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1.
Drug Saf ; 47(11): 1137-1148, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-38949714

RESUMEN

BACKGROUND: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring. OBJECTIVE: We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season. METHODS: In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination. RESULTS: In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18-65 years (59.7%), followed by those aged 3-17 years (47.0%), >65 years (35.7%), and 6-35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent. CONCLUSIONS: Across all age and risk groups for serious disease, no serious adverse events related to GSK's IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK's IIV4 across all recommended age groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: not applicable.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Vacunas contra la Influenza , Gripe Humana , Humanos , Vacunas contra la Influenza/efectos adversos , Vacunas contra la Influenza/administración & dosificación , Femenino , Masculino , Niño , Preescolar , Adolescente , Adulto , Lactante , Gripe Humana/prevención & control , Persona de Mediana Edad , Adulto Joven , Bélgica/epidemiología , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Alemania/epidemiología , España/epidemiología , Anciano , Estaciones del Año , Vacunas de Productos Inactivados/efectos adversos , Vacunas de Productos Inactivados/administración & dosificación , Vacunación/efectos adversos
2.
Eur J Gen Pract ; 30(1): 2320120, 2024 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38511739

RESUMEN

BACKGROUND: Periodontitis is a chronic inflammatory non-communicable disease (NCD) characterised by the destruction of the tooth-supporting apparatus (periodontium), including alveolar bone, the presence of periodontal pockets, and bleeding on probing. OBJECTIVES: To outline, for family doctors, the implications of the association between periodontal and systemic diseases; to explore the role of family doctors in managing periodontitis as an ubiquitous non-communicable disease (NCD). METHODS: The consensus reports of previous focused collaborative workshops between WONCA Europe and the European Federation of Periodontology (using previously undertaken systematic reviews), and a specifically commissioned systematic review formed the technical papers to underpin discussions. Working groups prepared proposals independently, and the proposals were subsequently discussed and approved at plenary meetings. RESULTS: Periodontitis is independently associated with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, obstructive sleep apnoea, and COVID-19 complications. Treatment of periodontitis has been associated with improvements in systemic health outcomes. The article also presents evidence gaps. Oral health care professionals (OHPs) and family doctors should collaborate in managing these conditions, including implementing strategies for early case detection of periodontitis in primary medical care centres and of systemic NCDs in oral/dental care settings. There is a need to raise awareness of periodontal diseases, their consequences, and the associated risk factors amongst family doctors. CONCLUSION: Closer collaboration between OHPs and family doctors is important in the early case detection and management of NCDs like cardiovascular diseases, diabetes mellitus, and respiratory diseases. Strategies for early case detection/prevention of NCDs, including periodontitis, should be developed for family doctors, other health professionals (OHPs), and healthcare funders. Evidence-based information on the reported associations between periodontitis and other NCDs should be made available to family doctors, OHPs, healthcare funders, patients, and the general population.


Periodontitis is independently associated with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, obstructive sleep apnoea, and COVID-19.Periodontal treatment for optimal outcomes improves diabetes outcomes and surrogate measures of cardiovascular risk.Closer collaboration between oral health care professionals and family doctors is important in the early case detection and management of non-communicable diseases.Information on the reported associations should be made available to family doctors, oral health professionals, healthcare funders, patients, and the general population.


Asunto(s)
COVID-19 , Enfermedades Cardiovasculares , Humanos , Europa (Continente) , COVID-19/complicaciones , COVID-19/epidemiología , Diabetes Mellitus/terapia , Diabetes Mellitus/epidemiología , Enfermedades Periodontales/terapia , Periodontitis/terapia , Periodontitis/epidemiología , Consenso
3.
Aten Primaria ; 56(6): 102853, 2024 Jun.
Artículo en Español | MEDLINE | ID: mdl-38244288

