Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 2.059
Filtrar
1.
Chimia (Aarau) ; 73(12): 1012-1017, 2019 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-31883553

RESUMO

Pharmacoepidemiology is the study of the safety and effectiveness of medications following market approval. The increased availability and size of healthcare utilization databases allows for the study of rare adverse events, sub-group analyses, and long-term follow-up. These datasets are large, including thousands of patient records spanning multiple years of observation, and representative of real-world clinical practice. Thus, one of the main advantages is the possibility to study the real-world safety and effectiveness of medications in uncontrolled environments. Due to the large size (volume), structure (variety), and availability (velocity) of observational healthcare databases there is a large interest in the application of natural language processing and machine learning, including the development of novel models to detect drug-drug interactions, patient phenotypes, and outcome prediction. This report will provide an overview of the current challenges in pharmacoepidemiology and where machine learning applications may be useful for filling the gap.


Assuntos
Ciência de Dados , Farmacoepidemiologia , Bases de Dados Factuais , Humanos , Aprendizado de Máquina , Medicina de Precisão
2.
Handb Exp Pharmacol ; 260: 433-451, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31768750

RESUMO

At the time of their marketing authorization, the effects of drugs and especially their efficacy have been mostly studied in randomized controlled clinical trials (RCT), comparing them to placebo or to existing drugs. However, RCT are by nature limited in their extent, and the often stringent inclusion and exclusion criteria destined to provide for homogeneous study populations reduce the generalizability of RCT results.The post-authorization evaluation of drugs (pharmacoepidemiology or real-world evidence (RWE)) covers the description of drug utilization and population risks or benefits of these drugs after they have been marketed and provided to their target populations. Though field studies have existed for a long time, modern pharmacoepidemiology has been made possible essentially by the emergence of large population databases compiled from claims data or electronic health records. The methods can be exposure or disease-based cohorts or event-driven case-based studies, tailored to the specific questions to be answered. They rely on scrupulous analysis and execution of impeccable methodology, to ensure the most reliable results possible.Pharmacoepidemiology requires knowledge of the pharmacology of drugs, of the clinical aspects of diseases and disease management, and of the epidemiological methods that can apply.


Assuntos
Farmacoepidemiologia/tendências , Bases de Dados Factuais , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(10): 1186-1190, 2019 Oct 10.
Artigo em Chinês | MEDLINE | ID: mdl-31658514

RESUMO

Pharmacoepidemiology refers to the use of epidemiological research methods in studying the application and use of drugs in large populations to evaluate the safety and efficacy of medical products. Therefore, standardized pharmacoepidemiology research is the basis of the above work. Based on systematic reviews of national and international pharmacoepidemiological methodological standards and guidelines, and in combination with Chinese medical and health practice and experts' opinions, the Professional Committee of Pharmacoepidemiology of Chinese Pharmaceutical Association developed the group standard, guide on methodological standards in pharmacoepidemiology (T/CPHARMA 002-2019), to better guide the work of pharmacoepidemiology. The guideline was designed to provide advice and reference for pharmacoepidemiology research by government, regulatory agencies, research institutions, and pharmaceutical manufacturers in China.


Assuntos
Farmacoepidemiologia/métodos , Farmacoepidemiologia/normas , Projetos de Pesquisa/normas , China , Guias como Assunto , Revisão Sistemática como Assunto
5.
Artigo em Inglês | MEDLINE | ID: mdl-31413891

