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AIMS: Adalimumab is a biological therapy used to treat different chronic inflammatory diseases. At present, there is an increasing number of adalimumab biosimilars. To assume the acceptability of interchangeability between reference adalimumab and biosimilars, there should be evidence about efficacy and safety of this switching. Regulation of this practice falls under the authority of individual European Union Member States. The aim of this study is to systematically review the evidence on the efficacy, safety and immunogenicity of switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases. METHODS: Studies presenting data about switching between reference adalimumab and biosimilars were identified by sensitive search strategies in Medline and EMBASE from 1 January 2004 to 30 June 2021. RESULTS: A total of 471 references were obtained and 21 finally included in the analysis (total number of patients switching: 2802). Eight different adalimumab biosimilars were tested after receiving reference adalimumab. Eight articles included rheumatoid arthritis (RA), one miscellaneous rheumatic disease, six psoriasis (PSO) and six inflammatory bowel disease (IBD) patients. Overall, the efficacy results in the switching groups were comparable to those obtained in the arms of continuous biosimilar and continuous reference adalimumab. There were no significant differences in treatment emergent adverse events, anti-drug or neutralising antibodies among the three groups. CONCLUSIONS: Switching between reference adalimumab and biosimilars has no impact on efficacy, safety and immunogenicity in patients with RA, PSO and IBD. This finding was consistent for the different adalimumab biosimilars analysed. These conclusions could probably be extended to other rheumatic diseases such as psoriatic arthritis and ankylosing spondylitis.
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Artrite Reumatoide , Medicamentos Biossimilares , Doenças Inflamatórias Intestinais , Psoríase , Doenças Reumáticas , Adalimumab/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/efeitos adversos , Doença Crônica , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Psoríase/tratamento farmacológico , Doenças Reumáticas/tratamento farmacológicoRESUMO
Context: Hepatocellular carcinoma is the third leading cause of cancer death. Currently, sorafenib is the treatment of choice in advanced hepatocarcinoma. Aims: Assessing the effectiveness and toxicity of sorafenib in real-word clinical practice in patients with hepatocarcinoma. Settings and Design: Single-centered observational retrospective study. Methods and Material: We included patients with hepatocarcinoma who began treatment with sorafenib between 2008 and 2018. We evaluated overall survival, time to progression, and response using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 5. 2020. Statistical Analysis Used: Kaplan-Meier curves and the log-rank test were used to determine the survival time and estimate factors associated with these events. Data were analyzed with SPSS 19.0 software. Results: We included 36 patients (88.9% male) with an average age of 64 ± 3.4 years. The tumor stage was advanced (C) in 21 patients (61.8%). We obtained a median overall survival of 8.5 months (IQR 3.14-18.9) and a time to progression of 4.5 months (IQR 2.4-8.8). The main degree of response was progression in 19 patients (36.1%), followed by stable disease in 13 (52.8%). The most commonly reported adverse reactions were: constitutional (83.3%), gastrointestinal (55%) and dermatological symptoms (50.0%). The development of grades 3 or 4 toxicity was not associated with increased overall survival (P = 0.719). Conclusions: The findings of the survival analysis obtained in real practice are similar to those obtained in pivotal clinical trials. Adverse reactions were different from those expected.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Sorafenibe , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Antineoplásicos/efeitos adversos , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/patologia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/patologia , Estudos Retrospectivos , Sorafenibe/efeitos adversosRESUMO
INTRODUCTION: The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in cognitive function domains, to analyze subgroups by the low-density lipoprotein cholesterol (LDL-C) achieved, and differences between alirocumab and evolocumab. METHODS: This has a multicenter, quasi-experimental design carried out in 12 Spanish hospitals from May 2020 to February 2023. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). RESULTS: Among 158 patients followed for a median of 99 weeks, 52% were taking evolocumab and 48% alirocumab; the mean change from baseline in MoCA score at follow-up was + 0.28 [95% CI (- 0.17 to 0.73; p = 0.216)]. There were no significant differences in the secondary endpoints-the visuospatial/executive domain + 0.04 (p = 0.651), naming domain - 0.01 (p = 0.671), attention/memory domain + 0.01 (p = 0.945); language domain - 0.10 (p = 0.145), abstraction domain + 0.03 (p = 0.624), and orientation domain - 0.05 (p = 0.224)-but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (p = 0.001). Neither were there any differences in the three stratified subgroups according to lowest attained LDL-C level-0-54 mg/dL, 55-69 mg/dL and ≥ 70 mg/dL; p = 0.454-or between alirocumab and evolocumab arms. CONCLUSION: We did not find effect of monoclonal antibody PCSK9i on neurocognitive function over 24 months of treatment, either in global MoCA score or different cognitive domains. An improvement in delayed recall memory was shown. The study showed no differences in the cognitive function between the prespecified subgroups, even among patients who achieved very low levels of LDL-C. There were no differences between alirocumab and evolocumab. REGISTRATION: ClinicalTtrials.gov Identifier number NCT04319081.
