ABSTRACT
Aims: Limited data exist on low-density lipoprotein-cholesterol (LDL-C) level variability or long-term persistence with the monoclonal antibody evolocumab in routine clinical practice. HEYMANS (NCT02770131) is the first multi-country, multicenter, observational study of European patients initiating evolocumab as part of their routine clinical management, based on local reimbursement criteria (overall data recently published). The aim of this analysis is to describe clinical characteristics, baseline and changes in LDL-C levels, treatment patterns and persistence to evolocumab over 30 months in the Spanish cohort using data from the HEYMANS Registry. Methods: HEYMANS was a prospective study of adult patients (≥18 years) who received at least one dose of evolocumab. A total of 1951 patients were enrolled from 12 countries and were followed up for 30 months after evolocumab initiation. Data were collected for 6 months before evolocumab initiation and up to 30 months thereafter. The Spanish cohort included patients who started evolocumab in routine clinical practice from March 2016 to September 2019. Demographic and clinical characteristics, lipid-lowering therapies (LLT), and lipid levels were collected. (AU)
Objetivos: Existen datos limitados sobre la variabilidad del nivel de colesterol de lipoproteínas de baja densidad (cLDL) o la persistencia a largo plazo con el anticuerpo monoclonal evolocumab en la práctica clínica habitual. HEYMANS (NCT02770131) es el primer estudio observacional multicéntrico y multinacional de pacientes europeos que iniciaron tratamiento con evolocumab en la práctica clínica habitual, basado en criterios de reembolso locales. El objetivo fue evaluar las características clínicas, los cambios en los niveles de cLDL, los patrones de tratamiento y la persistencia a este con evolocumab en la cohorte española con un seguimiento de 30 meses, utilizando datos del registro HEYMANS. Métodos: HEYMANS fue un estudio prospectivo de pacientes adultos (≥18 años) que recibieron al menos una dosis de evolocumab prescrita. Se incluyeron 1.951 sujetos de 12 países. Los datos fueron recopilados desde los seis meses previos al inicio del tratamiento hasta los 30 meses posteriores. La cohorte española incluyó pacientes que comenzaron evolocumab en la práctica clínica habitual desde marzo del 2016 hasta septiembre del 2019. Se recogieron las características demográficas y clínicas, los tratamientos hipolipemiantes (LLT) y el perfil lipídico. (AU)
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Anticholesteremic Agents , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Cholesterol, LDL , Prospective StudiesABSTRACT
AIMS: Limited data exist on low-density lipoprotein-cholesterol (LDL-C) level variability or long-term persistence with the monoclonal antibody evolocumab in routine clinical practice. HEYMANS (NCT02770131) is the first multi-country, multicenter, observational study of European patients initiating evolocumab as part of their routine clinical management, based on local reimbursement criteria (overall data recently published). The aim of this analysis is to describe clinical characteristics, baseline and changes in LDL-C levels, treatment patterns and persistence to evolocumab over 30 months in the Spanish cohort using data from the HEYMANS Registry. METHODS: HEYMANS was a prospective study of adult patients (≥18 years) who received at least one dose of evolocumab. A total of 1951 patients were enrolled from 12 countries and were followed up for 30 months after evolocumab initiation. Data were collected for 6 months before evolocumab initiation and up to 30 months thereafter. The Spanish cohort included patients who started evolocumab in routine clinical practice from March 2016 to September 2019. Demographic and clinical characteristics, lipid-lowering therapies (LLT), and lipid levels were collected. RESULTS: In total, 201 patients were included in the Spanish cohort. Median follow-up (Q1-Q3) was 30.0 (12-30) months. A total of 61.7% of patients were men and the mean (standard deviation) age was 59.5 (10.8) years. Most patients (68.7%) had experienced a prior cardiovascular event, 45.3% had coronary artery disease or stable angina, and 60.2% had a diagnosis of familial hypercholesterolemia. Overall, 57.7% of patients were receiving treatment with statins, most of them with high-intensity statins (85.3%); 45.8% of patients were intolerant to statins, and 26.4% of patients did not receive any LLT. At baseline, median (Q1-Q3) LDL-C levels were 151 (123-197) mg/dL. After 3 months of treatment, baseline LDL-C decreased by 66% to a median of 50 (30-83) mg/dL and these levels were maintained over time, with a median LDL-C of 55 (40-99) mg/dL at 30 months. At months 10-12 of treatment, LDL-C levels<55mg/dL were achieved by 56.3% of patients. LDL-C levels<70mg/dL were achieved by 70.1% of patients, and a lowering of LDL-C levels ≥50% was achieved by 76.8% of patients. The percentage of patients on evolocumab treatment was 95% at 12 months and 93% at 30 months. CONCLUSIONS: In the Spanish cohort in routine clinical practice, evolocumab therapy provided a reduction in LDL-C levels consistent with that reported in previous clinical trials, which was sustained during 30 months of follow-up. Treatment with evolocumab was started at LDL-C levels 50% higher than those recommended by The Spanish Society of Arteriosclerosis and the Therapeutic Positioning Report. The probability of achieving the 2019 ESC/EAS LDL-C goals would improve with combination therapy and also with a lower LDL-C threshold when starting evolocumab. Persistence to evolocumab remained high during follow-up, with a very low percentage of discontinuation (5% at 12 months; 7% at 30 months).
