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1.
Can Vet J ; 65(6): 559-564, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38827593

RESUMO

A 3-month-old female English setter dog was presented to the Faculty of Veterinary Medicine of the Université de Montréal (Quebec) with acute respiratory distress. The dog had moderately increased C-reactive protein concentrations, and thoracic radiographs revealed a moderate, caudodorsal, nodular-to-miliary alveolo-interstitial pulmonary pattern that was worse in the perihilar region. Initial differential diagnoses included a fungal pneumonia (e.g., blastomycosis or histoplasmosis). Cytology of the bronchoalveolar lavage revealed several round, green structures ~2 µm in diameter, consistent with fungal spores. The dog was hospitalized, but within 24 h the respiratory condition deteriorated and euthanasia was elected. Post-mortem panfungal PCR and sequencing tests identified the spores as Lycoperdon sp. Retrospectively, the owners recalled that the dog had played in a wood pile with mushrooms and had sneezed in a cloud of spores, implying inhalation of Lycoperdon spores. This is the first report of a confirmed case of canine lycoperdonosis in eastern Canada (Quebec), and the radiographic features in this case differed slightly from previous reports. Diagnosis before bronchoalveolar lavage analysis was challenging, as spore inhalation was not initially reported. Although the disease is infrequently reported in dogs, this case report reminds veterinarians to consider lycoperdonosis as a differential diagnosis when addressing animals presented with acute dyspnea with similar radiographic lesions, and highlights the importance of history and cytology in diagnosing this condition. Key clinical message: Hypersensitivity pneumonitis secondary to inhalation of Lycoperdon spores must be included in differential diagnoses for a dog with acute onset of respiratory signs and a nodular-to-miliary interstitial pulmonary pattern coalescing in patchy perihilar alveolar pulmonary lesions, and should prompt clinicians to question owners regarding inhalation of mushroom spores.Although cytological examination of a bronchoalveolar lavage reveals the presence of fungal spores, panfungal PCR and sequencing tests are needed to pinpoint the species involved.


Pneumopathie d'hypersensibilité associée à l'inhalation de spores de Lycoperdon (lycoperdonose) chez un chien setter anglais de 3 mois au Québec. Une chienne setter anglais âgée de 3 mois a été présentée à la Faculté de médecine vétérinaire de l'Université de Montréal (Québec) avec une détresse respiratoire aiguë. Le chien présentait des concentrations de protéine C-réactive modérément augmentées et les radiographies thoraciques ont révélé un schéma pulmonaire alvéolo-interstitiel modéré, caudodorsal, nodulaire à miliaire, pire dans la région périhilaire. Les diagnostics différentiels initiaux incluaient une pneumonie fongique (par exemple, blastomycose ou histoplasmose). La cytologie du lavage broncho-alvéolaire a révélé plusieurs structures rondes et vertes d'environ 2 µm de diamètre, compatibles avec des spores fongiques. Le chien a été hospitalisé, mais en 24 heures, l'état respiratoire s'est détérioré et l'euthanasie a été décidée. Les tests panfongiques PCR et de séquençage post-mortem ont identifié les spores comme étant Lycoperdon sp. Rétrospectivement, les propriétaires ont mentionné que le chien avait joué dans un tas de bois avec des champignons et avait éternué dans un nuage de spores, ce qui implique une inhalation de spores de Lycoperdon. Il s'agit du premier rapport d'un cas confirmé de lycoperdonose canine dans l'est du Canada (Québec), et les caractéristiques radiographiques de ce cas différaient légèrement des rapports précédents. Le diagnostic avant l'analyse du lavage broncho-alvéolaire était difficile, car l'inhalation de spores n'avait pas été initialement signalée. Bien que la maladie soit rarement rapportée chez les chiens, ce rapport de cas rappelle aux vétérinaires de considérer la lycoperdonose comme un diagnostic différentiel lorsqu'ils traitent des animaux présentant une dyspnée aiguë avec des lésions radiographiques similaires, et souligne l'importance de l'anamnèse et de la cytologie dans le diagnostic de cette affection.Message clinique clé : La pneumopathie d'hypersensibilité secondaire à l'inhalation de spores de Lycoperdon doit être incluse dans les diagnostics différentiels chez un chien présentant un début aigu de signes respiratoires et un schéma pulmonaire interstitiel nodulaire à miliaire fusionnant dans des lésions pulmonaires alvéolaires périhilaires inégales, et devrait inciter les cliniciens à interroger les propriétaires concernant l'inhalation de spores de champignons.Bien que l'examen cytologique d'un lavage broncho-alvéolaire révèle la présence de spores fongiques, des tests panfongiques PCR et de séquençage sont nécessaires pour identifier les espèces impliquées.(Traduit par Dr Serge Messier).


