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[PMID]:29172983
[Au] Autor:Douglas AG; Schwab P; Lane D; Kennedy K; Slabaugh SL; Bowe A
[Ad] Endereço:1 Humana Pharmacy Solutions, Humana, Louisville, Kentucky.
[Ti] Título:A Comparison of Brand and Biosimilar Granulocyte-Colony Stimulating Factors for Prophylaxis of Chemotherapy-Induced Febrile Neutropenia.
[So] Source:J Manag Care Spec Pharm;23(12):1221-1226, 2017 Dec.
[Is] ISSN:2376-1032
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Filgrastim-sndz, a granulocyte-colony stimulating factor (G-CSF), was introduced as a biosimilar to filgrastim in 2015, but real-world comparative effectiveness for filgrastim versus filgrastim-sndz has not been reported to date. OBJECTIVES: To (a) compare the incidence of febrile neutropenia for patients taking filgrastim versus those taking filgrastim-sndz and (b) compare the incidence of a potential serious adverse event for filgrastim versus filgrastim-sndz. METHODS: This retrospective cohort study identified patients receiving a G-CSF following chemotherapy, using administrative claims from the Humana Research Database. Patients enrolled in a Medicare Advantage Prescription Drug plan with a claim for a G-CSF from October 1, 2015, through September 30, 2016, were identified. G-CSF use had to occur within 6 days of exposure to chemotherapy and without any subsequent chemotherapy within 14 days after G-CSF use. Febrile neutropenia requiring hospitalization was defined as hospitalization within 14 days after G-CSF use with (a) diagnosis of infection and/or neutropenia (broad definition) or (b) infection and neutropenia diagnoses (narrow definition). Serious adverse drug events (spleen rupture, acute respiratory syndrome, serious allergic reactions, capillary leak syndrome, thrombocytopenia, leukocytosis, cutaneous vasculitis, or bones and muscle ache) were also identified within 14 days after G-CSF use. An incidence difference of < 1% with 90% CI crossing zero qualified as support for noninferiority. Two-tailed chi-square tests were also used to investigate differences. RESULTS: A total of 88 filgrastim and 101 filgrastim-sndz patients were identified. Filgrastim and filgrastim-sndz met the criteria for noninferiority based on an incidence difference of -0.6% (90% CI = -5.1%-4.0%; P = 0.84) for the broad definition of febrile neutropenia and a difference of -0.8% (90% CI = -3.8%-2.1%; P = 0.64) for the narrow definition. For the analysis of serious adverse events, an incidence difference of -2.5% (90% CI = -7.5%-2.5%; P = 0.42) for filgrastim compared with filgrastim-sndz was not sufficient to establish noninferiority. CONCLUSIONS: This study is one of the first analyses of real-world evidence regarding the noninferiority of filgrastim and filgrastim-sndz. The study results support noninferiority of filgrastim and filgrastim-sndz for prevention of febrile neutropenia requiring hospitalization. While noninferiority for serious adverse events was not supported, there was also no statistically significant difference between filgrastim and filgrastim-sndz. The study's small sample size could have limited the analysis of the relatively rare outcomes of febrile neutropenia requiring hospitalization and serious adverse events. A study including a larger numbers of patients taking filgrastim or filgrastim-sndz could provide additional insights. DISCLOSURES: This study received no outside funding. Douglas, Kennedy, and Slabaugh were employees of Humana Pharmacy Solutions at the time the study was conducted. Bowe, Schwab, and Lane were employees of Comprehensive Health Insights, a wholly owned subsidiary of Humana, at the time the study was conducted. Study concept and design were contributed by Douglas, Kennedy, Schwab, and Lane, along with Slabaugh and Bowe. Bowe took the lead in data collection, assisted by Schwab, and data interpretation was performed by Schwab, along with the other authors. The manuscript was written by Schwab, Lane, and Douglas and revised by Kennedy, Slabaugh, and Bowe, along with Schwab, Lane, and Douglas.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/administração & dosagem
Neutropenia Febril Induzida por Quimioterapia/prevenção & controle
Filgrastim/administração & dosagem
Fármacos Hematológicos/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Antineoplásicos/administração & dosagem
Antineoplásicos/efeitos adversos
Medicamentos Biossimilares/efeitos adversos
Neutropenia Febril Induzida por Quimioterapia/epidemiologia
Estudos de Coortes
Feminino
Filgrastim/efeitos adversos
Fármacos Hematológicos/efeitos adversos
Hospitalização/estatística & dados numéricos
Seres Humanos
Incidência
Estudos Longitudinais
Masculino
Meia-Idade
Estudos Retrospectivos
Fatores de Tempo
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Biosimilar Pharmaceuticals); 0 (Hematologic Agents); PVI5M0M1GW (Filgrastim)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.18553/jmcp.2017.23.12.1221


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[PMID]:29172977
[Au] Autor:Agboola F; Reddy P
[Ad] Endereço:1 Center for Drug Policy, Partners Healthcare, Somerville, Massachusetts.