Subject(s)
Anticholesteremic Agents , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Male , Adult , Humans , Middle Aged , Female , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Prospective Studies , Cholesterol, LDL , PCSK9 InhibitorsABSTRACT
BACKGROUND AND AIMS: We aimed to understand the impact of physicians' perception about LDL-cholesterol (LDLc) control on the management of patients with dyslipidemia in Spain. METHODS: We performed a cross-sectional and multicenter study, in which 435 healthcare professionals participated in face-to-face meetings, collecting qualitative and quantitative information related to hypercholesterolemia management. Additionally, aggregated anonymized data of the last 10 patients with hypercholesterolemia attended by each physician were collected. RESULTS: A total of 4,010 patients (8%, 13%, 16% and 61% with low, moderate, high, and very high cardiovascular [CV] risk) were included. Physicians' perception was that 62% of their patients attained LDLc goals (66%, 63%, 61% and 56%, for low, moderate, high and very high CV risk, respectively). However, when looking into the data only 31% (vs 62% p<0.01) of patients attained the LDLc goals (47%, 36%, 22% and 25%, respectively). Overall, 33% of patients were taking high intensity statins, 32% statin/ezetimibe, 21% low/moderate intensity statins and 4% PCSK9 inhibitors. These numbers were 38%, 45%, 8% and 6% for very high risk patients and 44%, 21%, 21% and 4% for high CV risk patients. In 32% of patients, a change in lipid lowering therapy was performed after the visit, mainly combining statins/ezetimibe (55%). CONCLUSIONS: In Spain, most patients with dyslipidemia do not achieve the recommended LDLc goals because of an insufficient intensification of lipid lowering therapy. On the one hand, this is in part due to physicians misperception on preventive LDLc control and the need for repeated advice to patient, and, on the other, to the lack of patient adherence.
Subject(s)
Anticholesteremic Agents , Dyslipidemias , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hypercholesterolemia , Humans , Cholesterol, LDL , Proprotein Convertase 9 , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/diagnosis , Hypercholesterolemia/drug therapy , Spain/epidemiology , Cross-Sectional Studies , Treatment Outcome , Ezetimibe/therapeutic use , Dyslipidemias/diagnosis , Dyslipidemias/drug therapy , Dyslipidemias/epidemiology , Perception , Anticholesteremic Agents/therapeutic useABSTRACT
Introducción y objetivos: El tratamiento de las dislipemias presenta gran variabilidad en la práctica clínica e importantes limitaciones que dificultan la consecución de los objetivos terapéuticos. Por ello, se ha diseñado un proyecto para evaluar el control de la dislipemia en España, identificar los puntos de mejora y tratar de optimizarlo. El objetivo de este artículo es describir la metodología del observatorio del tratamiento del paciente dislipémico en España. Métodos: Observatorio de recogida de información basada en la práctica clínica habitual y experiencia de los profesionales de la salud que atienden a pacientes dislipémicos en España. El observatorio recoge información por área sanitaria, a través de: (i) reunión presencial con tres especialidades médicas diferentes y (ii) información cuantitativa de manejo de pacientes con hipercolesterolemia (cuestionario ad hoc). La información incluye perfiles de paciente atendidos, carga asistencial, guías y protocolos utilizados, grado de control alcanzado, limitaciones y oportunidades de mejora en práctica clínica. Resultados: Se busca incluir 145 áreas sanitarias, contando con la participación de hasta 435 profesionales médicos de las 17 Comunidades Autónomas de España. La información recogida de los participantes permitirá disponer de datos agregados de más de 4.000 pacientes. Conclusiones: Este observatorio pretende conocer cómo se está tratando la hipercolesterolemia en la práctica clínica en España. Aunque los resultados preliminares muestran una importante área de mejora en el tratamiento de las dislipemias, se identifican también mecanismos para impulsar un cambio hacia la optimización de resultados en salud.(AU)
