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1.
Blood Purif ; 47 Suppl 4: 1, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31170707
2.
J Clin Apher ; 34(3): 171-354, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31180581

RESUMO

The American Society for Apheresis (ASFA) Journal of Clinical Apheresis (JCA) Special Issue Writing Committee is charged with reviewing, updating and categorizing indications for the evidence-based use of therapeutic apheresis (TA) in human disease. Since the 2007 JCA Special Issue (Fourth Edition), the committee has incorporated systematic review and evidence-based approaches in the grading and categorization of apheresis indications. This Eighth Edition of the JCA Special Issue continues to maintain this methodology and rigor in order to make recommendations on the use of apheresis in a wide variety of diseases/conditions. The JCA Eighth Edition, like its predecessor, continues to apply the category and grading system definitions in fact sheets. The general layout and concept of a fact sheet that was introduced in the Fourth Edition, has largely been maintained in this edition. Each fact sheet succinctly summarizes the evidence for the use of TA in a specific disease entity or medical condition. The Eighth Edition comprises 84 fact sheets for relevant diseases and medical conditions, with 157 graded and categorized indications and/or TA modalities. The Eighth Edition of the JCA Special Issue seeks to continue to serve as a key resource that guides the utilization of TA in the treatment of human disease.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Medicina Baseada em Evidências/normas , Humanos , Terapêutica/métodos , Estados Unidos , Redação
3.
Orv Hetil ; 160(19): 727-738, 2019 May.
Artigo em Húngaro | MEDLINE | ID: mdl-31055962

RESUMO

Therapeutic apheresis is a treatment option for several subspecialities. It is a relatively expensive intervention, which can only be done by dedicated centers based on specific indications. The Therapeutic Apheresis Committee and the National Health Insurance Fund of Hungary jointly control the number of interventions to be made, the introduction of new diagnoses and the application of new apheresis procedures in Hungary. In this work, we review the therapeutic practice of the period between 2013 and 2017 in Hungary, describing also the new modalities under implementation. Orv Hetil. 2019; 160(19): 727-738.


Assuntos
Remoção de Componentes Sanguíneos , Programas Nacionais de Saúde , Guias de Prática Clínica como Assunto , Terapêutica/normas , Remoção de Componentes Sanguíneos/métodos , Remoção de Componentes Sanguíneos/estatística & dados numéricos , Inquéritos Epidemiológicos , Humanos , Hungria , Troca Plasmática , Inquéritos e Questionários
4.
Transfus Apher Sci ; 58(3): 237-246, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31085053

RESUMO

The American Society for Apheresis (ASFA) regularly publishes evidence-based guidelines, with the most recent edition in 2016, to assist the requesting and/or apheresis physicians with the evaluation of therapeutic apheresis. Given that therapeutic plasma exchange (TPE) is one of the most common therapeutic apheresis procedures, in this review, we discuss the rationale of TPE in both ASFA category I (first-line therapy) and II (second-line therapy) indications. However, the ASFA Guidelines usually provide little guidance with regard to scheduling/urgency issues. Given that mobilizing resources to perform apheresis after-hours may be expensive and challenging, we classified the urgency of the procedures in this review into 3 distinct groups: emergent (i.e. TPE should be started as soon as possible, preferably within 4-6 h upon request), urgent (i.e. TPE should be initiated within 24 h of request), and routine (i.e. TPE may be performed during regular working hours) based on our experiences in clinical practices. A brief discussion of the technical aspects as well as important considerations for an apheresis consultation is also provided.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Troca Plasmática/métodos , Humanos , Sociedades Médicas , Estados Unidos
5.
Transfus Apher Sci ; 58(3): 281-286, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31047825

RESUMO

In Italy therapeutic apheresis procedures were carried out for the first time in the '70s. in the '80s the Italian Society of Hemapheresis was founded, formerly named SIDE, now SIdEM (Italian Society of Hemapheresis and Cellular Manipulation). From the beginning, the collection and the analysis of activity data have been seen as a way to improve the knowledge on mechanisms of action, to identify the correct rationale in order to intervene in the most appropriate clinical indications. Over the years the data collection has been refreshed and today we can rely on information representing the evolution of TA in Italy, from an organizational/technological viewpoint and according to clinical indications. Over the years the aspects that have mainly changed are the technologies, the organizational and managerial aspects and, above all, the clinical indications. The primary indication for therapeutic apheresis is still today the thrombotic thrombocytopenic purpura, but corrently, whenever a disease recognizes an autoimmune pathogenesis, the use of apheresis may be a valid therapeutic tool in the event of failure or partial efficacy of conventional drug therapy. The continuous monitoring of apheresis activity through Registries is a useful tool to follow the evolution of the apheresis practice.


