assists in systematically considering all factors in developing the conceptual model of an HTA, to make HTAs better reflect the decision problem.


Assuntos
Lista de Checagem , Ensaios Clínicos como Assunto/métodos , Técnicas de Apoio para a Decisão , Alocação de Recursos para a Atenção à Saúde , Projetos de Pesquisa , Avaliação da Tecnologia Biomédica , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/economia , Neoplasias da Mama/patologia , Ensaios Clínicos como Assunto/economia , Análise Custo-Benefício , Medicina Baseada em Evidências , Feminino , Alocação de Recursos para a Atenção à Saúde/economia , Pesquisa sobre Serviços de Saúde , Humanos , Modelos Econômicos , Avaliação da Tecnologia Biomédica/economia , Trastuzumab , Resultado do Tratamento
16.
Dyslexia ; 17(3): 256-67, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21793122

RESUMO

Studies of interventions for dyslexia have focused entirely on outcomes related to literacy. In this study, we considered a broader picture assessing improved quality of life compared with costs. A model served as a tool to compare costs and effects of treatment according to a new protocol and care as usual. Quality of life was measured and valued by proxies using a general quality-of-life instrument (EQ-5D). We considered medical cost and non-medical cost (e.g. remedial teaching). The model computed cost per successful treatment and cost per quality adjusted life year (QALY) in time. About 75% of the total costs was related to diagnostic tests to distinguish between children with severe dyslexia and children who have reading difficulties for other reasons. The costs per successful treatment of severe dyslexia were €36 366. Successful treatment showed a quality-of-life gain of about 11%. At primary school, the average cost per QALY for severe dyslexia amounted to €58 647. In the long term, the cost per QALY decreased to €26 386 at secondary school and €17 663 thereafter. The results of this study provide evidence that treatment of severe dyslexia is cost-effective when the investigated protocol is followed.


Assuntos
Análise Custo-Benefício/métodos , Dislexia/economia , Dislexia/terapia , Adolescente , Análise de Variância , Criança , Protocolos Clínicos , Dislexia/psicologia , Feminino , Humanos , Masculino , Modelos Teóricos , Qualidade de Vida/psicologia , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Resultado do Tratamento
17.
Pharmacoepidemiol Drug Saf ; 16(6): 668-74, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17072916

RESUMO

PURPOSE: To determine the association between opioid use and the occurrence of postoperative paralytic ileus (POI) after different types of surgery. METHODS: The PHARMO database was used to perform a case control study in which intramural drug utilisation data were linked to hospital discharge diagnoses. All patients admitted for digestive, abdominal or genito-urinary surgeries were selected in 1998-2003. Cases with coded POI (ICD-9-CM 560.1 and 564.4) and controls with no POI were matched 1:10. The association between coded POI and opioid use was assessed using conditional logistic regression. RESULTS: In 0.2% of all admissions (total of 180,279), patients developed POI and in 18% of all admissions, patients received opioids. Three hundred and sixty-six cases with POI were selected with their matching controls. The use of (nico)morphine was associated with the risk for developing POI (odds ratio (OR) 12.1, 95% confidence interval (CI) 5.4-27.1). The association between opioids and POI was most obvious in patients with abdominal surgery (OR 33.8, 95% CI 6.2-184.6) and patients without colon/colorectal/rectal tumours (OR 13.2, 95%CI 5.7-30.3). CONCLUSION: This study demonstrated a distinct association between the use of opioids, in particular natural opium alkaloids, and the risk for coded POI.


Assuntos
Analgésicos Opioides/efeitos adversos , Íleus/induzido quimicamente , Complicações Pós-Operatórias/induzido quimicamente , Adulto , Idoso , Estudos de Casos e Controles , Feminino , Humanos , Íleus/epidemiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia
18.
Pharmacoepidemiol Drug Saf ; 16(2): 166-72, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16700086