Assuntos
Inibidores de PCSK9 , Pró-Proteína Convertase 9 , Humanos , LDL-Colesterol , Seguimentos , Estudos Prospectivos , Cognição , Anticorpos Monoclonais/efeitos adversosRESUMO
The aim of this study was to evaluate the efficacy of a treat-and-extend (T&E) regimen of ranibizumab as the first-choice treatment in macular oedema (MO) secondary to branch retinal vein occlusion (BRVO). We conducted a retrospective study of 20 patients who developed MO due to BRVO treated with intravitreal ranibizumab in a T&E regimen between 2016 and 2017 with a minimum follow-up of two years. Patients were classified as complete responders if treated with ranibizumab alone or incomplete responders if salvage treatment with other medications or laser was needed. Data on best corrected visual acuity (BCVA) and central macular thickness (CMT) every 6 months were recorded. The mean BCVA (logMAR) improved from 0.60 ± 0.36 to 0.29 ± 0.44 and the CMT decreased from 559.85 ± 198.61 to 305.85 ± 11.78 µm. We found statistically significant differences between complete and incomplete responders on the average number of injections during the second year (2.46 ± 2.18 compared to 5.43 ± 1.27; p = 0.007) and change of the BCVA and CMT between both groups (p < 0.001) at 6, 12, 18 and 24 months. T&E seems to be effective in MO secondary to BRVO, improving visual function and decreasing CMT, with less need for injections.
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Background: Colorectal cancer is the ninth leading cause of death in Spain. The latest therapeutic developments in the advanced stages of this disease are the oral drugs trifluridine/tipiracil and regorafenib. Objective: Results of clinical trials (CTs) are not in real conditions and therefore, we want to study the effectiveness and the safety profile in the usual clinical practice and compare it with the bibliography. Materials and Methods: A retrospective and unicentric study was carried out in a health area of 500,000 inhabitants. Patients who started treatment with regorafenib and/or trifluridine/tipiracil were included from the date of marketing until June 2019. Patient-related variables, pathology, effectiveness, and treatment toxicity were collected. The statistical analysis was carried out with the PSPP program. Results: Fifty-four patients were analyzed. Men accounted for 59.3% of patients. Regorafenib was the treatment for 22.2% of patients and 77.8% received trifluridine/tipiracil. The reason for the drug's suspension was the disease progression in 85.2% of patients. No patient had a full response and 3.2% achieved partial response. The median progression-free survival time in treatments with regorafenib was 2.5 months (95% confidence interval [CI]: 0.0-5.4) and the overall survival time was 3.1 months (95% CI: 0.0-6.7), while in treatments with trifluridine/tipiracil, these data were, respectively, 2.8 (95% CI: 2.5-3.2) and 5.7 months (95% CI: 3.8-7.6). Side effects occurred in 91.7% of patients treated with regorafenib and in 100% of treated with trifluridine/tipiracil. Hematological adverse reactions were, on average, 0.4 ± 0.5/patient with regorafenib and 1.5 ± 0.9 with trifluridine/tipiracil. General (77.8%) and gastrointestinal disorders (50%) were common with both drugs. Conclusions: The effectiveness results of standard clinical practice are lower than those described in CTs and in the literature. The toxicity profile does reproduce what is described in the bibliography.