Assuntos
Alveolite Alérgica Extrínseca , Doenças do Cão , Esporos Fúngicos , Animais , Cães , Doenças do Cão/microbiologia , Doenças do Cão/diagnóstico , Feminino , Alveolite Alérgica Extrínseca/veterinária , Alveolite Alérgica Extrínseca/diagnóstico , Esporos Fúngicos/isolamento & purificação , Quebeque
2.
Front Vet Sci ; 11: 1365780, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38650852

RESUMO

Objectives: The study's primary goal was to assess the feasibility of the cricothyroidotomy technique (CTT) in cats and evaluate its success rate (i.e., secure airway access). Secondary outcomes were the assessment of the subjective difficulty of airway access based on body score condition and weight. Further secondary outcomes consisted of procedural time and scoring of associated complications. The current study hypothesized that the CTT procedure would provide secure airway access with a reasonable success rate. Materials and methods: A prospective experimental study assessing the performance of CTT and associated complications was conducted on 30 feline cadavers. A procedural datasheet was completed to subjectively grade difficulty of landmark palpation, guide placement and tube placement and expected success of the procedure. A dissection was then performed post-procedure by a blinded observer to evaluate for any associated damages. Results: CTT was successful in securing an airway in 100% of the cats. The time to completion of the CTT was rapid, with a median time of 49 s (ranging from 31 to 90 s) for securing an airway. Of importance, this procedure was judged to be overall easy (median "ease of procedure score" of 7/10; ranging from 3 to 10) by the experimenters. The post-procedural lesion rate was elevated (76.7%) in this population of cats, though based on the lesion scores, was deemed mild in 73.9% of the cases. Clinical significance: CTT warrants consideration as the primary option for emergency front-of-neck airway access for cats although further studies are necessary.

3.
Rev Infirm ; 73(297): 28-29, 2024 Jan.
Artigo em Francês | MEDLINE | ID: mdl-38242618

RESUMO

In the management of severe trauma, the aim is to assess the patient's clinical stability as quickly as possible, enabling referral to imaging (whole-body CT scan, embolization if necessary) or the operating room, or even the decision to perform in situ surgery (resuscitation thoracotomy). To cope with these critical situations, team training is essential, with the aim of ensuring the reproducibility of the difficulties encountered. High-fidelity in situ simulation is the ideal tool for meeting this training challenge.


Assuntos
Competência Clínica , Treinamento por Simulação , Humanos , Reprodutibilidade dos Testes , Equipe de Assistência ao Paciente , Treinamento por Simulação/métodos , Ressuscitação/educação
4.
Toxics ; 11(5)2023 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-37235278

RESUMO

We report a case of accidental nicotine intoxication following transdermal exposure in a 22-year-old man with no medical history, who worked in a company manufacturing e-liquids for electronic cigarettes. He accidentally spilled 300 mL of pure nicotine solution (>99%) on his right leg without wearing protective clothing or a mask. Less than a minute later, he experienced dizziness, nausea, and headaches, followed by painful burning sensations in the affected area. He immediately removed his pants and washed his leg thoroughly with water. He presented to the emergency department two hours later, where he exhibited a respiratory rate of 25 cpm, a heart rate of 70 bpm, headaches, abdominal pain, pallor, and vomiting. He recovered without specific treatment five hours post-intoxication. Plasma levels of nicotine, cotinine, and hydroxycotinine were measured five hours after exposure using liquid chromatography-mass spectrometry. The concentrations found were 447 ng/mL for nicotine, 1254 ng/mL for cotinine, and 197 ng/mL for hydroxycotinine. Nicotine is an alkaloid that can be highly toxic, with doses of 30-60 mg being potentially fatal. Transdermal intoxication is rare, with very few cases reported in the literature. This case highlights the risk of acute intoxication through cutaneous exposure to nicotine-containing liquid products and the need for protective clothing when handling such products in a professional context.

