Efecto de la variante Ómicron sobre la incidencia y la letalidad durante la 6 onda epidémica COVID-19 en España / Effect of the Omicron variant on cumulative incidence of infection and lethality during the sixth wave of the COVID-19 epidemic in Spain

La pandemia COVID-19 ha puesto a prueba los sistemas sanitarios a nivel mundial. Las sucesivas ondas epidémicas han mostrado características diferentes. La variante Ómicron del SARS-CoV-2 modificó el comportamiento epidémico que habían seguido las variantes previas. El objetivo de este análisis fue determinar las características epidemiológicas de la COVID-19 durante la 6.ª onda epidémica y sus diferencias según predominara las variantes Delta u Ómicron. Se analizaron los datos epidemiológicos correspondientes a la 6.ª onda epidémica publicados por los organismos oficiales, y se analizaron la incidencia acumulada de infección (IA-I) y las tasas de letalidad (TL), tanto del conjunto de España como de las diferentes Comunidades Autónomas, en el conjunto de la población y por grupos etarios. Los resultados mostraron que la IA-I era mayor con la variante Ómicron (10,89 vs. 0,75% con Delta) mientras que la TL lo era con la variante Delta (4,2 vs. 1,3‰ con Ómicron), así como una mayor tasa de hospitalización e ingreso en UCI con la variante Delta.(AU)

The COVID-19 pandemic has strained healthcare systems globally. The successive epidemic waves have shown different characteristics. The Omicron variant of SARS-CoV-2 modified the epidemic behavior that previous variants had followed. The aim of this analysis was to determine the epidemiological characteristics of COVID-19 during the sixth epidemic wave and its differences according to the predominance of the Delta or Omicron variants. The epidemiological data corresponding to the sixth wave of the epidemic published by official organizations were analyzed, and the cumulative incidence of infection (CI-I) and case fatality rates (CFR) were calculated, both for Spain as a whole and for the different Autonomous Communities, in the population as a whole and by age groups. The results showed that the CI-I was higher with the Ómicron variant (10.89% vs 0.75% with Delta) while the CFR was higher with the Delta variant (4.2‰ vs 1.3‰ with Ómicron), as well as a higher rate of hospitalization and ICU admission with the Delta variant.(AU)

Prevalence, impact and management of hypertension-mediated organ damage in type 2 diabetes patients.

OBJECTIVE: To determine the prevalence, impact and management of hypertension-mediated organ damage (HMOD) according to the presence of type 2 diabetes (T2DM). METHODS: IBERICAN is an ongoing multicenter, observational and prospective study, including outpatients aged 18-85 years who attended the Primary Care setting in Spain. In this study, the prevalence, impact and management of HMOD according to the presence of T2DM at baseline were analyzed. RESULTS: At baseline, 8066 patients (20.2% T2DM, 28.6% HMOD) were analyzed. Among patients with T2DM, 31.7% had hypertension, 29.8% dyslipidemia and 29.4% obesity and 49.3% had ≥1 HMOD, mainly high pulse pressure (29.6%), albuminuria (16.2%) and moderate renal impairment (13.6%). The presence of T2DM significantly increased the risk of having CV risk factors and HMOD. Among T2DM population, patients with HMOD had more dyslipidemia (78.2% vs 70.5%; P=0.001), hypertension (75.4% vs 66.4%; P=0.001), any CV disease (39.6% vs 16.1%; P=0.001) and received more drugs. Despite the majority of types of glucose-lowering agents were more frequently taken by those patients with HMOD, compared to the total T2DM population, the use of SGLT2 inhibitors and GLP-1 receptor agonists was marginal. CONCLUSIONS: In patients daily attended in primary care setting in Spain, one in five patients had T2DM and nearly half of these patients had HMOD. In patients with T2DM, the presence of HMOD was associated with a higher risk of CV risk factors and CV disease. Despite the very high CV risk, the use of glucose-lowering agents with proven CV benefit was markedly low.

[Effect of the Omicron variant on cumulative incidence of infection and lethality during the sixth wave of the COVID-19 epidemic in Spain]. / Efecto de la variante Ómicron sobre la incidencia y la letalidad durante la 6.ª onda epidémica COVID-19 en España.