RESUMO

PURPOSE: To assess recent and to predict future time trends in the incidence of osteoporosis using routine databases in The Netherlands in the period 1993-2015 and to compare estimations based on hip fractures versus a proxy based on pharmacy and hospitalisation data. METHODS: The incidence of hip fractures was estimated over the period 1986-2002 using information from the Dutch Medical Registry, covering more than 99% of all Dutch hospitalisations. Additionally, a proxy (hospitalisation for osteoporosis or osteoporotic fractures, treatment with glucocorticosteroids or treatment with anti-osteoporosis drugs) was constructed in order to identify osteoporotic patients in the PHARMO database. Age and gender specific incidences of hip fractures and osteoporosis were calculated and extrapolated to The Netherlands. Results of both studies were extrapolated till 2015 using a power function. RESULTS: The incidence of hip fractures decreased slightly (270 per 100,000 in 1993, 260 per 100,000 in 2002). The incidence of osteoporosis using the constructed proxy decreased from 870 per 100,000 in 1993 to 700 per 100,000 in 2002. The incidence of hip fractures and osteoporosis remained fairly constant when modelled till 2015. Both studies showed the same time trends. CONCLUSION: Both the estimations based on the hospitalisations for hip fracture and on our proxy for osteoporosis showed that the increase in the incidence of osteoporosis as observed in the 1990s is levelling off. Due to ageing of the population the absolute number of hip fractures will however increase. Our definition of osteoporosis resulted in a higher estimation of the incidence of osteoporosis and may be used in future studies to follow developments in osteoporosis prevalence and incidence.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Fraturas do Quadril/epidemiologia , Hospitalização/estatística & dados numéricos , Osteoporose/epidemiologia , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Prescrições de Medicamentos/estatística & dados numéricos , Epidemiologia/tendências , Feminino , Fraturas do Quadril/etiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Osteoporose/complicações , Osteoporose/tratamento farmacológico , Valor Preditivo dos Testes , Sistema de Registros , Distribuição por Sexo , Fatores de Tempo
19.
Eur Heart J ; 28(2): 154-9, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17158123

RESUMO

AIMS: To investigate the 'real world' effectiveness of robust statin therapy, focusing on the effect of dose and early treatment discontinuation on the risk of hospitalization for acute myocardial infarction (AMI). METHODS AND RESULTS: In the PHARMO database, including among others drug-dispensing and hospital discharge records for more than two million subjects in the Netherlands, 59,094 new users of statins in the period 1 January 1991 until 31 December 2004, >or=18 years of age were identified. In these patients, exposure to statins, both in terms of persistence and dose, was determined over the first two treatment years. To determine the risk for AMI, patients were followed from this 2-year time point until the first hospital admission for AMI, death, or end of the study period. A total of 31,557 patients (53%) discontinued statin use within 2 years; 20 883 patients (35%) were persistent users with an average equipotent dose>or=4. A 30% reduction in risk of hospitalization for AMI with persistent statin use was observed. The protective effect increased with a higher dose (20 and 40% risk reduction with an equipotent doseor=4, respectively). CONCLUSION: These results show that statins are suboptimally used in real life for having the maximum benefit in terms of preventing AMI.


Assuntos
Fidelidade a Diretrizes , Hospitalização/estatística & dados numéricos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Guias de Prática Clínica como Assunto , Adulto , Idoso , Estudos de Coortes , Humanos , Pessoa de Meia-Idade , Fatores de Risco
20.
Pharmacoepidemiol Drug Saf ; 15(7): 454-61, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16733834

RESUMO

Results from clinical trials and clinical practice have shown statins to be generally well tolerated with a low frequency of clinically relevant side effects. Nevertheless, there are rare occasions when adverse events (AEs), sometimes serious, may occur. Rosuvastatin is the newest statin to be approved in the USA and many other countries. As part of the continued assessment of the benefit-risk profile of rosuvastatin, AstraZeneca has developed a progressive, comprehensive pharmacoepidemiology programme to complement safety data obtained from randomised clinical trials and spontaneous reporting systems, which have demonstrated that rosuvastatin has a safety profile in line with comparator statins. This programme comprises nine studies conducted in recognised centres of excellence assessing over 50,000 patients treated with rosuvastatin. It consists of three components: patient characteristics studies (four studies), safety evaluation studies (four studies); and review of data generated from the Prescription-Event Monitoring (PEM) study, designed and run by an independent third party. Patient characteristics studies are designed to describe the characteristics and drug utilisation patterns of new users of rosuvastatin compared with new users of other statins in automated databases. Safety evaluation studies will examine the rates of specific AEs in different cohorts of statin users and determine risk factors for these events using data recorded prospectively in automated databases with case adjudication via medical record review. The independent PEM study will monitor any significant events recorded by general practitioners since starting rosuvastatin treatment. This article is an overview of the rationale and methodology of the rosuvastatin pharmacoepidemiology programme.


Assuntos
Fluorbenzenos/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Pirimidinas/efeitos adversos , Sulfonamidas/efeitos adversos , Canadá , Bases de Dados como Assunto , Humanos , Países Baixos , Farmacoepidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Rosuvastatina Cálcica , Segurança , Reino Unido , Estados Unidos
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