RESUMO

Background: Trends in the use of antipsychotics and alpha agonists for the treatment of tic disorders in Canadian children, and how closely these trends align with evidence-based guidelines on the pharmacotherapy of tic disorders, have not been explored. Methods: IQVIA's Canadian Disease and Therapeutic Index, a survey-based data set, was used to identify prescription patterns by physicians. Respondents recorded all patient visits during a 48-hour period in each quarter of the year, including patient age, gender, drug recommendation and therapeutic indication. Recommendations for alpha agonists and antipsychotics from 2012 to 2016 were analysed for children and adolescents with tic disorders. Results: Risperidone and clonidine were the most commonly recommended medications for tic disorders over the study period, with 36,868 and 35,500 recommendations in 2016, respectively. Recommendations for clonidine increased over the study period, whereas those for risperidone decreased. Guanfacine (approved in Canada in 2013) was used less frequently than clonidine. Clonidine was more frequently recommended than antipsychotics in children younger than 6, in whom antipsychotic recommendations were uncommon. Aripiprazole was the second most commonly recommended antipsychotic for tic disorders, with 22,892 recommendations in 2016. Of the first-generation antipsychotics, pimozide was most commonly recommended (11,334 recommendations in 2016); haloperidol was infrequently recommended. Discussion: The trends observed are in line with guideline recommendations reflected in the decreasing use of risperidone, and the growing use of clonidine and guanfacine. The growing use of aripiprazole is likely due to emerging evidence from clinical trials supporting its efficacy for tics. Recommendations for pimozide and haloperidol were limited, likely due to the greater adverse effects associated with these medications.


Assuntos
Antipsicóticos/uso terapêutico , Prescrições/estatística & dados numéricos , Transtornos de Tique/tratamento farmacológico , Síndrome de Tourette/tratamento farmacológico , Adolescente , Aripiprazol/uso terapêutico , Criança , Pré-Escolar , Feminino , Guanfacina/uso terapêutico , Humanos , Lactente , Masculino , Farmacoepidemiologia , Risperidona/uso terapêutico , Transtornos de Tique/epidemiologia
6.
BioDrugs ; 33(4): 345-352, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31313085

RESUMO

Several controversial issues related to challenges in the post-marketing studies of biological drugs, including biosimilars, were discussed at the International Society for Pharmacoepidemiology (ISPE) 2019 Mid-Year Meeting in Rome (Italy) in April. In recent years, the marketing of biosimilars has been growing, thus offering opportunities for wider access by patients to high-cost biological drugs as well as ensuring the economic sustainability of national healthcare systems. Through the comparability exercise required for marketing approval, the similarity of biosimilars to the reference products in terms of efficacy, safety and quality has to be demonstrated in pre-marketing studies. In Europe, the 15 years of experience of marketing of biosimilars has allowed the accumulation of a significant amount of scientific evidence confirming the comparability of the benefit-risk profile of biosimilars and originators. However, some aspects remain to be addressed both from a scientific and regulatory perspective, such as interchangeability and the automatic substitution of originators and biosimilars. The (long-term) monitoring of all biological drugs, including biosimilars, in real-world settings is warranted, with the ultimate goal of integrating pre- and post-marketing evidence relating to the aforementioned open questions. This conference report describes priorities, data sources and methodological strategies for the post-marketing surveillance of biological drugs in the era of biosimilars.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Farmacoepidemiologia/métodos , Vigilância de Produtos Comercializados/métodos , Congressos como Assunto , Cooperação Internacional , Medição de Risco/métodos , Roma , Sociedades Científicas , Fatores de Tempo
7.
Int J Clin Pharmacol Ther ; 57(9): 445-449, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31262397

RESUMO

OBJECTIVE: To assess the value and representativeness of the Zuellig Pharma Korea Consortium (ZPK-C) database, which contains drug wholesales data collected in a weekly interval, for its prospective use as a data source for pharmacoepidemiology studies. MATERIALS AND METHODS: Wholesales and nationwide claims data of antidiabetic and antihypertensive products were compared in 17 administrative regions using the defined daily dose per 100,000 inhabitants per day (DID) and its proportion for standardized evaluation. RESULTS: We found regional concordance in 12 and 13 regions (out of 17) for antidiabetic and antihypertensive products, respectively, of which concordance was higher in rural than metropolitan regions. CONCLUSION: The ZPK-C showed potential as a valuable data source for pharmacoepidemiology research.