The COVID-19 pandemic has strained healthcare systems globally. The successive epidemic waves have shown different characteristics. The Omicron variant of SARS-CoV-2 modified the epidemic behavior that previous variants had followed. The aim of this analysis was to determine the epidemiological characteristics of COVID-19 during the sixth epidemic wave and its differences according to the predominance of the Delta or Omicron variants. The epidemiological data corresponding to the sixth wave of the epidemic published by official organizations were analyzed, and the cumulative incidence of infection (CI-I) and case fatality rates (CFR) were calculated, both for Spain as a whole and for the different Autonomous Communities, in the population as a whole and by age groups. The results showed that the CI-I was higher with the Ómicron variant (10.89% vs 0.75% with Delta) while the CFR was higher with the Delta variant (4.2‰ vs 1.3‰ with Ómicron), as well as a higher rate of hospitalization and ICU admission with the Delta variant.

Case-fatality rate of SARS-CoV-2 infection during the third and fifth epidemic waves in Spain: Impact of vaccination / Tasa de letalidad de la infección por SARS-CoV-2 durante la tercera y quinta oleadas epidémicas en España: impacto de la vacunación

Introduction During the first and second epidemic waves in Spain, the SARS-CoV-2 case-fatality rates (CFRs) showed significant differences between Autonomous Communities (ACs). Comparing CFRs in the third and fifth epidemic waves can provide information on the impact of the different vaccination coverages in the ACs. Objective To evaluate the impact of vaccination on COVID-19 CFRs in the third and fifth epidemic waves in Spain, according to sex, age, and AC. Methods This work is an observational, descriptive study which uses data on COVID-19 infections, deaths, and vaccinees published by the Spanish Ministry of Health and the regional Health Departments of the ACs. The third epidemic wave was defined as the period from 26th December 2020 to 19th April 2021, and the fifth wave, from 19th July to 19th September 2021. The CFRs (deaths per 1000 infected [‰]) were calculated according to sex, age group, and AC. The standardized case-fatality ratio (SCFR) was adjusted for age and sex for each wave. We estimated the correlation between CFRs and their change between the two epidemic waves with the vaccination coverages reached at the beginning of the fifth wave. Results The CFR in the fifth wave (5.7‰) was lower than in the third wave (16.5‰). In addition, the CFR in both waves was significantly higher in men than in women, and in older people than in younger ones. A decrease in the CFR between both waves was only observed in those older than 49. A strong direct and positive correlation (R2a=0.8399) was found between vaccination coverage by age group and decrease in CFR between both epidemic waves. Significant differences were seen between ACs in the two waves, as regards both CFRs and SCFRs. When comparing ACs, a direct correlation was observed between vaccination coverage and CFRs in the fifth wave, and also – although weak – between vaccination coverage and decrease in CFR between both waves (AU)

Introducción Durante la primera y segunda oleadas epidémicas en España, las tasas de letalidad (TL) por SARS-CoV-2 mostraron diferencias significativas entre comunidades autónomas (CC. AA.). La comparación de las TL en la tercera y quinta oleadas epidémicas puede aportar información sobre el impacto de las diferentes coberturas vacunales en las CC. AA. Objetivo Evaluar el impacto de la vacunación sobre las TL de COVID-19 en la tercera y quinta onda epidémica en España, según sexo, edad y CC. AA. Métodos Este trabajo es un estudio observacional, descriptivo, que utiliza los datos de infectados, fallecidos y vacunados por COVID-19 publicados por el Ministerio de Sanidad y las Consejerías de Sanidad de las CC. AA. La tercera onda epidémica se definió como el periodo comprendido entre el 26 de diciembre de 2020 y el 19 de abril de 2021, y la quinta onda, entre el 19 de julio y el 19 de septiembre de 2021. Las TL (muertes por cada 1.000 infectados [‰]) se calcularon en función del sexo, el grupo de edad y la CC. AA. La razón estandarizada de letalidad (REL) se ajustó por edad y sexo para cada oleada. Se estimó la correlación entre las TL y su cambio entre las 2 oleadas epidémicas con las coberturas de vacunación alcanzadas al inicio de la quinta oleada. Resultados La TL en la quinta onda (5,7‰) fue inferior a la de la tercera onda (16,5‰). Además, la TL en ambas oleadas fue significativamente mayor en varones que en mujeres, y en personas mayores que en jóvenes. Solo se observó una disminución de la TL entre ambas oleadas en los mayores de 49 años. Se encontró una fuerte correlación directa y positiva (R2a=0,8399) entre la cobertura de vacunación por grupo de edad y la disminución de la TL entre ambas oleadas epidémicas (AU)

Assessment of frailty in the person with type 2 diabetes mellitus: Expert analysis.

