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OBJECTIVES: To characterise the exposure to valproate within a cohort of pregnant women using electronic health records (EHRs) from Catalonia (System for the Development of Research in Primary Care, SIDIAP). DESIGN: Drug-utilisation cohort study covering the period from January 2011 to June 2020. The study included pregnancy episodes of women from Catalonia identified by the algorithm. SETTING: Data were sourced from SIDIAP, a comprehensive EHR repository that includes information from various data sources: recorded prescriptions (both hospital and primary care), diagnoses and sociodemographic characteristics identified by primary care physicians, and sexual and reproductive health data from ASSIR (used by gynaecologists and midwives). PARTICIPANTS: Women aged 12-50 with at least one pregnancy episode occurred during January 2011-June 2020 and at least a prescription of valproate during pregnancy. PRIMARY AND SECONDARY OUTCOMES: Primary outcomes included valproate exposure, measured through prevalence and cumulative incidence in pregnancy episodes and by trimester. The impact of regulatory measures (risk mitigation measures, RMMs) was assessed, and prescriptions over time were analysed using interrupted time series analysis. Secondary outcomes included health issues, pregnancy outcomes, smoking habits and socioeconomic characteristics. RESULTS: A total of 99 605 pregnancies were identified, with at least 3.03 (95% CI 2.69 to 3.39) exposed to valproate at some point (302 pregnancies, 276 women). The median pregnancy duration was 38.30 weeks (IQR 12.6-40.1), and the median age at pregnancy was 32.37 years (IQR 27.20-36.56). Epilepsy was the most frequent health issue. The prevalence and cumulative incidence of valproate prescriptions decreased during pregnancy and increased postpregnancy. The RMMs implemented in 2014 led to a reduction in monthly valproate prescriptions during pregnancy in this cohort. CONCLUSIONS: The study highlights the decline in valproate prescriptions during pregnancy due to RMMs and underscores the need for standardised methodologies in future studies to ensure the safety of pregnant patients and optimise scientific evidence.
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Anticonvulsivantes , Complicações na Gravidez , Ácido Valproico , Humanos , Feminino , Ácido Valproico/uso terapêutico , Gravidez , Espanha/epidemiologia , Adulto , Anticonvulsivantes/uso terapêutico , Anticonvulsivantes/efeitos adversos , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/epidemiologia , Adolescente , Adulto Jovem , Pessoa de Meia-Idade , Registros Eletrônicos de Saúde , Estudos de Coortes , Criança , Epilepsia/tratamento farmacológico , Epilepsia/epidemiologia , Prescrições de Medicamentos/estatística & dados numéricos , Resultado da Gravidez/epidemiologia , Saúde da MulherRESUMO
OBJECTIVE: A common consultation since the beginning of the vaccination campaign against COVID-19 was related to people with a history of allergy to drugs or other vaccines. The objective of the study was to describe what happened after the administration of the vaccine against COVID-19 in people with a history of moderate and severe allergy, vaccinated against COVID-19 in a Primary Care Emergency Center (PCEC). METHODS: Observational descriptive study with sixty-four people with a history of moderate and severe allergy was carried out, vaccinated in PCEP, between May and October 2021, in the Barcelonés Nord and Maresme (Barcelona province), after assessment by primary care pharmacologists and pharmacists. The percentage of people with adverse events that occurred after vaccination during their stay in the PCEP, the types detected and severity were calculated. Subsequently, a telephone survey was conducted to determine patient satisfaction. A descriptive analysis (calculation of proportions) was performed. RESULTS: The mean age of 49.7 years (from twelve to ninety-four years) and 90.6% were women. 87.5% of the administered vaccines were Comirnaty®. Adverse events occurring after vaccination were detected in fifteen patients (23.4%), of whom four (6.25%) were manifestations of hypersensitivity, all classified as mild. The reasons for vaccination were a history of allergy to NSAIDs (45.3%), antibiotics (32.8%), analgesics (17.2%), vaccines (28.1%), other substances (40.6%) and anaphylaxis (26.6%). The degree of general satisfaction was 9.11 (out of 10). CONCLUSIONS: The percentage of patients with a history of anaphylaxis and allergic drug reactions who present hypersensitivity reactions to COVID-19 vaccines is 6.25% and all are mild.