RESUMEN

OBJECTIVE: To evaluate the effectiveness of the incorporation of the clinical assistant in improving the control of type 2 diabetes mellitus and hypertension in a primary care center. DESIGN: Quasi-experimental study (pre-post), with a control group, with a 1-year follow-up. SETTING: Primary care center. PARTICIPANTS: Patients between the ages of 18 and 85 with a diagnosis of diabetes type 2 and/or hypertension were selected. INTERVENTION: Incorporation of the figure of the clinical assistant, previously trained. The latter contacted the patient to explain their role and obtain informed consent, assessed compliance with the protocols, and when they were incomplete and/or detected warning signs, referred the patient directly to medicine and/or nursing. RESULTS: Three thousand and sixty-four patients participated, 30.74% assigned to the intervention group. Fifty percent were women. The mean age was 68.5 years (SD 11.07). 93.59% of diabetic patients in the intervention group had at least one determination of glycosylated hemoglobin compared to 86.83% in the control group (p=0.003). Fundus and diabetic foot screening was significantly higher in the intervention group (94.31% and 85.41% vs. 83.49% and 72.38%). 88.43% of the patients in the intervention group had registered blood pressure figures compared to 62.06% of the patients in the control group (p<0.05). There were not statistically significant differences in the control of blood pressure between the patients with recorded measures (p=0.478). CONCLUSIONS: Clinical assistants can facilitate the implementation and compliance with chronic diseases protocols, and in the long run improve the degree of control of these patients and the quality of care.


Asunto(s)
Diabetes Mellitus Tipo 2 , Hipertensión , Atención Primaria de Salud , Humanos , Femenino , Masculino , Anciano , Diabetes Mellitus Tipo 2/complicaciones , Persona de Mediana Edad , Adulto , Anciano de 80 o más Años , Estudios Controlados Antes y Después , Adolescente
4.
Clin Investig Arterioscler ; 36(3): 101-107, 2024.
Artículo en Inglés, Español | MEDLINE | ID: mdl-38220535

RESUMEN

BACKGROUND: This study aimed to validate the IberScore cardiovascular risk model in a population attended in the primary care setting. METHODS: A cohort of patients with no history of cardiovascular disease visited in a primary care center during the years 2008 and/or 2009 and followed up until 2018 was selected. Cardiovascular risk was calculated with the IberScore formula for all the subjects of the cohort and the model was calibrated, graphically represented by risk deciles the proportion of expected events and proportion of observed events at 10-year follow-up, stratified by sex. The area under the ROC curve was calculated to assess the discrimination of the model. RESULTS: A total of 10,085 patients visited during the years 2008 and/or 2009 were included in the study. Men showed a mean 10-year risk of suffering a fatal or non-fatal cardiovascular events according to IberScore of 17.07% (SD 20.13), with a mean estimated vascular age of more than 4 years higher than the biological age; while women had a mean 10-year risk of 7.91% (SD 9.03), with an estimated vascular age of more than 2 years above the biological age. The area under the ROC curve showed a discrimination index of the model of 0.86 (95% CI 0.84-0.88) in men and 0.82 (95% CI 0.79-0.85) in women. CONCLUSION: IberScore model discriminates well in the population attended in primary care but the model overestimates the risk.


Asunto(s)
Enfermedades Cardiovasculares , Factores de Riesgo de Enfermedad Cardiaca , Atención Primaria de Salud , Humanos , Masculino , Femenino , Enfermedades Cardiovasculares/epidemiología , Persona de Mediana Edad , Anciano , Medición de Riesgo/métodos , Estudios de Cohortes , Estudios de Seguimiento , Factores Sexuales , Adulto , Curva ROC , Factores de Edad
5.
Rev Esp Salud Publica ; 972023 Oct 11.
Artículo en Español | MEDLINE | ID: mdl-37921377