INTRODUCTION: People with type 2 diabetes mellitus (DM2) have a higher prevalence of frailty compared to those without DM2. However, there is a lack of consensus on the diagnosis and clinical management of frail individuals with DM2. OBJECTIVES: This study aims to identify limitations and current needs in the use of the frailty concept in PCDM2 (people with DM2), as well as define and evaluate the dimensions that should be included in its routine clinical assessment. METHODS: A multidisciplinary team of eight health professionals from different hospitals in Spain participated in a process based on the nominal group technique. RESULTS: The study identified eight limitations in the assessment of frailty in PCDM2, categorized by importance, and 10 unmet needs related to the diagnosis and follow-up of the disease. Additionally, seven dimensions were identified that should be included in the definition of frail individuals with DM2, prioritized by importance and novelty. CONCLUSIONS: This article aims to increase knowledge and usage of the frailty concept in individuals with DM2 within the medical community. It also suggests the potential for future projects to develop a consensus definition of frailty tailored to this specific group.

Case-fatality rate of SARS-CoV-2 infection during the third and fifth epidemic waves in Spain: Impact of vaccination.

INTRODUCTION: During the first and second epidemic waves in Spain, the SARS-CoV-2 case-fatality rates (CFRs) showed significant differences between Autonomous Communities (ACs). Comparing CFRs in the third and fifth epidemic waves can provide information on the impact of the different vaccination coverages in the ACs. OBJECTIVE: To evaluate the impact of vaccination on COVID-19 CFRs in the third and fifth epidemic waves in Spain, according to sex, age, and AC. METHODS: This work is an observational, descriptive study which uses data on COVID-19 infections, deaths, and vaccinees published by the Spanish Ministry of Health and the regional Health Departments of the ACs. The third epidemic wave was defined as the period from 26th December 2020 to 19th April 2021, and the fifth wave, from 19th July to 19th September 2021. The CFRs (deaths per 1000 infected [‰]) were calculated according to sex, age group, and AC. The standardized case-fatality ratio (SCFR) was adjusted for age and sex for each wave. We estimated the correlation between CFRs and their change between the two epidemic waves with the vaccination coverages reached at the beginning of the fifth wave. RESULTS: The CFR in the fifth wave (5.7‰) was lower than in the third wave (16.5‰). In addition, the CFR in both waves was significantly higher in men than in women, and in older people than in younger ones. A decrease in the CFR between both waves was only observed in those older than 49. A strong direct and positive correlation (R2a=0.8399) was found between vaccination coverage by age group and decrease in CFR between both epidemic waves. Significant differences were seen between ACs in the two waves, as regards both CFRs and SCFRs. When comparing ACs, a direct correlation was observed between vaccination coverage and CFRs in the fifth wave, and also - although weak - between vaccination coverage and decrease in CFR between both waves. CONCLUSION: The CFR significantly decreased in Spain between the third and the fifth epidemic waves in population aged 50 or older, probably due to the high vaccination coverage in that age group. Differences were observed between CFRs and SCFRs between ACs that are not explained by the differences in vaccination coverage, suggesting the need for further research and evaluation.

Factores asociados al control óptimo simultáneo de la diabetes, hipertensión arterial e hipercolesterolemia en la población diabética. Estudio BPC diabetes / Factors associated with the optimum simultaneous control of diabetes, arterial hypertension and hypercholesterolemia in the diabetic population. BPC Diabetes study

Objetivos: Conocer el grado de control óptimo simultáneo de la diabetes (DM), hipertensión arterial (HTA) e hipercolesterolemia y determinar los factores asociados. Material y métodos: Estudio descriptivo transversal en pacientes diabéticos de 18 o más de edad, seleccionados consecutivamente en consultas de medicina de familia (MF). Los datos de los pacientes se obtuvieron mediante acceso a la historia informatizada, registrándose variables clínicas y analíticas de interés. Se consideró buen control metabólico una HbA1c < 7%, buen control de la presión arterial (PA) valores < 140/80 mmHg y buen control de colesterol LDL (c-LDL) valores < 100 mg/dL. Se realizó análisis bivariante y se calcularon odds ratio (OD) en un modelo de regresión logística. El estudio fue aprobado por el CEIm del Hospital Clínico San Carlos (Madrid). Resultados: Se incluyó a 1.420 pacientes (55,8% varones), con una edad media (DE) de 70,6 (10,8) años. El 75,9% eran hipertensos y el 69,1% dislipémicos. Los valores de HbA1c fueron de 6,9 (1,2) %, PA sistólica 135,0 (16,8) mmHg, PA diastólica 75,9 (10,6) mmHg y LDL-colesterol 93,7 (32,8) mg/dL. El buen control metabólico de la DM se alcanzó en el 63% (intervalo de confianza [IC] 95%: 60,4-65,5), el buen control de la HTA en el 42,6% (IC 95%: 40,0-45,2) y el buen control de colesterol LDL en el 61,1% (IC 95%: 58,4-63,7) de los pacientes. El buen control de los tres factores de riesgo cardiovascular (FRCV) simultáneamente se alcanzó en el 16,1% (IC 95%: 14,2-18,1). Se observó una asociación positiva e independiente (p < 0,05) entre el buen control simultáneo de los FRCV con la edad (OR: 1.017) y los antecedentes personales de enfermedad cardiovascular (OR: 1.596). Conclusiones: Los resultados de nuestro estudio indican que una proporción pequeña, menos de dos de cada 10 pacientes cumplen los objetivos de buen control recomendados por las guías de práctica clínica (AU)