Assuntos
Bases de Dados de Produtos Farmacêuticos , Farmacoepidemiologia , República da Coreia
8.
Medicina (Ribeiräo Preto) ; 52(3)jul.-set. 2019.
Artigo em Português | LILACS | ID: biblio-1025540

RESUMO

RESUMO Modelo de estudo: Trata-se de um estudo do tipo observacional, descritivo e transversal. Objetivo: Avaliar o comportamento de adesão ao tratamento antirretroviral de pessoas convivendo com HIV/aids que participam de um Grupo de Adesão. Métodos: O questionário foi respondido por 15 pacientes maiores de 18 anos, independente do sexo, com diagnóstico confirmado de AIDS que participam de um Grupo de Adesão em um serviço de dispensação de antirretrovirais, e que após receberem informações pertinentes ao estudo, aceitaram participar voluntariamente, por meio da assinatura do Termo de Consentimento Livre e Esclarecido. Resultado: A maioria dos participantes era do sexo masculino, acima de 40 anos (73,3%) e 26,6% eram economicamente ativos. Quanto à sexualidade, 80% dos entrevistados declararam ser heterossexual. Quanto à escolaridade, 60% não havia completado o ensino médio. O tempo de diagnóstico da doença predominante foi entre 10 e 16 anos, sendo que 46,6% referiram possuir outros problemas de saúde, como toxoplasmose, herpes, tuberculose e leishmaniose. A análise do questionário de adesão mostrou que 33,3% possuía uma boa adesão ao tratamento antirretroviral. Entre as interações droga-droga identificadas, 44,4% ocorreram entre os antirretrovirais. Conclusão: A partir da realização deste estudo foi possível concluir que 66,66% dos entrevistados relataram que em algum momento houve uma descontinuidade do tratamento, revelando uma dificuldade na manutenção do uso dos antirretrovirais em indivíduos convivendo com HIV/AIDS. No contexto da farmacoepidemiologia antirretroviral, as potenciais interações medicamentosas identificadas neste estudo foram eventos que afetam a resposta terapêutica levando a toxicidade (AU)


Study design: This is an observational, descriptive, and cross-sectional study. Objective: Evaluating the adher-ence behavior to the antiretroviral treatment of people living with HIV/Aids who participate in an Adherence Group. Methods: The questionnaire was answered by 15 patients older than 18 years of age, regardless of sex, with a confirmed diagnosis of AIDS participating in an Adherence Group at an antiretroviral dispensing service, who, after receiving information related to the study, agreed to participate voluntarily, by singing the Written Informed Consent Form. Results: The majority of the participants were male, over 40 years old (73.3%) and 26.6% were economically active. Regarding sexuality, 80% of the interviewees stated that they were heterosexual. As for schooling, 60% had not finished high school. The time of diagnosis of the disease predominant was between 10 and 16 years, and 46.6% reported having other health problems, like toxoplasmosis, herpes, tuberculosis, and leishmaniasis. The analysis of the adherence questionnaire showed that 33.3% had good adherence to antiretroviral treatment. Among the drug-drug interactions identified, 44.4% occurred among antirretrovirals. Conclusion: Based on this study, it was possible to conclude that 66,66% at some point there was a discontinuation of treatment, revealing a difficulty in maintaining antiretroviral use in individuals living with HIV/aids. In the scenario of antiretroviral pharmacoepidemiology, the po-tential drug interactions identified in this study were events that affect the therapeutic response leading to toxicity (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Infecções por HIV , Síndrome de Imunodeficiência Adquirida , Farmacoepidemiologia , Fármacos Anti-HIV , Adesão à Medicação
10.
Eur J Clin Pharmacol ; 75(8): 1125-1133, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30949726

