AIMS: Most heterozygous familial hypercholesterolaemia (FH) patients require intensive lipid-lowering therapy (LLT) including PCSK9 inhibitors (PCSK9is) to reach current low-density lipoprotein cholesterol (LDL-C) goals. Persistence with chronic treatment is important to reduce the burden of atherosclerotic cardiovascular disease. We analysed persistence, efficacy, and impact on quality of life (QoL) of PCSK9i in FH patients in clinical practice setting. METHODS AND RESULTS: Spanish Familial Hypercholesterolaemia Cohort Study (SAFEHEART) is an open, prospective study in genetically defined FH patients in Spain. Patients ≥18 years of age (n = 696, 46% females) on stable LLT treated with PCSK9i were analysed. Median LDL-C at starting PCSK9i was 145 mg/dL [interquartile range (IQR), 123-177], 3.8 mmol/L (IQR 3.2-4.6). After a median follow up of 3.7 years (IQR 2.3-4.8), 27 patients (4%) discontinued PCSK9i treatment: 5 temporarily (0.7%) and 22 permanently (3.2%). Persistence with PCSK9i was 96.1% in the whole period. Median LDL-C levels and % LDL-C reduction attained after 1 year of treatment and in the last follow-up visit were 63 mg/dL (IQR 43-88), 1.6 mmol/L (IQR 1.1-2.23); 61 mg/dL (IQR 44-82), 1.6 mmol/L (IQR 1.1-2.1); 57.6% (IQR 39.5-69); and 58% (IQR 44-68), respectively. 2016 and 2019 ESC/EAS LDL-C goals were attained by 77 and 48% of patients, respectively, at the last follow-up visit (P < 0.001). Mean QoL score increased slightly in the first year and remained stable. CONCLUSION: Long-term persistence with PCSK9i in FH patients is very high, with a good QoL. Effectiveness in LDL-C reduction and LDL-C goal achievement dramatically improved with PCSK9i in this high-risk population in clinical practice setting. TRIAL REGISTRATION: ClinicalTrials.gov number NCT02693548.
Anticholesteremic Agents , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hyperlipoproteinemia Type II , Female , Humans , Male , PCSK9 Inhibitors , Cholesterol, LDL , Anticholesteremic Agents/therapeutic use , Proprotein Convertase 9 , Quality of Life , Cohort Studies , Prospective Studies , Hyperlipoproteinemia Type II/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use
BACKGROUND: PCSK9 inhibitors are a treatment option for patients with familial hypercholesterolemia not on low-density lipoprotein cholesterol goals despite the use of maximally tolerated high intensity-statins dose. OBJECTIVE: To evaluate the efficacy of alirocumab and evolocumab in LDL-C reduction and targets attainment in patients with heterozygous familial hypercholesterolemia in clinical practice setting. METHODS: SAFEHEART is an open, long-term prospective study of a cohort of subjects with molecular diagnosis of familial hypercholesterolemia. This study analyze subjects ≥ 20 years of age on stable lipid-lowering therapy, who received PCSK9 inhibitors during the period 2016 to January 2020. RESULTS: 433 patients (mean age 55 years, 53% male, 39% with cardiovascular disease) were included and followed-up for a median of 2.5 years (IQR 1.6-3.0). Median LDL-C level prior to PCSK9 inhibitors was 145 mg/dL (IQR 125-173). The addition of PCSK9 inhibitors (211 alirocumab, 222 evolocumab) reduced LDL-C by 58% (IQR 41-70) p<0.001, in men and women, achieving a median LDL-C level of 62 mg/dL (IQR 44-87) without differences between both PCSK9 inhibitors. Out of them 67% with and 80% without cardiovascular disease reached 2016 ESC/EAS LDL-C targets, and 46% very high risk and 50% high risk patients achieved 2019 ESC/EAS LDL-C goals. Independent predictor factors for attainment of 2019 ESC/EAS LDL-C goals were to be male, smoking and the use of statins with ezetimibe. Both inhibitors were well tolerated. CONCLUSIONS: PCSK9 inhibitors on top of maximum lipid-lowering treatment significantly reduced LDL-C levels in patients with familial hypercholesterolemia and improved the achievement of LDL-C targets.
