Situación actual de los anticoagulantes orales de acción directa en atención primaria de España. Posicionamiento de SEMERGEN en 2023 / Current situation of direct oral anticoagulants in primary care in Spain: Positioning of SEMERGEN in 2023

La anticoagulación oral es clave para disminuir el riesgo de ictus en la fibrilación auricular. Aunque clásicamente los antagonistas de la vitaminaK (AVK) se han empleado para este fin, han sido ampliamente superados por los anticoagulantes orales de acción directa (ACOD), como lo demuestran las evidencias provenientes de los ensayos clínicos, estudios de vida real y poblacionales. De hecho, todas las guías de práctica clínica recomiendan su uso de manera preferencial sobre los AVK. Sin embargo, en España la prescripción de los ACOD está subordinada a un visado de inspección que recoge las condiciones clínicas definidas en el Informe de Posicionamiento Terapéutico de la Agencia Española del Medicamento, y que todavía impone importantes restricciones a su uso, limitando los beneficios del empleo de los ACOD en los pacientes con fibrilación auricular (FA), y generando además inequidades entre las diferentes comunidades autónomas. De hecho, el empleo de los ACOD en España es muy inferior a los países de nuestro entorno. Esto ha provocado que en otros países ha disminuido la incidencia de ictus isquémico a nivel poblacional, junto con una reducción del coste por paciente con FA, pero en España este descenso ha sido discreto. Por todo ello, y en aras de la sostenibilidad del sistema sanitario, pedimos la eliminación del visado para que los ACOD se puedan prescribir de acuerdo a las recomendaciones realizadas por las guías. Además, también apostamos por el refuerzo de la formación y de las decisiones consensuadas con el paciente, siendo el médico de familia un actor clave en la protección del paciente con FA.(AU)

Oral anticoagulation is the key to reduce the risk of stroke in atrial fibrillation. Although vitaminK antagonists (VKA) have classically been used for this purpose, they have been largely overcome by direct oral anticoagulants (DOAC), as demonstrated by evidence from clinical trials, real-life and population studies. In fact, all clinical practice guidelines recommend their use preferentially over VKA. However, in Spain the prescription of DOAC is subordinated to an inspection visa that includes the clinical conditions defined in the Therapeutic Positioning Report of the Spanish Medicines Agency, and that still imposes important restrictions on their use, limiting the benefits of using DOACs in patients with atrial fibrillation (AF), and also generating inequalities between the different autonomous communities. In fact, the use of DOAC in Spain is much lower than that observed in neighboring countries. This has made that while in other countries the incidence of ischemic stroke has decreased at the population level, along with a reduction in the cost per patient with AF, in Spain this decrease has been modest. For all these reasons, and for assuring the sustainability of the health care system, we ask for the elimination of the visa so that DOAC can be prescribed according to the recommendations made by the guidelines. In addition, we are also committed to reinforce medical education and decisions made by consensus with the patient, with the primary care physician acquiring a key role in the protection of the patient with AF.(AU)

[Current situation of direct oral anticoagulants in primary care in Spain: Positioning of SEMERGEN in 2023]. / Situación actual de los anticoagulantes orales de acción directa en atención primaria de España. Posicionamiento de SEMERGEN en 2023.

Oral anticoagulation is the key to reduce the risk of stroke in atrial fibrillation. Although vitaminK antagonists (VKA) have classically been used for this purpose, they have been largely overcome by direct oral anticoagulants (DOAC), as demonstrated by evidence from clinical trials, real-life and population studies. In fact, all clinical practice guidelines recommend their use preferentially over VKA. However, in Spain the prescription of DOAC is subordinated to an inspection visa that includes the clinical conditions defined in the Therapeutic Positioning Report of the Spanish Medicines Agency, and that still imposes important restrictions on their use, limiting the benefits of using DOACs in patients with atrial fibrillation (AF), and also generating inequalities between the different autonomous communities. In fact, the use of DOAC in Spain is much lower than that observed in neighboring countries. This has made that while in other countries the incidence of ischemic stroke has decreased at the population level, along with a reduction in the cost per patient with AF, in Spain this decrease has been modest. For all these reasons, and for assuring the sustainability of the health care system, we ask for the elimination of the visa so that DOAC can be prescribed according to the recommendations made by the guidelines. In addition, we are also committed to reinforce medical education and decisions made by consensus with the patient, with the primary care physician acquiring a key role in the protection of the patient with AF.

Evaluation of prophylaxis in primary prevention with acetylsalicylic acid in people with diabetes: A scoping review.

