Patients With High Cardiovascular Risk as Candidates to Bempedoic Acid, After Treatment With Statins, Ezetimibe and PCSK9 Inhibitors: An Estimation and Cost-Effectiveness Analysis.

ABSTRACT: Low-density lipoprotein cholesterol (LDLc) is the lead effector of atherosclerosis and main treatment target. Bempedoic acid is a novel oral drug in the therapeutic armamentarium which is able to reduce LDLc. The objectives of this study were (1) to select the potential patients for administering bempedoic acid such as those with a very high cardiovascular risk in which objectives of LDLc were not achieved despite conventional treatment with PCSK9 inhibitors (PCSK9i) and/or statins and ezetimibe and (2) to estimate the cost-effectiveness of bempedoic acid in different scenarios. The methods used were a multicenter and retrospective study of 652 patients initiating treatment with any PCSK9 inhibitor in 17 different hospitals. Before and on-treatment LDLc cholesterol levels, medical treatments, clinical indication, and baseline characteristics were recorded. The results obtained from 443 subjects in secondary prevention were analyzed. The mean (±) LDLc level at baseline was 142.5 ± 46.4 mg/dL and 61.5 ± 40.5 mg/dL in the follow-up, with a reduction of 55.9% ( P < 0.0001); 71.6% of the patients reached the target of LDL < 55 mg/dL or >50% reduction. Of those patients treated with medium-intensity and low-intensity statins plus PCSK9 inhibitors (with or without ezetimibe), only 5.7% of them were able to reduce LDL below 55 mg/dL and the main LDLc reduction in this group was the lowest (42.9% on average). Patients with TG values >135 mg/dL represented 41.6% of the sample, of which approximately 10% of them were using fibrates. Assuming only LDLc reduction and the UK price, the incremental cost-effectiveness ratio was 88,359€; 83,117€; 82,378€; and 79,015€ for different discount rates. In conclusion, one-third of the patients could achieve the target LDL proposed in the 2019 ESC/EAS guidelines. Approximately 10% of them could also benefit from treating hypertriglyceridemia as indicated in the 2021 ESC guidelines on cardiovascular disease prevention. Patients with medium-intensity and low-intensity statins plus PCSK9i and ezetimibe would be the most benefited. Bempedoic acid could be a not cost-efficacy therapy in all the scenarios, but we need to wait for the CLEAR OUTCOMES Trial results.

Effect of PCSK9 inhibitors on remnant cholesterol and lipid residual risk: The LIPID-REAL registry.

BACKGROUND: Monoclonal antibodies that inhibit the proprotein convertase subtilisin/kexin type 9 (PCSK9) reduce low-density lipoprotein cholesterol (LDLc) by 55%, regardless of baseline treatments. Nonetheless, the effect of other lipid parameters, such as cholesterol remnants or, the so-called lipid residual risk, is unknown. METHODS: Multicenter and retrospective registry of patients treated with PCSK9 inhibitors from 14 different hospitals in Spain. Before and on-treatment lipid parameters were recorded. Residual lipid risk was estimated by (1) cholesterol remnants, (2) triglycerides/HDLc ratio (TG/HDL), (3) total cholesterol/HDLc (TC/HDL) and (4) the triglycerides-to-glucose index (TGGi). RESULTS: Six hundred fifty-two patients were analysed, mean age of 60.2 (9.63) years, 24.69% women and mean LDLc before treatment 149.24 (49.86) mg/dl. Median time to second blood determination was 187.5 days. On-treatment LDLc was 67.46 (45.78) mg/dl, which represented a 55% reduction. Significant reductions were observed for TG/HDL ratio, cholesterol remnants, TC/HDL ratio and TGGi. As consequence, 34.61% patients had LDLc <55 mg/dl and cholesterol remnants <30 mg/dl; additionally, 31.95% had cholesterol remnants <30 mg/dl but LDLc >55 mg/dl. Patients who had levels of cholesterol remnants >30 mg/dl before initiating the treatment with PCSK9 had higher reductions in cholesterol remnants, TG/HDL ratio, TC/HDL and TGGi. By contrast, no reduction differences were observed according to baseline LDLc (< or > the mean), age, gender or obesity. CONCLUSIONS: This multicenter and retrospective registry of real-world patients treated with PCSK9 inhibitors demonstrates a positive effect on cholesterol remnants and lipid residual risk beyond LDLc reductions.