Objectives: To know the degree of simultaneous optimal control of diabetes (DM), high blood pressure (BP) and hypercholesterolemia and determine the associated factors. Material and method: Cross-sectional descriptive study in diabetic patients 18 years aged or older selected consecutively in primary care centers (PC). Patient data were obtained through access to electronical clinical history. Clinical and analytical variables of interest were registered. Good metabolic control was considered as HbA1c < 7%, good blood pressure control (PA) as values < 140/80 mmHg and good LDL cholesterol control (c-LDL) as values < 100 mg/dL. Bivariate analysis was performed and odds ratio were calculated in a logistic regression model. The study was approved by the San Carlos Clinical Hospital's Clinical Research Ethics Committee (CREC), in Madrid. Results: 1420 patients (55.8% male), with an average (SD) age of 70.6 (10.8) years were included. 75.9% were hypertensive patients, and 69.1% dyslipemic. HbA1c values were 6.9 (1.2) %, sistolic BP 135.0 (16.8) mmHg, diastolic BP 75.9 (10.6) mmHg and LDL-cholesterol 93.7 (32.8) mg/dL. Good metabolic control of DM was achieved at 63.0% (95% CI: 60.4–65.5), good control of HTA at 42.6% (95% CI: 40.0–45.2) and good LDL cholesterol control in 61.1% (95% IC: 58.4–63.7) of patients. Good simultaneous control of the three cardiovascular risk factors (CVRF) was reached at 16.1% (95% CI: 14.2–18.1). A positive and independent association (p<0.05) was observed between good simultaneous control of CVRF with age (OR: 1.017) and with personal history of cardiovascular disease (OR: 1.596). Conclusions: The results of our study indicate that a small proportion, less than two out of 10 patients, meet the good control goals recommended by clinical practice guidelines. We found important differences between patients with and without cardiovascular disease (AU)

Tasas de letalidad por SARS-CoV-2 según Comunidades Autónomas durante la segunda onda epidémica en España / Case-fatality rates of SARS-CoV-2 infection according to Autonomous Communities during the second epidemic wave in Spain

Introducción: En España, los sistemas sanitarios están transferidos a las Comunidades Autónomas (CC.AA.), constituyendo 19 sistemas sanitarios con gestión y recursos diferenciados. Durante la primera onda epidémica de la COVID-19 se objetivaron diferencias en los sistemas de declaración y en las tasas de letalidad (TL) entre las CC.AA. El objetivo de este estudio fue analizar las TL por CC.AA. durante la segunda onda epidémica (del 20 de julio al 25 de diciembre de 2020) y su relación con la prevalencia de la infección. Material y métodos: Se realizó un estudio observacional descriptivo con la información disponible sobre el número de fallecidos por COVID-19 registrados en el Ministerio de Sanidad, Consejerías de Salud y los Departamentos de Salud Pública de las CC.AA. y según el exceso de mortalidad informado por el Sistema de Monitorización de Mortalidad Diaria (MoMo). La prevalencia de la infección se estimó a partir de las diferencias entre la segunda y cuarta ronda del estudio ENE-COVID y sus intervalos de confianza del 95%. Se calcularon las TL (fallecidos por cada mil infectados) globales, por sexo, grupos de edad (< 65 y ≥ 65 años) y CC.AA. Se calculó la razón estandarizada de letalidad por edad (REL) de las CC.AA. utilizando las TL de España para cada grupo de etario. Estas estimaciones se realizaron con las defunciones declaradas oficialmente (TLo) y el exceso de defunciones estimadas por MoMo (TLMo). Se estimaron las correlaciones entre las prevalencias de infección y las TLo y TLMo, ponderando por población. Resultados: Para el conjunto de España, la TLo durante la segunda onda epidémica fue del 7,6%, oscilando entre 3,8% de Baleares y 16,4% de Asturias, y la TLMo fue de 10,1%, oscilando entre el 4,8% de Madrid y el 21,7% en Asturias. Se observaron diferencias significativas entre la TLo y la TLMo en Canarias, Castilla la Mancha, Extremadura, Comunidad Valenciana, Andalucía y las Ciudades Autónomas de Ceuta y Melilla (AU)

