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Enlace permanente de la investigaciónInternational and multicenter real‐world study of sorafenib‐treated patients with hepatocellular carcinoma under dialysis / Juan Ignacio Marín Zuluaga
Título : International and multicenter real‐world study of sorafenib‐treated patients with hepatocellular carcinoma under dialysis Tipo de documento : documento electrónico Autores : Juan Ignacio Marín Zuluaga, Fecha de publicación : 2020 Títulos uniformes : Liver International Idioma : Inglés (eng) Palabras clave : Hepatocellular carcinoma sorafenib dialysis adverse events safety survival Resumen : Background & Aims: Information on safety and efficacy of systemic treatment in patients with hepatocellular carcinoma (HCC) under dialysis are limited due to patient exclusion from clinical trials. Thus, we aimed to evaluate the rate, prevalence, tolerability, and outcome of sorafenib in this population. Methods: We report a multicenter study comprising patients from Latin America and Europe. Patients treated with sorafenib were enrolled; demographics, dose modifications, adverse events (AEs), treatment duration, and outcome of patients undergoing dialysis were recorded. Results: As of March 2018, 6156 HCC patients were treated in 44 centres and 22 patients were concomitantly under dialysis (0.36%). The median age was 65.5 years, 40.9% had hepatitis C, 75% had Child‐Pugh A, and 85% were Barcelona Clinic Liver Cancer‐C. The median time to first dose modification, treatment duration and overall survival rate were 2.4 months (interquartile ranges [IQR], 0.8‐3.8), 10.8 months (IQR, 4.5‐16.9), and 17.5 months (95% CI, 7.2‐24.5), respectively. Seventeen patients required at least 1 dose modification. The main causes of first dose modification were asthenia/worsening of Eastern Cooperative Oncology Group‐Performance Status and diarrhoea. At the time of death or last follow‐up, four patients were still on treatment and 18 had discontinued sorafenib: 14 were due to tumour progression, 2 were sorafenib‐related, and 2 were non‐sorafenib‐related AE. Conclusions: The outcomes observed in this cohort seem comparable to those in the non‐dialysis population. Thus, to the best of our knowledge, this is the largest and most informative dataset regarding systemic treatment outcomes in HCC patients undergoing dialysis. Mención de responsabilidad : Álvaro Díaz-González, Marco Sanduzzi-Zamparelli, Leonardo G da Fonseca, Giovan G Di Costanzo, Rogerio Alves, Massimo Iavarone, Cassia Leal, Rodolfo Sacco, Ana M Matilla, Manuel Hernández-Guerra, Gabriel Aballay Soteras, Marcus-Alexander Wörns, Matthias Pinter, María Varela, Morten Ladekarl, Aline L Chagas, Beatriz Mínguez, Juan I Arenas, Alessandro Granito, Yolanda Sánchez-Torrijos, Ángela Rojas, Carlos Rodríguez de Lope, Mario R Alvares-da-Silva, Sonia Pascual, Lorenza Rimassa, José L Lledó, Carlos Huertas, Bruno Sangro, Edoardo G Giannini, Manuel Delgado, Mercedes Vergara, Christie Perelló, Alberto Lue, Margarita Sala, Adolfo Gallego, Susanna Coll, Tania Hernáez, Federico Piñero, Gustavo Pereira, Alex França, Juan Marín, Margarita Anders, Vivianne Mello, Mar Lozano, Jean C Nault, Josemaría Menéndez, Ignacio García Juárez, Jordi Bruix, María Reig Referencia : Liver Int. 2020 Jun;40(6):1467-1476. DOI (Digital Object Identifier) : 10.1111/liv.14436 PMID : 32170821 En línea : https://onlinelibrary.wiley.com/doi/epdf/10.1111/liv.14436 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5102 International and multicenter real‐world study of sorafenib‐treated patients with hepatocellular carcinoma under dialysis [documento electrónico] / Juan Ignacio Marín Zuluaga, . - 2020.