Sex Differences in Low-Density Lipoprotein Cholesterol Reduction With PCSK9 Inhibitors in Real-world Patients: The LIPID-REAL Registry.

BACKGROUND: Previous evidence supports that monoclonal antibodies that inhibit the proprotein convertase subtilisin/kexin type 9 (PCSK9) reduce low-density lipoprotein cholesterol (LDLc) by 50%-65%, regardless of baseline treatments. We tested possible sex differences in a multicentre registry of real-world patients treated with PCSK9 inhibitors. METHODS: This is a multicentre and retrospective study of 652 patients initiating treatment with any PCSK9 inhibitor in 18 different hospitals. Before-treatment and on-treatment LDLc and medical treatments, clinical indication, and clinical features were recorded. RESULTS: Women represented 24.69% of the cohort. The use of statins was similar in both sexes, but women were receiving most frequently ezetimibe. Before-treatment median LDLc was 135 (interquartile range 115-166) mg, and it was higher in women. The median on-treatment LDLc was 57 (interquartile range 38-84) mg/dL, which represented a mean 54.5% reduction. On-treatment LDLc was higher in women, and the mean LDLc reduction was lower in women (47.4% vs. 56.9%; P = 0.0002) receiving evolocumab or alirocumab. The percentage of patients who achieved ≥50% LDLc reduction was higher in men (71.36% vs. 57.62%; P = 0.002). According to LDLc before-treatment quartiles, LDLc reduction was statistically lower in women in the 2 highest and a significant interaction of women and baseline LDLc >135 mg/dL was observed. Women were negatively associated with lower rates of LDLc treatment target achievement (odds ratio: 0.31). Differences were also observed in women with body mas index >25 kg/m2. Only 14 patients (2.14%) presented side effects. CONCLUSIONS: This multicentre and retrospective registry of real-world patients treated with PCSK9 inhibitors highlights significant gender differences in LDLc reduction.

Organ donation after controlled cardiac death under Maastricht category iii: Ethical implications and end of life care. / La donación de órganos en asistolia controlada tipo iii de Maastricht: implicaciones éticas y cuidados al final de la vida.

The decrease in potential donation after brain death has resulted in a need to evaluate alternative sources. Donation after cardiac death is a good option. The objectives of this article are to describe the Maastricht type iii controlled organ donation characteristics and to determine end-of-life care and the role of nurses in the donation process. In this type of donation, cardiocirculatory arrest is predictable after the limitation of life sustaining treatments. These are patients for whom there are no effective therapy options and, in the context of an organised and planned practice involving all the professionals involved in the care of the patient, the decision is made, in consultation with the family, to withdraw life support measures. This limitation of life sustaining treatments is never carried out with the aim of making a Maastricht iii donation, but to avoid prolonging the dying process through useless and possibly degrading interventions. The obligation of the health team is to provide a dignified death and this not only includes the absence of pain, but the patient and their family must be guaranteed a feeling of calmness and serenity. Once the decision has been taken to withhold or withdraw measures, the nurse has an important role in the implementation of a palliative care plan in where physicians, nurses and patients/families should be involved and whose focus should be on patients' dignity and comfort, considering their physical, psychological and spiritual needs.

[Informal caretakers in Spain, their profile and care provided]. / Los cuidadores informales en España. Perfil y cuidados prestados.

The authors carried out a systematic search in main data bases and a methodological content review by paired authors about selected publications. The authors reviewed and analyzed 332 articles about informal caretakers and they chose 182 which complied with their selection criteria. The profile for informal caretakers of persons aged over 65 in Spain is identified as well as the type of care he/she provides. It is worth highlighting the introduction of a new factor in caretaking for the elderly during recent years at a national Spanish level, and since the 1990s on an international level: paid non-professional immigrant caretakers. This phenomenon makes the different traits which ethnic minority caretakers have reflect on the dynamics and the results of this study.

Safety and quality in critical patient care. / Seguridad y calidad en la atención al paciente crítico.