[Ti] Título:Conversion from Filgrastim to Tbo-filgrastim: Experience of a Large Health Care System.
[So] Source:J Manag Care Spec Pharm;23(12):1214-1218, 2017 Dec.
[Is] ISSN:2376-1032
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: In 2008, tbo-filgrastim was approved as a biosimilar in Europe and then approved in the United States by the FDA in 2012 as a biologic product with 1 similar indication to filgrastim. Because tbo-filgrastim was less expensive than filgrastim, and clinical information and expert opinion supported similarity, the Pharmacy & Therapeutics Committee of a large health care system approved tbo-filgrastim as the preferred granulocyte-colony stimulating factor (G-CSF) product in March 2014. OBJECTIVES: To (a) assess the use of filgrastim and tbo-filgrastim products by comparing baseline characteristics, setting of care, indication for use, and payer type and (b) understand potential barriers of conversion to tbo-filgrastim. METHODS: A retrospective evaluation of filgrastim and tbo-filgrastim use was conducted on all patients (N = 204) who received the drugs between July 2015 and December 2015 at the 2 largest hospitals in the health system. Baseline characteristics, indication requiring use of filgrastim or tbo-filgrastim, setting of care, and payer information were collected from electronic medical records, and descriptive analyses were conducted. RESULTS: Overall, G-CSFs were administered to 204 patients for 261 episodes of care (filgrastim and tbo-filgrastim were used in 65 and 196 episodes of care, respectively). Baseline characteristics were similar between the 59 patients who received filgrastim and the 174 patients who received tbo-filgrastim. G-CSF was primarily used in the inpatient setting (163 episodes of care, 63%) with 90% of patients using tbo-filgrastim. In the outpatient setting (98 episodes of care, 38%), filgrastim and tbo-filgrastim were each used by 50% of patients. Tbo-filgrastim was the preferred G-CSF by clinical providers for all indications, except for stem cell mobilization, where filgrastim use was higher (55% vs. 45% of 71 episodes of care). In the outpatient setting, analysis by payers showed that the majority of patients on commercial plans were using filgrastim (58%), while half of Medicare patients were using filgrastim (50%, n = 12). Twelve patients were self-paid, and all were using tbo-filgrastim. Subgroup analysis by hospital showed differences in utilization patterns. CONCLUSIONS: Although tbo-filgrastim was the preferred G-CSF in our formulary, 29% of patients continued to receive filgrastim. Conversion to tbo-filgrastim has been largely successful, but extra steps may be needed to achieve full conversion to biosimilars. DISCLOSURES: No outside funding supported this study. Agboola was employed by Partners Healthcare at the time of the study. The authors have nothing to disclose. Study concept and design were contributed equally by Agboola and Reddy. Agboola collected the data, and data interpretation was performed by both authors. The manuscript was written primarily by Agboola, with assistance from Reddy. Both authors revised the manuscript.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/administração & dosagem
Filgrastim/administração & dosagem
Fármacos Hematológicos/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Idoso
Assistência Ambulatorial/estatística & dados numéricos
Medicamentos Biossimilares/economia
Feminino
Filgrastim/economia
Fármacos Hematológicos/economia
Hospitalização/estatística & dados numéricos
Seres Humanos
Masculino
Medicare/estatística & dados numéricos
Meia-Idade
Estudos Retrospectivos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Biosimilar Pharmaceuticals); 0 (Hematologic Agents); PVI5M0M1GW (Filgrastim)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.18553/jmcp.2017.23.12.1214


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[PMID]:29069007
[Au] Autor:Gao Y; Gong M; Zhang C; Kong X; Ma Y
[Ad] Endereço:aDepartment of Hematology bDepartment of Pharmacology, China-Japan Friendship Hospital, Beijing, China.
[Ti] Título:Successful eltrombopag treatment of severe refractory thrombocytopenia in chronic myelomonocytic leukemia: Two cases reports: A CARE-compliant article.