BACKGROUND: The efficacy and safety of acetylsalicylic acid (ASA) prophylaxis for the primary prevention of atherosclerotic cardiovascular disease (ACVD) remain controversial in people with diabetes (DM) without ACVD, because the possible increased risk of major bleeding could outweigh the potential reduction in the risk of mortality and of major adverse cardiovascular events (MACE) considered individually or together. OBJECTIVE: To evaluate the overall risk-benefit of ASA prophylaxis in primary prevention in people with DM and to compare the recommendations of the guidelines with the results of the meta-analyses (MA) and systematic reviews (SR). MATERIAL AND METHODS: We searched Medline, Google Scholar, Embase, and the Cochrane Library for SR and MA published from 2009 to 2020 which compared the effects of ASA prophylaxis versus placebo or control followed up for at least one year in people with DM without ACVD. Heterogeneity among the randomized clinical trials (RCT) included in the SR and MA was assessed. Cardiovascular outcomes of efficacy (all-cause mortality [ACM], cardiovascular mortality [CVM], myocardial infarction [MI], stroke and MACE) and of safety (major bleeding events [MBE], major gastrointestinal bleeding events [MGIBE], and intracranial and extracranial bleeding) were shown. RESULTS: The recommendations of 12 guidelines were evaluated. The results of 25 SR and MA that included a total of 20 RCT were assessed. None of the MA or SR showed that ASA prophylaxis decreased the risk of ACM, CVM or MI. Only two of the 19 SR and MA that evaluated ischemic stroke showed a decrease in the stroke risk (mean 20.0% [SD±5.7]), bordering on statistical significance. Almost half of the MA and SR showed, bordering on statistical significance, a risk reduction for the MACE composite endpoint (mean 10.5% [SD±3.3]). The significant increases in MGIBE risk ranged from 35% to 55%. The significant increases in the risk of MBE and extracraneal bleeding were 33.4% (SD±14.9) and 54.5% (SD±0.7) respectively. CONCLUSION: The overall risk-benefit assessment of ASA prophylaxis in primary prevention suggests that it should not be applied in people with DM.

[Risk of falls and drug use in patients over 65 years of age. The PYCAF study]. / Riesgo de caídas y consumo de fármacos en los pacientes mayores de 65 años. Estudio PYCAF.

OBJECTIVE: To evaluate the risk of falls and its relationship with the multiple drug use in the non-institutionalised elderly. MATERIALS AND METHODS: The PYCAF study (Prevalence and Characteristics of the Fragile Elderly) is a cross-sectional, descriptive and multicentre study in patients> 65 years of age. A fall was considered high risk when it took more than 20seconds to perform the Timed Up and Go test. Consuming between 5 and 9 drugs is considered multiple drug (MD) use, and extreme multiple drug (EMD) use the consumption of 10 or more drugs. Adjusted logistic regression models evaluated the association between multiple drug use and EMD and the risk of falls. RESULTS: A total of 2,461 patients (57.9% women), with a mean age (SD) 76.0 (± 7.0) years, were included in the study. The mean consumption of medications was 6.6 ± 3.7, range 0-23. Multiple drug use was present in 50.6%, and EMD in 19.2% of patients. A high risk of falls was observed in 13.7% of patients. The prevalence of high risk of falls was more than 2times higher in patients with EMD (ORa = 2.07, 95% CI = 1.27 - 3.38) and MD (ORa = 1.95, 95% CI = 1.26 - 2.99). CONCLUSIONS: MD and EMD are associated with a high risk of falls in patients over 65 years of age. The risk of falls in elderly patients should be assessed before prescribing medication.

[Clinical and socio-sanitary characteristics in adults older than 65 years attended in the Primary Care setting. The PYCAF study]. / Características clínicas y sociosanitarias en mayores de 65 años asistidos en atención primaria. Estudio PYCAF.

OBJECTIVE: To describe the clinical and socio-sanitary characteristics of adults older than 65 years attended in a Primary Care setting. MATERIAL AND METHODS: The PYCAF study (Prevalence and Characteristics of the Fragile Elderly) is a descriptive, cross-sectional and multicentre study, in which patients older than 65 years attended in clinical practice in Primary Care in Spain were consecutively included. RESULTS: A total of 2,461 patients (mean age 76.0±6.9 years, 57.9% women) were included in the study. The coexistence of cardiovascular risk factors and comorbidities was frequent, with arterial hypertension (73.7%) being the most prevalent, followed by dyslipidaemia (58.3%), arthrosis (56.4%), obesity (34.0%), and diabetes (28.9%). Some degree of cognitive impairment was observed in 13.4% of patients. Women had higher rates of frailty (61.0% vs. 51.8%; P<.001). Just under half (47.4%) of subjects were taking more than 6 drugs, with the prescription being higher in women (44.2% vs. 49.8%; P=.047). Just under half (49.5%) of patients made more than 10 visits to Primary Care, 25.9% of patients 4 or more visits to the specialist, and 22.3% of patients were admitted to hospital in the last year. CONCLUSIONS: The PYCAF study shows that elderly patients have a higher prevalence of chronic cardiovascular and non-cardiovascular diseases, which leads to high polypharmacy. The latter has consequences both on patient safety and on the direct and indirect costs of the National Health System that emanate from the care of patients over 65 years of age. Half the sample has fragility.