Assuntos
Remoção de Componentes Sanguíneos , Sistema de Registros , Remoção de Componentes Sanguíneos/história , Remoção de Componentes Sanguíneos/métodos , História do Século XX , História do Século XXI , Humanos , Itália
6.
Transplant Proc ; 51(5): 1365-1370, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31056246

RESUMO

BACKGROUND: The management of acute or, in particular, chronic antibody-mediated rejection (AMR) resulting from donor-specific HLA antibodies (DSA) is a critical barrier to obtaining better long-term graft survival. To ascertain the efficacy of anti-AMR therapies, the transition of intra-graft DSA (g-DSA) was assessed. METHODS: Allograft biopsy specimens were analyzed by graft immunocomplex capture fluorescence analysis, as previously described. One hundred recipients who underwent graft biopsies between April 2016 and December 2017 were enrolled for this study. Fifteen recipients diagnosed with g-DSA positive (+) received anti-humoral treatments and underwent follow-up biopsies. g-DSA levels were assessed again by a follow-up biopsy at 6-12 months following the treatments. RESULTS: With anti-humoral treatments, 9 out of 15 recipients comprised a g-DSA negative (-) (3.59 ± 2.82-.58 ± .25): g-DSA6-12- group, while the remaining 6 recipients comprised a g-DSA +(20.6 ± 17.0-14.9 ± 14.1): g-DSA6-12+ group. The initial g-DSA scores were significantly higher in the g-DSA6-12+ group (P = .01). All samples were diagnosed as chronic AMR in the g-DSA+ groups, whereas there were 3 chronic AMR, 4 acute AMR, and 2 incomplete AMR samples in the g-DSA- group. Interestingly, the frequency of responsible DSA belonging to class II tended to be higher in the g-DSA6-12+ group (4/6) compared to the g-DSA6-12- group (2/9) (P = .14). CONCLUSION: These results imply that chronic exposure to DSA causes significant and irreversible damage to the allograft. Timely and adequate anti-humoral intervention might reverse the early phase of AMR with complete clearance of g-DSA.


Assuntos
Rejeição de Enxerto/prevenção & controle , Fatores Imunológicos/uso terapêutico , Isoanticorpos/imunologia , Transplante de Rim , Rituximab/uso terapêutico , Adulto , Biópsia , Remoção de Componentes Sanguíneos/métodos , Feminino , Rejeição de Enxerto/imunologia , Humanos , Isoanticorpos/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Doadores de Tecidos , Transplante Homólogo
7.
Hypertension ; 74(1): 145-153, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31079531

RESUMO

Preeclampsia is a hypertensive pregnancy disease associated with a massive increase in sFlt-1 (soluble form of the vascular endothelial growth factor 1) in the maternal circulation, responsible for angiogenic imbalance and endothelial dysfunction. Pilot studies suggest that extracorporeal apheresis may reduce circulating sFlt-1 and prolong pregnancy. Nonspecific apheresis systems have potential adverse effects because of the capture of many other molecules. Our concept is based on a specific and competitive apheresis approach using VEGF (vascular endothelial growth factor) functionalized magnetic beads to capture sFlt-1 while releasing endogenous PlGF (placental growth factor) to restore a physiological angiogenic balance. Magnetic beads were functionalized with VEGF to capture sFlt-1. Experiments were performed using PBS, conditioned media from human trophoblastic cells, and human plasma. The proof of concept was validated in dynamic conditions in a microfluidic device as an approach mimicking real apheresis. Magnetic beads were functionalized with VEGF and characterized to evaluate their surface ligand density and recognition capabilities. VEGF-coated magnetic beads proved to be an efficient support in capturing sFlt-1 and releasing PlGF. In static conditions, sFlt-1 concentration decreased by 33±13%, whereas PlGF concentration increased by 27±10%. In dynamic conditions, the performances were improved, with 40% reduction of sFlt-1 and up to 2-fold increase of free PlGF. The sFlt-1/PlGF ratio was reduced by 63% in the plasma of preeclamptic patients. Apheresis was also associated with VEGF release. A ligand-based approach using VEGF-coated beads is an effective approach to the capture of sFlt-1 and the release of endogenous PlGF. It offers new perspectives for the treatment of preeclampsia.