RESUMEN

This document summarises the evidence regarding the association between adverse pregnancy outcomes (APOs), such as hypertensive disorders, preterm birth, gestational diabetes, fetal growth defects (small for gestational age and/or fetal growth restriction), placental abruption, fetal loss, and the risk that a pregnant individual in developing vascular risk factors (VR) that may lead to future vascular disease (VD): coronary heart disease, stroke, peripheral vascular disease, and heart failure. Furthermore, this document emphasises the importance of recognising APOs when assessing VR in women. A history of APOs serves as a sufficient indicator for primary prevention of VD. In fact, adopting a healthy diet and increasing physical activity among women with APOs, starting during pregnancy and/or postpartum, and maintaining it throughout life are significant interventions that can reduce VR. On the other hand, breastfeeding can also reduce the future VR of women, including a lower risk of mortality. Future studies evaluating the use of aspirin, statins, and metformin, among others, in women with a history of APOs could strengthen recommendations regarding pharmacotherapy for primary prevention of VD in these patients. Various healthcare system options exist to improve the transition of care for women with APOs between different healthcare professionals and implement long-term VR reduction strategies. One potential process could involve incorporating the fourth-trimester concept into clinical recommendations and healthcare policies.


Este documento resume la evidencia que existe entre los resultados adversos del embarazo (RAE), tales como son los trastornos hipertensivos, el parto pretérmino, la diabetes gestacional, los defectos en el crecimiento fetal (feto pequeño para la edad gestacional y/o restricción del crecimiento), el desprendimiento de placenta y la pérdida fetal, y el riesgo que tiene una persona gestante de desarrollar factores de riesgo vascular (RV) que pueden terminar provocando enfermedad vascular (EV) futura: cardiopatía coronaria, accidente cerebrovascular, enfermedad vascular periférica e insuficiencia cardíaca. Asimismo, este documento destaca la importancia de saber reconocer los RAE cuando se evalúa el RV en mujeres. Un antecedente de RAE es un indicador suficiente para hacer una prevención primaria de EV. De hecho, adoptar una dieta saludable y aumentar la actividad física entre las mujeres con RAE, de inicio en el embarazo y/o postparto y manteniéndolo a lo largo de la vida, son intervenciones importantes que permiten disminuir el RV. Por otro lado, la lactancia materna también puede disminuir el RV posterior de la mujer, incluyendo menos riesgo de mortalidad. Estudios futuros que evalúen el uso del ácido acetilsalicílico, las estatinas y la metformina, entre otros, en las mujeres con antecedentes de RAE podrían reforzar las recomendaciones sobre el uso de la farmacoterapia en la prevención primaria de la EV entre estas pacientes. Existen diferentes opciones dentro de los sistemas de salud para mejorar la transición de la atención de las mujeres con RAE entre los diferentes profesionales e implementar estrategias para reducir su RV a largo plazo. Una posible estrategia podría ser la incorporación del concepto del cuarto trimestre en las recomendaciones clínicas y las políticas de atención de la salud.


Asunto(s)
Hipertensión , Nacimiento Prematuro , Humanos , Embarazo , Femenino , Recién Nacido , Placenta , España , Hipertensión/tratamiento farmacológico , Retardo del Crecimiento Fetal , Estudios Retrospectivos
6.
Nefrologia (Engl Ed) ; 43(3): 360-369, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37635013

RESUMEN

We present the Spanish adaptation of the 2021 European Guidelines on Cardiovascular Disease (CVD) prevention in clinical practice. The current guidelines besides the individual approach greatly emphasize on the importance of population level approaches to the prevention of cardiovascular diseases. Systematic global CVD risk assessment is recommended in individuals with any major vascular risk factor. Regarding LDL-Cholesterol, blood pressure, and glycemic control in patients with diabetes mellitus, goals and targets remain as recommended in previous guidelines. However, it is proposed a new, stepwise approach (Step 1 and 2) to treatment intensification as a tool to help physicians and patients pursue these targets in a way that fits patient profile. After Step 1, considering proceeding to the intensified goals of Step 2 is mandatory, and this intensification will be based on 10-year CVD risk, lifetime CVD risk and treatment benefit, comorbidities and patient preferences. The updated SCORE algorithm-SCORE2, SCORE-OP- is recommended in these guidelines, which estimates an individual's 10-year risk of fatal and non-fatal CVD events (myocardial infarction, stroke) in healthy men and women aged 40-89 years. Another new and important recommendation is the use of different categories of risk according different age groups (< 50, 50-69, ≥70 years). Different flow charts of CVD risk and risk factor treatment in apparently healthy persons, in patients with established atherosclerotic CVD, and in diabetic patients are recommended. Patients with chronic kidney disease are considered high risk or very high-risk patients according to the levels of glomerular filtration rate and albumin-to-creatinine ratio. New lifestyle recommendations adapted to the ones published by the Spanish Ministry of Health as well as recommendations focused on the management of lipids, blood pressure, diabetes and chronic renal failure are included.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus , Masculino , Humanos , Femenino , Enfermedades Cardiovasculares/epidemiología , Factores de Riesgo , Estilo de Vida , Diabetes Mellitus/epidemiología , Comorbilidad
7.
Clin Infect Dis ; 77(11): 1521-1530, 2023 11 30.
Artículo en Inglés | MEDLINE | ID: mdl-37466374