[So] Source:Medicine (Baltimore);96(43):e8337, 2017 Oct.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Thrombocytopenia in chronic myelomonocytic leukemia (CMML) is usually attributed to impaired marrow production resulting from cytotoxic drug use or CMML itself ("CMML-induced thrombocytopenia"). In very rare cases, immune thrombocytopenia (ITP) can be a complication of CMML ("CMML-associated ITP"). However, treatment of severe thrombocytopenia in patients with CMML is still a challenge. PATIENT CONCERNS: Case 1 was a 61-year-old female patient admitted to our hospital because of skin petechiae and purpura for 6 days. She had increased monocyte cell count (1.82 × 10/L), markedly decreased platelet count (2 × 10/L), hypercellularity of the megakaryocyte lineage with many immature megakaryocytes, and ZRSR2(zinc finger CCCH-type, RNA binding motif and serine/arginine rich 2) mutation. She failed to the treatment of corticosteroids, intravenous immunoglobulin (IVIg), TPO (thrombopoietin), and cyclosporin A (CsA). Case 2 was a 72-year-old female patient with thrombocytosis and monocytosis for 4 years, and thrombocytopenia for 6 months. After 10 courses of decitabine therapy, she had a persistent severe thrombocytopenia and decreased number of megakaryocytes, TET2 (tet methylcytosine dioxygenase 2) and SRSF2 (serine and arginine rich splicing factor 2) mutations were detected. She was dependent on platelet transfusion. DIAGNOSES: Case 1 was diagnosed as CMML-associated ITP, and case 2 as CMML with decitabine therapy-induced thrombocytopenia. INTERVENTIONS: Both patients were treated with eltrombopag. OUTCOMES: In both patients, the platelet counts returned to the normal within 1 week after eltrombopag therapy. The platelet count in case 1 patient remained stable at 141-200 × 10/L for 20 months with stopping therapy for 3 months. In case 2 patient, eltrombopag was stopped 1 month later. Her platelet count decreased to 41 × 10/L, but was stable at ∼30 × 10/L for 3 months with platelet transfusion independency for 12 months. Both patients had no adverse effects with eltrombopag. LESSONS: CMML-associated ITP is very rare and easily misdiagnosed. To the best of our knowledge, case 1 is the first reported case of the successful treatment of CMML-associated ITP with eltrombopag. Both CMML-associated ITP and decitabine therapy-induced thrombocytopenia in these 2 patients were highly sensitive and safe to eltrombopag therapy.
[Mh] Termos MeSH primário: Azacitidina/análogos & derivados
Benzoatos/administração & dosagem
Hidrazinas/administração & dosagem
Leucemia Mielomonocítica Crônica
Púrpura Trombocitopênica Idiopática
Pirazóis/administração & dosagem
Trombocitopenia
Trombopoetina/agonistas
[Mh] Termos MeSH secundário: Idoso
Antimetabólitos Antineoplásicos/efeitos adversos
Azacitidina/efeitos adversos
Proteínas de Ligação a DNA/genética
Monitoramento de Medicamentos
Feminino
Fármacos Hematológicos/administração & dosagem
Seres Humanos
Leucemia Mielomonocítica Crônica/sangue
Leucemia Mielomonocítica Crônica/complicações
Leucemia Mielomonocítica Crônica/diagnóstico
Leucemia Mielomonocítica Crônica/tratamento farmacológico
Meia-Idade
Mutação
Proteínas Nucleares/genética
Contagem de Plaquetas/métodos
Proteínas Proto-Oncogênicas/genética
Púrpura Trombocitopênica Idiopática/diagnóstico
Púrpura Trombocitopênica Idiopática/tratamento farmacológico
Púrpura Trombocitopênica Idiopática/etiologia
Púrpura Trombocitopênica Idiopática/fisiopatologia
Ribonucleoproteínas/genética
Fatores de Processamento de Serina-Arginina/genética
Trombocitopenia/induzido quimicamente
Trombocitopenia/diagnóstico
Trombocitopenia/tratamento farmacológico
Trombocitopenia/fisiopatologia
Resultado do Tratamento
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antimetabolites, Antineoplastic); 0 (Benzoates); 0 (DNA-Binding Proteins); 0 (Hematologic Agents); 0 (Hydrazines); 0 (Nuclear Proteins); 0 (Proto-Oncogene Proteins); 0 (Pyrazoles); 0 (Ribonucleoproteins); 0 (TET2 protein, human); 0 (ZRSR2 protein, human); 147153-65-9 (SRSF2 protein, human); 170974-22-8 (Serine-Arginine Splicing Factors); 776B62CQ27 (decitabine); 9014-42-0 (Thrombopoietin); M801H13NRU (Azacitidine); S56D65XJ9G (eltrombopag)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171101
[Lr] Data última revisão:
171101
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171026
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000008337


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[PMID]:28835400
[Au] Autor:Markus HS; Larsson SC; Kuker W; Schulz UG; Ford I; Rothwell PM; Clifton A; VIST Investigators
[Ad] Endereço:From the Stroke Research Group (H.S.M., S.C.L.), Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus; Nuffield Department of Clinical Neurosciences (W.K., U.G.S., P.M.R.), John Radcliffe Hospital, University of Oxford; Robertson Centre for Biostatistics (I.F.),
[Ti] Título:Stenting for symptomatic vertebral artery stenosis: The Vertebral Artery Ischaemia Stenting Trial.