Assuntos
Dispositivos Lab-On-A-Chip , Pré-Eclâmpsia/terapia , Fator A de Crescimento do Endotélio Vascular/farmacologia , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/metabolismo , Indutores da Angiogênese , Remoção de Componentes Sanguíneos/métodos , Velocidade do Fluxo Sanguíneo , Células Cultivadas , Feminino , Humanos , Técnicas In Vitro , Magnetismo/métodos , Projetos Piloto , Placenta/citologia , Pré-Eclâmpsia/patologia , Gravidez , Sensibilidade e Especificidade , Trofoblastos/citologia , Trofoblastos/fisiologia
8.
J Stroke Cerebrovasc Dis ; 28(8): e110-e112, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31126786

RESUMO

Polycythemia vera is a chronic myeloproliferative neoplasm, which is primarily characterized by elevated erythrocyte count with the risk of thrombosis, hemorrhage, and vasomotor symptoms. More common reported about bleeding events are gastrointestinal, mucosal, and cutaneous bleeding. Spontaneous cerebral hemorrhage/bleeding is seldom reported. Here, we report the case of a 50-year-old female with polycythemia vera who developed a spontaneous cerebral hemorrhage. She improved significantly after hydroxyurea agent and red cell apheresis, and the hematocrit decreased from 74% to 40%.


Assuntos
Hemorragia Cerebral/etiologia , Policitemia Vera/complicações , Biópsia , Remoção de Componentes Sanguíneos/métodos , Exame de Medula Óssea , Angiografia Cerebral/métodos , Hemorragia Cerebral/diagnóstico por imagem , Angiografia por Tomografia Computadorizada , Feminino , Hematócrito , Fármacos Hematológicos/uso terapêutico , Humanos , Hidroxiureia/uso terapêutico , Imagem por Ressonância Magnética , Pessoa de Meia-Idade , Policitemia Vera/sangue , Policitemia Vera/diagnóstico , Policitemia Vera/terapia , Resultado do Tratamento
10.
G Ital Nefrol ; 36(2)2019 Apr.
Artigo em Italiano | MEDLINE | ID: mdl-30983168

RESUMO

Therapeutic apheresis is by now a century-old extracorporeal procedure, but it is still very much relevant thanks to advances in medical device technology. In addition to the classic plasma exchange, we now have double filtration techniques, plasma absorption, immunoadsorption, leuko and cyto-apheresis, LDL apheresis. The application of these highly selective techniques has opened up new perspectives in the treatment of various nephrological diseases. Unfortunately, renal diseases that can be treated with apheretic techniques are often relatively rare and this prevents us from carrying out extensive studies aimed at demonstrating the real benefits of these methods. Every three years, the American Society of Apheresis provides solid recommendations regarding the diseases that can be treated with apheresis. New immunosuppressants, immuno-modulating substances and monoclonal antibodies are becoming extremely selective and sophisticated weapons against diseases with a clearly identified causal agent. This does not exclude the fact that, due to economic reasons or even to minimize the side effects of these new drugs, apheretic techniques could still retain an important, if ancillary, role.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Nefropatias/terapia , Remoção de Componentes Sanguíneos/efeitos adversos , Citaferese/métodos , Eficiência , Humanos , Imunoterapia/métodos , Nefrologistas/normas , Plasmaferese/métodos , Guias de Prática Clínica como Assunto , Diálise Renal/métodos
11.
Expert Opin Drug Saf ; 18(5): 403-414, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30945578