RESUMEN

BACKGROUND: Molnupiravir is an orally administered antiviral authorized for COVID-19 treatment in adults at high risk of progression to severe disease. Here, we report secondary and post hoc analyses of participants' self-reported symptoms in the MOVe-OUT trial, which evaluated molnupiravir initiated within 5 days of symptom onset in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19. METHODS: Eligible participants completed a 15-item symptom diary daily from day 1 (randomization) through day 29, rating symptom severity as "none," "mild," "moderate," or "severe"; loss of smell and loss of taste were rated as "yes" or "no." Time to sustained symptom resolution/improvement was defined as the number of days from randomization to the first of 3 consecutive days of reduced severity, without subsequent relapse. Time to symptom progression was defined as the number of days from randomization to the first of 2 consecutive days of worsening severity. The Kaplan-Meier method was used to estimate event rates at various time points. The Cox proportional hazards model was used to estimate the hazard ratio between molnupiravir and placebo. RESULTS: For most targeted COVID-19 symptoms, sustained resolution/improvement was more likely, and progression was less likely, in the molnupiravir versus placebo group through day 29. When evaluating 5 distinctive symptoms of COVID-19, molnupiravir participants had a shorter median time to first resolution (18 vs 20 d) and first alleviation (13 vs 15 d) of symptoms compared with placebo. CONCLUSIONS: Molnupiravir treatment in at-risk, unvaccinated patients resulted in improved clinical outcomes for most participant-reported COVID-19 symptoms compared with placebo. Clinical Trials Registration. ClinicalTrials.gov: NCT04575597.


Asunto(s)
COVID-19 , Adulto , Humanos , SARS-CoV-2 , Tratamiento Farmacológico de COVID-19 , Medición de Resultados Informados por el Paciente , Resultado del Tratamiento
8.
Hepatol Int ; 17(4): 773-791, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37204656

RESUMEN

BACKGROUND: Fatty liver disease in the absence of excessive alcohol consumption is an increasingly common condition with a global prevalence of ~ 25-30% and is also associated with cardiovascular disease (CVD). Since systemic metabolic dysfunction underlies its pathogenesis, the term metabolic (dysfunction)-associated fatty liver disease (MAFLD) has been proposed for this condition. MAFLD is closely intertwined with obesity, type 2 diabetes mellitus and atherogenic dyslipidemia, which are established cardiovascular risk factors. Unlike CVD, which has received attention in the literature on fatty liver disease, the CVD risk associated with MAFLD is often underestimated, especially among Cardiologists. METHODS AND RESULTS: A multidisciplinary panel of fifty-two international experts comprising Hepatologists, Endocrinologists, Diabetologists, Cardiologists and Family Physicians from six continents (Asia, Europe, North America, South America, Africa and Oceania) participated in a formal Delphi survey and developed consensus statements on the association between MAFLD and the risk of CVD. Statements were developed on different aspects of CVD risk, ranging from epidemiology to mechanisms, screening, and management. CONCULSIONS: The expert panel identified important clinical associations between MAFLD and the risk of CVD that could serve to increase awareness of the adverse metabolic and cardiovascular outcomes of MAFLD. Finally, the expert panel also suggests potential areas for future research.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Hepatopatías , Enfermedad del Hígado Graso no Alcohólico , Humanos , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Asia , Consenso
9.
J Clin Periodontol ; 50(6): 819-841, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36935200