Assuntos
Neoplasias Colorretais , Uracila , Masculino , Humanos , Estudos Retrospectivos , Uracila/efeitos adversos , Neoplasias Colorretais/patologia , Trifluridina/efeitos adversos , Compostos de Fenilureia/efeitos adversos , Combinação de Medicamentos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversosRESUMO
OBJECTIVES: MEMOGAL study (NCT04319081) is aimed at evaluating changes in cognitive function in patients treated with PCSK9 inhibitors (PCSK9i). This is the first analysis: (1) discussion about the role of the Hospital Pharmacists during the pandemic, and also the assessment of the impact of COVID-19 in the lipid control; (2) descriptive analysis; (3) effectiveness in LDL cholesterol (LDL-c) reduction of alirocumab and evolocumab; (4) communicate PCSK9i safety. MATERIAL AND METHODS: It is a prospective Real-World Evidence analysis of patients that take PCSK9i for the first time in the usual clinical practice, and they are included after the first dispensation in the public pharmacy consultations of 12 Hospitals in Galicia from May 2020 to April 2021. Baseline values of LDL-c are the previous values before taking PCSK9 and the follow-up values are in 6 months time. RESULTS: 89 patients were included. 86.5% with cardiovascular disease and 53.9% with statin intolerances. 78.8% of the patients were treated with high intensity statins. Statins most used were rosuvastatin (34.1%) and atorvastatin (20.5%). Baseline value of LDL-c was 148mg/dL and the follow-up value was 71mg/dL. The baseline value of patients treated with alirocumab (N=43) was 144mg/dL and 73mg/dL in the follow-up. With evolocumab (N=46) was 151mg/dL in basaline and 69mg/dL in follow-up. The LDLc- reduction was 51.21% with evolocumab and 51.05% with alirocumab. 43.1% of the patients showed values >70mg/dL in six month time; 19.4% between 69mg/dl and 55mg/dL and 37.5% <55mg/dL. 58.3% of the patients achieved a reduction >50% of LDL-c. The adverse events were: injection point reaction (N=2), myalgias (N=1), flu-like symptoms (N=1) and neurocognitive worsening (N=1). CONCLUSIONS: (1) Despite the number of prescriptions was reduced because of the pandemic, the lipid control was not affected. (2) Half of the patients treated with PSCK9i is due to statins intolerance and the 86% is for secondary prevention. (2) The reduction results were similar to pivotal clinical trials. Despite this, 39% of the total of the patients and 60% of patients with dual teraphy did not reach the goal of ESC/EAS guidelines (<55mg/dL and/or reduction>50%). There were not significant differences between evolocumab and alirocumab: 51.21% vs 51.05% (P=.972). (3) There were not any adverse events of special interest. The possible neurocognitive worsening will be studied as the primary endpoint once the MEMOGAL study has been completed.
Assuntos
Anticolesterolemiantes , Tratamento Farmacológico da COVID-19 , COVID-19 , Inibidores de PCSK9 , Anticolesterolemiantes/efeitos adversos , COVID-19/epidemiologia , LDL-Colesterol , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Inibidores de PCSK9/efeitos adversos , Pandemias , Pró-Proteína Convertase 9 , Estudos ProspectivosRESUMO
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.