RESUMO

INTRODUCTION: Homozygous familial hypercholesterolemia (HoFH) is a rare and life-threatening lipid disorder characterized by extremely elevated low-density lipoprotein-cholesterol (LDL-C) concentrations and premature atherosclerotic cardiovascular disease (CVD). Conventional lipid-lowering agents remain insufficient in managing this disease, which emphasize the unmet medical need for potential therapies capable of lowering LDL-C and decreasing CVD risk in this patient population. AREAS COVERED: Novel LDL receptor (LDLR) independent drugs have been recently approved or are in development for the treatment of HoFH, including lomitapide (Juxtapid®). This oral microsomal triglyceride transfer protein (MTP) inhibitor was approved in 2012 in several countries as an adjunct to a low-fat diet and other lipid-lowering drugs with or without LDL apheresis to treat patients with HoFH. This review summarizes key safety and efficacy data of lomitapide from clinical trials and 'real-life' experience. EXPERT OPINION: While lomitapide is an interesting therapy for treating HoFH, long-term safety, as well as cardiovascular outcome data, are yet to be provided. Precision medicine has recently contributed to the development of several agents designed to address the unmet medical need of HoFH. However, combining safety, efficacy, accessibility, and affordability in a single therapy constitutes very challenging individual and societal paradigms in HoFH treatment.


Assuntos
Anticolesterolemiantes/administração & dosagem , Benzimidazóis/administração & dosagem , Hiperlipoproteinemia Tipo II/tratamento farmacológico , Anticolesterolemiantes/efeitos adversos , Anticolesterolemiantes/farmacologia , Benzimidazóis/efeitos adversos , Benzimidazóis/farmacologia , Remoção de Componentes Sanguíneos/métodos , Proteínas de Transporte/antagonistas & inibidores , LDL-Colesterol/sangue , Humanos , Hiperlipoproteinemia Tipo II/fisiopatologia , Receptores de LDL/metabolismo , Fatores de Tempo
12.
Clin Res Cardiol Suppl ; 14(Suppl 1): 39-44, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30875001

RESUMO

Patients with symptomatic peripheral arterial disease (PAD) are at a very high risk of cardiovascular morbidity and mortality. Elevated lipoprotein(a) levels have been shown to be a risk factor for coronary artery disease (CAD) and stroke. More recently elevated lipoprotein(a) levels have also been demonstrated to be associated with prevalent and incident PAD, and even may be a stronger risk factor for PAD compared with CAD. Lipoprotein apheresis is currently the only efficient way to lower lipoprotein(a) levels. Lipoprotein(a) apheresis has been shown to reduce major coronary events in patients with CAD. There is increasing evidence that lipoprotein(a) apheresis also reduces the rate of major adverse limb events such as peripheral revascularizations and amputations in PAD patients, and improves symptoms of PAD such as pain on exertion. This review summarizes the current knowledge on the clinical role of lipoprotein(a) for PAD and the disease-specific effect of lipoprotein(a) apheresis, and suggests indications for screening for and treating of elevated lipoprotein(a) levels in patients with PAD.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Lipoproteína(a)/sangue , Doença Arterial Periférica/sangue , Doença da Artéria Coronariana/sangue , Humanos , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/terapia , Fatores de Risco
13.
Drug Discov Ther ; 13(1): 59-61, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30880324

RESUMO

Familial hypercholesterolemia (FH) is a form of primary hyperlipoproteinemia characterized by the presence of high concentrations of serum low density lipoprotein (LDL) cholesterol, increased tendency to form xanthomas and early onset of coronary artery disease. This disease is an autosomal dominant disorder caused by defects in the gene that encode for the LDL receptor. Homozygous familial hypercholesterolemia is a rare occurrence and here we report a case of an 18-year-old girl with familial hypercholesterolemia treated with anti-lipidemic drugs and controlled only with LDL apheresis. The patient expired after 3 months highlighting the difficulties in management due to economic constraints in a resource limited setting in spite of availability of effective therapy.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Hiperlipoproteinemia Tipo II/sangue , Hiperlipoproteinemia Tipo II/terapia , Lipoproteínas LDL/sangue , Adolescente , Feminino , Homozigoto , Humanos , Hiperlipoproteinemia Tipo II/diagnóstico , Hiperlipoproteinemia Tipo II/genética
14.
Clin Res Cardiol Suppl ; 14(Suppl 1): 33-38, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30838552