OBJETIVO: Una consulta habitual desde el inicio de la campaña de vacunación frente a la COVID-19 fue la relacionada con personas que tienen antecedentes de alergia a fármacos u otras vacunas. El objetivo del estudio fue describir lo ocurrido tras la administración de la vacuna frente a la COVID-19 en personas con antecedentes de alergia moderada y grave, en un Centro de Urgencias de Atención Primaria (CUAP). METODOS: Se realizó un estudio observacional descriptivo con sesenta y cuatro personas que tenían antecedentes de alergia moderada y grave, vacunadas en CUAP, entre mayo y octubre de 2021, en el Barcelonés Nord i Maresme (provincia de Barcelona), previa valoración por farmacólogos y farmacéuticos de Atención Primaria. Se calculó el porcentaje de personas con acontecimientos adversos ocurridos tras la vacunación en el transcurso de su estancia en el CUAP, los tipos detectados y la gravedad. Posteriormente, se realizó una encuesta telefónica para conocer la satisfacción de los pacientes. Se realizó un análisis descriptivo (cálculo de proporciones). RESULTADOS: La media de edad de las personas participantes fue de 49,7 años (de doce a noventa y cuatro años) y el 90,6% fueron mujeres. El 87,5% de las vacunas administradas fue Comirnaty®. Se detectaron acontecimientos adversos ocurridos tras la vacunación en quince pacientes (23,4%), de los que en cuatro casos (6,25%) fueron manifestaciones de hipersensibilidad, todas catalogadas como leves. Los motivos de vacunación fueron antecedentes de alergia a AINE (45,3%), antibióticos (32,8%), analgésicos (17,2%), vacunas (28,1%), otras sustancias (40,6%) y anafilaxia (26,6%). El grado de satisfacción general fue de 9,11 (sobre 10). CONCLUSIONES: El porcentaje de pacientes con antecedentes de anafilaxia y reacciones alérgicas a medicamentos que presentan reacciones de hipersensibilidad a las vacunas frente a la COVID-19 es del 6,25% y todas son leves.
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Anafilaxia , Vacinas contra COVID-19 , COVID-19 , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anafilaxia/induzido quimicamente , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Espanha , Criança , Adolescente , Adulto Jovem , Adulto , Idoso , Idoso de 80 Anos ou maisRESUMO
OBJECTIVES: To develop an algorithm to identify pregnancy episodes in women at childbearing age using SIDIAP (Information System for the Improvement of Research in Primary Care) data (Catalunya, Spain).To describe drugs dispensed during gestation. DESIGN: Construction of an algorithm to identify all pregnancy episodes occurred from January 2011 to June 2020 in women aged 12-50. The variables used to create the algorithm include first day of last menstrual period, reasons for pregnancy termination and diagnoses registered in the primary healthcare records. Population-based cohort study including the pregnancy episodes identified by the algorithm. SETTING: Catalonia, Spain. PARTICIPANTS: All women aged 12-50 with at least one pregnancy episode occurred during January 2011-June 2020. INTERVENTIONS: No interventions performed. PRIMARY AND SECONDARY OUTCOME MEASURES: Identification of pregnancy episodes through an algorithm and description of drug exposure. RESULTS: We identified 327 865 pregnancy episodes in 250 910 people with a mean age of 31.3 years. During the study period, 83.4% of the episodes were exposed to at least one drug. The most frequent groups dispensed were iron preparations (48% of pregnancy episodes), iodine therapy (40.2%), analgesics and antipyretics (28%), penicillins (19.8%), vitamin B12 plus folic acid (19.7%) and non-steroidal anti-inflammatory drugs (NSAIDs, 15.1%). The supplements were more frequently dispensed at least twice, and the drugs for acute conditions were mainly dispensed only once during the pregnancy episode. CONCLUSIONS: We developed an algorithm to automatically identify the pregnancy periods in SIDIAP.We described prescription drugs used during pregnancy. The most used ones were supplements, analgesics, NSAID or antibiotics.SIDIAP might be an efficient database to study drug safety during pregnancy and the consequences of drug use in the offspring. TRIAL REGISTRATION NUMBER: EUPAS37675.