5.
Kidney Int Rep ; 6(7): 1829-1839, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34307977

RESUMO

INTRODUCTION: Erythropoiesis-stimulating agents, standard of care for anemia of end-stage kidney disease, are associated with cardiovascular events. We evaluated the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis. METHODS: SIERRAS was a phase 3, randomized, open-label, active-controlled study enrolled adults on dialysis for end-stage kidney disease receiving erythropoiesis-stimulating agents for anemia. Patients were randomized (1:1) to thrice-weekly roxadustat or epoetin alfa. Doses were based on previous epoetin alfa dose and adjusted in the roxadustat arm to maintain hemoglobin at ∼11 g/dl during treatment. Epoetin alfa dosing was adjusted per US package insert. Primary efficacy endpoint was mean hemoglobin (g/dl) change from baseline averaged over weeks 28 to 52. Treatment-emergent adverse events were monitored. RESULTS: Enrolled patients (roxadustat, n = 370 and epoetin alfa, n = 371) had similar mean (SD) baseline hemoglobin levels (10.30 [0.66] g/dl). Mean (SD) hemoglobin changes for weeks 28 to 52 were 0.39 (0.93) and -0.09 (0.84) in roxadustat and epoetin alfa, respectively. Roxadustat was noninferior (least squares mean difference: 0.48 [95% confidence interval: 0.37, 0.59]; P < 0.001) to epoetin alfa. Tolerability was comparable between treatments. CONCLUSION: In end-stage kidney disease, roxadustat was noninferior to epoetin alfa in up to 52 weeks of treatment in this erythropoietin-stimulating agent conversion study. Roxadustat had an acceptable tolerability profile.

6.
Aust Crit Care ; 34(2): 160-166, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33509706

RESUMO

BACKGROUND: A high number of thrombotic complications have been reported in critically ill patients with coronavirus disease 2019 (COVID-19) and appear to be related to a hypercoagulable state. Evidence regarding detection, management, and monitoring of COVID-19-associated coagulopathy is still missing. We propose to describe the thrombus viscoelastic properties to investigate the mechanisms of hypercoagulability in patients with COVID-19. METHODS: Thromboelastography (TEG) was performed in 24 consecutive patients admitted to a single intensive care unit for COVID-19 pneumonia, and 10 had a second TEG before being discharged alive from the intensive care unit. RESULTS: Compared with a group of 20 healthy participants, patients with COVID-19 had significantly decreased values of reaction time, coagulation time, and lysis index and increased values of α angle, maximum amplitude, clot strength, and coagulation index. Velocity curves were consistent with increased generation of thrombin. These values persisted in surviving patients despite their good clinical course. DISCUSSION: In patients with COVID-19, TEG demonstrates a complex and prolonged hypercoagulable state including fast initiation of coagulation and clot reinforcement, low fibrinolysis, high potential of thrombin generation, and high fibrinogen and platelet contribution. The antithrombotic strategy in patients with COVID-19 during intensive care hospitalisation and after discharge should be investigated in further studies.


Assuntos
COVID-19/sangue , Pneumonia Viral/sangue , Tromboelastografia , Trombofilia/diagnóstico , Trombofilia/virologia , Idoso , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/virologia , SARS-CoV-2
7.
Head Neck ; 42(7): 1361-1362, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32347991

RESUMO

As an aerosol and droplets generating procedure, tracheostomy increases contamination risks for health workers in the coronavirus disease context. To preserve the health care system capacity and to limit virus cross-transmission, protecting caregivers against coronavirus infection is of critical importance. We report the use of external fixator equipment to set up a physical interface between the patient's neck and the caregiver performing a tracheostomy in COVID-19 patients. Once the metal frame set in place, it is wrapped with a single-use clear and sterile cover for surgical C-arm. This installation is simple, easy, and fast to achieve and can be carried out with inexpensive material available in every hospital. This physical interface is an additional safety measure that prevents the direct projection of secretions or droplets. It should, of course, only be considered as a complement to strict compliance with barrier precautions and personal protective equipment.