RESUMEN

AIM: To explore the implications for dentists and family doctors of the association between periodontal and systemic diseases and the role of dentists and family doctors in managing non-communicable diseases (NCDs) and promoting healthy lifestyles. MATERIALS AND METHODS: The consensus reports of the previous Focused Workshops on the associations between periodontitis and diabetes (2017) and periodontitis and cardiovascular diseases (2019) formed the technical reviews to underpin discussions on both topics. For the association with respiratory diseases, a systematic review was specifically commissioned for the Workshop discussions. Working groups prepared proposals independently, and then the proposals were discussed and approved at plenary meetings. RESULTS: Periodontitis is independently associated with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea and COVID-19 complications. Dentists and family doctors should collaborate in managing NCDs, implementing strategies for early detection of periodontitis in primary care centres and of cardiovascular diseases or diabetes in dental settings. Family doctors should be informed about periodontal diseases and their consequences, and oral health professionals (OHPs) should be informed about the relevance of NCDs and the associated risk factors. CONCLUSIONS: Closer collaboration between OHPs and family doctors is important in the early detection and management of NCDs and in promoting healthy lifestyles. Pathways for early case detection of periodontitis in family medicine practices and of NCDs in dental practices should be developed and evaluated.


Asunto(s)
COVID-19 , Enfermedades Cardiovasculares , Diabetes Mellitus , Enfermedades Periodontales , Periodontitis , Enfermedades Respiratorias , Humanos , Consenso , Enfermedades Cardiovasculares/complicaciones , COVID-19/complicaciones , Enfermedades Periodontales/complicaciones , Enfermedades Periodontales/terapia , Periodontitis/complicaciones , Enfermedades Respiratorias/complicaciones , Europa (Continente)
10.
Clin Investig Arterioscler ; 35(3): 115-122, 2023.
Artículo en Inglés, Español | MEDLINE | ID: mdl-36344347

RESUMEN

INTRODUCTION: The function to estimate lifetime cardiovascular risk -IBERLIFERISK- in Spanish working population, obtained a satisfactory discrimination; however, there was a slight overestimation of the risk in men and an underestimation of the risk in women. OBJECTIVE: To recalibrate the current lifetime risk equation after extending the follow-up by 3 years. METHODS: Retrospective cohort study. 762.058 workers who underwent an occupational health examination between 2004 and 2007 were included. All episodes of temporary sickness and cardiovascular mortality up to December 2017 were evaluated. Regression models were combined to take into account the presence of competing risks in estimating cardiovascular risk in the derivation cohort. Calibration was performed by graphically representing the proportion of expected and observed events at 10 years of follow-up in the validation cohort, stratifying by risk deciles and calculating the Spiegelhalter Z statistic. Discrimination was evaluated graphically using the Receiver Operating Curve (ROC) and calculating Harrell's C index. RESULTS: The mean age was 35.48 years (SD 10.56). 71.14% were men. Harrell's C index was 0.78 (95% CI 0.76-0.79) in men and 0.73 (95% CI 0.69-0.77) in women. In general, there was a slight degree of underestimation in women and overestimation in men in the last decile of risk, although the Spiegelhalter Z statistic was not statistically significant in both sexes (p>0.05). CONCLUSIONS: The updated model continues to discriminate satisfactorily, although the model's calibration has not substantially improved with the new update.


Asunto(s)
Enfermedades Cardiovasculares , Masculino , Humanos , Femenino , Adulto , Factores de Riesgo , Estudios Retrospectivos , Medición de Riesgo , España , Factores de Riesgo de Enfermedad Cardiaca
13.
BMC Cardiovasc Disord ; 22(1): 560, 2022 12 22.
Artículo en Inglés | MEDLINE | ID: mdl-36550424

RESUMEN

BACKGROUND: Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. METHODS: The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. RESULTS: The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. CONCLUSION: The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).