Assuntos
Anticolesterolemiantes , Inibidores de Hidroximetilglutaril-CoA Redutases , Hipercolesterolemia , Pró-Proteína Convertase 9 , Anticorpos Monoclonais/efeitos adversos , Anticolesterolemiantes/efeitos adversos , LDL-Colesterol , Humanos , Hipercolesterolemia/tratamento farmacológico , Inibidores de PCSK9 , Estudos Retrospectivos , Subtilisinas , Resultado do TratamentoRESUMO
OBJECTIVE: The objective of this study was to assess the results of applying Lean Methodology in the design of a standardized medication storage model in hospitalization departments. METHOD: Descriptive and retrospective study conducted between September 2017 and January 2019 in a tertiary level hospital. The Pharmacy Service led the creation of a multidisciplinary team. Lean Methodology was used to establish the components and organization and identification criteria that made up the standardized medication storage model. The stocks of each hospitalization department were reviewed and quantified, the final amount of stock needed was agreed with the supervisor of each department, and the economic impact of the implementation of the standardized medication model was assessed. A questionnaire was designed and sent to nursing staff to determine their level of satisfaction with the new model. RESULTS: The standardized medication storage model was scaled up to 20 nursing departments, leading to an overall reduction of 56.72% in the number of pharmaceutical dosage forms available (5,688 vs 2,462). The number of high-risk drugs was reduced by 40.73% (631 vs 374). This elimination of wastage achieved a saving of 25,357.98. A total of 58 nurses returned the questionnaires (20.70% of the total): 22.40% worked a fixed shift and 77.60% worked a rotating shift. The mean score on overall satisfaction was 5.79 ± 3.61 (scores ranged from 1 to 10). CONCLUSIONS: The application of Lean Methodology is very useful for the management of medication stocks in hospitalization departments. The implementation of a standardized medication storage model leads to economic savings and a marked reduction in the number of active ingredients and high-risk medications. The nursing staff were satisfied with the implementation of the model, suggesting that we should continue to pursue this effective line of action.
Objetivo: El objetivo del estudio es evaluar los resultados de la aplicación de la metodología Lean en el diseño de un modelo estandarizado de almacenaje de medicación en las unidades de hospitalización. Método: Estudio descriptivo y retrospectivo desarrollado entre septiembre de 2017 y enero de 2019 en un hospital de tercer nivel. Se creó un equipo multidisciplinar liderado por el Servicio de Farmacia. Se empleó la metodología Lean para establecer los elementos y criterios de organización e identificación que conformaron el modelo estandarizado de almacenaje de medicación. Se revisaron y cuantificaron los stocks de cada unidad de hospitalización, se consensuó la medicación con la supervisora de cada unidad y se estimó el impacto económico de la implantación del modelo estandarizado. Se diseñó y envió una encuesta para evaluar la satisfacción de enfermería con el nuevo modelo.Resultados: El modelo estandarizado de almacenaje se aplicó en 20 unidades de enfermería y supuso una reducción global del 56,72% en el número de presentaciones de principios activos disponibles (5.688 versus 2.462). Se disminuyó el número de presentaciones de principios activos de medicamentos de alto riesgo en un 40,73% (631 versus 374). La eliminación de este despilfarro supuso un ahorro económico de 25.357,98 . Se recibieron 58 respuestas a la encuesta de satisfacción del personal de enfermería (20,70% del total de encuestas enviadas), de las que un 22,40% correspondieron al turno fijo y 77,60% al turno rotativo. La media de la satisfacción global (valorada entre 1 y 10) fue de 5,79 ± 3,61.Conclusiones: La aplicación de la metodología Lean es útil para la gestión de stocks de medicación de las unidades de hospitalización. La implantación del modelo estandarizado de almacenaje conlleva un ahorro económico y una reducción del número de presentaciones de principios activos y de medicamentos de alto riesgo. El personal de enfermería está conforme con la implantación del modelo, lo que nos plantea seguir en esta línea de mejora.