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Algoritmos , Anti-Inflamatórios não Esteroides , Gravidez , Humanos , Feminino , Adulto , Espanha/epidemiologia , Estudos de Coortes , Atenção Primária à SaúdeRESUMO
BACKGROUND: Since March of 2020, the scientific community has been engaged a marathon to answer the different questions that COVID-19 pandemic has brought. During this time, Ethics Committees played an important role in reviewing the research protocols, COVID-19 or not, ensuring that the quality of scientific research is not relaxed by the hasty need for answers. METHODS: Descriptive study from January 2019 to December 2021, comparing COVID-19 protocols to those not COVID-19 related protocols and comparing the work overload. Variables related to the characteristics of the research protocols (i.e. study design, funding ), the principal investigators (gender, PhD degree, professional role ) and outcomes of the Ethics Committee process (requirements of modifications and time until approval) were analyze. RESULTS: The number of sessions increased during COVID-19 pandemics (12 in 2019, 25 in 2020 and 18 in 2021). In total 751 protocols were evaluated during the study period; 513 (68.3%) had an observational design and 434 (57.8%) had no funding. The principal investigator was a woman in 491 (65.4%) studies and a General Practitioner in 330 (43.9%). The mean of the days until the protocol approval was 42.09 days (SD 60.2) with a decrease of 20.1 days from 2019 to 2021. A total of 614 (81.7%) protocols were approved, 336 (54.7%) within the first month after their initial evaluation. Less than half of the protocols were COVID-19 related (208, 44.3%). The COVID-19 protocols main topics were impact on the population (71, 34.1%); and COVID-19 pharmacological treatments (including vaccines) showed a higher increase in 2021 (37, 30.3%). CONCLUSIONS: Despite the work overload during the pandemic due to the increase in the number of meetings and protocols, the IDIAPJGol EC reviewed all of them (COVID-19 or not) adapting to the new situation but according to its criteria of good practices to provide a quick response in the EC opinion. In Primary Health Care the most study designs have been observational studies, many of them with no funding and led by GPs. In 2021 there was an increase in the number of protocols focused on drugs, most likely related to COVID-19 vaccines studies.
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COVID-19 , Feminino , Humanos , COVID-19/epidemiologia , Pandemias , Comitês de Ética em Pesquisa , Vacinas contra COVID-19 , Espanha/epidemiologia , Pesquisa sobre Serviços de SaúdeRESUMO
BACKGROUND: Since the use of electronic health records (EHRs) in an automated way, pharmacovigilance or pharmacoepidemiology studies have been used to characterize the therapy using different algorithms. Although progress has been made in this area for monotherapy, with combinations of 2 or more drugs the challenge to characterize the treatment increases significantly, and more research is needed. OBJECTIVE: The goal of the research was to develop and describe a novel algorithm that automatically returns the most likely therapy of one drug or combinations of 2 or more drugs over time. METHODS: We used the Information System for Research in Primary Care as our reference EHR platform for the smooth algorithm development. The algorithm was inspired by statistical methods based on moving averages and depends on a parameter Wt, a flexible window that determines the level of smoothing. The effect of Wt was evaluated in a simulation study on the same data set with different window lengths. To understand the algorithm performance in a clinical or pharmacological perspective, we conducted a validation study. We designed 4 pharmacological scenarios and asked 4 independent professionals to compare a traditional method against the smooth algorithm. Data from the simulation and validation studies were then analyzed. RESULTS: The Wt parameter had an impact over the raw data. As we increased the window length, more patient were modified and the number of smoothed patients augmented, although we rarely observed changes of more than 5% of the total data. In the validation study, significant differences were obtained in the performance of the smooth algorithm over the traditional method. These differences were consistent across pharmacological scenarios. CONCLUSIONS: The smooth algorithm is an automated approach that standardizes, simplifies, and improves data processing in drug exposition studies using EHRs. This algorithm can be generalized to almost any pharmacological medication and model the drug exposure to facilitate the detection of treatment switches, discontinuations, and terminations throughout the study period.