[So] Source:Neurology;89(12):1229-1236, 2017 Sep 19.
[Is] ISSN:1526-632X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To compare in the Vertebral Artery Ischaemia Stenting Trial (VIST) the risks and benefits of vertebral angioplasty and stenting with best medical treatment (BMT) alone for symptomatic vertebral artery stenosis. METHODS: VIST was a prospective, randomized, open-blinded endpoint clinical trial performed in 14 hospitals in the United Kingdom. Participants with symptomatic vertebral stenosis ≥50% were randomly assigned (1:1) to vertebral angioplasty/stenting plus BMT or to BMT alone with randomization stratified by site of stenosis (extracranial vs intracranial). Because of slow recruitment and cessation of funding, recruitment was stopped after 182 participants. Follow-up was a minimum of ≥1 year for each participant. RESULTS: Three patients did not contribute any follow-up data and were excluded, leaving 91 patients in the stent group and 88 in the medical group. Mean follow-up was 3.5 (interquartile range 2.1-4.7) years. Of 61 patients who were stented, stenosis was extracranial in 48 (78.7%) and intracranial in 13 (21.3%). No periprocedural complications occurred with extracranial stenting; 2 strokes occurred during intracranial stenting. The primary endpoint of fatal or nonfatal stroke occurred in 5 patients in the stent group vs 12 in the medical group (hazard ratio 0.40, 95% confidence interval 0.14-1.13, = 0.08), with an absolute risk reduction of 25 strokes per 1,000 person-years. The hazard ratio for stroke or TIA was 0.50 ( = 0.05). CONCLUSIONS: Stenting in extracranial stenosis appears safe with low complication rates. Large phase 3 trials are required to determine whether stenting reduces stroke risk. ISRCTNCOM IDENTIFIER: ISRCTN95212240. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with symptomatic vertebral stenosis, angioplasty with stenting does not reduce the risk of stroke. However, the study lacked the precision to exclude a benefit from stenting.
[Mh] Termos MeSH primário: Angioplastia/métodos
Fármacos Hematológicos/uso terapêutico
Avaliação de Resultados (Cuidados de Saúde)
Intervenção Coronária Percutânea/métodos
Stents
Insuficiência Vertebrobasilar/terapia
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Angioplastia/efeitos adversos
Feminino
Seguimentos
Seres Humanos
Ataque Isquêmico Transitório/etiologia
Masculino
Meia-Idade
Intervenção Coronária Percutânea/efeitos adversos
Método Simples-Cego
Acidente Vascular Cerebral/etiologia
Insuficiência Vertebrobasilar/complicações
Insuficiência Vertebrobasilar/tratamento farmacológico
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Hematologic Agents)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171004
[Lr] Data última revisão:
171004
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170825
[St] Status:MEDLINE
[do] DOI:10.1212/WNL.0000000000004385


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[PMID]:28682868
[Au] Autor:Katayama K; Tokuda Y
[Ad] Endereço:aDepartment of General Medicine, Shirakawa Satellite for Teaching And Research (STAR), Fukushima Medical University, Shirakawa bDepartment of Medicine, Muribushi Okinawa Project for Teaching Hospitals, Okinawa, Japan.
[Ti] Título:Mineralocorticoid responsive hyponatremia of the elderly: A systematic review.