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Assistência Farmacêutica , Hospitalização , Humanos , Estudos Retrospectivos , Inquéritos e Questionários , Centros de Atenção TerciáriaRESUMO
BACKGROUND: Although the electronic prescribing software is the same for all hospitals of a regional health service, each has its own drug database, which it is responsible for maintaining. The aim of this study was to develop a consensus to standardize the hospital drug database of the electronic prescribing software, and to apply this tool to the electronic prescribing system of an oncology outpatient clinic of a Spanish tertiary-level hospital. Additionally, we sought to analyze the impact of the implemented actions on the health care services provided. METHODS: This was a prospective study carried out over a period of 15 months by a group of pharmacists representing all Organizational Integrated Management Systems of a regional health service, and coordinated by the General Subdirectorate of Pharmaceuticals. RESULTS: A total of 500 drugs and 500 active pharmaceutical ingredients included in the hospital drug database were standardized to implement the electronic prescribing system in the oncology outpatient clinic. The implementation of such standardization process yielded a 70% decrease in medication errors. In the satisfaction survey concerning the usefulness of the tall-man letters implemented in the electronic prescribing system, the interviewed doctors reported the highest levels of satisfaction. CONCLUSIONS: The creation of consensus documents to standardize the hospital drug database served to unify the information available in the regional hospital pharmacy services of an autonomous community. In addition, the implementation of the electronic prescribing system in the oncology outpatient clinic of a tertiary-level hospital resulted in a decrease in the number of medication errors.
Assuntos
Bases de Dados de Produtos Farmacêuticos/normas , Prescrição Eletrônica , Sistemas de Medicação no Hospital/normas , Preparações Farmacêuticas , Consenso , Estudos Prospectivos , Software , Espanha , Centros de Atenção TerciáriaRESUMO
BACKGROUND: The care transition is the time when more medication errors occur. The aim of this study is to analyze the usefulness of a pharmacotherapeutic report model at hospital discharge to prevent medication errors and to simplify pharmacotherapy during a patient's transition from the hospital to primary care. METHODS: Prospective study including patients diagnosed with chronic obstructive pulmonary disease who were admitted to a short-stay unit or an emergency room. Relevant variables were extracted from the patients' clinical history and SPSS software was used to carry out the statistical analysis. Direct costs were also calculated. RESULTS: 79.3% of patients were polymedicated, 15.5% of patients were identified as nonadherent to the treatment, 12.1% were users of alternative therapies, and 10.3% had been prescribed drugs that could be monitored. In 32.8% of the reports, reference was made to the primary care pharmacists with a view to resolve any pharmacotherapeutic discrepancies. A total of 132 discrepancies were identified, the majority being related to medicinal requirements (necessary/unnecessary medication). The major cause of drug-related problems (DRPs) were prescription errors. The drugs that were mainly involved in the onset of DRPs belonged to the R group, and the degree of simplification of the pharmacotherapy was 7.6%. The total cost avoided with the reconciliation was 200/patient. CONCLUSION: A continuity program was implemented based on the drafting of a pharmacotherapeutic report, which allowed for detecting discrepancies and updating the patients' pharmacotherapeutic history, resulting in financial savings after its implementation.
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Erros de Medicação/prevenção & controle , Reconciliação de Medicamentos/métodos , Alta do Paciente , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Redução de Custos , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Doença Pulmonar Obstrutiva Crônica/economiaRESUMO
OBJECTIVE: To analyse the factors leading to greater satisfaction among patients attending the outpatient hospital pharmacy (OPh). METHODS: A cross-sectional study was conducted of patients attending the OPh of a 1250-bed university hospital. A self-administered questionnaire for measuring outpatients' satisfaction was developed. Global satisfaction was measured on a scale of 1 to 10. Indices of perceived quality for accessibility, interpersonal professional-patient relationship and the convenience of the process were modelled through a principal component analysis using varimax rotation. The relationship between the principal components and overall satisfaction was evaluated using regression analysis. RESULTS: A questionnaire-based survey was conducted between May and June 2015. A total of 509 valid responses (86.9% response rate) were collected from the OPh. The overall satisfaction score was 7.81 (95% CI 7.59 to 8.04). The principal component analysis produced two components that explained 62.1% of the variance. The first component (CP1) contained questions related to the adequacy of the resources and services. The second component (CP2) contained questions about interpersonal professional-patient relationship. An additional unit in the CP2 was associated with a 3.23 increased risk of having higher satisfaction scores, while an increase of an additional unit in CP1 was associated with a 1.93 increased risk of having higher satisfaction scores. CONCLUSIONS: Our study shows that the factor which predicts the satisfaction of patients who come to the OPh is the quality of care provided by pharmacists-in particular, information provided, resolution of doubts, personal attention and time devoted to the patient.