RESUMO

PURPOSE: Multi-morbidity and polypharmacy are common among older people. It is essential to provide a better understanding of the complexity of prescription drug use among older adults to optimise rational pharmacotherapy. Population-based utilisation data in this age group is limited. Using the Danish nationwide health registries, we aimed to characterise drug use among Danish individuals ≥ 60 years. METHODS: This is a descriptive population-based study assessing drug prescription patterns in 2015 in the full Danish population aged ≥ 60 years. The use of specific therapeutic subgroups and chemical subgroups and its dependence on age were described using descriptive statistics. Profiles of drug combination patterns were evaluated using latent class analysis. RESULTS: We included 1,424,775 residents (median age 70 years, 53% women). Of all the older adults, 89% filled at least one prescription during 2015. The median number of drug groups used was five per person. The most used single drug groups were paracetamol and analogues (34%), statins (33%) and platelet aggregation inhibitors (24%). Eighteen drug profiles with different drug combination patterns were identified. One drug profile with expected use of zero drugs and 11 drug profiles expected to receive more than five different therapeutic subgroup drugs were identified. CONCLUSION: The use of drugs is extensive both at the population level and increasing with age at an individual level. Separating the population into different homogenous groups related to drug use resulted in 18 different drug profiles, of which 11 drug profiles received on average more than five different therapeutic subgroup drugs.


Assuntos
Uso de Medicamentos/estatística & dados numéricos , Farmacoepidemiologia/estatística & dados numéricos , Polimedicação , Medicamentos sob Prescrição/uso terapêutico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Dinamarca/epidemiologia , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros/estatística & dados numéricos
12.
Z Kinder Jugendpsychiatr Psychother ; 47(6): 542-546, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31012801

RESUMO

This review starts from the finding that there is strong persistence of ADHD problems into adult life, despite the availability of effective treatment with stimulants and other drugs. Short-term trials in adults reveal that those drugs can still be efficacious in adults. Pharmacoepidemiology studies, on the other hand, clearly show that most young people discontinue medication during adolescence. Neuropharmacology research suggests a waning of stimulant effects after a few years. Longitudinal studies are scarce but provide some evidence that prognosis is often determined by factors other than the core symptoms of inattentiveness and impulsive overactivity. The implications for clinical practice are discussed. Continuing care, especially during the follow-up after initial therapy, needs further development.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/administração & dosagem , Estimulantes do Sistema Nervoso Central/uso terapêutico , Farmacoepidemiologia , Humanos , Estudos Longitudinais , Prognóstico , Resultado do Tratamento
13.
Maturitas ; 123: 55-60, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31027678

RESUMO

OBJECTIVES: To assess how women in Sweden with breast cancer (BC), endometrial cancer (EC), and/or pulmonary embolism (PE) were dispensed menopausal hormone therapy (HT). STUDY DESIGN: A retrospective study of Swedish women aged 40 years or more on 31 December 2005 (n = 2,863,643), followed through to December 2011. The study analysed three mandatory national healthcare registries: the Swedish Prescribed Drug Register, the National Inpatient Register and the Cancer Register. New users were defined as having a first dispensation after at least a 9-month break, and thus were possible to identify from April 2006. New users with at least one of the diagnoses BC, EC or PE before the first dispensation were classified as having a relative or absolute contraindication for HT. MAIN OUTCOME MEASURES: The relative risks of having HT dispensed after being diagnosed with BC, EC and/or PE. RESULTS: In total, 171,714 women had at least one of the diagnoses BC, EC or PE. The relative risk of having hormone therapy dispensed (current and new users) after being diagnosed with any of the diagnoses was significantly lower (PE, IRR 0.11, 95% CI 0.10-0.12;/ BC, IRR 0.12, 95% CI 0.11-0.13; EC, IRR 0.43, CI 0.40-0.46) than for women without these diagnoses. CONCLUSIONS: One in about 250 women started treatment with HT after being diagnosed with BC, PE or EC. Swedish prescribers seem to be well aware of the recommendations for HT use in women with contraindications. A few women, however, are prescribed HT despite having BC, EC or PE, possibly after careful evaluation of the risks and benefits and giving informed consent. Women with a history of PE were prescribed transdermal HT to a larger extent than women in general, in line with results from observational studies.