[So] Source:Medicine (Baltimore);96(27):e7154, 2017 Jul.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Mineralocorticoid responsive hyponatremia of the elderly (MRHE) is an emerging concept of hyponatremia in aged people. Diagnosis of MRHE requires exclusion of syndrome of inappropriate antidiuresis and adrenal dysfunction. Thus we aimed to evaluate the characteristics of all patients with suspected MRHE available for a review. METHODS: We conducted a systematic review using MEDLINE and Google scholar. We included published case reports of adult patients diagnosed as MRHE, written by English and Japanese language. Serum and urine electrolytes as well as the levels of antidiuretic hormone (ADH), cortisol, plasma renin activity (PRA), and aldosterone were analyzed. RESULTS: A total of 27 MRHE patients were identified in 9 reports. In these patients, average age was 79 years, median serum sodium was 117 mEq/L. The median levels of ADH, cortisol, PRA, and aldosterone were 0.9 pg/mL, 18.7 µg/dL, 0.37 ng/mL/h, and 39.6 pg/mL, respectively. Water restriction test was conducted in 7 patients. Random sample cortisol measurements did not exceed satisfactory levels to rule out adrenal dysfunction in four cases. No cases underwent low-dose adrenocorticotropic hormone stimulation test. Only 27 patients from 9 case reports in Japanese were eligible for inclusion in our study. CONCLUSION: All published cases of MRHE as a cause of hyponatremia are described for the first time. In these cases, latent adrenal sufficiency might have been hidden and should have been excluded.
[Mh] Termos MeSH primário: Fármacos Hematológicos/uso terapêutico
Hiponatremia/tratamento farmacológico
Mineralocorticoides/uso terapêutico
[Mh] Termos MeSH secundário: Idoso
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Hematologic Agents); 0 (Mineralocorticoids)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170724
[Lr] Data última revisão:
170724
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170707
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000007154


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[PMID]:28616874
[Au] Autor:Fenaux P; Muus P; Kantarjian H; Lyons RM; Larson RA; Sekeres MA; Becker PS; Orejudos A; Franklin J
[Ad] Endereço:Service d'Hématologie Clinique, Hôpital St. Louis and Paris 7 University, Paris, France.
[Ti] Título:Romiplostim monotherapy in thrombocytopenic patients with myelodysplastic syndromes: long-term safety and efficacy.
[So] Source:Br J Haematol;178(6):906-913, 2017 Sep.
[Is] ISSN:1365-2141
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Romiplostim can improve platelet counts in about 50% of patients with low- or intermediate 1-risk (lower risk) myelodysplastic syndromes (MDS) and thrombocytopenia, but its long-term toxicity and efficacy are not known. This open-label extension study evaluated the long-term safety and efficacy of romiplostim in 60 patients with lower risk MDS and platelet counts ≤50 × 10 /l. The primary endpoint was adverse event (AE) incidence. Secondary endpoints were efficacy parameters, including bleeding events and platelet response. Median (range) treatment time in the extension study and the median observation times thereafter were 25 (2-181) and 57 (11-209) weeks, respectively. Treatment-related AEs and serious AEs were reported in 14/60 (23%) and 4/60 (7%) patients, respectively. Progression to acute myeloid leukaemia (AML) occurred in two patients after 44 and 46 weeks. Patients (n = 34, 57%) with a platelet response were further evaluated for length of response. Median (range) response duration was 33 (7-174) weeks; 28/34 (82%) patients had a continuous response. Five of 34 patients (15%) had grade ≥3 bleeding events; three when the platelet count was >50 × 10 /l. There were no new safety concerns and the rate of progression to AML was low; response to romiplostim was maintained for most patients.
