El cáncer es responsable de una proporción importante de la carga total de morbilidad en la población mundial. Sin embargo, no afecta a todas las subpoblaciones por igual. Para la mayoría de los tipos de cáncer, los países desarrollados tienen tasas de incidencia más altas, aunque las tasas aumentan desproporcionadamente en los países en desarrollo. En España, la incidencia del cáncer varía en función de una serie de factores. Actualmente existe un vacío en el conocimiento sobre las tendencias temporales de la incidencia del cáncer en España y, más concretamente, en Catalunya. Nuestro objetivo es describir las tasas de incidencia anual de cáncer de los 5 tipos de cáncer sólido más incidentes en España (cáncer de mama, próstata, colorrectal, pulmón y vejiga) desde 2009 hasta 2018 utilizando la base de datos SIDIAP. SIDIAP es una recopilación de historias clínicas longitudinales pseudoanonimizadas de casi seis millones de pacientes de Catalunya (80% de la población) registrados en 370 centros de atención primaria, y es representativa del total de la población catalana por sexo, edad y distribución geográfica. Las tasas de incidencia del cáncer se estratificarán por sexo y niveles de privación del índice MEDEA para investigar las subpoblaciones que son más vulnerables a los tipos de cáncer especificados. Esto ayudará a planificar futuras intervenciones que puedan ser más específicas y efectivas para las poblaciones con un mayor riesgo.

Serious adverse events have been reported among antidementia drug users. We aim to analyse the use and comparative safety of the antidementia drugs in primary care centres in Catalonia (Spain).
Design: A population-based cohort study using real-world primary health care data (SIDIAP database), standardized to the Common Data Model OMOP with hospital linkage (CMBD database). A nested case-control approach will be adopted to assess risk of adverse events (AE) during the study period (2007-2020). Inclusion criteria: for the drug utilization study (DUS) we will include individuals with at least 40 year or older with dementia, registered for at least 1 year before cohort entry and with at least 1 prescription of rivastigmine, galantamine, donepezil or memantine during study period. For the safety study we will include patients from the DUS with an incident use (no previous 365 days use) of any of the study drugs. For the nested case control analysis, we will create a cohort of patients with dementia without treatment (anytime). Exposure (DUS/Safety): prescription of rivastigmine, donepezil, galantamine or memantine. Outcomes: (DUS) demographics, comorbidities, prescriber-type, prescribing pattern and proportion of ‘prescription cascade’ drugs (prescriptions generated to alleviate adverse events). Outcomes (safety study): AEs related to disorders of the skin, cardiovascular, gastrointestinal, neurological, psychiatric, sleep, urinary and respiratory disorders, falls, hospitalizations and all-cause mortality.
Statistics: Yearly age-sex incidence rates (IR) and Kaplan Meier curves to assess the duration and drug discontinuation. Adjusted and unadjusted IR of AEs, Hazard Ratios (95% confidence intervals (CI)) using Cox proportional hazard models, and Odds Ratios (95% CI) using nested case-control analysis with conditional logistic regression will be assessed. Each case will be matched (age, sex, Charlson Comorbidity Index and socioeconomic status) with up to 10 controls.
Expected results: With this large population-based cohort study based on routinely collected primary care data with hospital linkage we expect to provide an in-depth characterization of the population that uses any of the currently commercialised antidementia drugs. Because we are using routinely collected real-world information, which differs from the information gathered in randomized controlled trials, we will be able to provide a more accurate picture of the patients that finally receive the drugs to treat dementia. We will also analyse the proportion of patients with a ‘prescription cascade’ and this will contribute to the identification of adverse events that have been misclassified as new medical conditions. Finally, the comparative safety study carried out will inform us about the risk of adverse events between users and non-users of antidementia drugs. Given the increasing availability of non-pharmacological treatments to treat dementia, this information will help clinicians to assess the risk-benefit of these drugs. The other comparative safety studies, between acetylcholinesterase inhibitors versus N-methyl-D-aspartate receptor antagonists and between galantamine and donepezil versus rivastigmine will also contribute to decision making of clinicians and can be the base of other prospective head-to-head comparison studies.