Asunto(s)
Enfermedades Cardiovasculares , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Humanos , Antihipertensivos/efectos adversos , LDL-Colesterol , Combinación de Medicamentos , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/tratamiento farmacológico , Colesterol , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos
15.
Artículo en Inglés | MEDLINE | ID: mdl-36360704

RESUMEN

AIMS: Nurse-led case management (CM) may improve quality of life (QoL) for advanced heart failure (HF) patients. No systematic review (SR), however, has summarized its effectiveness/cost-effectiveness. We aimed to evaluate the effect of such programs in primary care settings in advanced HF patients. We examined and summarized evidence on QoL, mortality, hospitalization, self-care, and cost-effectiveness. METHODS AND RESULTS: The MEDLINE, CINAHL, Embase, Clinical Trials, WHO, Registry of International Clinical Trials, and Central Cochrane were searched up to March 2022. The Consensus Health Economic Criteria instrument to assess risk-of-bias in economic evaluations, Cochrane risk-of-bias 2 for clinical trials, and an adaptation of Robins-I for quasi-experimental and cohort studies were employed. Results from nurse-led CM programs did not reduce mortality (RR 0.78, 95% CI 0.53 to 1.15; participants = 1345; studies = 6; I2 = 47%). They decreased HF hospitalizations (HR 0.79, 95% CI 0.68 to 0.91; participants = 1989; studies = 8; I2 = 0%) and all-cause ones (HR 0.73, 95% CI 0.60 to 0.89; participants = 1012; studies = 5; I2 = 36%). QoL improved in medium-term follow-up (SMD 0.18, 95% CI 0.05 to 0.32; participants = 1228; studies = 8; I2 = 28%), and self-care was not statistically significant improved (SMD 0.66, 95% CI -0.84 to 2.17; participants = 450; studies = 3; I2 = 97%). A wide variety of costs ranging from USD 4975 to EUR 27,538 was observed. The intervention was cost-effective at ≤EUR 60,000/QALY. CONCLUSIONS: Nurse-led CM reduces all-cause hospital admissions and HF hospitalizations but not all-cause mortality. QoL improved at medium-term follow-up. Such programs could be cost-effective in high-income countries.


Asunto(s)
Insuficiencia Cardíaca , Calidad de Vida , Humanos , Análisis Costo-Beneficio , Manejo de Caso , Insuficiencia Cardíaca/tratamiento farmacológico , Atención Primaria de Salud
16.
JMIR Diabetes ; 7(4): e40377, 2022 Oct 03.
Artículo en Inglés | MEDLINE | ID: mdl-36190763

RESUMEN

BACKGROUND: Diabetes is a major health care problem, reaching epidemic numbers worldwide. Reducing hemoglobin A1c (HbA1c) levels to recommended targets is associated with a marked decrease in the risk of type 2 diabetes mellitus (T2DM)-related complications. The implementation of new technologies, particularly telemedicine, may be helpful to facilitate self-care and empower people with T2DM, leading to improved metabolic control of the disease. OBJECTIVE: This study aimed to analyze the effect of a home digital patient empowerment and communication tool (DeMpower App) on metabolic control in people with inadequately controlled T2DM. METHODS: The DeMpower study was multicenter with a retrospective (observational: 52 weeks of follow-up) and prospective (interventional: 52 weeks of follow-up) design that included people with T2DM, aged ≥18 and ≤80 years, with HbA1c levels ≥7.5% to ≤9.5%, receiving treatment with noninsulin antihyperglycemic agents, and able to use a smartphone app. Individuals were randomly assigned (2:1) to the DeMpower app-empowered group or control group. We describe the effect of empowerment on the proportion of patients achieving the study glycemic target, defined as HbA1c≤7.5% with a ≥0.5% reduction in HbA1c at week 24. RESULTS: Due to the COVID-19 pandemic, the study was stopped prematurely, and 50 patients (33 in the DeMpower app-empowered group and 17 in the control group) were analyzed. There was a trend toward a higher proportion of patients achieving the study glycemic target (46% vs 18%; P=.07) in the DeMpower app group that was statistically significant when the target was HbA1c≤7.5% (64% vs 24%; P=.02) or HbA1c≤8% (85% vs 53%; P=.02). The mean HbA1c was significantly reduced at week 24 (-0.81, SD 0.89 vs -0.15, SD 1.03; P=.03); trends for improvement in other cardiovascular risk factors, medication adherence, and satisfaction were observed. CONCLUSIONS: The results suggest that patient empowerment through home digital tools has a potential effect on metabolic control, which might be even more relevant during the COVID-19 pandemic and in a digital health scenario.