Introduction: In Spain, health systems are transferred to the Autonomous Communities (AC), constituting 19 health systems with differentiated management and resources. During the first epidemic wave of COVID-19, differences were observed in reporting systems and in case-fatality rates (FR) between the AC. The objective of this study was to analyze the FR according to AC. during the 2 nd epidemic wave (from July 20 to December 25, 2020), and its relationship with the prevalence of infection. Material and methods: A descriptive observational study was carried out, extracting the information available on the number of deaths from COVID-19 registered in the Ministry of Health, the Health Councils and the Public Health Departments of the AC, and according to the excess mortality reported by the System Monitoring of Daily Mortality (MoMo). The prevalence of infection was estimated from the differences between the second and fourth rounds of the ENE-COVID study and their 95% confidence intervals. The global FR (deaths per thousand infected) were calculated according to sex, age groups (< 65 and ≥ 65 years) and AC. The age-Standardized Fatality Rates (SFR) of the AC were calculated using the FR of Spain for each age group. These estimates were made with officially declared deaths (FRo) and excess deaths estimated by MoMo (FRMo). The correlations between the prevalences of infection and the FRo and FRMo were estimated, weighting by population. Results: For the whole of Spain, the FRo during the second epidemic wave was 7.6%, oscillating between 3.8% in the Balearic Islands and 16.4% in Asturias, and the TLMo was 10.1%, oscillating between 4.8% from Madrid and 21.7% in Asturias. Significant differences were observed between the FRo and the FRMo in the Canary Islands, Castilla la Mancha, Extremadura, the Valencian Community, Andalusia and the Autonomous Cities of Ceuta and Melilla. The FRo was significantly higher in men (8.2%) than in women (7.1%) (AU)

[Case-fatality rates of SARS-CoV-2 infection according to Autonomous Communities during the second epidemic wave in Spain]. / Tasas de letalidad por SARS-CoV-2 según Comunidades Autónomas durante la segunda onda epidémica en España.

INTRODUCTION: In Spain, health systems are transferred to the Autonomous Communities (AC), constituting 19 health systems with differentiated management and resources. During the first epidemic wave of COVID-19, differences were observed in reporting systems and in case-fatality rates (FR) between the AC. The objective of this study was to analyze the FR according to AC. during the 2 nd epidemic wave (from July 20 to December 25, 2020), and its relationship with the prevalence of infection. MATERIAL AND METHODS: A descriptive observational study was carried out, extracting the information available on the number of deaths from COVID-19 registered in the Ministry of Health, the Health Councils and the Public Health Departments of the AC, and according to the excess mortality reported by the System Monitoring of Daily Mortality (MoMo). The prevalence of infection was estimated from the differences between the second and fourth rounds of the ENE-COVID study and their 95% confidence intervals. The global FR (deaths per thousand infected) were calculated according to sex, age groups (< 65 and ≥ 65 years) and AC. The age-Standardized Fatality Rates (SFR) of the AC were calculated using the FR of Spain for each age group. These estimates were made with officially declared deaths (FRo) and excess deaths estimated by MoMo (FRMo). The correlations between the prevalences of infection and the FRo and FRMo were estimated, weighting by population. RESULTS: For the whole of Spain, the FRo during the second epidemic wave was 7.6%, oscillating between 3.8% in the Balearic Islands and 16.4% in Asturias, and the TLMo was 10.1%, oscillating between 4.8% from Madrid and 21.7% in Asturias. Significant differences were observed between the FRo and the FRMo in the Canary Islands, Castilla la Mancha, Extremadura, the Valencian Community, Andalusia and the Autonomous Cities of Ceuta and Melilla. The FRo was significantly higher in men (8.2%) than in women (7.1%). The FRo and FRMo were significantly higher in the age group ≥ 65 years (55.4% and 72.2% respectively) than in the group <65 years (0.5% and 1.4% respectively). The Basque Country, Aragon, Andalusia and Castilla la Mancha presented SFR significantly higher than the global FR of Spain. The correlations between the prevalence of infection and the FRo were inverse. CONCLUSIONS: The case-fatality from COVID-19 during the second epidemic wave in Spain improved compared to the first wave. The case-fatality rates were higher in men and the elderly people, and varied significantly between AC. It is necessary to delve into the analysis of the causes of these differences.