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Objetivos: El estudio MEMOGAL (NCT04319081) está dirigido a evaluar cambios en la función cognitiva en pacientes tratados con inhibidores de la PCSK9 (iPCSK9). Se realiza primer análisis: 1) discutir el papel de los farmacéuticos hospitalarios durante de la pandemia, así como evaluar el impacto de la misma en el control lipídico; 2) análisis descriptivo; 3) eficacia en reducción de colesterol-LDL (c-LDL) de alirocumab y evolocumab; y 4) reportar seguridad de los iPCSK9. Material y métodos: Se trata de un análisis prospectivo en vida real de pacientes tratados por primera vez con iPCSK9 en la práctica clínica habitual e incluidos en su primera dispensación en las consultas de farmacia de 12 hospitales de Galicia desde mayo de 2020-abril de 2021. Los valores basales de c-LDL son los previos al inicio del tratamiento con iPCSK9 y como seguimiento los valores a los 6 meses. Resultados: Se incluyeron 89 pacientes. El 86,5% con enfermedad cardiovascular y un 53,9% intolerancia a las estatinas. Un 78,8% de los pacientes fueron tratados con estatinas de alta intensidad. Las estatinas más usadas fueron rosuvastatina (34,1%) y atorvastatina (20,5%). El nivel basal de c-LDL fue 148mg/dl y de 71mg/dl al seguimiento. Los pacientes tratados con alirocumab (n=43) presentaban valores basales de 144mg/dl y de 73mg/dl al seguimiento y con evolocumab (n=46) de 151mg/dl basal y 69mg/dl al seguimiento. La reducción de c-LDL fue para evolocumab 51,21% y alirocumab 51,05%. El 43,1% presentaba a los 6 meses valores>70mg/dl, el 19,4% entre 55 y 69mg/dl y el 37,5%<55mg/dl. Los pacientes que obtuvieron una reducción>50% de c-LDL fueron el 58,3%. Los eventos adversos presentados fueron: reacción en el lugar de inyección (n=2), mialgias (n=1), síntomas pseudogripales (n=1) y deterioro neurocognitivo (n=1).(AU)
Objectives: MEMOGAL study (NCT04319081) is aimed at evaluating changes in cognitive function in patients treated with PCSK9 inhibitors (PCSK9i). This is the first analysis: (1) discussion about the role of the Hospital Pharmacists during the pandemic, and also the assessment of the impact of COVID-19 in the lipid control; (2) descriptive analysis; (3) effectiveness in LDL cholesterol (LDL-c) reduction of alirocumab and evolocumab; (4) communicate PCSK9i safety. Material and methods: It is a prospective Real-World Evidence analysis of patients that take PCSK9i for the first time in the usual clinical practice, and they are included after the first dispensation in the public pharmacy consultations of 12 Hospitals in Galicia from May 2020 to April 2021. Baseline values of LDL-c are the previous values before taking PCSK9 and the follow-up values are in 6 months time. Results: 89 patients were included. 86.5% with cardiovascular disease and 53.9% with statin intolerances. 78.8% of the patients were treated with high intensity statins. Statins most used were rosuvastatin (34.1%) and atorvastatin (20.5%). Baseline value of LDL-c was 148mg/dL and the follow-up value was 71mg/dL. The baseline value of patients treated with alirocumab (N=43) was 144mg/dL and 73mg/dL in the follow-up. With evolocumab (N=46) was 151mg/dL in basaline and 69mg/dL in follow-up. The LDLc- reduction was 51.21% with evolocumab and 51.05% with alirocumab. 43.1% of the patients showed values >70mg/dL in six month time; 19.4% between 69mg/dl and 55mg/dL and 37.5% <55mg/dL. 58.3% of the patients achieved a reduction >50% of LDL-c. The adverse events were: injection point reaction (N=2), myalgias (N=1), flu-like symptoms (N=1) and neurocognitive worsening (N=1).(AU)
Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Lipídeos , Coronavírus Relacionado à Síndrome Respiratória Aguda Grave , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Pró-Proteína Convertase 9 , Cognição , Farmacologia , Avaliação de Sintomas , Estudos Prospectivos , ArterioscleroseRESUMO