Assuntos
Infecções por Coronavirus/prevenção & controle , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Saúde Ocupacional , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Equipamentos de Proteção/estatística & dados numéricos , Traqueostomia/métodos , COVID-19 , China , Infecções por Coronavirus/epidemiologia , Desenho de Equipamento , Feminino , Pessoal de Saúde/estatística & dados numéricos , Humanos , Controle de Infecções/métodos , Masculino , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Traqueostomia/instrumentação
9.
J Crit Care ; 54: 292-297, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31813460

RESUMO

PURPOSE: Patient data management systems (PDMS) are widely used in intensive care units (ICUs) to improve care traceability. Verbal orders are still used for prescriptions requiring immediate execution but should be subsequently recorded in the system. We assessed the rapid sequence induction (RSI) traceability for endotracheal intubation in an ICU dedicated PDMS. MATERIALS AND METHODS: A retrospective study was conducted on anonymous databases in 21 ICUs. Endotracheal tube insertions performed during one year were compared to the number of RSI registered in the PDMS. RESULTS: We listed 5516 endotracheal tube insertions. A suxamethonium injection was registered in 829 cases and a rocuronium administration in 909 cases. The RSI traceability rate in the overall cohort was 31.5% and was greater in the units where nurses were allowed to record a drug administration before the computerized physician order entry. CONCLUSIONS: PDMS are supposed to improve prescription completeness and traceability, but our study suggests an opposite result. A co-responsibility policy between physicians and nurses should be promoted to improve care traceability. PDMS ergonomic improvements and enhanced integration in clinical workflow might also result in better compliance with documentation requirements. In each centre, indicators of PDMS correct use should be defined and periodically monitored.


Assuntos
Unidades de Terapia Intensiva , Sistemas de Registro de Ordens Médicas , Avaliação de Resultados em Cuidados de Saúde , Indução e Intubação de Sequência Rápida , França , Humanos , Estudos Retrospectivos , Inquéritos e Questionários
10.
Can Vet J ; 60(11): 1177-1181, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31692596

RESUMO

This report describes a disseminated Neospora caninum infection with cutaneous involvement as the primary presenting clinical sign, in an apparently immunocompetent 7-year-old, spayed female boxer dog. The dog had an 8-day history of progressive lethargy associated with the appearance of multiple cutaneous and ulcerated masses, followed by an acute deterioration of her clinical status. Blood analysis revealed thrombocytopenia, increased liver enzyme activity, and partial thromboplastin time. Disseminated intravascular coagulation was suspected. Tachyzoites were identified on cutaneous cytology and species was determined by polymerase chain reaction (PCR) assays on blood and cerebrospinal fluid. The post-mortem evaluation revealed involvement of the neurological system, liver, lung, and skin.


Infection systémique disséminée par Neospora caninum avec lésions cutanées comme présentation clinique initiale chez un chien. Ce cas clinique décrit une infection disséminée par Neospora caninum, avec atteinte cutanée comme présentation clinique initiale, chez une femelle Boxer stérilisée de 7 ans apparemment immunocompétente. La chienne présentait une léthargie progressive depuis 8 jours associée à l'apparition de multiples masses cutanées ulcérées, suivie d'une détérioration aigüe de son état général. L'analyse sanguine a révélé une thrombocytopénie, une augmentation des enzymes hépatiques et du temps de thromboplastine partiel. Une coagulation intravasculaire disséminée a été soupçonnée. Des tachyzoïtes ont été mis en évidence sur la cytologie cutanée et l'espèce a été identifiée par PCR sur le sang et le liquide céphalorachidien. L'évaluation post-mortem a révélé une atteinte du système neurologique, du foie, des poumons et de la peau.(Traduit par les auteurs).


Assuntos
Coccidiose/veterinária , Doenças do Cão , Neospora/genética , Dermatopatias/veterinária , Animais , Cães , Feminino , Reação em Cadeia da Polimerase/veterinária
11.
Am J Nephrol ; 45(5): 380-388, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28343225