RESUMO

BACKGROUND: Lipoprotein(a) (Lp(a)) is a genetic risk factor for cardiovascular disease (CVD) and is associated with the induction and sustaining of atherosclerotic cardiovascular diseases (ASCVD). Since 2008 Lp(a) along with progressive CVD has been approved as an indication for regular lipoprotein apheresis (LA) in Germany. The German Lipoprotein Apheresis Registry (GLAR) has been initiated to provide statistical evidence for the assessment of extracorporeal procedures to treat dyslipidemia for both LDL-cholesterol (LDL-C) and Lp(a). The GLAR now allows prospective investigations over a 5-year period about annual incidence rates of cardiovascular events. Here Lp(a) patients (LDL-C < 100 mg/dl; Lp(a) > 60 mg/dl or >120 nmol/l) showed the same reduction of major coronary (83%) and non-coronary events (63%) as had been formerly shown in the Pro(a)LiFe study. However, Lp(a) is not only an apolipoprotein(a) (apo(a)) and LDL-C containing particle, which is covalently bound to a LDL-C core by a disulphide bridge. The composition of this particle, inter alia containing oxidized phospholipids, gives pro-atherosclerotic, pro-inflammatory, and pro-thrombotic properties, inducing atherosclerotic processes mainly in the arterial wall. However, recent investigations have shown that a reduction of inflammatory settings without LDL-C or Lp(a) reduction may reduce ASCVD events. Lipoprotein apheresis (LA) could not only reduce LDL-C and Lp(a) in parallel, but also different inflammatory and coagulation parameters. In summary lipoprotein apheresis is not only anti-atherosclerotic, but also anti-inflammatory and anti-thrombotic and therefore an ideal treatment option with respect to the shown reduction of major adverse coronary events (MACE) and major adverse non-coronary events (MANCE) by reducing Lp(a) levels.


Assuntos
Aterosclerose/sangue , Remoção de Componentes Sanguíneos/métodos , Doenças Cardiovasculares/sangue , Lipoproteína(a)/sangue , Aterosclerose/genética , Aterosclerose/terapia , Doenças Cardiovasculares/genética , Doenças Cardiovasculares/terapia , LDL-Colesterol/sangue , Dislipidemias/terapia , Predisposição Genética para Doença , Alemanha , Humanos , Lipoproteína(a)/genética , Sistema de Registros , Fatores de Risco
15.
Clin Res Cardiol Suppl ; 14(Suppl 1): 13-19, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30838554

RESUMO

Lipoprotein(a) (Lp(a)) is an independent cardiovascular risk factor playing a causal role for atherosclerotic cardiovascular disease (ASCVD). Early or progressive ASCVD or a familial predisposition are key findings which can be associated with Lp(a)-hyperlipoproteinemia (Lp(a)-HLP). The German guideline for the indication of lipoprotein apheresis in patients with Lp(a)-HLP has proved to be of value to identify patients at highest risk, using the composite of a Lp(a) threshold >60 mg/dl (>120 nmol/l) and clinical ASCVD progression despite effective LDL-C lowering therapy. In particular for such patients it appears to be plausible that Lp(a)-associated risk would increase cardiovascular mortality as the most important part of total mortality in Western populations. By the majority of existing investigations an association of Lp(a) concentration on total or cardiovascular mortality was demonstrated. However, inconsistency in the findings between studies exists without a clear trend for any study feature to explain this. Genetic homogeneity of the population, long-term follow-up, and clinically guided selection of patients might be important to further clarify the impact of Lp(a) concentration on progression of ASCVD, and finally total or cardiovascular mortality. LDL and Lp(a) particles exhibit a mutual effect modification on related ASCVD risk. Therefore, LDL-C levels and concomitant LDL-C lowering treatment must be considered in this context. Prospective evaluation is needed to document that specific Lp(a)-lowering additional to targeted LDL-C lowering will in fact reduce cardiovascular or total mortality.


Assuntos
Aterosclerose/prevenção & controle , Doenças Cardiovasculares/prevenção & controle , Lipoproteína(a)/sangue , Aterosclerose/sangue , Aterosclerose/mortalidade , Remoção de Componentes Sanguíneos/métodos , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/mortalidade , LDL-Colesterol/sangue , Progressão da Doença , Humanos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Fatores de Risco
16.
Clin Res Cardiol Suppl ; 14(Suppl 1): 20-27, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30838556