Obra : Liver International
Idioma : Inglés (eng)
Palabras clave : Hepatocellular carcinoma sorafenib dialysis adverse events safety survival Resumen : Background & Aims: Information on safety and efficacy of systemic treatment in patients with hepatocellular carcinoma (HCC) under dialysis are limited due to patient exclusion from clinical trials. Thus, we aimed to evaluate the rate, prevalence, tolerability, and outcome of sorafenib in this population. Methods: We report a multicenter study comprising patients from Latin America and Europe. Patients treated with sorafenib were enrolled; demographics, dose modifications, adverse events (AEs), treatment duration, and outcome of patients undergoing dialysis were recorded. Results: As of March 2018, 6156 HCC patients were treated in 44 centres and 22 patients were concomitantly under dialysis (0.36%). The median age was 65.5 years, 40.9% had hepatitis C, 75% had Child‐Pugh A, and 85% were Barcelona Clinic Liver Cancer‐C. The median time to first dose modification, treatment duration and overall survival rate were 2.4 months (interquartile ranges [IQR], 0.8‐3.8), 10.8 months (IQR, 4.5‐16.9), and 17.5 months (95% CI, 7.2‐24.5), respectively. Seventeen patients required at least 1 dose modification. The main causes of first dose modification were asthenia/worsening of Eastern Cooperative Oncology Group‐Performance Status and diarrhoea. At the time of death or last follow‐up, four patients were still on treatment and 18 had discontinued sorafenib: 14 were due to tumour progression, 2 were sorafenib‐related, and 2 were non‐sorafenib‐related AE. Conclusions: The outcomes observed in this cohort seem comparable to those in the non‐dialysis population. Thus, to the best of our knowledge, this is the largest and most informative dataset regarding systemic treatment outcomes in HCC patients undergoing dialysis. Mención de responsabilidad : Álvaro Díaz-González, Marco Sanduzzi-Zamparelli, Leonardo G da Fonseca, Giovan G Di Costanzo, Rogerio Alves, Massimo Iavarone, Cassia Leal, Rodolfo Sacco, Ana M Matilla, Manuel Hernández-Guerra, Gabriel Aballay Soteras, Marcus-Alexander Wörns, Matthias Pinter, María Varela, Morten Ladekarl, Aline L Chagas, Beatriz Mínguez, Juan I Arenas, Alessandro Granito, Yolanda Sánchez-Torrijos, Ángela Rojas, Carlos Rodríguez de Lope, Mario R Alvares-da-Silva, Sonia Pascual, Lorenza Rimassa, José L Lledó, Carlos Huertas, Bruno Sangro, Edoardo G Giannini, Manuel Delgado, Mercedes Vergara, Christie Perelló, Alberto Lue, Margarita Sala, Adolfo Gallego, Susanna Coll, Tania Hernáez, Federico Piñero, Gustavo Pereira, Alex França, Juan Marín, Margarita Anders, Vivianne Mello, Mar Lozano, Jean C Nault, Josemaría Menéndez, Ignacio García Juárez, Jordi Bruix, María Reig Referencia : Liver Int. 2020 Jun;40(6):1467-1476. DOI (Digital Object Identifier) : 10.1111/liv.14436 PMID : 32170821 En línea : https://onlinelibrary.wiley.com/doi/epdf/10.1111/liv.14436 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=5102 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD001332 AC-2020-036 Archivo digital Producción Científica Artículos científicos Disponible
Título : Physicians' awareness of gadolinium retention and MRI timing practices in the longitudinal management of pituitary tumors: a "Pituitary Society" survey Tipo de documento : documento electrónico Autores : Luis Vicente Syro Moreno, Fecha de publicación : 2019 Títulos uniformes : Pituitary Idioma : Inglés (eng) Palabras clave : Adenoma Contrast Gadolinium Imaging Neuroendocrinologists Neurosurgeons Pituitar Safety Survey Tumor Resumen : Purpose: In view of mounting attention related to possible brain retention of gadolinium-based contrast agents (GBCAs) in patients with normal renal function, our purpose was to detail results from a survey of pituitary experts to assess: 1) the timing interval and frequency of pituitary magnetic resonance imaging (MRI) following surgical and/or medical and/or radiation therapy of pituitary tumors, 2) awareness of the types of GBCAs used and their possible safety issues. Methods: The Pituitary Society Education Committee composed a survey with 12 multiple choice questions, 8 of which