[Factors associated with the optimum simultaneous control of diabetes, arterial hypertension and hypercholesterolemia in the diabetic population. BPC Diabetes study]. / Factores asociados al control óptimo simultáneo de la diabetes, hipertensión arterial e hipercolesterolemia en la población diabética. Estudio BPC diabetes.

OBJECTIVES: To know the degree of simultaneous optimal control of diabetes (DM), high blood pressure (BP) and hypercholesterolemia and determine the associated factors. MATERIAL AND METHOD: Cross-sectional descriptive study in diabetic patients 18 years aged or older selected consecutively in primary care centers (PC). Patient data were obtained through access to electronical clinical history. Clinical and analytical variables of interest were registered. Good metabolic control was considered as HbA1c < 7%, good blood pressure control (PA) as values < 140/80 mmHg and good LDL cholesterol control (c-LDL) as values < 100 mg/dL. Bivariate analysis was performed and odds ratio were calculated in a logistic regression model. The study was approved by the San Carlos Clinical Hospital's Clinical Research Ethics Committee (CREC), in Madrid. RESULTS: 1420 patients (55.8% male), with an average (SD) age of 70.6 (10.8) years were included. 75.9% were hypertensive patients, and 69.1% dyslipemic. HbA1c values were 6.9 (1.2) %, sistolic BP 135.0 (16.8) mmHg, diastolic BP 75.9 (10.6) mmHg and LDL-cholesterol 93.7 (32.8) mg/dL. Good metabolic control of DM was achieved at 63.0% (95% CI: 60.4-65.5), good control of HTA at 42.6% (95% CI: 40.0-45.2) and good LDL cholesterol control in 61.1% (95% IC: 58.4-63.7) of patients. Good simultaneous control of the three cardiovascular risk factors (CVRF) was reached at 16.1% (95% CI: 14.2-18.1). A positive and independent association (p<0.05) was observed between good simultaneous control of CVRF with age (OR: 1.017) and with personal history of cardiovascular disease (OR: 1.596). CONCLUSIONS: The results of our study indicate that a small proportion, less than two out of 10 patients, meet the good control goals recommended by clinical practice guidelines. We found important differences between patients with and without cardiovascular disease.

[Application of the PCR number of cycle threshold value (Ct) in COVID-19]. / Aplicación del valor umbral del número de ciclos (Ct) de PCR en la COVID-19.

The SARS-CoV-2 pandemic persists with all its virulence despite 650,382,819 doses of COVID vaccine worldwide. The reference test for infection identification is reverse transcription polymerase chain reaction (RT-qPCR). The usefulness of this test may be diminished by simplifying its result as positive or negative. Determining the number of cycles (Ct) in positive RT-qPCR tests can assist in decision-making when interpreted in the clinical context of patients.

[Factors associated with cardiovascular risk and cardiovascular and renal disease in the IBERICAN study: Final results]. / Factores asociados al riesgo cardiovascular y enfermedad cardiovascular y renal en el estudio IBERICAN (Identificación de la poBlación Española de RIesgo CArdiovascular y reNal): resultados definitivos.

OBJECTIVE: To analyse the prevalence in clinical practice of cardiovascular risk factors (CVRF) and cardiovascular disease (CVD), as well as their causal relationship, in the study inclusion visit. MATERIAL AND METHODS: Cross-sectional analysis of the study inclusion visit of 8,066 patients of 18 to 85years of age included in the IBERICAN study. By reviewing the medical history, analytics and medical visits, the patient's physician has collected socio-demographic information, personal and family history and prevalence of CVRF and CVD and renal disease. A multivariate analysis was carried out using a logistic regression that included the autonomous region variable as a random effect variable, in order to analyse the impact of certain variables on the development of each CVRF, metabolic syndrome, subclinical organ damage, renal disease, and CVD. RESULTS: Dyslipidaemia was 2.4 times more frequent in diabetics, and the risk was increased by 59% in hypertensive patients. Arterial hypertension was twice as frequent in diabetics, and increased 94% in hyperuricaemic patients and 62.1% in dyslipidaemia patients. Diabetes mellitus was 2.5 times higher in dyslipidaemia patients, and 2.2 times higher in hypertensive patients. CVD was four times more frequent in patients with a family history, and the risk in women was increased by 90.8% and by 53.8% in patients with renal disease. CONCLUSIONS: The Spanish population seen in Primary Care that were analysed in the IBERICAN study had a high prevalence of CVRF and CVD, which gives it a high CVR. The multivariate analysis performed shows a close causal relationship between the CVRF with each other, and with renal disease and CVD.

[Skills perceived by general practitioners for providing care to immigrant patients]. / Aptitudes percibidas por el médico de familia en la atención a pacientes inmigrantes.