Assuntos
Neoplasias da Mama/epidemiologia , Contraindicações de Medicamentos , Neoplasias do Endométrio/epidemiologia , Terapia de Reposição de Estrogênios/estatística & dados numéricos , Embolia Pulmonar/epidemiologia , Sistema de Registros , Idoso , Estudos de Coortes , Terapia de Reposição de Estrogênios/métodos , Feminino , Ginecologia , Humanos , Pessoa de Meia-Idade , Farmacoepidemiologia , Estudos Retrospectivos , Suécia/epidemiologia , Adesivo Transdérmico
14.
Einstein (Sao Paulo) ; 17(2): eAO4435, 2019 Apr 01.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30942279

RESUMO

OBJECTIVE: To develop a scale of anticholinergic activity drugs used in Brazil, to be applied in health care and pharmacoepidemiology research. METHODS: We performed a literature review on PubMed/MEDLINE® to identify previously published scales of anticholinergic drugs. This scale started with anticholinergic drugs, and those with known anticholinergic activity as per the 4th level, chemical-therapeutic subgroup, of the Anatomical Therapeutic Chemical classification. We also included drugs with high anticholinergic activity, as described in a list of potentially inappropriate medications for use in older adults, according to the 2015 American Geriatrics Society Beers Criteria. Drugs listed in at least two anticholinergic scales were added. Then we verified which drugs in the previous steps were marketed in Brazil. We assigned a score of 1, 2 and 3, based on their anticholinergic action. RESULTS: A total of 273 anticholinergic drugs were identified, of which 125 were included in the scale. We identified 45 (36.0%) drugs with a score of 3, 13 (10.4%) with a score of 2, and 67 (53.6%) with a score of 1. Drugs for the nervous and respiratory systems were the most frequent in the scale. Eight drugs were not present in previous scales. CONCLUSION: The methodology used for development of the Brazilian anticholinergic activity scale is simple, systematized, reproducible and easy to update. The scale allows evaluating the impact of anticholinergic burden on health outcomes, and can potentially contribute to pharmacoepidemiology research, leading to more accurate measurements of anticholinergic activity.


Assuntos
Antagonistas Colinérgicos/farmacologia , Antagonistas Colinérgicos/normas , Idoso , Brasil , Antagonistas Colinérgicos/classificação , Humanos , Farmacoepidemiologia , Padrões de Referência , Reprodutibilidade dos Testes , Medição de Risco
15.
Therapie ; 74(2): 279-288, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30824175

RESUMO

Some concerns have emerged about the evidence of benefits on survival outcomes or quality of life of new anticancer drugs. In parallel, the decreased cancer mortality leads to an increased number of patients exposed to cancer treatment-related consequences. In this context, pharmacoepidemiology is crucial to assess anticancer drug use, effectiveness and safety in real life conditions. We aimed to describe strengths, limitations and considerations associated with the use of the French national health insurance database (système national des données de santé [SNDS]) to conduct pharmacoepidemiological studies in oncology. The SNDS represents a powerful tool in pharmacoepidemiology owing to its extensive coverage, accurate description and quantification of drug exposure and individual data on patients. The main limitations of this database ensue from the administrative nature resulting in technical difficulties in its management and gaps in availability of data. Another limitation is the lack of accurate identification of diseases, comorbidities or outcomes and potential confounding with notably the lack of data regarding cancer stage, prognosis or risk factors. Finally, the accurate identification of the nature of chemotherapy received by patients is sometimes complex. To minimize these limitations, several approaches and statistical methods could be used as highlighted by national or international initiatives. First, the SNDS may be linked with cancer registry or clinical data. Then, several data sources could be combined using meta-analytical methods. The development of methodological tools and the use of standardized methods are crucial to enhance the quality of studies that can impact clinical practice and guide public decision. Pharmacoepidemiological approaches and pharmacovigilance represent an important cornerstone in oncology for signal detection or long-term follow up of cancer patients. In this context, validated methods to identify cancer patients and to describe chemotherapy regimens within these data should be promoted and remain too scarce despite international guidelines. Moreover, limits and strength of each data sources should be systematically discussed according to the research question. Optimized and framed use of claims database represents a future challenge in onco-pharmacoepidemiology.