specifically addressed the time interval and frequency of MRI in the longitudinal management of pituitary tumors. The survey was distributed at two meetings; the International Pituitary Neurosurgeons Society conference in San Diego, CA, on February 18th, 2018, and the Pituitary Society Membership and Career Development Forum, Chicago, IL on March 18th, 2018. Results: There is consensus among pituitary endocrinologists and neurosurgeons that long-term repeated imaging is recommended in most pituitary tumors, although the precise strategy of timing varied depending on the specialist group and the specific clinical context of the adenoma. The data also suggest that International Pituitary Neurosurgeons Society neurosurgeons, as well as Pituitary Society neuroendocrinologists, are sometimes unaware of which contrast agents are used by their institution, and many are also unaware that evidence of long-term brain retention has been reported with the use of GBCAsin patients with normal function. Conclusions: International pituitary endocrinologists and pituitary neurosurgeons experts suggest ongoing MRIs for the management of pituitary tumors; strategies vary based on clinical context, but also on individual experience and practice. Mención de responsabilidad : Lisa B Nachtigall, Niki Karavitaki, Katja Kiseljak-Vassiliades, Luma Ghalib, Hidenori Fukuoka, Luis V Syro, Daniel Kelly, Maria Fleseriu Referencia : Pituitary. 2019 Feb;22(1):37-45. DOI (Digital Object Identifier) : 10.1007/s11102-018-0924-0 PMID : 30456434 En línea : https://link.springer.com/article/10.1007%2Fs11102-018-0924-0 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4128 Physicians' awareness of gadolinium retention and MRI timing practices in the longitudinal management of pituitary tumors: a "Pituitary Society" survey [documento electrónico] / Luis Vicente Syro Moreno, . - 2019.
Obra : Pituitary
Idioma : Inglés (eng)
Palabras clave : Adenoma Contrast Gadolinium Imaging Neuroendocrinologists Neurosurgeons Pituitar Safety Survey Tumor Resumen : Purpose: In view of mounting attention related to possible brain retention of gadolinium-based contrast agents (GBCAs) in patients with normal renal function, our purpose was to detail results from a survey of pituitary experts to assess: 1) the timing interval and frequency of pituitary magnetic resonance imaging (MRI) following surgical and/or medical and/or radiation therapy of pituitary tumors, 2) awareness of the types of GBCAs used and their possible safety issues. Methods: The Pituitary Society Education Committee composed a survey with 12 multiple choice questions, 8 of which specifically addressed the time interval and frequency of MRI in the longitudinal management of pituitary tumors. The survey was distributed at two meetings; the International Pituitary Neurosurgeons Society conference in San Diego, CA, on February 18th, 2018, and the Pituitary Society Membership and Career Development Forum, Chicago, IL on March 18th, 2018. Results: There is consensus among pituitary endocrinologists and neurosurgeons that long-term repeated imaging is recommended in most pituitary tumors, although the precise strategy of timing varied depending on the specialist group and the specific clinical context of the adenoma. The data also suggest that International Pituitary Neurosurgeons Society neurosurgeons, as well as Pituitary Society neuroendocrinologists, are sometimes unaware of which contrast agents are used by their institution, and many are also unaware that evidence of long-term brain retention has been reported with the use of GBCAsin patients with normal function. Conclusions: International pituitary endocrinologists and pituitary neurosurgeons experts suggest ongoing MRIs for the management of pituitary tumors; strategies vary based on clinical context, but also on individual experience and practice. Mención de responsabilidad : Lisa B Nachtigall, Niki Karavitaki, Katja Kiseljak-Vassiliades, Luma Ghalib, Hidenori Fukuoka, Luis V Syro, Daniel Kelly, Maria Fleseriu Referencia : Pituitary. 2019 Feb;22(1):37-45. DOI (Digital Object Identifier) : 10.1007/s11102-018-0924-0 PMID : 30456434 En línea : https://link.springer.com/article/10.1007%2Fs11102-018-0924-0 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4128 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000739 AC-2018-026 Archivo digital Producción Científica Artículos científicos Disponible