OBJECTIVE: To identify the skills perceived by general practitioners for providing competent care to immigrants MATERIAL AND METHODS: Observational, descriptive and cross-sectional study with data collection using a 21-item questionnaire completed electronically by the general practitioners and validated by the National Validation Commission of SEMERGEN. It was structured with closed-ended, multiple-choice test questions, including variables related to the doctor and variables related to the immigrant patient. The level of professional competence was assessed using a 1 to 10 Likert scale. RESULTS: A total 610 family physicians with a mean age of 47.5±12.3 years responded and 64.1% were women. Of these, 112 (18.4%) were residents. The response rate was 4.9%. A large majority (72.6%) had not taken part in continuing education courses on caring for immigrants in the last 5years. Participants reported difficulties in the clinic: 73% of the cases with the language, 38.7% with the allotted time, and 32.3% due to knowledge of the culture. Most (96.9%) of patients attended the clinic due to a common illness. The cause in 14.4% was related to the migratory process (infectious disease acquired in the country of origin), and in 26.4% with the health conditions in the host country (lack of stable housing, overcrowding, and conditions of work). The perceived level of competence was 6.2±1.9. CONCLUSIONS: The competence perceived by general practitioners in providing care to immigrants is moderate. The most important barriers for these professionals are ignorance of the language, lack of time allocated for consultation, and ignorance of the patient's culture.

[Analysis of the level of compliance to the clinical practice guidelines recommendations for the diagnosis and monitoring of chronic vascular complications in type2 diabetes in Primary Care]. / Análisis del grado de cumplimiento de las recomendaciones de las guías de práctica clínica para el diagnóstico y seguimiento de las complicaciones crónicas vasculares en la diabetes tipo 2 en atención primaria.

OBJECTIVE: To evaluate the level of compliance to the clinical practice guidelines (CPG) recommendations for the diagnosis and monitoring of the main chronic vascular complications of patients with type2 diabetes (DM2) in Primary Care (PC). MATERIAL AND METHODS: A retrospective cross-sectional descriptive study was conducted on patients aged 18years and over and consecutively selected in PC. Patient data were obtained by direct interview and access to the computerised history, and recording the clinical and analytical variables of interest. The determination and recording of urine microalbumin (MALB), glomerular filtration rate (GFR), foot examination (pulse palpation, monofilament or tuning fork), and electrocardiogram (ECG), if performed annually, and the eye fundus (FO) every two years. RESULTS: A total of 1,420 patients were included, of which 55.8% were male. The mean age (SD) was 70.6 (10.8) years and the mean onset of the diabetes was 9.3 (6.2) years. The mean BMI (kg /m2) was 30.1 (5.4) in females and 29.5 (4.7) in males (P=.023), and a mean HbA1c (%) of 6.9 (1.2). Good metabolic control of DM was achieved in 63.0% (95%CI: 60.4-65.5). In the last two years, 976 (68.7%; 95%CI: 66.2-71.1) patients had an eye fundus examination. The urine microalbumin had been performed on 1,228 patients (86.5%; 95%CI: 84.6-88.2). The mean glomerular filtration rate was performed on 1,391 patients (98.0%; 95%CI: 97.1-98.6), the foot pulses examination on 626 (44.1%; 95%CI: 41.5-46.7), and the neurological examination on 473 patients (33.3%; 95%CI: 30.8-35.8). CONCLUSIONS: The results of the present study indicate that the presence of retinopathy or neuropathy is not explored in a significant percentage of patients with DM2. Only seven out of ten patients have been screened for retinopathy, one in three had a neurological examination, and only one in four have all the scans recommended by the CPG.

[Clinical and economic consequences in patients initiating therapy with clopidogrel brand-name vs. generic: A real-life retrospective study]. / Consecuencias clínicas y económicas en pacientes que inician tratamiento con clopidogrel de marca vs. genérico: estudio retrospectivo de vida real.