Assuntos
Antineoplásicos/administração & dosagem , Bases de Dados Factuais/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Farmacoepidemiologia/métodos , Humanos , Programas Nacionais de Saúde/estatística & dados numéricos , Farmacovigilância , Qualidade de Vida , Sobrevida
16.
Therapie ; 74(2): 187-197, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30819408

RESUMO

Pharmacoepidemiology is the study of interactions between drugs and human populations, investigating, in real conditions of life, benefits, risks and use of drugs. Pharmacoepidemiology applies to drugs and their pharmacological evaluations, the different methods also used in epidemiology to assess in real conditions of life, benefits, risks and use of drugs. Pharmacoepidemiologic studies are ad-hoc studies or studies on databases. Specific methods exist to measure drug exposure, as well as indicators of compliance and misuse of drugs. Various designs for descriptive and explanatory studies exist, in a context in which a growing proportion of studies are carried out using medico-administrative data. The limits traditionally affecting the study designs are modified in this context, almost any design selected for the conduct of a study from these databases then deriving from a cohort in whom the information has been recorded prospectively and exhaustively.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacoepidemiologia/métodos , Projetos de Pesquisa , Bases de Dados Factuais , Humanos
17.
Rev Bras Epidemiol ; 21Suppl 02(Suppl 02): e180006, 2019 Feb 04.
Artigo em Português, Inglês | MEDLINE | ID: mdl-30726351

RESUMO

INTRODUCTION: The use of polypharmacy may be due to the concomitant presence of chronic conditions, medical care by several doctors simultaneously and self-medication. Combined with the vulnerability of the elderly to the effects of drugs due to pharmacokinetic and pharmacodynamic changes, polypharmacy makes this population more susceptible to adverse outcomes. In Brazil, studies show that polypharmacy is a common problem among elderly people. However, few information is available on the association between polypharmacy and mortality. OBJECTIVE: It was assessed the survival of the elderly from São Paulo city exposed to the use of polypharmacy (five or more medications). METHODS: That was a population-based cohort, the Health, Well-Being and Aging Study (SABE Study), conducted from 2006 to 2010. The sample was composed of 1,258 individuals aged 60 years or more. The Kaplan-Meier method and Cox proportional risks model were used to examine the association between polypharmacy and mortality. RESULTS: The probability of survival after five years of the users of polypharmacy at baseline was 77.2%, while among the non-users was 85.5%. Polypharmacy remained as a risk factor for death even after adjustment in other conditions associated with mortality, such as age, gender, income, chronic diseases and hospitalization. CONCLUSION: The results point polypharmacy as an indicator of mortality in elderly people. The use of multiple medications by the elderly should be carefully assessed to avoid or minimize the damage to this population.


Assuntos
Idoso/estatística & dados numéricos , Mortalidade , Polimedicação , Distribuição por Idade , Fatores Etários , Idoso de 80 Anos ou mais , Envelhecimento , Brasil/epidemiologia , Feminino , Nível de Saúde , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Farmacoepidemiologia , Fatores de Risco , Distribuição por Sexo , Fatores Socioeconômicos , Fatores de Tempo
18.
Therapie ; 74(2): 261-269, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30704765