Título : Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: A systematic review Tipo de documento : documento electrónico Autores : Lady Diana Ladino Malagón, Fecha de publicación : 2018 Títulos uniformes : Seizure Idioma : Inglés (eng) Palabras clave : Adds-on therapy behavior efficacy refractory epilepsy safety side effect Resumen : Purpose: Lacosamide, is one of the newer antiepileptic drug approved for focal drug-resistant epilepsy as an add-on treatment in patients older than 16 years. However, there is growing evidence of its use, safety and efficacy in children. We aim to evaluate efficacy and tolerability of lacosamide in focal and generalized drug-resistant epilepsy and refractory status epilepticus in the pediatric population. Methods: We conducted a systematic review on MEDLINE, EMBASE, COCHRANE, Google Scholar and Scielo from January 2008 to January 2017. The primary outcome was the efficacy of lacosamide in children with drug-resistant epilepsy and refractory status epilepticus. Efficacy and adverse events attributed to lacosamide were extracted from each publication and systematically reported. We performed no meta-analyses due to limited available data. Results: Of 175 abstracts identified by the search, 82 were reviewed as full-text. Twenty-six articles fulfilled eligibility criteria and described outcomes in 797 patients (57% male). The majority of studies were retrospective (69%) small series (84%). On average 51% of patients had 50% or greater seizure reduction. The mean seizure freedom rate was 24%. Adverse effects occurred in 18–59% of patients. The main events were dizziness, sedation, gastrointestinal upset, mood and behavioral changes. Half of the patients with Lennox Gastaut syndrome showed 50% or greater seizure reduction, 32% did not response to lacosamide and 17% suffered seizure aggravation. Conclusion: Current evidence shows lacosamide as a good option in pediatric patients with focal drug-resistant epilepsy and refractory status epilepticus as an add-on therapy given its efficacy on seizure control and safety profile. The use of lacosamide in Lennox-Gastaut syndrome shows conflicting data. Large randomized controlled studies in the pediatric population are necessary to substantiate these findings. Mención de responsabilidad : Johann Sebastián Ortiz de la Rosa, Lady Diana Ladino, Paula Juliana Rodríguez, María Camila Rueda, Juan Pablo Polanía, Angie Catalina Castañeda Referencia : Seizure. 2018 Mar;56:34-40. DOI (Digital Object Identifier) : 10.1016/j.seizure.2018.01.014 PMID : 29428899 En línea : https://www.seizure-journal.com/article/S1059-1311(17)30689-1/fulltext Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4191 Efficacy of lacosamide in children and adolescents with drug-resistant epilepsy and refractory status epilepticus: A systematic review [documento electrónico] / Lady Diana Ladino Malagón, . - 2018.
Obra : Seizure
Idioma : Inglés (eng)
Palabras clave : Adds-on therapy behavior efficacy refractory epilepsy safety side effect Resumen : Purpose: Lacosamide, is one of the newer antiepileptic drug approved for focal drug-resistant epilepsy as an add-on treatment in patients older than 16 years. However, there is growing evidence of its use, safety and efficacy in children. We aim to evaluate efficacy and tolerability of lacosamide in focal and generalized drug-resistant epilepsy and refractory status epilepticus in the pediatric population. Methods: We conducted a systematic review on MEDLINE, EMBASE, COCHRANE, Google Scholar and Scielo from January 2008 to January 2017. The primary outcome was the efficacy of lacosamide in children with drug-resistant epilepsy and refractory status epilepticus. Efficacy and adverse events attributed to lacosamide were extracted from each publication and systematically reported. We performed no meta-analyses due to limited available data. Results: Of 175 abstracts identified by the search, 82 were reviewed as