[Mh] Termos MeSH primário: Fármacos Hematológicos/efeitos adversos
Síndromes Mielodisplásicas/tratamento farmacológico
Proteínas Recombinantes de Fusão/efeitos adversos
Trombocitopenia/tratamento farmacológico
Trombopoetina/efeitos adversos
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Progressão da Doença
Esquema de Medicação
Feminino
Seguimentos
Fármacos Hematológicos/administração & dosagem
Fármacos Hematológicos/uso terapêutico
Hemorragia/induzido quimicamente
Seres Humanos
Leucemia Mieloide Aguda/induzido quimicamente
Masculino
Meia-Idade
Síndromes Mielodisplásicas/sangue
Contagem de Plaquetas
Receptores Fc/administração & dosagem
Receptores Fc/uso terapêutico
Receptores de Trombopoetina/agonistas
Proteínas Recombinantes de Fusão/administração & dosagem
Proteínas Recombinantes de Fusão/uso terapêutico
Trombocitopenia/sangue
Trombopoetina/administração & dosagem
Trombopoetina/uso terapêutico
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Hematologic Agents); 0 (Receptors, Fc); 0 (Receptors, Thrombopoietin); 0 (Recombinant Fusion Proteins); 143641-95-6 (MPL protein, human); 9014-42-0 (Thrombopoietin); GN5XU2DXKV (romiplostim)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171010
[Lr] Data última revisão:
171010
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170616
[St] Status:MEDLINE
[do] DOI:10.1111/bjh.14792


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[PMID]:28423296
[Au] Autor:Townsley DM; Scheinberg P; Winkler T; Desmond R; Dumitriu B; Rios O; Weinstein B; Valdez J; Lotter J; Feng X; Desierto M; Leuva H; Bevans M; Wu C; Larochelle A; Calvo KR; Dunbar CE; Young NS
[Ad] Endereço:From the Hematology Branch (D.M.T., T.W., R.D., B.D., O.R., B.W., J.V., J.L., X.F., M.D., H.L., A.L., C.E.D., N.S.Y.) and the Office of Biostatistics Research (C.W.), National Heart, Lung, and Blood Institute, and the Nursing Research and Translational Science Section, Department of Nursing (M.B.),
[Ti] Título:Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia.
[So] Source:N Engl J Med;376(16):1540-1550, 2017 04 20.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Acquired aplastic anemia results from immune-mediated destruction of bone marrow. Immunosuppressive therapies are effective, but reduced numbers of residual stem cells may limit their efficacy. In patients with aplastic anemia that was refractory to immunosuppression, eltrombopag, a synthetic thrombopoietin-receptor agonist, led to clinically significant increases in blood counts in almost half the patients. We combined standard immunosuppressive therapy with eltrombopag in previously untreated patients with severe aplastic anemia. METHODS: We enrolled 92 consecutive patients in a prospective phase 1-2 study of immunosuppressive therapy plus eltrombopag. The three consecutively enrolled cohorts differed with regard to the timing of initiation and the duration of the eltrombopag regimen (cohort 1 received eltrombopag from day 14 to 6 months, cohort 2 from day 14 to 3 months, and cohort 3 from day 1 to 6 months). The cohorts were analyzed separately. The primary outcome was complete hematologic response at 6 months. Secondary end points included overall response, survival, relapse, and clonal evolution to myeloid cancer. RESULTS: The rate of complete response at 6 months was 33% in cohort 1, 26% in cohort 2, and 58% in cohort 3. The overall response rates at 6 months were 80%, 87%, and 94%, respectively. The complete and overall response rates in the combined cohorts were higher than in our historical cohort, in which the rate of complete response was 10% and the overall response rate was 66%. At a median follow-up of 2 years, the survival rate was 97%; one patient died during the study from a nonhematologic cause. Marked increases in bone marrow cellularity, CD34+ cell number, and frequency of early hematopoietic progenitors were noted. Rates of relapse and clonal evolution were similar to our historical experience. Severe rashes occurred in two patients, resulting in the early discontinuation of eltrombopag. CONCLUSIONS: The addition of eltrombopag to immunosuppressive therapy was associated with markedly higher rates of hematologic response among patients with severe aplastic anemia than in a historical cohort. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT01623167 .).
[Mh] Termos MeSH primário: Anemia Aplástica/tratamento farmacológico
Benzoatos/uso terapêutico
Fármacos Hematológicos/uso terapêutico
Hidrazinas/uso terapêutico
Imunossupressores/uso terapêutico
Pirazóis/uso terapêutico
Receptores de Trombopoetina/agonistas
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Antígenos CD34
Soro Antilinfocitário/uso terapêutico
Benzoatos/efeitos adversos
Contagem de Células
Ciclosporina/uso terapêutico
Quimioterapia Combinada
Feminino
Fármacos Hematológicos/efeitos adversos
Seres Humanos
Hidrazinas/efeitos adversos
Imunossupressão
Masculino
Meia-Idade
Estudos Prospectivos
Pirazóis/efeitos adversos
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (Antigens, CD34); 0 (Antilymphocyte Serum); 0 (Benzoates); 0 (Hematologic Agents); 0 (Hydrazines); 0 (Immunosuppressive Agents); 0 (Pyrazoles); 0 (Receptors, Thrombopoietin); 83HN0GTJ6D (Cyclosporine); S56D65XJ9G (eltrombopag)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171020
[Lr] Data última revisão:
171020
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170420
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1613878


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[PMID]:28376985
[Au] Autor:Tsu LV; Berry AJ; Krunic N; Penny S; Le S
[Ti] Título:A Clinical Review of Surgical vs Transcatheter Aortic Valve Replacement in Geriatric Patients.