17.
Clin Investig Arterioscler ; 34(4): 219-228, 2022.
Artículo en Inglés, Español | MEDLINE | ID: mdl-35906022

RESUMEN

We present the Spanish adaptation of the 2021 European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. The current guidelines besides the individual approach greatly emphasize on the importance of population level approaches to the prevention of cardiovascular diseases. Systematic global cardiovascular disease risk assessment is recommended in individuals with any major vascular risk factor. Regarding LDL-cholesterol, blood pressure, and glycemic control in patients with diabetes mellitus, goals and targets remain as recommended in previous guidelines. However, it is proposed a new, stepwise approach (steps 1 and 2) to treatment intensification as a tool to help physicians and patients pursue these targets in a way that fits patient profile. After step 1, considering proceeding to the intensified goals of step 2 is mandatory, and this intensification will be based on 10-year cardiovascular disease risk, lifetime cardiovascular disease risk and treatment benefit, comorbidities and patient preferences. The updated SCORE algorithm ?SCORE2, SCORE2-OP? is recommended in these guidelines, which estimates an individual's 10-year risk of fatal and non-fatal cardiovascular disease events (myocardial infarction, stroke) in healthy men and women aged 40-89 years. Another new and important recommendation is the use of different categories of risk according to different age groups (<50, 50-69, ≥70 years). Different flow charts of cardiovascular disease risk and risk factor treatment in apparently healthy persons, in patients with established atherosclerotic cardiovascular disease, and in diabetic patients are recommended. Patients with chronic kidney disease are considered high risk or very high-risk patients according to the levels of glomerular filtration rate and albumin-to-creatinine ratio. New lifestyle recommendations adapted to the ones published by the Spanish Ministry of Health as well as recommendations focused on the management of lipids, blood pressure, diabetes and chronic renal failure are included.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus , Anciano , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/prevención & control , LDL-Colesterol , Diabetes Mellitus/terapia , Femenino , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Factores de Riesgo
18.
Rev Esp Salud Publica ; 962022 Mar 01.
Artículo en Español | MEDLINE | ID: mdl-35228510

RESUMEN

We present the Spanish adaptation of the 2021 European Guidelines on Cardiovascular Disease (CVD) prevention in clinical practice. The current guidelines besides the individual approach greatly emphasize on the importance of population level approaches to the prevention of cardiovascular diseases. Systematic global CVD risk assessment is recommended in individuals with any major vascular risk factor. Regarding LDL-Cholesterol, blood pressure, and glycemic control in patients with diabetes mellitus, goals and targets remain as recommended in previous guidelines. However, it is proposed a new, stepwise approach (Step 1 and 2) to treatment intensification as a tool to help physicians and patients pursue these targets in a way that fits patient profile. After Step 1, considering proceeding to the intensified goals of Step 2 is mandatory, and this intensification will be based on 10-year CVD risk, lifetime CVD risk and treatment benefit, comorbidities and patient preferences. The updated SCORE algorithm (SCORE2, SCORE-OP) is recommended in these guidelines, which estimates an individual's 10-year risk of fatal and non-fatal CVD events (myocardial infarction, stroke) in healthy men and women aged 40-89 years. Another new and important recommendation is the use of different categories of risk according different age groups (<50, 50-69, >70 years). Different flow charts of CVD risk and risk factor treatment in apparently healthy persons, in patients with established atherosclerotic CVD, and in diabetic patients are recommended. Patients with chronic kidney disease are considered high risk or very high-risk patients according to the levels of glomerular filtration rate and albumin-to-creatinine ratio. New lifestyle recommendations adapted to the ones published by the Spanish Ministry of Health as well as recommendations focused on the management of lipids, blood pressure, diabetes and chronic renal failure are included.