full-text. Twenty-six articles fulfilled eligibility criteria and described outcomes in 797 patients (57% male). The majority of studies were retrospective (69%) small series (84%). On average 51% of patients had 50% or greater seizure reduction. The mean seizure freedom rate was 24%. Adverse effects occurred in 18–59% of patients. The main events were dizziness, sedation, gastrointestinal upset, mood and behavioral changes. Half of the patients with Lennox Gastaut syndrome showed 50% or greater seizure reduction, 32% did not response to lacosamide and 17% suffered seizure aggravation. Conclusion: Current evidence shows lacosamide as a good option in pediatric patients with focal drug-resistant epilepsy and refractory status epilepticus as an add-on therapy given its efficacy on seizure control and safety profile. The use of lacosamide in Lennox-Gastaut syndrome shows conflicting data. Large randomized controlled studies in the pediatric population are necessary to substantiate these findings. Mención de responsabilidad : Johann Sebastián Ortiz de la Rosa, Lady Diana Ladino, Paula Juliana Rodríguez, María Camila Rueda, Juan Pablo Polanía, Angie Catalina Castañeda Referencia : Seizure. 2018 Mar;56:34-40. DOI (Digital Object Identifier) : 10.1016/j.seizure.2018.01.014 PMID : 29428899 En línea : https://www.seizure-journal.com/article/S1059-1311(17)30689-1/fulltext Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4191 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000805 AC-2018-092 Archivo digital Producción Científica Artículos científicos Disponible 
Título : Effects of hypertonic saline vs normal saline on lactate clearance after cardiovascular surgery Tipo de documento : documento electrónico Autores : Fabián Alberto Jaimes Barragán, Fecha de publicación : 2017 Títulos uniformes : Archivos de Cardiología de México Idioma : Inglés (eng) Palabras clave : Heart surgery Hypertonic saline solution Lactate Hemodynamic profile Safety Colombia Resumen : Background: The postoperative care of patients subjected to cardiac surgery frequently require a complete recovery with intravenous fluids, but crystalloid solutions like normal saline may increase the interstitial oedema, and itis also well known that fluid overload increases mortality. Objective: To compare the effect of 7.5% hypertonic saline (HS) with 0.9% normal saline (NS) on lactate clearance, as well as the haemodynamic response of patients during the first day after cardiovascular bypass surgery. Methods: The study included patients 18 years of age and older with coronary artery disease and/or heart valve disease, and who underwent bypass surgery and/or cardiac valve replacement and were randomly assigned to receive 4 mL/kg of HS or NS intravenously for 30 min once they were admitted to the ICU. Lactate, arterial blood gases, heart rate, central venous pressure, and pulmonary wedge pressure were measured at 0, 6, 12, and 24 h after being admitted to the ICU. The analyses were carried out with an intention-to-treat principle. Results: Out of a total of 494 patients evaluated, 102 were included and assigned to the HS groups (51 patients) or NS (51 patients). The mean age of the participants was 59 ± 14 years, and 59.8% were male. No statistically significant differences were observed between two groups in the lactate clearance, or in any of the secondary outcomes. Conclusions: Our study failed to show a better lactate clearance in the group on hypertonic saline, and with no evidence of a higher incidence of adverse effects in that group. Mención de responsabilidad : Luis Horacio Atehortúa-López, Ray Mendoza-Franco, José Fernando Escobar-Serna, Luis Alejandro Urrego, Fernando Alzate, Fabian Jaimes Referencia : Arch Cardiol Mex. 2018 Apr - Jun;88(2):100-106. DOI (Digital Object Identifier) : 10.1016/j.acmx.2017.02.004 PMID : 28292572 Derechos de uso : CC BY-NC-ND En línea : http://www.archivoscardiologia.com/previos/(2018)%20ACM%20Vol%2088.%202%20ABRIL- [...] Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4085 Effects of hypertonic saline vs normal saline on lactate clearance after cardiovascular surgery [documento electrónico] / Fabián Alberto Jaimes Barragán, . - 2017.
