ABSTRACT
PURPOSE: To evaluate the effectiveness, adverse reactions, and adherence to treatment of hypolipidemic inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9is) in a context of real clinical practice. METHODS: We present an observational, retrospective, descriptive, multicenter study of patients with hypercholesterolemia who began treatment with PCSK9is between January 2017 and December 2019, with a minimum treatment period of 3 months. The main variable we recorded was the frequency of cardiovascular events (cardiovascular death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina) in patients treated with PCSK9is. We recorded patient demographic characteristics and cardiovascular risk factors at onset of treatment as well as LDL-C levels and their reductions at 3, 6, 12, and 24 months. We calculated adherence to treatment and recorded the adverse reactions during treatment. FINDINGS: A total of 154 patients were studied, 64 (41.6%) of whom were treated with alirocumab and 90 (58.4%) with evolocumab. The initial dose of alirocumab was 75 mg every 14 days in 48 patients (75%) and 150 mg eery 14 days in 16 (25%). All patients who in the evolocumab group received a dose of 140 mg every 14 days. The mean (SD) basal LDL-C level was 159.6 (50.1) mg/dL, the level at 3 months was 87.9 (49.9) mg/dL (mean [SD] decrease, 44.5% [28.2%]), the level at 6 months was 86.7 (49.2) mg/dL (mean [SD] decrease, 46.3% [25.6%]), and the level at 12 months was 80.5 (41.4) (mean [SD] decrease, 48.9% [23.0%]). These values were maintained at 24 months (mean [SD], 80.3 [41.8] mg/dL; mean [SD] decrease, 47.9% [27.8%]). The percentage decrease of LDL-C for both drugs was approximately 50%, which was maintained until 24 months after treatment. Six patients (3.9%) presented with some cardiovascular event: acute myocardial infarction (2 [1.3%]), stroke (1 [0.65%]), coronary revascularization (1 [0.65%]), and hospitalization for unstable angina (2 [1.3%]). We did not see any adverse reactions related to PCSK9i treatment in 76.5% of patients. In the first 6 months, adherence to treatment with PCSK9is, measured as the possession ratio, was a mean (SD) of 99.4% (3.9%). In the rest of the study period (6-24 months), the mean (SD) adherence to treatment was 99.2% (4.7%). IMPLICATIONS: The frequency of cardiovascular events in patients treated with PCSK9is was low and occurred despite adequate adherence to treatment (100% possession ratio) with PCSK9is and concomitant treatment with other hypolipidemics. The effectiveness of PCSK9is is similar to that referred to in other published studies with PCSK9is, and this was maintained in the long term (24 months) with few adverse events, all of which were mild.
Subject(s)
Anticholesteremic Agents , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hypercholesterolemia , Proprotein Convertase 9 , Antibodies, Monoclonal/adverse effects , Anticholesteremic Agents/adverse effects , Cholesterol, LDL , Humans , Hypercholesterolemia/drug therapy , PCSK9 Inhibitors , Retrospective Studies , Subtilisins , Treatment OutcomeABSTRACT
INTRODUCCIÓN: La colonización/infección crónica por Pseudomonas aeruginosa de las bronquiectasias se relaciona con daño anatómico, deterioro más rápido de la función pulmonar, aumento del número de exacerbaciones y mayor morbi-mortalidad. La colistina nebulizada disminuye la carga bacteriana, esperándose una reducción en número y gravedad de las exacerbaciones y retraso del deterioro pulmonar. El objetivo principal fue valorar si el tratamiento con colistina nebulizada, durante al menos 6 meses, reduce el número de ingresos y visitas a urgencias. MATERIAL Y MÉTODOS: Estudio observacional, retrospectivo y no intervencionista llevado a cabo en una estructura organizativa de gestión integrada. Se seleccionaron pacientes con bronquiectasias no fibrosis quística, mayores de 18 años, colonizados / infectados por P. aeruginosa que recibieron al menos 6 meses colistina nebulizada. De la historia clínica informatizada (IANUS(R) V.04.20.0503) y de la receta electrónica del SERGAS, se recogieron datos clínicos, microbiológicos y de tratamiento de los pacientes, que fueron divididos en dos periodos de tiempo: 1) 6 meses pretratamiento y durante el tratamiento y 2) 12 meses pretratamiento y durante el tratamiento, en aquellos pacientes que completaron 1 año de tratamiento. RESULTADOS: Se incluyeron 44 pacientes y de ellos, 29 (65,9%) tuvieron un seguimiento de 12 meses. El uso de colistina nebulizada disminuyó de forma significativa el número de visitas a urgencias (a los 6 meses), la frecuencia y duración de las hospitalizaciones (a los 6 y 12 meses), el consumo de antibióticos (a los 6 y 12 meses) y los cultivos positivos para P. aeruginosa. El tratamiento fue bien tolerado en casi todos los pacientes. CONCLUSIONES: El tratamiento con colistina nebulizada durante 6 y 12 meses de bronquiectasias no fibrosis quística, colonizadas / infectadas por P. aeruginosa, parece beneficioso para el paciente desde el punto de vista clínico y de calidad de vida y podría reducir el coste económico del proceso
INTRODUCTION: Chronic colonisation/infection by Pseudomonas aeruginosa of the bronchiectasis is related to a faster deterioration of lung function, an increase in the number of exacerbations and a higher morbidity and mortality. Nebulised colistin decreases bacteria load. Therefore, a reduction in the number and in the severity of exacerbations and a delay of pulmonary decline is expected. The main objective is to evaluate if the treatment with nebulised colistin, for at least 6 months reduces the number of admissions and visits to the emergency department. MATERIAL AND METHODS: Observational, retrospective and non-interventionist study carried out in an organizational structure with an integrated management. Patients with non-cystic fibrosis bronchiectasis colonised / infected by P. aeruginosa, older than 18 years, were selected. Patients must have received nebulized colistin during at least 6 months. Clinical, microbiological and therapeutic data from the patients were collected from the SERGAS computerized clinical history (IANUS(R) V.4.20.0503) and the electronic prescription, which were divided into two time periods: 1) 6 months pre-treatment and during the treatment and 2) 12 months pre-treatment and during the treatment, in those who completed 1 year of treatment. RESULTS: Forty-four patients were included and of these, 29 (65.9%) had a follow-up of 12 months. The use of nebulized colistin decreased significantly the number of visits to the emergency (at 6 months), the frequency and duration of hospitalizations admissions (at 6 and 12 months), the antibiotic consumption (at 6 and 12 months) and the positive cultures. The treatment was well tolerated in almost all patients. CONCLUSIONS: The treatment with nebulised colistin during 6 and 12 months of non-cystic fibrosis bronchiectasis, colonised/infected by P. aeruginosa, seems beneficial for the patient, from the clinical and quality of life point of view, and could reduce the economic cost of the process