Antibodies, Monoclonal, Humanized/administration & dosage , Hyperlipoproteinemia Type II/blood , Hyperlipoproteinemia Type II/drug therapy , PCSK9 Inhibitors/administration & dosage , Aged , Cholesterol, LDL/antagonists & inhibitors , Cholesterol, LDL/blood , Cohort Studies , Female , Follow-Up Studies , Humans , Hyperlipoproteinemia Type II/diagnosis , Injections, Subcutaneous , Male , Middle Aged , Prospective Studies , Treatment Outcome
OBJETIVO: Estudio de la anemia en una unidad de cuidados paliativos (UCP) hospitalaria y del tratamiento empleado para su mejoría. Pacientes y MÉTODO: Estudio descriptivo, observacional y prospectivo de los pacientes ingresados en la UCP del Hospital General Universitario de Ciudad Real durante un año de seguimiento (junio de 2010 a junio de 2011) que presentaban síndrome anémico. El protocolo de estudio incluyó datos epidemiológicos, tipo de tumor y tratamiento recibido para la anemia. El control de los síntomas se midió con la escala ESAS y la supervivencia con la PaPScore. RESULTADOS: Durante el tiempo de estudio ingresaron en la unidad 208 pacientes. Se incluyeron en el estudio 65 (31,2%). De ellos 37 (57%) eran varones y 28 (43%) mujeres. La edad media fue de 70,5 años. El motivo de ingreso fue el síndrome anémico en 7 (10,8%) casos. El tipo de tumor más frecuente fue el gastrointestinal (25 [38,5%]), seguido del urológico (15 [23,1%]) y el pulmonar (14 [21,5%]). La causa más frecuente fue haber recibido quimioterapia (QT) previa, seguida de trastornos crónicos, déficit de ácido fólico y ferropenia. En 19 (29,2%) casos la etiología fue multifactorial y en 16 (24,6%) desconocida. Se administraron 42 tratamientos a 22 (33,8%) PACIENTES: 15 de ácido fólico, 13 de hierro, 12 transfusiones de hematíes y 2 de vitamina B12. Según la PaPScore se encontraban en el grupo A el 38,4% de los pacientes, en el B el 44,6% y en el C el 17%. CONCLUSIONES: La anemia en el paciente oncológico en tratamiento paliativo con frecuencia se debe a varias etiologías
OBJECTIVE: To study anaemia in cancer patients as well as the type of treatment used in a Palliative Care Unit (PCU). PATIENTS AND METHOD: Descriptive, prospective observational study of patients admitted to the General University Hospital PCU of Ciudad Real during a one year follow up (June 2010-2011) who had an anaemic syndrome. The study protocol included epidemiological data, type of tumour, and the treatment received for anaemia. Control of symptoms was measured with the ESAS scale, and patient survival with the PaP Score scale. RESULTS: The unit admitted 208 patients during the study period, of whom 65 (31.2%) were included. Of these, 37 (57%) were male and 28 (43%) were female. The mean age of the patients was 70.5 years. The reason for admission was anaemic syndrome in 7 (10.8%) of the cases. The most common type of tumour was gastrointestinal 25 (38.5%), followed by urological 15 (23.1%), and lung 14 (21.5%). The most common aetiology was receiving previous chemotherapy, followed by chronic disorders, folic acid and iron deficiency. In 19 (29.2%) cases the aetiology was multifactorial, and in 16 (24.6%) unknown. Forty-two treatments were administered to 22 (33.8%) PATIENTS: 15 with folic acid, 13 with iron, 12 transfusions of red blood cells, and 2 with vitamin B12. According to the PaP Score, 38.4% of patients were in group A, 44.6%, in group B, and 17% in group C. CONCLUSIONS: The anaemia in cancer patients receiving palliative treatment is of various aetiologies
Female , Humans , Male , Middle Aged , Anemia/complications , Anemia/therapy , Neoplasms/complications , Palliative Care/methods , Palliative Care/trends , Hospice Care/methods , Intensive Care Units , Critical Care/methods , Critical Care , Erythrocyte Transfusion , Intensive Care Units/organization & administration , Intensive Care Units/standards , Intensive Care Units/trends , Prospective Studies , Clinical Protocols , Blood Substitutes/therapeutic use
Objetivos: Conocer el impacto en nuestro lugar de trabajo del aumento de resistencias antibióticas en las infecciones respiratorias. Material y métodos: Se ha realizado un estudio observacional retrospectivo de los pacientes con cultivo de esputo significativo ingresados en el Servicio de Medicina Interna del Hospital General de Ciudad Real desde enero a diciembre de 2008. Se ha recogido información sobre las características epidemiológicas, microbiológicas, patrones de resistencia y tratamiento. Resultados: Se han incluido un total de 60 pacientes. En el 83,3% existía algún factor predisponente. En 43 de los casos el diagnóstico se hizo en los meses de primavera y verano. La reagudización de la EPOC ha sido el diagnóstico más frecuente (61,7%). El microorganismo más frecuentemente aislado ha sido Pseudomonas spp. (41,7%). En nuestro hospital los antimicrobianos más empleados en el tratamiento inicial son levofloxacino (36,7%) y amoxicilina-clavulánico (26,7%). Los antibióticos con mayor porcentaje de resistencia han sido ciprofloxacino en E. coli (66,7%) y Pseudomonas spp. (60%) y penicilinas en S. pneumoniae (100%). Conclusiones: Los resultados presentados ponen de manifiesto la importante presencia de resistencias de los microorganismos causantes de infecciones respiratorias a los antibióticos de uso más habitual(AU)
Objectives. Understanding the impact on our work place of increasing antibiotic resistance in respiratory infections. Material and methods. We have performed a retrospective observational study on patients with significant sputum culture admitted to Internal Medicine Service Hospital General in Ciudad Real from January to December 2008. Information has been collected on the epidemiological, microbiological features, resistance patterns and treatment. Results. The total number of patients included in this study was 60. In 83.3% there was a predisposing factor. In 43 cases the diagnosis was made in spring and summer months. The exacerbation of COPD was the most frequent diagnosis (61.7%). The most frequently isolated organism was Pseudomonas spp. (41.7%). In our hospital the most commonly used antimicrobials in the initial treatment are levofloxacin (36.7%) and amoxicillinclavulanate (26.7%). The antibiotics with the highest percentage of antibiotic resistance were ciprofloxacin in E. coli (66.7%) and Pseudomonas spp. (60%), penicillin for S. pneumoniae (100%). Conclusions. The results of this study demonstrate the significant presence of resistance to most commonly used antibiotics in microorganisms which cause respiratory infections(AU)
Humans , Male , Female , Adult , Middle Aged , Respiratory Tract Infections/drug therapy , Respiratory Tract Infections/epidemiology , Drug Resistance , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/drug therapy , Sputum/microbiology , Respiratory Tract Infections/etiology , Respiratory Tract Infections/prevention & control , Drug Resistance, Microbial , Retrospective Studies , Sputum