Obra : Archivos de Cardiología de México
Idioma : Inglés (eng)
Palabras clave : Heart surgery Hypertonic saline solution Lactate Hemodynamic profile Safety Colombia Resumen : Background: The postoperative care of patients subjected to cardiac surgery frequently require a complete recovery with intravenous fluids, but crystalloid solutions like normal saline may increase the interstitial oedema, and itis also well known that fluid overload increases mortality. Objective: To compare the effect of 7.5% hypertonic saline (HS) with 0.9% normal saline (NS) on lactate clearance, as well as the haemodynamic response of patients during the first day after cardiovascular bypass surgery. Methods: The study included patients 18 years of age and older with coronary artery disease and/or heart valve disease, and who underwent bypass surgery and/or cardiac valve replacement and were randomly assigned to receive 4 mL/kg of HS or NS intravenously for 30 min once they were admitted to the ICU. Lactate, arterial blood gases, heart rate, central venous pressure, and pulmonary wedge pressure were measured at 0, 6, 12, and 24 h after being admitted to the ICU. The analyses were carried out with an intention-to-treat principle. Results: Out of a total of 494 patients evaluated, 102 were included and assigned to the HS groups (51 patients) or NS (51 patients). The mean age of the participants was 59 ± 14 years, and 59.8% were male. No statistically significant differences were observed between two groups in the lactate clearance, or in any of the secondary outcomes. Conclusions: Our study failed to show a better lactate clearance in the group on hypertonic saline, and with no evidence of a higher incidence of adverse effects in that group. Mención de responsabilidad : Luis Horacio Atehortúa-López, Ray Mendoza-Franco, José Fernando Escobar-Serna, Luis Alejandro Urrego, Fernando Alzate, Fabian Jaimes Referencia : Arch Cardiol Mex. 2018 Apr - Jun;88(2):100-106. DOI (Digital Object Identifier) : 10.1016/j.acmx.2017.02.004 PMID : 28292572 Derechos de uso : CC BY-NC-ND En línea : http://www.archivoscardiologia.com/previos/(2018)%20ACM%20Vol%2088.%202%20ABRIL- [...] Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4085 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000694 AC-2017-083 Archivo digital Producción Científica Artículos científicos Disponible Documentos electrónicos
2017-083.pdfAdobe Acrobat PDF
Título : A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia Tipo de documento : documento electrónico Autores : Kenny Mauricio Gálvez Cárdenas, Fecha de publicación : 2017 Títulos uniformes : Revista Brasileira de Hematologia e Hemoterapia Idioma : Inglés (eng) Palabras clave : Sickle cell disease SANGUINATE Safety Clinical trial Resumen : Background: Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickl cell anemia and comorbidities. Methods: An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160mg/kg) of SANGUINATE or 15 mg/kg hydroxyurea. Another 12 subjects received either a high dose (320mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements. Results: Musculoskeletal related adverse events were the most common. Transient tro-ponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients. Conclusions: The clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials. Mención de responsabilidad : Hemant Misra, James Bainbridge, John Berryman, Abraham Abuchowski, Kenneth Mauricio Galvez, Luis Fernando Uribe, Angel Luis Hernandez, Nestor Rodolfo Sosa Referencia : Rev Bras Hematol Hemoter. 2017 Jan - Mar;39(1):20-27. DOI (Digital Object Identifier) : 10.1016/j.bjhh.2016.08.004 PMID : 28270341 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1516848416300986 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4019 A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia [documento electrónico] / Kenny Mauricio Gálvez Cárdenas, . - 2017.
Obra : Revista Brasileira de Hematologia e Hemoterapia
Idioma : Inglés (eng)
Palabras clave : Sickle cell disease SANGUINATE Safety Clinical trial Resumen : Background: Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickl cell anemia and comorbidities. Methods: An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160mg/kg) of SANGUINATE or 15 mg/kg hydroxyurea. Another 12 subjects received either a high dose (320mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements. Results: Musculoskeletal related adverse events were the most common. Transient tro-ponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients. Conclusions: The clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials. Mención de responsabilidad : Hemant Misra, James Bainbridge, John Berryman, Abraham Abuchowski, Kenneth Mauricio Galvez, Luis Fernando Uribe, Angel Luis Hernandez, Nestor Rodolfo Sosa Referencia : Rev Bras Hematol Hemoter. 2017 Jan - Mar;39(1):20-27. DOI (Digital Object Identifier) : 10.1016/j.bjhh.2016.08.004 PMID : 28270341 En línea : https://linkinghub.elsevier.com/retrieve/pii/S1516848416300986 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4019 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000616 AC-2017-005 Archivo digital Producción Científica Artículos científicos Disponible