OBJECTIVE: To evaluate the adherence to treatment, resource use, and costs in subjects initiating treatment with brand-name versus generic clopidogrel for acute coronary syndrome (ACS) and peripheral arterial disease (PAD). PATIENTS AND METHODS: Observational, retrospective study based on the medical records of patients aged ≥18 years who initiated treatment with clopidogrel (brand-name vs. generic) between 4 April 2015 and 31 March 2017. Four study groups were compared, and the follow-up was one year. The main measurements were: comorbidity, treatment adherence, medication possession ratio (MPR), resource use, and costs. The results were analysed using multivariate analysis. The level of statistical significance was P<.05. RESULTS: Four groups were compared: a) ACS: brand-name clopidogrel (N=1,067) vs. generic (N=3,504), and b) PAD: brand-name clopidogrel (N=425) vs. generic (N=994). In the ACS comparison (mean age: 69.7 years, 61.4% male), adherence (65.3% vs. 61.0%, P<.001), adjusted hazard ratio 0.85 and MPR (89.8% vs. 86.7%, P=.045) were more superior with brand-name clopidogrel than with the generic and with a lower mean cost per unit (€2,890 vs. €3,865, P=.001). In the PAD comparison, similar results were observed: persistence (64.7% vs. 58.9%, P=.039); adjusted hazard-ratio 0.86 and MPR (88.6% vs. 81.7%; P=.013) were more superior with brand-name clopidogrel than for the generic, with a lower mean cost per unit (€2,880 vs. €3,532, P=.044). CONCLUSIONS: There was better treatment adherence in patients initiating treatment with brand-name compared with generic clopidogrel for ACS and PAD, resulting in lower health costs for the Spanish National Health System.

[Description of the sample, design and methods of the study for the identification of the Spanish population at cardiovascular and renal risk (IBERICAN)]. / Descripción de la muestra, diseño y métodos del estudio para la identificación de la población española de riesgo cardiovascular y renal (IBERICAN).

BACKGROUND AND OBJECTIVE: Cardiovascular diseases (CVD) are the leading cause of death in Spain, and although the incidence rates have been declining for years due to improvements in prevention and treatment, there is still room for further reduction. Primary Care has a leading role in the prevention and control of these diseases. Determining the prevalence and incidence of cardiovascular risk factors and cardiovascular diseases in the Spanish adult population attended in Primary Care is the objective of the study to identify the Spanish population at cardiovascular and renal risk (IBERICAN). MATERIAL AND METHODS: A prospective cohort study was conducted using a consecutive non-probabilistic sampling population between 18 and 85 years that attended Primary Care centres between April 1, 2014 and October 31, 2018. By reviewing the medical history, laboratory results, and medical visits, the Primary Care physicians collected socio-demographic information, personal and family history of the patients, as well as prevalence and incidence of cardiovascular risk factors and cardiovascular and renal disease. The incidents and associated factors will be estimated using proportional risk models of Cox and Kaplan-Meier Curves. RESULTS: A total of 8,066 patients have been recruited by 531 Primary Care physicians from all Autonomous Communities of Spain as part of the IBERICAN cohort, with the exception of Ceuta. The mean age of the cohort is 57.9 years with 54.5% women. Obesity, dyslipidaemia, and hypertension are the most prevalent cardiovascular risk factors. There was a history of CVD in16.3%, and 25.5% had a subclinical organ lesion. CONCLUSION: The IBERICAN study is a cohort of people treated in Primary Care that expects to provide relevant information on the factors that determine the incidence of cardiovascular and renal disease in Spain.

[Knowledge about Biosimilars in Primary Care: a study by the Spanish Society of Primary Care Physicians (SEMERGEN)]. / Conocimiento sobre biosimilares en Atención Primaria: Un estudio de la Sociedad Española de Médicos de Atención Primaria (SEMERGEN).

INTRODUCTION: The objective of this study was to evaluate the awareness and training needs on biosimilar drugs in Primary Care (PC) physicians. MATERIAL AND METHODS: Descriptive cross-sectional study based on an on-line questionnaire with a total of 34 multiple choice questions, published on the SEMERGEN website. The main Knowledge areas were: biosimilar definition; regulatory and legal framework; prescription, traceability, interchangeability and pharmacovigilance; availability of biosimilars in the PC setting, and the biosimilars contribution to sustainability. The software used for the analysis and data processing was the Barbwin 7.5. RESULTS: An analysis was performed on the responses from 701 questionnaires completed. There was a slight majority (57%) of women participants. The majority of participant worked in urban centres (60.91%). The definition of biosimilar was not known by 58% of those that responded, and 73% were unaware that the management of biosimilars and generics was not comparable. Most (84%) of those that responded were not aware that the studies required for the approval of biosimilars is different from reference biological medicines. Around two-thirds (66%) those that responded did not know of any biosimilars available in PC setting, and the 94% were also unaware of the Spanish legal framework for the management of biosimilar medicines. CONCLUSIONS: The current knowledge about biosimilars among PC physicians is low. The critical areas in need of further training include specific information on biosimilars currently available in PC setting, as well as key aspects regarding prescription, interchangeability and pharmacovigilance requirements. Six out of ten doctors do not know of any biosimilar used in PC in Spain.