RESUMO

Lipoprotein(a) (Lp(a)) is an internationally recognized atherogenic risk factor which is inherited and not changed by nutrition or physical activity. At present, only proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors may modestly decrease its concentration (but not in all patients)-leading to a certain decrease in cardiovascular events (CVE) in controlled studies. However, at present an elevation of Lp(a) is not a generally accepted indication for their use. More effective is lipoprotein apheresis (LA) therapy with respect to both lowering Lp(a) levels and reduction of CVE. In the future, an antisense oligonucleotide against apolipoprotein(a) will probably be available. Atherosclerosis in patients with an elevation of Lp(a) may affect several vessel regions (carotids, aorta, coronaries, leg arteries). Thus, Lp(a) should be measured in high-risk patients. These patients are usually cared for by their family doctors and by other specialists who should closely cooperate. Lipidologists should decide whether costly therapies like PCSK9 inhibitors or LA should be started. The main aim of current therapy is to optimize all other risk factors (LDL cholesterol, hypertension, diabetes mellitus, body weight, renal insufficiency). Patients should be regularly monitored (lab data, heart, arteries). This paper describes the duties of physicians of different specialties when caring for patients with high Lp(a) concentrations.


Assuntos
Aterosclerose/prevenção & controle , Doenças Cardiovasculares/prevenção & controle , Lipoproteína(a)/sangue , Aterosclerose/sangue , Remoção de Componentes Sanguíneos/métodos , Doenças Cardiovasculares/sangue , Humanos , Comunicação Interdisciplinar , Papel do Médico , Médicos/organização & administração , Pró-Proteína Convertase 9/antagonistas & inibidores , Fatores de Risco
17.
J Clin Apher ; 34(4): 423-433, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30817043

RESUMO

INTRODUCTION: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition with monoclonal antibodies has complemented the armamentarium of lipid-lowering therapy (LLT) before the final step of commencing chronic lipoprotein apheresis (LA). Data are scarce on patients who, after escalation of LLT with PCSK9 antibodies, have commenced chronic LA or PCSK9 antibody treatment during ongoing long-term LA. PATIENTS AND METHODS: In this study, a cohort of 110 patients with established atherosclerotic cardiovascular disease (ASCVD) due to hypercholesterolemia or concomitant lipoprotein(a)-hyperlipoproteinemia, who received PCSK9 antibodies for the first time during routine care, were consecutively identified. RESULTS: Mean LDL-C concentration prior to initiation of LA or PCSK9 antibody treatment was 5.3 ± 2.6 mmol/L (205 ± 102 mg/dL). Due to established ASCVD, the risk-adjusted LDL-C target value was <1.8 mmol/L (<70 mg/dL) in all patients. Use of PCSK9 antibodies increased the proportion of patients attaining the LDL-C target concentration by 41.8% overall. Treatment emergent adverse events (TEAE) associated with PCSK9 antibody medication were reported in 35 patients (31.8%). Discontinuation of PCSK9 antibody therapy due to TEAEs occurred in 25 patients (22.7%). CONCLUSION: Finally, 55.5% of patients received a combination of PCSK9 antibody therapy and LA at individually optimized treatment frequencies resulting in an increase of target attainment in 54.1% of patients. About 18.1% of chronic LA patients terminated LA treatment in this real-world study. The termination of long-term LA therapy, which has hitherto prevented the progression of ASCVD, requires careful individual risk assessment and cannot be recommended by the general criteria of LDL-C reduction.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Remoção de Componentes Sanguíneos/métodos , Terapia Combinada/métodos , Lipoproteínas/isolamento & purificação , Pró-Proteína Convertase 9/antagonistas & inibidores , Aterosclerose/terapia , LDL-Colesterol/isolamento & purificação , Inibidores Enzimáticos/uso terapêutico , Feminino , Humanos , Hipercolesterolemia/terapia , Lipídeos/isolamento & purificação , Lipoproteína(a)/isolamento & purificação , Masculino , Pessoa de Meia-Idade , Pró-Proteína Convertase 9/imunologia
18.
J Clin Apher ; 34(4): 461-467, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30817045