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OBJECTIVE: Taking medicinal herbs (MH) is frequent in patients and can cause interactions with others medications. Consumption of MH could be high in chronic patients with complexity (CPC) and produce interactions with drugs and knowledge about these drugs in primary health care (PC) professionals about these interactions is low. The aim was to measure the prevalence of potencial interactions between HM and drugs in CPC and evaluate the degree of knowledge of PC professionals. METHODS: Descriptive observational study in a population of CPC assigned to two PC teams. We investigated MH consumption through interviews and review potential drug interactions. We evaluated the degree of professionals knowledge through a survey designed for the study. A descriptive analysis was carried out. The Student-t test for paired data was used to compare the means.The statistical significance was established at p<0.05. RESULTS: The survey was distributed among 179 patients, mean age 76.9 years old (DE 9.7), 54.6% women. 62.57% (112) take MH. We detected 88 potentially relevant interactions in 51 patients (45.54%). Of the 219 professionals interviewed 51.1% consider that their knowledge about MH were low and 64,4% thought that was important to know the mH consumption of their patients. CONCLUSIONS: We detected a high prevalence of MH consumption in CPC and interactions between herbs medicinal and drugs. Lack of knowledge of PC health professionals is important. It's necessary to record this consumption in the medical history and improve the knowledge of professionals about MH to detect possible interactions, reduce the associated risk and improve the quality of care.
OBJETIVO: El consumo de plantas medicinales (PM) es frecuente en pacientes y puede causar interacciones con otros medicamentos. El consumo de PM puede ser alto en pacientes crónicos complejos (PCC) y producir interacciones con su medicación y el conocimiento sobre estos fármacos en profesionales sanitarios de Atención Primaria (AP) es bajo. El objetivo del estudio fue medir prevalencia de interacciones potenciales entre PM y medicamentos en PCC y evaluar grado de conocimiento de los profesionales de AP. METODOS: Estudio observacional descriptivo en una población de PCC asignados a dos equipos de AP. Se evaluaron el consumo de PM mediante entrevistas y se revisaron las interacciones potenciales con su medicación. Se evaluó el grado de conocimiento de los profesionales mediante una encuesta diseñada para el estudio. Se realizó un análisis descriptivo, La comparación de medias se realizó con la prueba t de Student. La significación estadística se estableció en p<0,05. RESULTADOS: La encuesta se distribuyó entre 179 pacientes, con una edad media de 76,9 años (DE 9,7), 54,6% mujeres. El 62,57% (112) consumieron PM. Detectamos 88 interacciones potencialmente relevantes en 51 pacientes (45,54%). De los 219 profesionales entrevistados el 51,1% consideraron que sus conocimientos sobre PM eran bajos y 64,4% pensaron que era importante conocer el consumo de PM de sus pacientes. CONCLUSIONES: Detectamos una alta prevalencia del consumo de PM en PCC y de interacciones entre PM y medicamentos. La falta de conocimientos de los profesionales sanitarios es importante. Es necesario registrar en la historia clínica este consumo y mejorar el conocimiento de los profesionales de AP sobre PM para detectar posibles interacciones, disminuir el riesgo asociado y mejorar la calidad asistencial.
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Doença Crônica , Interações Ervas-Drogas , Atenção Primária à Saúde , Idoso , Doença Crônica/tratamento farmacológico , Feminino , Humanos , Masculino , EspanhaRESUMO
RATIONALE: The use of psychotropic drugs in the paediatric population has not been the subject of many studies, due to the fact that this population is generally not included in clinical trials and these drugs are not authorized for use on minors. OBJECTIVES: This study aims to provide an accurate description of psychotropic drug use in children and adolescents in the North of Europe and Catalonia. METHODS: Data from 2008 to 2017 on psychotropic drug consumption in children and adolescents were retrieved from the databases of Catalonia, Denmark, Norway and Sweden. Psychotropic drugs were divided into antipsychotics, anxiolytics (also hypnotics and sedatives), antidepressants and psychostimulants. Data were stratified by group of age (0-4, 5-9, 10-14 and 15-19/15-17 for Denmark and Catalonia) and sex. RESULTS: Overall, the group of anxiolytics shows the highest consumption and the group of antipsychotics the lowest. In 2017, Sweden was the country with the highest consumption of psychotropic drugs (6.67) and has the highest increase in consumption (152.8%), and Denmark has the lowest consumption for all groups (3.13). Catalonia shows a decrease in psychotropic drugs (-15.9%). Girls consume more than twice as many antidepressants as boys while the opposite is true for psychostimulants. Risperidone and quetiapine are among the most consumed antipsychotics in the Nordic countries, whereas in Catalonia they are risperidone and aripiprazole. Among antidepressants, sertraline is the most consumed. No differences are found among the psychostimulants. CONCLUSIONS: Psychotropic consumption in younger populations is increasing, although there are differences between the countries as far as which drugs are used. Nordic countries show a higher prevalence of use than Catalonia. Psychotropic drug consumption increases with age, except for psychostimulants, which have the highest utilization rate among 10-14-year-olds.