[So] Source:Consult Pharm;32(4):202-214, 2017 Apr 01.
[Is] ISSN:0888-5109
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To provide an up-to-date review of the available evidence regarding management of elderly patients after transcatheter aortic valve replacement (TAVR). DATA SOURCES: A PubMed search of articles published (September 1969-December 2016) was done using a combination of the following words: aortic valve stenosis, geriatric, elderly, transcatheter aortic valve replacement, surgical aortic valve replacement, transcatheter aortic valve implantation (TAVI), and dual antiplatelet therapy. STUDY SELECTION/DATA EXTRACTION: Relevant original research, review articles, and guidelines were assessed for the management of elderly patients after TAVR. References from the above literature were also evaluated. Articles were selected for inclusion based on relevance to the topic, detailed methods, and complete results. DATA SYNTHESIS: Aortic valve stenosis is common in the geriatric population. While patients were historically treated with surgical aortic valve replacement (AVR), more patients are now undergoing TAVR. This article reviews the current literature regarding outcomes and pharmacotherapy between surgical and TAVR in the elderly population. CONCLUSION: Appropriate management of pharmacotherapy after surgical or TAVR can help improve outcomes in elderly patients, and pharmacists can provide guidance regarding evidence-based therapy.
[Mh] Termos MeSH primário: Estenose da Valva Aórtica/cirurgia
Fármacos Hematológicos/administração & dosagem
Trombose/prevenção & controle
Substituição da Valva Aórtica Transcateter/métodos
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Anticoagulantes/administração & dosagem
Antitrombinas/administração & dosagem
Fibrinolíticos/administração & dosagem
Seres Humanos
Coeficiente Internacional Normatizado
Inibidores da Agregação de Plaquetas/administração & dosagem
Guias de Prática Clínica como Assunto
Ensaios Clínicos Controlados Aleatórios como Assunto
Vitamina K/antagonistas & inibidores
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anticoagulants); 0 (Antithrombins); 0 (Fibrinolytic Agents); 0 (Hematologic Agents); 0 (Platelet Aggregation Inhibitors); 12001-79-5 (Vitamin K)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170619
[Lr] Data última revisão:
170619
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170406
[St] Status:MEDLINE
[do] DOI:10.4140/TCP.n.2017.202


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[PMID]:28369083
[Au] Autor:Rahbari M; Rahlfs S; Jortzik E; Bogeski I; Becker K
[Ad] Endereço:Biochemistry and Molecular Biology, Interdisciplinary Research Center, Justus Liebig University Giessen, Giessen, Hessen, Germany.
[Ti] Título:H2O2 dynamics in the malaria parasite Plasmodium falciparum.
[So] Source:PLoS One;12(4):e0174837, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Hydrogen peroxide is an important antimicrobial agent but is also crucially involved in redox signaling and pathogen-host cell interactions. As a basis for systematically investigating intracellular H2O2 dynamics and regulation in living malaria parasites, we established the genetically encoded fluorescent H2O2 sensors roGFP2-Orp1 and HyPer-3 in Plasmodium falciparum. Both ratiometric redox probes as well as the pH control SypHer were expressed in the cytosol of blood-stage parasites. Both redox sensors showed reproducible sensitivity towards H2O2 in the lower micromolar range in vitro and in the parasites. Due to the pH sensitivity of HyPer-3, we used parasites expressing roGFP2-Orp1 for evaluation of short-, medium-, and long-term effects of antimalarial drugs on H2O2 levels and detoxification in Plasmodium. None of the quinolines or artemisinins tested had detectable direct effects on the H2O2 homeostasis at pharmacologically relevant concentrations. However, pre-treatment of the cells with antimalarial drugs or heat shock led to a higher tolerance towards exogenous H2O2. The systematic evaluation and comparison of the two genetically encoded cytosolic H2O2 probes in malaria parasites provides a basis for studying parasite-host cell interactions or drug effects with spatio-temporal resolution while preserving cell integrity.