Presentamos la adaptación española de las Guías Europeas de Prevención Cardiovascular 2021. En esta actualización además del abordaje individual, se pone mucho más énfasis en las políticas sanitarias como estrategia de prevención poblacional. Se recomienda el cálculo del riesgo vascular de manera sistemática a todas las personas adultas con algún factor de riesgo vascular. Los objetivos terapéuticos para el colesterol LDL, la presión arterial y la glucemia no han cambiado respecto a las anteriores guías, pero se recomienda alcanzar estos objetivos de forma escalonada (etapas 1 y 2). Se recomienda llegar siempre hasta la etapa 2, y la intensificación del tratamiento dependerá del riesgo a los 10 años y de por vida, del beneficio del tratamiento, de las comorbilidades, de la fragilidad y de las preferencias de los pacientes. Las guías presentan por primera vez un nuevo modelo para calcular el riesgo (SCORE2 y SCORE2 OP) de morbimortalidad vascular en los próximos 10 años (infarto de miocardio, ictus y mortalidad vascular) en hombres y mujeres entre 40 y 89 años. Otra de las novedades sustanciales es el establecimiento de diferentes umbrales de riesgo dependiendo de la edad (<50, 50-69, >70 años). Se presentan diferentes algoritmos de cálculo del riesgo vascular y tratamiento de los factores de riesgo vascular para personas aparentemente sanas, pacientes con diabetes y pacientes con enfermedad vascular aterosclerótica. Los pacientes con enfermedad renal crónica se considerarán de riesgo alto o muy alto según la tasa del filtrado glomerular y el cociente albúmina/creatinina. Se incluyen innovaciones en las recomendaciones sobre los estilos de vida, adaptadas a las recomendaciones del Ministerio de Sanidad, así como aspectos novedosos relacionados con el control de los lípidos, la presión arterial, la diabetes y la insuficiencia renal crónica.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus , Adulto , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus/prevención & control , Femenino , Humanos , Estilo de Vida , Masculino , Persona de Mediana Edad , Factores de Riesgo , España
19.
Artículo en Inglés | MEDLINE | ID: mdl-35162857

RESUMEN

BACKGROUND: The COVID-19 pandemic is a major challenge for health systems, citizens and policymakers worldwide. It is not known how many people are affected with longer term sequelae after acute COVID-19 and a wide range of prevalence estimates have been reported with a high heterogeneity between studies. METHODS: We designed a cross-sectional study to estimate the prevalence of post COVID-19 conditions in a community setting. We selected a random sample of 579 individuals from three different primary health care centers and collected information on symptoms through a standardized questionnaire. RESULTS: Our main study finding was an overall population prevalence of 14.34% (95% CI 11.58-17.46%) of post COVID-19. Only 9% of patients were hospitalized in our study. Prevalence was higher in women than men (15.63% versus 13.06%) and the most frequent persistent symptoms were fatigue (44.6%), smell impairment (27.7%) and dyspnea (24.09%). CONCLUSIONS: The prevalence of post COVID-19 condition was lower than expected according to other studies published in the literature. The prevalence was higher in women than men, and the most frequent persistent symptoms were fatigue, smell impairment, and dyspnea.


Asunto(s)
COVID-19 , Pandemias , Estudios Transversales , Femenino , Humanos , Masculino , Prevalencia , Atención Primaria de Salud , SARS-CoV-2
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