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Bases de Dados Factuais/tendências , Transtornos do Neurodesenvolvimento/tratamento farmacológico , Transtornos do Neurodesenvolvimento/epidemiologia , Vigilância da População , Psicotrópicos/uso terapêutico , Adolescente , Antidepressivos/uso terapêutico , Antipsicóticos/uso terapêutico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Criança , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Masculino , Transtornos do Neurodesenvolvimento/psicologia , Vigilância da População/métodos , Prevalência , Países Escandinavos e Nórdicos/epidemiologia , Espanha/epidemiologia , Fatores de TempoRESUMO
OBJECTIVE: To analyse the impact of a formative / informative intervention on the treatment of non-oncological chronic pain in Primary Care. DESIGN: Quasi-experimental study before-after, and follow-up of the patient cohort. LOCATION: 64 Primary Care teams/centres (770 physicians). PARTICIPANTS: Patients≥14 years without an oncological diagnosis on: 1) fentanyl citrate, 2) major opioids and≥2 anxiolytics-hypnotics, 3) long-term major and minor opioids, 4) transdermal lidocaine, out of indication. INTERVENTION: Dissemination of recommendations for the treatment of non-oncological chronic pain and the reporting of the incidents of their patients to each doctor. MAIN MEASUREMENTS: Number of incidents in 2 cross sections (June 2017 and June 2018). Number of incidents in June 2017, which were maintained in June 2018 (prospective cohort). RESULTS: Of the 2,465 incidents detected in 2017, there was a 21.1% reduction after the intervention. The reduction was higher (61.8%, p<.001) in the prospective cohort. In absolute values, the most important reduction was in incidences of lidocaine patches outside of indication (1,032 incidences). The approved indication was found in less than 8% of the treated patients. CONCLUSIONS: The intervention reduced the number of patients with incidences, and this reduction was higher in the prospective cohort, confirming the efficacy of sending information about patients with incidences to their physicians. The incorporation of new treatments during the follow-up year was significant, so these interventions should be perpetuated over time.
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Dor Crônica , Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Fentanila , Humanos , Atenção Primária à Saúde , Estudos ProspectivosRESUMO
OBJECTIVE: Quantitative study: To assess the prevalence of inadequacy of treatment for osteoporosis in primary prevention (OPP) in women aged 60-74years. Qualitative study: To evaluate the diagnostic and treatment criteria of the OPP and it's variability in primary care physicians (PC) and specialists. MATERIAL AND METHODS: Quantitative study: observational, cross-sectional and retrospective study. POPULATION: women aged 60-74years with active treatment for OPP (n=424) in May 2012. Inadequacy if they had ≤2 risk factors with a DXA or DXA T-score ≥-2.4. Qualitative study: Delphi technique (15items) and two rounds of consultation. PERIOD: March-April 2014. POPULATION: PC physicians, rheumatologists and orthopaedic surgeons (n=251). Random sampling. RESULTS: Quantitative study: degree of inadequacy is 63.4%. In 43.2% isn't mention a diagnosis of osteoporosis. In 82.3% there isn't mention of risk factors. TREATMENT: bisphosphonate 40.3% and calcium +vitaminD 47.9%. Qualitative study: 23% respond to the first round, and of these 67% the second round. Items with higher agreement were the important of the evaluation of risk factors for diagnosis and bisphosphonates for treatment. Items with fewer consensuses were using the FRAX and densitometry and treatment with only calcium +vitaminD. CONCLUSIONS: The percentage of inadequacy is high. The degree of registration in medical history is low. The Delphi method is useful for detecting discrepancies between recommendations of clinical practice guidelines and results.