Relevance and aplicability: Population-based cohort studies that use routinely collected health care data have gained importance in the last years because of their ability to provide evidence that could not be generated through randomized controlled trials. This is more important in pharmacoepidemiology given that subjects that are included in the pivotal trials of the drugs usually differ greatly from the overall population that finally receives the medication. The ageing of the populations foresees an increase in the cognitive related disorders including dementia and Alzheimer disease. Although the actual medications to treat dementia (rivastigmine, galantamine, donepezil and memantine) were commercialized more than a decade ago, few are the studies that have analysed their real-world adverse effects at a population level, none of them in Spain, and even fewer are the ones that have done this comparing the different medications. Regardless of the new therapies that are being recently developed to treat dementia the great burden of the treatment still relies on these four medications and therefore is it necessary to fully identify, describe in depth the patients that are using these drugs. The comparative safety analysis results will help health care providers and clinicians to assess the risk-benefits of these drugs to avoid future adverse events or better target patients who receive medication. At last, this can also be a hypothesis generating study given that it will help identify the characteristics of the population at an increased risk of adverse events which could help design future antidementia drug studies.

Serious adverse events have been reported among antidementia drug users. We aim to analyse the use and comparative safety of the antidementia drugs in primary care centres in Catalonia (Spain).
Design: A population-based cohort study using real-world primary health care data (SIDIAP database), standardized to the Common Data Model OMOP with hospital linkage (CMBD database). A nested case-control approach will be adopted to assess risk of adverse events (AE) during the study period (2007-2020). Inclusion criteria: for the drug utilization study (DUS) we will include individuals with at least 40 year or older with dementia, registered for at least 1 year before cohort entry and with at least 1 prescription of rivastigmine, galantamine, donepezil or memantine during study period. For the safety study we will include patients from the DUS with an incident use (no previous 365 days use) of any of the study drugs. For the nested case control analysis, we will create a cohort of patients with dementia without treatment (anytime). Exposure (DUS/Safety): prescription of rivastigmine, donepezil, galantamine or memantine. Outcomes: (DUS) demographics, comorbidities, prescriber-type, prescribing pattern and proportion of ‘prescription cascade’ drugs (prescriptions generated to alleviate adverse events). Outcomes (safety study): AEs related to disorders of the skin, cardiovascular, gastrointestinal, neurological, psychiatric, sleep, urinary and respiratory disorders, falls, hospitalizations and all-cause mortality.
Statistics: Yearly age-sex incidence rates (IR) and Kaplan Meier curves to assess the duration and drug discontinuation. Adjusted and unadjusted IR of AEs, Hazard Ratios (95% confidence intervals (CI)) using Cox proportional hazard models, and Odds Ratios (95% CI) using nested case-control analysis with conditional logistic regression will be assessed. Each case will be matched (age, sex, Charlson Comorbidity Index and socioeconomic status) with up to 10 controls.
Expected results: With this large population-based cohort study based on routinely collected primary care data with hospital linkage we expect to provide an in-depth characterization of the population that uses any of the currently commercialised antidementia drugs. Because we are using routinely collected real-world information, which differs from the information gathered in randomized controlled trials, we will be able to provide a more accurate picture of the patients that finally receive the drugs to treat dementia. We will also analyse the proportion of patients with a ‘prescription cascade’ and this will contribute to the identification of adverse events that have been misclassified as new medical conditions. Finally, the comparative safety study carried out will inform us about the risk of adverse events between users and non-users of antidementia drugs. Given the increasing availability of non-pharmacological treatments to treat dementia, this information will help clinicians to assess the risk-benefit of these drugs. The other comparative safety studies, between acetylcholinesterase inhibitors versus N-methyl-D-aspartate receptor antagonists and between galantamine and donepezil versus rivastigmine will also contribute to decision making of clinicians and can be the base of other prospective head-to-head comparison studies.
Relevance and aplicability: Population-based cohort studies that use routinely collected health care data have gained importance in the last years because of their ability to provide evidence that could not be generated through randomized controlled trials. This is more important in pharmacoepidemiology given that subjects that are included in the pivotal trials of the drugs usually differ greatly from the overall population that finally receives the medication. The ageing of the populations foresees an increase in the cognitive related disorders including dementia and Alzheimer disease. Although the actual medications to treat dementia (rivastigmine, galantamine, donepezil and memantine) were commercialized more than a decade ago, few are the studies that have analysed their real-world adverse effects at a population level, none of them in Spain, and even fewer are the ones that have done this comparing the different medications. Regardless of the new therapies that are being recently developed to treat dementia the great burden of the treatment still relies on these four medications and therefore is it necessary to fully identify, describe in depth the patients that are using these drugs. The comparative safety analysis results will help health care providers and clinicians to assess the risk-benefits of these drugs to avoid future adverse events or better target patients who receive medication. At last, this can also be a hypothesis generating study given that it will help identify the characteristics of the population at an increased risk of adverse events which could help design future antidementia drug studies.