Introduction and objectives: The treatment of dyslipidemia exhibits wide variability in clinical practice and important limitations that make lipid-lowering goals more difficult to attain. Getting to know the management of these patients in clinical practice is key to understand the existing barriers and to define actions that contribute to achieving the therapeutic goals from the most recent Clinical Practice Guidelines. Methods: Observatory where the information gathered is based on routine clinical practice and the experience from the healthcare professionals involved in the treatment of dyslipidemia in Spain. The information is collected by health area through: (i) face-to-face meeting with three different medical specialties and (ii) quantitative information related to hypercholesterolemia patients management (ad-hoc questionnaire). Information includes patients profiles, assistance burden, guidelines and protocols used, goal attainment, limitations and opportunities in clinical practice. Results: 145 health areas are planned to be included, with the participation of up to 435 healthcare professionals from the 17 Autonomous Regions of Spain. Information collection will result in aggregated data from over four thousand patients. Conclusions: This observatory aims to understand how hypercholesterolemia is being treated in routine clinical practice in Spain. Even though the preliminary results show important improvement areas in the treatment of dyslipidemias, mechanisms to drive a change towards health outcomes optimization are also identified.(AU)
Subject(s)
Dyslipidemias , Clinical Protocols , Hypercholesterolemia/drug therapy , Hypercholesterolemia/therapy , Outcome and Process Assessment, Health Care , Hypolipidemic Agents , Spain , Evidence-Based PracticeABSTRACT
INTRODUCTION AND OBJECTIVES: The treatment of dyslipidemia exhibits wide variability in clinical practice and important limitations that make lipid-lowering goals more difficult to attain. Getting to know the management of these patients in clinical practice is key to understand the existing barriers and to define actions that contribute to achieving the therapeutic goals from the most recent Clinical Practice Guidelines. METHODS: Observatory where the information gathered is based on routine clinical practice and the experience from the healthcare professionals involved in the treatment of dyslipidemia in Spain. The information is collected by health area through: (i) face-to-face meeting with three different medical specialties and (ii) quantitative information related to hypercholesterolemia patients' management (ad-hoc questionnaire). Information includes patients' profiles, assistance burden, guidelines and protocols used, goal attainment, limitations and opportunities in clinical practice. RESULTS: 145 health areas are planned to be included, with the participation of up to 435 healthcare professionals from the 17 Autonomous Regions of Spain. Information collection will result in aggregated data from over four thousand patients. CONCLUSIONS: This observatory aims to understand how hypercholesterolemia is being treated in routine clinical practice in Spain. Even though the preliminary results show important improvement areas in the treatment of dyslipidemias, mechanisms to drive a change towards health outcomes optimization are also identified.
Subject(s)
Dyslipidemias , Hypercholesterolemia , Dyslipidemias/drug therapy , Humans , Hypercholesterolemia/therapy , Spain , Surveys and QuestionnairesABSTRACT
Bempedoic acid acts by inhibiting adenosine triphosphate-citrate lyase (ACL) and consequently cholesterol biosynthesis, leading to increased expression of LDL receptors and increasing low-density lipoproteins (LDL-C) plasma clearence. It is a prodrug for oral administration with intracellular activation. It is activatedin liver cells and to a lesser extent in kidney cells, being absent in adipose tissue and muscle cells. Therefore, unlike statins, its potential myotoxic effect is very limited. It has recently been approved as a lipid-lowering drug in combination with diet, with statins, or with other lipid-lowering drugs in patients with hypercholesterolaemia, mixed dyslipidaemia, statin intolerance, or when these are contraindicated. The marketing of bempedoic acid implies, in clinical practice, having a new family of lipid-lowering drugs.