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Osteoporose/tratamento farmacológico , Osteoporose/prevenção & controle , Prevenção Primária/normas , Idoso , Estudos Transversais , Estudos de Avaliação como Assunto , Feminino , Humanos , Pessoa de Meia-Idade , Padrões de Prática Médica , Pesquisa Qualitativa , Melhoria de Qualidade , Estudos RetrospectivosRESUMO
PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality. Copyright © 2016 John Wiley & Sons, Ltd.
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Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/administração & dosagem , Inibidores da Agregação Plaquetária/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Hemorragia Cerebral/induzido quimicamente , Hemorragia Cerebral/epidemiologia , Estudos de Coortes , Bases de Dados Factuais , Registros Eletrônicos de Saúde , Feminino , Fibrinolíticos/efeitos adversos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Atenção Primária à Saúde , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Espanha , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Vitamina K/antagonistas & inibidoresRESUMO
PURPOSE: The purpose of this study is to describe the pharmacologic management of rate and rhythm and assess which factors are associated with the prescription of these drugs in patients with nonvalvular atrial fibrillation (AF) from the Effectiveness, Safety, and Costs in Atrial Fibrillation study. METHODS: This retrospective, cross-sectional study describes the pharmacologic rate and rhythm control management strategies adopted during 2012 in all patients diagnosed as having nonvalvular AF in 2007 to 2011. The data source is the Information System for the Improvement of Research in Primary Care database, which is based on primary care electronic health records. To answer the study objectives, 3 multivariate regression models to assess the independent factors associated with the prescription of these drugs were conducted for 2012. The rate and rhythm control drugs assessed were ß-blockers, nondihydropyridine calcium channel blockers, antiarrhythmic agents, and digoxin. FINDINGS: A total of 21,304 patients were diagnosed as having nonvalvular AF; 11,638 (54.6%) had at least one heart rate measure during 2012. Of them, 7777 (66.8%) received one or more rate and/or rhythm control drugs during 2012. Most patients (5751 [73.9%] of 7777) received only one drug for rate and/or rhythm control. Rate control agents were the most frequently used in 2012, with ß-blockers the most prescribed group (4091 patients [52.6%]). A variety of different variables were associated with the prescription of rate and/or rhythm control drugs in the multivariate regression models. IMPLICATIONS: The most used pharmacologic treatment of rate and rhythm control in our AF population is ß-blockers, indicating that a rate control strategy is preferred in our setting, as widely recommended.
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Antagonistas Adrenérgicos beta , Fibrilação Atrial , Fármacos Cardiovasculares , Frequência Cardíaca/efeitos dos fármacos , Antagonistas Adrenérgicos beta/farmacologia , Antagonistas Adrenérgicos beta/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/fisiopatologia , Fármacos Cardiovasculares/farmacologia , Fármacos Cardiovasculares/uso terapêutico , Estudos Transversais , Registros Eletrônicos de Saúde , Humanos , Atenção Primária à Saúde , Estudos RetrospectivosRESUMO
PURPOSE: Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain. PARTICIPANTS: The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007-2012. FINDINGS TO DATE: A total of 22,585 patients with non-valvular atrial fibrillation were included in the baseline description. Their mean age was 72.8 years and 51.6% were men. The most commonly prescribed antithrombotics were vitamin K antagonists (40.1% of patients) and platelet aggregation inhibitors (32.9%); 25.3% had not been prescribed antithrombotic treatment. Age, gender, comorbidities and co-medication at baseline were similar to those reported for previous studies. FUTURE PLANS: The next phase in the ESC-FA study will involve assessing the effectiveness and safety of antithrombotic treatments, analysing stroke events and bleeding episodes' rates in our patients (rest of phase I), describing the current management of the disease and its costs in our setting, and assessing how the introduction of new oral anticoagulants changes the stroke prevention in non-valvular atrial fibrillation.