RESUMO

BACKGROUND: Therapeutic options for the treatment of anemia secondary to chronic kidney disease (CKD) remain limited. Vadadustat (AKB-6548) is an oral hypoxia-inducible factor prolyl-hydroxylase domain (HIF-PHD) inhibitor that is being investigated for the treatment of anemia secondary to CKD. METHODS: A phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial (NCT01381094) was undertaken in adults with anemia secondary to CKD stage 3 or 4. Eligible subjects were evenly randomized to 5 groups: 240, 370, 500, or 630 mg of once-daily oral vadadustat or placebo for 6 weeks. All subjects received low-dose supplemental oral iron (50 mg daily). The primary endpoint was the mean absolute change in hemoglobin (Hb) from baseline to the end of treatment. Secondary endpoints included iron indices, safety, and tolerability. RESULTS: Ninety-three subjects were randomized. Compared with placebo, vadadustat significantly increased Hb after 6 weeks in a dose-dependent manner (analysis of variance; p < 0.0001). Vadadustat increased the total iron-binding capacity and decreased concentrations of ferritin and hepcidin. The proportion of subjects with at least 1 treatment-emergent adverse event was similar between vadadustat- and placebo-treated groups. No significant changes in blood pressure, vascular endothelial growth factor, C-reactive protein, or total cholesterol were observed. Limitations of this study included its small sample size and short treatment duration. CONCLUSIONS: Vadadustat increased Hb levels and improved biomarkers of iron mobilization and utilization in patients with anemia secondary to stage 3 or 4 CKD. Global multicenter, randomized phase 3 trials are ongoing in non-dialysis-dependent and dialysis-dependent patients.


Assuntos
Anemia/tratamento farmacológico , Glicina/análogos & derivados , Prolina Dioxigenases do Fator Induzível por Hipóxia/antagonistas & inibidores , Ácidos Picolínicos/uso terapêutico , Insuficiência Renal Crônica/tratamento farmacológico , Adulto , Idoso , Anemia/sangue , Anemia/etiologia , Biomarcadores/sangue , Proteína C-Reativa/análise , Colesterol/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Eritropoetina/sangue , Feminino , Ferritinas/sangue , Ferritinas/metabolismo , Glicina/farmacologia , Glicina/uso terapêutico , Hemoglobinas/análise , Hepcidinas/sangue , Hepcidinas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Ácidos Picolínicos/farmacologia , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/complicações , Fator A de Crescimento do Endotélio Vascular/sangue
12.
Nephrol Dial Transplant ; 29(4): 833-42, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23963731

RESUMO

BACKGROUND: Iron-deficiency anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) frequently requires parenteral iron replacement, but existing therapies often require multiple administrations. We evaluated the efficacy and cardiovascular safety of ferric carboxymaltose (FCM), a non-dextran parenteral iron permitting large single-dose infusions, versus iron sucrose in patients with iron-deficiency anemia and NDD-CKD. METHODS: A total of 2584 participants were randomized to two doses of FCM 750 mg in one week, or iron sucrose 200 mg administered in up to five infusions in 14 days. The primary efficacy endpoint was the mean change to highest hemoglobin from baseline to Day 56. The primary composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, congestive heart failure, arrhythmias and hyper- and hypotensive events. RESULTS: The mean hemoglobin increase was 1.13 g/dL in the FCM group and 0.92 g/dL in the iron sucrose group (95% CI, 0.13-0.28). Similar results were observed across all subgroups, except Stage 2 CKD. More subjects in the FCM group achieved a hemoglobin increase of ≥ 1.0 g/dL between baseline and Day 56 (48.6 versus 41.0%; 95% CI, 3.6-11.6%). There was no significant difference between FCM and iron sucrose recipients with respect to the primary composite safety endpoint, including the major adverse cardiac events of death, myocardial infarction, or stroke. A significant difference in the number of protocol-defined, predominantly transient hypertensive episodes was observed in the FCM group. CONCLUSIONS: Two 750-mg infusions of FCM are a safe and effective alternative to multiple lower dose iron sucrose infusions in NDD-CKD patients with iron-deficiency anemia.


Assuntos
Anemia Ferropriva/terapia , Compostos Férricos/administração & dosagem , Taxa de Filtração Glomerular/fisiologia , Ácido Glucárico/administração & dosagem , Ferro/sangue , Maltose/análogos & derivados , Insuficiência Renal Crônica/fisiopatologia , Idoso , Anemia Ferropriva/sangue , Anemia Ferropriva/etiologia , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Óxido de Ferro Sacarado , Hematínicos/administração & dosagem , Hemoglobinas/metabolismo , Humanos , Infusões Intravenosas , Masculino , Maltose/administração & dosagem , Pessoa de Meia-Idade , Diálise Renal , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/complicações , Resultado do Tratamento
13.
Clin J Am Soc Nephrol ; 8(4): 538-45, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23243269