[Mh] Termos MeSH primário: Antimaláricos/farmacologia
Peróxido de Hidrogênio/metabolismo
Plasmodium falciparum/efeitos dos fármacos
[Mh] Termos MeSH secundário: Western Blotting
Citosol/efeitos dos fármacos
Citosol/metabolismo
Eritrócitos/efeitos dos fármacos
Eritrócitos/parasitologia
Eritrócitos/fisiologia
Escherichia coli
Fármacos Hematológicos/farmacologia
Homeostase/efeitos dos fármacos
Temperatura Alta
Seres Humanos
Concentração de Íons de Hidrogênio
Microscopia Confocal
Oxirredução/efeitos dos fármacos
Plasmodium falciparum/metabolismo
Proteínas Recombinantes/metabolismo
Saponinas/farmacologia
Transfecção
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antimalarials); 0 (Hematologic Agents); 0 (Recombinant Proteins); 0 (Saponins); BBX060AN9V (Hydrogen Peroxide)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170830
[Lr] Data última revisão:
170830
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170404
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0174837


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[PMID]:28362168
[Au] Autor:Satyamitra M; Kumar VP; Biswas S; Cary L; Dickson L; Venkataraman S; Ghosh SP
[Ad] Endereço:a Radiation and Nuclear Countermeasure Program, DAIT, NIAID, NIH, Bethesda, Maryland 20889.
[Ti] Título:Impact of Abbreviated Filgrastim Schedule on Survival and Hematopoietic Recovery after Irradiation in Four Mouse Strains with Different Radiosensitivity.
[So] Source:Radiat Res;187(6):659-671, 2017 Jun.
[Is] ISSN:1938-5404
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Filgrastim (Neupogen , granulocyte-colony stimulating factor) is among the few countermeasures recommended for management of patients in the event of lethal total-body irradiation. Despite the plethora of studies using filgrastim as a radiation countermeasure, relatively little is known about the optimal dose schedule of filgrastim to mitigate radiation lethality. We evaluated the efficacy of filgrastim in improving 30-day survival of CD2F1 mice irradiated with a lethal dose (LD ) in the AFRRI cobalt-60 facility. We tested different schedules of 1, 3, 5, 10 or 16 once-daily injections of filgrastim initiated one day after irradiation. Time optimization studies with filgrastim treatment were also performed, beginning 6-48 h postirradiation. Maximum survival was observed with 3 daily doses of 0.17 mg/kg filgrastim. Survival efficacy of the 3-day treatment was compared against the conventional 16-day filgrastim treatment after irradiation in four mouse strains with varying radiation sensitivities: C3H/HeN, C57BL/6, B6C3F1 and CD2F1. Blood indices, bone marrow histopathology and colony forming unit assays were also evaluated. Filgrastim significantly increased 30-day survival (P < 0.001) with a 3-day treatment compared to 16-day treatment. Filgrastim did not prevent cytopenia nadirs, but facilitated faster recovery of white blood cells, neutrophils, red blood cells, platelets, lymphocytes and hematocrits in all four strains. Accelerated hematopoietic recovery was also reflected in faster bone marrow reconstitution and significant increase in hematopoietic progenitors (P < 0.001) in all four mouse strains. These data indicate that prompt and abbreviated filgrastim treatment has potential benefit for triage in the event of a radiological incident for treating acute hematopoietic syndrome.
[Mh] Termos MeSH primário: Filgrastim/administração & dosagem
Doenças Hematológicas/prevenção & controle
Hematopoese/efeitos dos fármacos
Hematopoese/efeitos da radiação
Lesões por Radiação/prevenção & controle
Taxa de Sobrevida
[Mh] Termos MeSH secundário: Animais
Relação Dose-Resposta à Radiação
Esquema de Medicação
Fármacos Hematológicos/administração & dosagem
Doenças Hematológicas/patologia
Doenças Hematológicas/fisiopatologia
Masculino
Camundongos
Dose de Radiação
Lesões por Radiação/patologia
Lesões por Radiação/fisiopatologia
Tolerância a Radiação/efeitos dos fármacos
Protetores contra Radiação/administração & dosagem
Recuperação de Função Fisiológica/efeitos dos fármacos
Especificidade da Espécie
Resultado do Tratamento
Irradiação Corporal Total/efeitos adversos
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Hematologic Agents); 0 (Radiation-Protective Agents); PVI5M0M1GW (Filgrastim)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170818
[Lr] Data última revisão:
170818
[Sb] Subgrupo de revista:IM; S
[Da] Data de entrada para processamento:170401
[St] Status:MEDLINE
[do] DOI:10.1667/RR14555.1



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