The care quality has gradually been placed in the center of the health system, reaching the patient safety a greater role as one of the key dimensions of quality in recent years. The monitoring, measurement and improvement of safety and quality of care in the Intensive Care Unit represent a great challenge for the critical care community. Health interventions carry a risk of adverse events or events that can cause injury, disability and even death in patients. In Intensive Care Unit, the severity of the critical patient, communication barriers, a high number of activities per patient per day, the practice of diagnostic procedures and invasive treatments, and the quantity and complexity of the information received, among others, put at risk these units as areas for the occurrence of adverse events. This article presents some of the strategies and interventions proposed and tested internationally to optimize the care of critical patients and improve the safety culture in the Intensive Care Unit.

[Appropriateness of hospital admissions to a pulmonology department]. / Adecuación de los ingresos hospitalarios en un servicio de neumología.

OBJECTIVES: To analyze the rate of inappropriate admissions to a pulmonology department over the period of a year and to establish the reasons for such admission and predictors. PATIENTS AND METHODS: All 2004 admissions to the pulmonology department of the Hospital de Valme were analyzed using a version of the Appropriateness Evaluation Protocol (AEP) developed for concurrent review. Two physicians who were not directly involved in admitting the patients performed the review. A logistic regression analysis was performed in order to identify the independent predictors of inappropriate hospital admission. RESULTS: Of the 633 admissions analyzed, 92.1% (n = 583) were appropriate and 7.9% (n = 50) were inappropriate. The main reason for considering an admission to be inappropriate was that the patients in question could have been managed as outpatients (70%), whereas appropriate admissions were most frequently justified by the need for parenteral treatment (76.3%) or respiratory therapy (62%). In the logistic regression analysis, the variables that were independently associated with inappropriate admission were nonurgent admission (odds ratio, 2.82; 95% confidence interval, 1.28-6.21; P = .01), and a neoplasia diagnosis as the reason for admission (odds ratio, 8.57; 95% confidence interval, 2.69-27.24; P < .0005). CONCLUSIONS: The rate of inappropriate hospital admissions was lower than that reported in other studies. Most inappropriate admissions were of patients who could have been managed as outpatients. An admission diagnosis of neoplasm and nonurgent admission were independent predictors of inappropriateness.

Validez y confiabilidad de la escala de salud mental positiva / Validity and reliability based on the scale of possitive mental health

El objetivo del presente estudio consistió en demostrar la validez y confiabilidad de la Escala de Salud Mental Positiva en 400 trabajadores del Sector Salud de Michoacán, México. Para este propósito se realizaron los siguientes procesos: 1) De acuerdo a la teoría y a los indicadores, se definió lo que se requería medir; 2) Se revisaron los instrumentos existentes; 3) Se generó, revisó y decantó una serie de Ítems; 4) Se aplicó la Escala de Salud Mental a la muestra; 5) Se evaluaron los Ítems para obtener su validación y confiabilidad. La estructura factorial de la escala se evaluó mediante un análisis con el método de componentes principales y rotación Varimax. Los resultados muestran una confiabilidad de 0,862, considerándose adecuado para su aplicación en la población mexicana.

This paper focus on showing the validity and reliability based on the Scale of Positive Mental Health in 400 Health dpt workers from Michoacan, Mexico. For this purpose some procedures were performed as follow: 1. According to the indicators, it was defined what it was required measure; 2. Current instruments were reviewed; 3. Number of items were generated, decided and reviewed; 4. Mental health scale was applied for population sampled; 5. Items were assessed for its validation and reliability. Scale factorial structure was assessed using factor analysis and taking into account main components method and rotation. The results show 0.862 high reliability considered appropriate to be used for Mexican population.

[General principles for scientific reading and writing]. / Principios generales en escritura y lectura científica.

OBJECTIVE: To present an introduction to scientific writing and reading. METHODS/RESULTS: To analyse the most frequently used different formats of scientific-technical documents as reported by UNESCO (1983) including Scientific journals, books, monographs, presentations to congresses, technical reports, yearbooks and bulletins. We describe the main characteristics of each one. CONCLUSIONS: To emphasize the importance of written communication, in its different formats, in health sciences, for health care professionals formation and information.

[Types, structure, and function of scientific articles]. / Tipos, estructura y funciones de los artículos científicos.

OBJECTIVE: To define the importance of the scientific article as a source of original information. METHODS: To describe the fundamental contents of the scientific article and its three different formats: original scientific article, review article and case reports. CONCLUSIONS: The contents and structure of the different documents vary depending on the type of article considered as a result of the goal pursued with its publication.