OBJETIVO: El objetivo del estudio es evaluar los resultados de la aplica-ción de la metodología Lean en el diseño de un modelo estandarizado de almacenaje de medicación en las unidades de hospitalización. MÉTODO: Estudio descriptivo y retrospectivo desarrollado entre septiembre de 2017 y enero de 2019 en un hospital de tercer nivel. Se creó un equipo multidisciplinar liderado por el Servicio de Farmacia. Se empleó la metodología Lean para establecer los elementos y criterios de organización e identificación que conformaron el modelo estandarizado de almacenaje de medicación. Se revisaron y cuantificaron los stocks de cada unidad de hospitalización, se consensuó la medicación con la supervisora de cada unidad y se estimó el impacto económico de la implantación del modelo estandarizado. Se diseñó y envió una encuesta para evaluar la satisfacción de enfermería con el nuevo modelo. RESULTADOS: El modelo estandarizado de almacenaje se aplicó en 20 unidades de enfermería y supuso una reducción global del 56,72% en el número de presentaciones de principios activos disponibles (5.688 versus2.462). Se disminuyó el número de presentaciones de principios activos de medicamentos de alto riesgo en un 40,73% (631 versus 374). La eliminación de este despilfarro supuso un ahorro económico de 25.357,98 (Euro). Se recibieron 58 respuestas a la encuesta de satisfacción del personal de enfermería (20,70% del total de encuestas enviadas), de las que un 22,40% correspondieron al turno fijo y 77,60% al turno rotativo. La media de la satisfacción global (valorada entre 1 y 10) fue de 5,79 ± 3,61. CONCLUSIONES: La aplicación de la metodología Lean es útil para la gestión de stocks de medicación de las unidades de hospitalización. La implantación del modelo estandarizado de almacenaje conlleva un ahorro económico y una reducción del número de presentaciones de principios activos y de medicamentos de alto riesgo. El personal de enfermería está conforme con la implantación del modelo, lo que nos plantea seguir en esta línea de mejora
OBJECTIVE: The objective of this study was to assess the results of applying Lean Methodology in the design of a standardized medication storage model in hospitalization departments. METHOD: Descriptive and retrospective study conducted between September 2017 and January 2019 in a tertiary level hospital. The Pharmacy Service led the creation of a multidisciplinary team. Lean Methodology was used to establish the components and organization and identification criteria that made up the standardized medication storage model. The stocks of each hospitalization department were reviewed and quantified, the final amount of stock needed was agreed with the supervisor of each department, and the economic impact of the implementation of the standardized medication model was assessed. A questionnaire was designed and sent to nursing staff to determine their level of satisfaction with the new model. RESULTS: The standardized medication storage model was scaled up to 20 nursing departments, leading to an overall reduction of 56.72% in the number of pharmaceutical dosage forms available (5,688 vs 2,462). The number of high-risk drugs was reduced by 40.73% (631 vs 374). This elimination of wastage achieved a saving of (Euro)25,357.98. A total of 58 nurses returned the questionnaires (20.70% of the total): 22.40% worked a fixed shift and 77.60% worked a rotating shift. The mean score on overall satisfaction was 5.79 ± 3.61 (scores ranged from 1 to 10). CONCLUSIONS: The application of Lean Methodology is very useful for the management of medication stocks in hospitalization departments. The implementation of a standardized medication storage model leads to economic savings and a marked reduction in the number of active ingredients and high-risk medications. The nursing staff were satisfied with the implementation of the model, suggesting that we should continue to pursue this effective line of action