RESUMO

BACKGROUND AND OBJECTIVES: Peginesatide (Omontys) is a novel, synthetic, PEGylated, peptide-based erythropoiesis-stimulating agent (ESA) that is designed to specifically stimulate the erythropoietin receptor. This study evaluated maintenance of hemoglobin levels in patients after conversion from darbepoetin alfa to once-monthly peginesatide. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This open-label, multicenter study included 101 CKD patients, 52 of whom were receiving dialysis. The duration of the study was 24 weeks. The primary endpoint was the mean change in hemoglobin from baseline to the evaluation period (weeks 19-24). The study was conducted during the period from September 22, 2008 to December 24, 2009. RESULTS: The mean change among hemodialysis patients was -0.42 g/dl (95% confidence interval, -0.65 to -0.19) and the mean change among CKD nondialysis patients was 0.49 g/dl (95% confidence interval, 0.26-0.71). The percentages of patients who maintained hemoglobin levels within ±1.0 g/dl of baseline values were as follows: 80.0% for hemodialysis and 68.1% for nondialysis, and73.3% for hemodialysis and 68.1% for nondialysis within the target range of 10.0-12.0 g/dl. Few patients received red blood cell transfusions (hemodialysis, 5.8%; nondialysis, 2.0%). Seventy-nine patients experienced adverse events, the majority of which were mild or moderate in severity. There were 40 serious adverse events and 2 deaths reported. CONCLUSIONS: In this study, once-monthly peginesatide resulted in a slight decrease in mean hemoglobin levels in individuals on hemodialysis and a small increase in individuals with CKD who were not on dialysis.


Assuntos
Anemia/tratamento farmacológico , Eritropoetina/análogos & derivados , Hematínicos/administração & dosagem , Falência Renal Crônica/complicações , Peptídeos/administração & dosagem , Diálise Renal , Idoso , Idoso de 80 Anos ou mais , Anemia/sangue , Anemia/etiologia , Darbepoetina alfa , Relação Dose-Resposta a Droga , Eritropoetina/uso terapêutico , Feminino , Hematínicos/efeitos adversos , Hemoglobinas/metabolismo , Humanos , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Peptídeos/efeitos adversos , Resultado do Tratamento
14.
BMC Nephrol ; 13: 95, 2012 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-22935486

RESUMO

BACKGROUND: Peginesatide is a peptide-based erythropoiesis-stimulating agent that was designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis. The primary objective of this phase 2 dose-finding study was to determine the once-monthly peginesatide dosing strategy that would maintain hemoglobin within ±1.0 g/dL of baseline values after conversion from epoetin alfa; the safety of peginesatide was evaluated concurrently. METHODS: Chronic hemodialysis patients on stable regimens of epoetin alfa were sequentially assigned to cohorts that differed on (1) how the peginesatide starting dose was determined (using a single epoetin alfa-to-peginesatide dose conversion ratio or a tiered, weight-based or absolute-dose conversion table) and on (2) whether or not a 1-week erythropoiesis-stimulating agent-free interval was used. Peginesatide doses were titrated to maintain hemoglobin levels within ±1.0 g/dL from baseline. RESULTS: A total of 164 patients were enrolled and received intravenous peginesatide every 4 weeks for up to 6 doses; the duration of the study including follow-up was ≤29 weeks. Overall, the proportion of patients with hemoglobin levels within ±1.0 g/dL of baseline increased over the course of the study from 39% (Weeks 2-13) to 54% (Weeks 18-25). Cohorts that used tiered dose conversion tables trended towards having more stable peginesatide doses than did those cohorts that used a single dose conversion ratio. Moreover, cohorts that used an erythropoiesis-stimulating agent-free interval did not have the substantial initial increase in hemoglobin levels that was seen in those cohorts that did not use such an interval. In this study, the safety profile of peginesatide was consistent with those of marketed erythropoiesis-stimulating agents. CONCLUSIONS: The results of this study were used to guide the dosing regimens used subsequently in phase 3 studies. Once-monthly peginesatide is feasible in hemodialysis patients. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT00228449.


Assuntos
Anemia/tratamento farmacológico , Hematínicos/administração & dosagem , Peptídeos/administração & dosagem , Diálise Renal/efeitos adversos , Insuficiência Renal Crônica/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/epidemiologia , Estudos de Coortes , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/epidemiologia , Resultado do Tratamento
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