Serious adverse events have been reported among antidementia drug users. We aim to analyse the use and comparative safety of the antidementia drugs in primary care centres in Catalonia (Spain).
Design: A population-based cohort study using real-world primary health care data (SIDIAP database), standardized to the Common Data Model OMOP with hospital linkage (CMBD database). A nested case-control approach will be adopted to assess risk of adverse events (AE) during the study period (2007-2020). Inclusion criteria: for the drug utilization study (DUS) we will include individuals with at least 40 year or older with dementia, registered for at least 1 year before cohort entry and with at least 1 prescription of rivastigmine, galantamine, donepezil or memantine during study period. For the safety study we will include patients from the DUS with an incident use (no previous 365 days use) of any of the study drugs. For the nested case control analysis, we will create a cohort of patients with dementia without treatment (anytime). Exposure (DUS/Safety): prescription of rivastigmine, donepezil, galantamine or memantine. Outcomes: (DUS) demographics, comorbidities, prescriber-type, prescribing pattern and proportion of ‘prescription cascade’ drugs (prescriptions generated to alleviate adverse events). Outcomes (safety study): AEs related to disorders of the skin, cardiovascular, gastrointestinal, neurological, psychiatric, sleep, urinary and respiratory disorders, falls, hospitalizations and all-cause mortality.
Statistics: Yearly age-sex incidence rates (IR) and Kaplan Meier curves to assess the duration and drug discontinuation. Adjusted and unadjusted IR of AEs, Hazard Ratios (95% confidence intervals (CI)) using Cox proportional hazard models, and Odds Ratios (95% CI) using nested case-control analysis with conditional logistic regression will be assessed. Each case will be matched (age, sex, Charlson Comorbidity Index and socioeconomic status) with up to 10 controls.
Expected results: With this large population-based cohort study based on routinely collected primary care data with hospital linkage we expect to provide an in-depth characterization of the population that uses any of the currently commercialised antidementia drugs. Because we are using routinely collected real-world information, which differs from the information gathered in randomized controlled trials, we will be able to provide a more accurate picture of the patients that finally receive the drugs to treat dementia. We will also analyse the proportion of patients with a ‘prescription cascade’ and this will contribute to the identification of adverse events that have been misclassified as new medical conditions. Finally, the comparative safety study carried out will inform us about the risk of adverse events between users and non-users of antidementia drugs. Given the increasing availability of non-pharmacological treatments to treat dementia, this information will help clinicians to assess the risk-benefit of these drugs. The other comparative safety studies, between acetylcholinesterase inhibitors versus N-methyl-D-aspartate receptor antagonists and between galantamine and donepezil versus rivastigmine will also contribute to decision making of clinicians and can be the base of other prospective head-to-head comparison studies.
Relevance and aplicability: Population-based cohort studies that use routinely collected health care data have gained importance in the last years because of their ability to provide evidence that could not be generated through randomized controlled trials. This is more important in pharmacoepidemiology given that subjects that are included in the pivotal trials of the drugs usually differ greatly from the overall population that finally receives the medication. The ageing of the populations foresees an increase in the cognitive related disorders including dementia and Alzheimer disease. Although the actual medications to treat dementia (rivastigmine, galantamine, donepezil and memantine) were commercialized more than a decade ago, few are the studies that have analysed their real-world adverse effects at a population level, none of them in Spain, and even fewer are the ones that have done this comparing the different medications. Regardless of the new therapies that are being recently developed to treat dementia the great burden of the treatment still relies on these four medications and therefore is it necessary to fully identify, describe in depth the patients that are using these drugs. The comparative safety analysis results will help health care providers and clinicians to assess the risk-benefits of these drugs to avoid future adverse events or better target patients who receive medication. At last, this can also be a hypothesis generating study given that it will help identify the characteristics of the population at an increased risk of adverse events which could help design future antidementia drug studies.