Subject(s)
Dicarboxylic Acids/administration & dosage , Dyslipidemias/drug therapy , Fatty Acids/administration & dosage , Hypolipidemic Agents/administration & dosage , Dicarboxylic Acids/pharmacokinetics , Dicarboxylic Acids/pharmacology , Drug Therapy, Combination , Fatty Acids/pharmacokinetics , Fatty Acids/pharmacology , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hypercholesterolemia/drug therapy , Hypolipidemic Agents/pharmacokinetics , Hypolipidemic Agents/pharmacologyABSTRACT
PURPOSE: To determine the incidence and relationship of diabetic retinopathy (DR), microalbuminuria and overt nephropathy (ON). METHOD: A 20-year prospective study, in a cohort of 110 consecutive type 1 diabetes mellitus (DM) patients, without diabetic retinopathy or microalbuminuria at enrolment in 1990. RESULTS: The 20-year incidence of any DR was 70.91%, microalbuminuria 42.72%, and ON was 23.63%. Regarding the risk factors: pre pubertal age at diagnosis was significant for DR and ON, LDL-cholesterol and CT/HDL-cholesterol were significant for DR but not for microalbuminuria or ON. The relationship between DR and ON demonstrated that DR was a significant risk factor for ON, but ON was significant for sight-threatening DR. At the end of the study, two major groups of patients were formed: patients with DR only and patients with DR and ON. For the development of only DR we can assume that the most important risk factor is the duration of DM, followed by the high levels of HbA1c, pre-pubertal age at onset, and arterial hypertension; and for the development of ON and DR simultaneously, risk factors are higher levels of HbA1c, arterial hypertension, DM duration and pre-pubertal age at onset. CONCLUSIONS: In the current study, two major groups of patients have been formed, those who developed only DR and those who developed DR and ON. For the former, incidence increased as DM duration increased, and for the latter incidence appeared to be closely related to levels of HbA1c.
Subject(s)
Albuminuria/etiology , Diabetes Mellitus, Type 1/complications , Diabetic Nephropathies/complications , Diabetic Retinopathy/complications , Age of Onset , Albuminuria/epidemiology , Albuminuria/metabolism , Albuminuria/physiopathology , Cohort Studies , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/therapy , Diabetes Mellitus, Type 1/urine , Diabetic Nephropathies/epidemiology , Diabetic Nephropathies/metabolism , Diabetic Nephropathies/physiopathology , Diabetic Retinopathy/epidemiology , Diabetic Retinopathy/metabolism , Diabetic Retinopathy/physiopathology , Discriminant Analysis , Female , Follow-Up Studies , Glycated Hemoglobin/analysis , Hospitals, Public , Humans , Hypercholesterolemia/complications , Hypercholesterolemia/epidemiology , Hypercholesterolemia/metabolism , Hypercholesterolemia/physiopathology , Hyperglycemia/prevention & control , Incidence , Male , Prospective Studies , Risk Factors , Severity of Illness Index , Spain/epidemiologyABSTRACT
AIMS: To determine the 10-year incidence of diabetic retinopathy (DR) and macular edema (DME), and its relationship with its risk factors in a sample of type 1 diabetes mellitus. METHODS: A total of 334 patients without diabetic retinopathy at baseline underwent a 10-year prospective study, the risk factors included: age, gender, diabetes duration, HbA1c, LDL-C, HDl-C, TC/HDL-C ratio, ApoA1, ApoB, ApoB/ApoA1 ratio, and triglycerides were recorded. Risk factors for diabetic macular edema (DME) were also recorded. RESULTS: The 10-year incidence of any DR was 35.90%, and 11.07% developed DME. The risk factors for DR and DME were: diabetes duration, high glycosylated level, and arterial hypertension, and overt nephropathy was well correlated with DME. The lipid study demonstrated that ApoB/ApoA1 ratio was significant for any DR [HRR: 0.594 (0.416-0.848), p=0.01], and DME [HRR: 0.601 (0.433-0.894), p=0.009]. The TC/HDL ratio was only significant for DME [HRR: 0.624 (0.440-0.886), p=0.008]; other lipids values were not significant for any groups studied. CONCLUSIONS: In the present study, the ApoB/ApoA1 ratio was significant to the 10-year incidence of diabetic retinopathy and to macular edema; and the TC/HDL ratio was significant to a 10-year incidence of macular edema.