RESUMO

INTRODUCTION: Autologous bone marrow transplantation is a component of the malignant hemopathy therapy. The preferred mobilization and collection method is apheresis. The aim of this study is to compare three protocols analyzing the effect of plerixafor, higher dose of G-CSF and large volume leukapheresis (LVL). MATERIALS AND METHODS: A retrospective cohort study including 119 patients referred for mobilization. Three protocols were compared: (a) G-CSF 10 µg/kg/day subcutaneous (sc) × 4 days mobilizing 1 to 1.5 blood volumes. (b) G-CSF 10 µg/kg/day sc × 4 days + plerixafor 0.24 mg/kg/day sc preventively or as a rescue agent mobilizing 1 to 1.5 blood volumes. (c) G-CSF 20 µg/kg/day sc × 4 days ± plerixafor 0.24 mg/kg/day sc preventively or as a rescue agent mobilizing 3 to 4 blood volumes. RESULTS: The average number of days of apheresis was reduced to 1.37 with protocol 3. The average cost per patient was reduced by 67% compared with protocol 2 and increased by only 5% compared with protocol 1, reducing the failure rate to 0%. CONCLUSION: Adding preemptive or rescue plerixafor (protocol 2) to G-CSF 10 µg/kg/day alone (protocol 1) did not improve the days of apheresis nor the number of CD34+ cells collected but had higher cost and failure rate. Using LVL, plerixafor and G-CSF 20 µg/kg/day (protocol 3) decreased the number of sessions to 1.37, reduced the failure rate to 0% and led to a significant increase in the number of CD34+ cells collected without toxicity and with a similar cost to protocol 1.


Assuntos
Remoção de Componentes Sanguíneos/economia , Protocolos Clínicos/normas , Custos e Análise de Custo , Mobilização de Células-Tronco Hematopoéticas/economia , Adulto , Idoso , Antígenos CD34/análise , Remoção de Componentes Sanguíneos/métodos , Volume Sanguíneo , Estudos de Coortes , Esquema de Medicação , Feminino , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Mobilização de Células-Tronco Hematopoéticas/métodos , Compostos Heterocíclicos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo
19.
J Clin Apher ; 34(4): 468-473, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30829417

RESUMO

A mini extracorporeal photopheresis (mini-ECP) "off line" technique has been developed for use in the treatment of small children and patients with apheresis contraindications. Until now various methods have been used for buffy coat separation from whole blood. In this report we describe a protocol for mini buffy coat preparation using the automated Sepax laboratory separator for "off line" ECP treatment in a low body weight child with graft-vs-host-disease. According to our results this alternative method has been proven feasible and tolerable.


Assuntos
Buffy Coat/citologia , Doença Enxerto-Hospedeiro/terapia , Fotoferese/métodos , Remoção de Componentes Sanguíneos/métodos , Peso Corporal , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Resultado do Tratamento
20.
Clin Res Cardiol Suppl ; 14(Suppl 1): 51-56, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30859384

RESUMO

Elevated levels of lipoprotein(a) (Lp(a)) contribute to the risk of early and severe cardiovascular disease (CVD) and Lp(a) is acknowledged as a risk factor to be included in risk assessment. The established lipid-modifying medical therapies do not lower Lp(a) except niacin but no data of endpoint trials are available. Of the new lipid-modifying drugs a few have some impact on Lp(a). Whether the Lp(a) lowering effect contributes to the reduction of CVD events would have to be shown in Lp(a) dedicated trials. None of the available agents is indicated to lower Lp(a). Lipoprotein apheresis lowers levels of Lp(a) significantly by >60% per treatment. Trial data and data of the German Lipoprotein Apheresis Registry show that regular apheresis reduces cardiovascular events. The Apo(a) antisense oligonucleotide is the only approach to specifically lower Lp(a). The IONIS-APO(a)Rx phase 1 and 2 trials showed very substantial decreases of Lp(a) and good tolerability. The hepatospecific variant IONIS-APO(a)-LRx is 30 times more potent. The results of the IONIS-APO(a)-LRx phase 2 trial were presented recently. The highest dosages reduced Lp(a) by 72 and 80%; in about 81 and 98% Lp(a) levels <50 mg/dl were achieved. Tolerability and safety were confirmed, whereby injection site reactions were the most common side effects. This raises hope that the planned phase 3 trial will reproduce these findings and show a reduction of cardiovascular events.


Assuntos
Remoção de Componentes Sanguíneos/métodos , Doenças Cardiovasculares/sangue , Lipoproteína(a)/administração & dosagem , Oligonucleotídeos Antissenso/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Relação Dose-Resposta a Droga , Humanos , Hipolipemiantes/administração & dosagem , Lipoproteína(a)/sangue , Niacina/administração & dosagem , Oligonucleotídeos Antissenso/efeitos adversos , Medição de Risco/métodos , Fatores de Risco
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