RESUMO

The evaluation of the real-life benefits and risks of statins in population is a major pharmacoepidemiological issue, given their widespread use for cardiovascular prevention. The purpose of this review was not to be exhaustive but to show the contributions of pharmacoepidemiology for various aspects of the evaluation of statins such as real-life drug use, effectiveness and risk. Statins are among the most used drugs in the world, but recent data show a slight decrease in use. Actual statin users are older, and have more comorbidities than those studied in clinical trials, but this does not seem to compromise their effectiveness, unlike the compliance issues that are common with these drugs. Beyond the known adverse reactions of statins from the clinical trials, risks of statins can be varied and sometimes difficult to evaluate, considering the ubiquity of cholesterol throughout the body, from drug or endogenous molecule metabolism to the construction of cell membranes or cell activities.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Farmacoepidemiologia , Doenças Cardiovasculares/etiologia , Colesterol/metabolismo , Ensaios Clínicos como Assunto/estatística & dados numéricos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Adesão à Medicação/estatística & dados numéricos
19.
Therapie ; 74(2): 301-306, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30704766

RESUMO

During the past few decades, it has been stated that a paradigm shift has occurred in the assessment and management of patient related drug safety. Some of these changes have resulted in a significant increase in the importance of pharmacoepidemiology and its use in pharmacovigilance. For European member states, the Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols and results of imposed and non-imposed post-authorization safety studies (PASS). Between 2013 and 2017, the total number of PASS during this 5-years period of the different products, including protocols and results, was 1062. The number of protocols of PASS is increasing over time, except in 2017 where a 25% decrease has been observed. Whereas, PASS results steadily increased over the 5years period. Between 2014 and 2017, about 29% (n=137) of PRAC reviewed protocols were imposed. The number of imposed PASS was almost constant over time with a mean of 34.3±7.6 imposed protocols per year and 3.5±1.74 imposed results per year. The need for the implementation of PASS for pharmacovigilance regulatory activities is increasing. Nevertheless, conducting such studies remains difficult.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacoepidemiologia/métodos , Farmacovigilância , União Europeia , Humanos , Legislação de Medicamentos , Farmacoepidemiologia/tendências , Medição de Risco/métodos , Medição de Risco/tendências , Gestão de Riscos/métodos , Fatores de Tempo
20.
PLoS One ; 14(2): e0212460, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30763385

RESUMO

In recent years, low dose naltrexone (LDN) has been used as an off-label therapy for several chronic diseases. Results from small laboratory and clinical studies indicate some beneficial effects of LDN in autoimmune diseases, but clinical research on LDN in rheumatic disease is limited. Using a pharmacoepidemiological approach, we wanted to test the hypothesis that starting LDN leads to reduced dispensing of medicines used in the treatment of rheumatic disease. We performed a controlled before-after study based on the Norwegian Prescription Database (NorPD) to compare prescriptions to patients one year before and one year after starting LDN in 2013. The identified patients (n = 360) were stratified into three groups based on LDN exposure. Outcomes were differences in dispensing of medicines used in rheumatic disease. In persistent LDN users, there was a 13% relative reduction in cumulative defined daily doses (DDD) of all medicines examined corresponding to -73.3 DDD per patient (95% CI -120,2 to -26.4, p = 0.003), and 23% reduction of analgesics (-21.6 DDD (95% CI -35.5 to -7.6, p<0.009)). There was no significant DDD change in patients with lower LDN exposure. Persistent LDN users had significantly reduced DDDs of NSAID and opioids, and a lower proportion of users of DMARDs (-6.7 percentage points, 95% CI -12.3 to-1.0, p = 0.028), TNF-α antagonists and opioids. There was a decrease in the number of NSAID users among patients with the least LDN exposure. Important limitations are that prescription data are proxies for clinical effects and that a control group unexposed to LDN is lacking. The results support the hypothesis that persistent use of LDN reduces the need for medication used in the treatment of rheumatic and seropositive arthritis. Randomised clinical trials on LDN in rheumatic disease are warranted.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Artrite/tratamento farmacológico , Naltrexona/administração & dosagem , Idoso , Antirreumáticos/administração & dosagem , Estudos Controlados Antes e Depois , Prescrições de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Antagonistas de Entorpecentes/administração & dosagem , Noruega , Uso Off-Label , Farmacoepidemiologia , Sistema de Registros
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA