Revisión sistemática y coste efectividad del tratamiento con abobotulinumtoxinA Para la espasticidad post-ictus en comparación con fisioterapia / Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy

Objective Post-stroke spasticity (PSS) is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. Methods A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of PSS in adults were included. The synthesis of information from the review provided the parameters for the design of a cost-effectiveness analysis of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. Results In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment (SoC)... (AU)

Antecedentes La espasticidad post-ictus es una enfermedad común que afecta a los adultos y causa una carga grave a los pacientes que la padecen. El objetivo de la revisión fue realizar un análisis coste-efectividad (ACE) del tratamiento de la espasticidad post-ictus, en adultos, con abobotulinumtoxinA (aboBoNT-A) en comparación con el tratamiento convencional, basado en los resultados de una revisión sistemática de la literatura. Dado que este tratamiento se proporciona siempre al mismo tiempo que el tratamiento convencional, el ACE se realizó del tratamiento aboBoNT-A con el tratamiento convencional, en comparación con recibir únicamente el tratamiento convencional. Métodos Se realizó una revisión sistemática de la literatura en EMBASE (incluyendo Medline y Pubmed), Scopus y otras fuentes (Google Scholar). Se incluyeron artículos de todo tipo que proporcionaran información sobre los costes y/o las medidas de efectividad de los tratamientos actuales del PSS en adultos. La síntesis de la información de la revisión proporcionó los parámetros para el diseño de un análisis coste-efectividad del mencionado tratamiento de interés. Se comparó la perspectiva social con una perspectiva donde solo se observaron los costes directos del tratamiento. Resultados Se revisaron un total de 532 resúmenes. Se revisó la información completa de 40 artículos y se seleccionaron 13 artículos para la extracción completa de datos. La información de estos documentos se sintetizó y utilizó para desarrollar un modelo de coste-efectividad. En todos los artículos incluidos se identificó el tratamiento con fisioterapia como el tratamiento convencional principal... (AU)

Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy. / [Artículo traducido] Revisión sistemática y coste-efectividad del tratamiento con abobotulinumtoxinA para la espasticidad postictus en comparación con la fisioterapia.

OBJECTIVE: Post-stroke spasticity is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. METHODS: A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of post-stroke spasticity in adults were included. The synthesis of information from the review provided the parameters for the design of a CEA of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. RESULTS: In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment. The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY. CONCLUSION: The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.

Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy.

OBJECTIVE: Post-stroke spasticity (PSS) is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. METHODS: A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of PSS in adults were included. The synthesis of information from the review provided the parameters for the design of a cost-effectiveness analysis of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. RESULTS: In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment (SoC). The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY. CONCLUSION: The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.

Intracranial migration of a ventriculoperitoneal shunt: A case report and literature review.

Background: The intracranial migration of a ventriculoperitoneal shunt (VPS) has been previously described, it is a very rare event, and the mechanisms of this migration have not yet been elucidated. Case Description: Newborn at 38 weeks of gestation by cesarean section, with congenital hydrocephalus due to Dandy-Walker malformation that required right Frazier VPS placement. At 2-month follow-up, computed tomography of the skull showed cranial migration of VPS and dysfunction. At evaluation, there were signs of systemic infection. External ventricular drainage was placed and an intravenous antibiotic scheme for Gram-positive bacteria was started. After 3 months, cerebrospinal fluid cultures were negative and definitive VPS was decided. Conclusion: Different possible mechanisms have been proposed, such as negative intraventricular pressure, positive intra-abdominal pressure, use of valveless catheters, excessive burr hole size, as well as such as occipital ventricular access, thin cortical mantle, incorrect distal and proximal fixation, short distance between the peritoneum and ventricles, and a possible inflammatory reaction to the catheter material (silicone). A combination of these different mechanisms contributes to proximal shunt migration. Although the placement of a VPS is a procedure well taught since the 1st years of neurosurgical residency, it is not exempt from complications. Although, as was previously stated in this paper, the incidence of a complete cranial VPS migration is extremely rare, and only a few cases are documented, it is still important to report this type of cases and to try to elucidate the possible mechanisms involved.

Hypertrophic cardiomyopathy in a patient with secondary hypoparathyroidism: A case report.

Parathyroid hormone (PTH) has direct and indirect actions on cardiovascular cells. The effects of chronic hypoparathyroidism on cardiac morphology, function, and conduction are still unclear. Low PTH states are associated with multiple manifestations in the heart, acute or chronic. Acute hypocalcemic cardiomyopathy is a transient dilated cardiomyopathy with reduced ejection fraction and diffuse left ventricular hypokinesia. Chronic hypoparathyroidism-associated cardiomyopathy is a rare disease that may cause reduced myocardial tension, cardiac cavity enlargement, arrhythmias, and congestive heart failure. Here, we describe a 73-year-old woman with chronic hypoparathyroidism and hypocalcemia, who developed a hypertrophic cardiomyopathy, and not a dilated hypocalcemia-associated cardiomyopathy, which would be usually the case.

Bilateral striopallidal calcinosis secondary to systemic lupus erythematosus.

Bilateral symmetric striatopallidal calcinosis with or without deposits in dentate nucleus, thalamus, and white matter is reported in patients ranging from asymptomatic, metabolic, toxic, and genetic autosomal dominant, familial or sporadic forms. Of the connective tissue diseases, it has been reported in very few cases in patients with systemic lupus erythematosus, many incorrectly labeled as Fahr syndrome without even having hypoparathyroidism. Here we describe a 30-year-old female patient with neuropsychiatric systemic lupus erythematosus manifested at diagnosis with mood disorders and anxiety, and 1-year later develops Lupus headache; Incidentally, an aneurism of the right middle cerebral artery and bilateral and symmetric calcifications of the caudate and lenticular nuclei were noted; this finding is a rarely reported manifestation of neuropsychiatric systemic lupus erythematosus. A review of the literature based on this case was carried out in electronic databases. There are approximately 29 patients reported in the literature, with calcifications in the basal ganglia associated with systemic lupus erythematosus occurs almost exclusively in young women (96.5%) with a mean age of 33.36 years (2 months-76 years), with a race predilection for Asians (65.5%). Regarding the neuropsychiatric syndromes defined by the American College of Rheumatology, the most frequently associated are movement disorders; followed by cognitive dysfunction, seizure disorders, mood disorders, cerebrovascular disease, psychosis, and acute confusional state, transverse myelitis, and demyelinating syndrome. The mean duration time of the SLE to detection of the basal ganglia calcification is 7.62 years (3 days-31 years).

Wound Dehiscence After Occipital Encephalocele Surgical Repair in a Neonate: Management Alternative.

Encephaloceles are congenital malformations of the neural tube, mostly located in the occipital region in the Western world. Its presence is related to many complications, among which cognitive impairment and death are the most important. The diagnosis is usually made in the prenatal period, but sometimes due to poor control, this is not feasible. Surgery is required as early as possible to prevent further damage. Sometimes we can face complications related to the procedure, such as wound dehiscence, which has been the aim of this work. Many different types of treatments have been proposed for this complication: nevertheless, they result in invasive management. We present the case of a neonate's wound dehiscence, managed with potable water washes and a correct sterile technique, shown to be safe, reduce the in-patient costs, as well as improve the patient's and their family's quality of life (QoL).

Neurenteric Cyst of the Posterior Cranial Fossa: A Case Report and Literature Review.

Neurenteric cysts (NCs) are rare benign endodermal lesions of the central nervous system (CNS), most commonly found in the spinal cord. Intracranial lesions are rare, among which the posterior fossa appears to be the predominant location. We present a case of a 60-year-old man who presented with a suddenly decreased level of consciousness. After a series of radiological studies were done, a multilobulated cystic lesion in the right posterior fossa was observed. Surgical resection was performed and based on its histopathological characteristics, NC diagnosis was confirmed. Because of the wide list of differential diagnoses and low specificity of radiological features, surgical gross total resection remains the most effective treatment, followed by diagnosis confirmation through histopathological techniques.

Proof of concept for the use of trained sniffer dogs to detect osteosarcoma.

Sarcomas are mesenchymal cancers which often show an aggressive behavior and patient survival largely depends on an early detection. In last years, much attention has been given to the fact that cancer patients release specific odorous volatile organic compounds (VOCs) that can be efficiently detected by properly trained sniffer dogs. Here, we have evaluated for the first time the ability of sniffer dogs (n = 2) to detect osteosarcoma cell cultures and patient samples. One of the two dogs was successfully trained to discriminate osteosarcoma patient-derived primary cells from mesenchymal stem/stromal cells (MSCs) obtained from healthy individuals. After the training phase, the dog was able to detect osteosarcoma specific odor cues in a different panel of 6 osteosarcoma cell lines with sensitivity and specificity rates between 95 and 100%. Moreover, the same VOCs were also detected by the sniffer dog in saliva samples from osteosarcoma patients (n = 2) and discriminated from samples from healthy individuals with a similar efficacy. Altogether, these results indicate that there are common odor profiles shared by cultures of osteosarcoma cells and body fluid samples from patients and provide a first proof of concept about the potential of canine odor detection as a non-invasive screening method to detect osteosarcomas.

Neuroprotective effect of dapsone in patients with aneurysmal subarachnoid hemorrhage: a prospective, randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: In this study, the authors sought to define the differences in the incidence of delayed cerebral ischemia (DCI) between patients treated with dapsone and those treated with placebo. Secondary objectives were to define the clinical outcome at discharge and 3 months and the incidence of brain infarction. METHODS: A prospective, randomized, double-blind, placebo-controlled study was performed and included patients with aneurysmal subarachnoid hemorrhage (SAH) within 5 days from ictus who were candidates for aneurysm occlusion, and who had a Fisher grade of 3 or 4. Patients with sulfa or sulfone drug allergies, hemoglobin < 11 g/dl, known G6PD deficiency, and those refusing informed consent were excluded. A minimal relevant effect decrease of 35% in the incidence of DCI was established. Patients were randomly assigned to receive a regimen of dapsone 2.5 ml (100 mg) daily or a placebo (aluminum hydroxide suspension, 2.5 ml daily). Both groups received validated treatment for aneurysmal SAH. The appearance of DCI on CT was assessed in every patient at discharge and 3 months later. We used the chi-square test to compare the DCI incidence between both groups, and the Student t-test or nonparametric tests to compare quantitative variables. RESULTS: Overall, 48 patients (70.8% women and 29.2% men) were included. The mean age was 50 years (SD 14.28 years, range 18-72 years). Prerandomization and postrandomization characteristics were balanced, except for the necessity of intra-arterial nimodipine administration in patients treated with placebo (15.4% vs 45.5%, p = 0.029. The incidence of DCI, the primary endpoint, for the whole cohort was 43.8% and was significantly lower in the dapsone group (26.9% vs 63.6%, p = 0.011). In addition, the irreversible DCI incidence was lower in the dapsone group (11.5% vs 54.5%, p = 0.12). A favorable modified Rankin Scale score was more frequent in the dapsone group at discharge and at 3 months (76.9% vs 36.4%, p = 0.005 and 80% vs 38.9%, p = 0.019, respectively). Also, the brain infarction incidence was lower in the dapsone group (19.2% vs 63.6%, p = 0.001). There was no difference between groups regarding adverse events. CONCLUSIONS: Dapsone seems to play a role as a prophylactic agent in patients at high risk of developing DCI after aneurysmal SAH. A multicenter investigation is necessary to increase the study population and confirm the consistency of the results observed in this study.

Subarachnoid Hemorrhage From Rupture of an Undiagnosed Posterior Circulation Aneurysm During Sellar Tumor Surgery.

Association between cerebral aneurysms and sellar tumors has been previously reported. Rupture of anterior circulation aneurysms during a transsphenoidal surgery causing massive subarachnoid hemorrhage (SAH) is uncommon, but rupture of a posterior circulation aneurysm is an infrequent event. We present three cases of SAH secondary to rupture of an undetected posterior circulation aneurysm during transsphenoidal surgery to treat a sellar tumor. The common factor in these cases was the adverse outcome despite treatment.  The fatal outcome seen in all these cases questions whether to include a (magnetic resonance) MR angiography or (computed tomography) CT angiography during preoperative evaluation for sellar tumors in order to identify inadvertently associated aneurysms.

Hypothalamic Cavernous Malformation: Surgical Technique and Literature Review.

Hypothalamic cavernous malformation (HCM) is rare, and to our knowledge, there are only 28 cases reported in the literature. An 18-year-old male presented two years ago with a severe headache followed by right eye blindness. Following imaging studies, a bleeding hypothalamic cavernoma was discovered together with another incidental cavernoma in the brain. We sustained the diagnosis of cavernomatosis, and conservative treatment was indicated. A year later, he presented severe headache and vomit; for this reason, the patient underwent a new MRI which showed a new bleeding episode of the HCM lesion. We carried out an endocrinological assessment, and microsurgical resection was recommended. Although visual impairment persisted as expected in the postoperative period, he showed good clinical recovery overall. Hypothalamic location of a cavernous malformation is infrequent, accounting for only 1% or less of these lesions, and are known to cause a variety of symptoms inducing headache, visual disturbance, and less frequently, hypothalamus dysfunction. Surgical intervention can be considered after a second symptomatic bleed, always assessing the risk of non-favorable postsurgical outcomes against the intrinsic risk that these malformations imply. Case reports like this are essential to reach a consensus towards the best treatment option for HCM.

Macro Pituitary Adenoma and Frontal Calcified Cavernous Malformation: A Coincidence or a True Partnership?

Collision tumors are rare neoplasms composed of two different types of histological tissues in the same organ. The most frequent association with cerebral cavernous malformations (CCMs) are meningiomas, gliomas, and gangliogliomas, while the most frequent sellar collision is between pituitary adenoma (PA) and craniopharyngiomas, and still very few cases have been reported. We present the case of a 43-year-old woman who started two months ago with a fall from her height followed by severe headache and bilateral hemianopsia. An isointense, enhancing sellar tumor, and a right frontal lesion compatible with CCM were observed on MRI. Surgery was performed through anterior interhemispheric and endoscopic transnasal approaches for the cavernoma and the sellar tumor, respectively, removing both lesions and sending them to pathology. The sellar tumor corresponded to a PA showing positive immunohistochemistry for prolactin and follicle-stimulating hormone (FSH). In the post-op period, the patient developed a seizure and diabetes insipidus, for which she received appropriate treatment. Our findings were conclusive with a collision tumor, since both lesions presented two different histological tissues. Different densities were observed in both lesions using imaging studies, which were later confirmed with histopathology and immunohistochemistry.

Spontaneous regression of a thrombosed cerebral arteriovenous malformation in a patient with a prothrombotic state associated with multiple myeloma: A case report and literature review.

BACKGROUND: Cerebral arteriovenous malformations (AVMs) are pathologic communications between veins and arteries of the brain vasculature. Its spontaneous regression is rare, and many factors have been described in the effort to explain this phenomenon, including a hypercoagulable state. CASE DESCRIPTION: We present the case of a spontaneous unruptured AVM regression in a patient where thrombosis of the malformation was found, probably due to a prothrombotic state associated with multiple myeloma (MM). CONCLUSION: We aim to contribute to the study of this rare phenomenon, presenting the relationship between a hypercoagulable state caused by MM and the spontaneous AVM regression that has not been previously reported.

Clinical outcome of patients with COVID-19 Pneumonia treated with corticosteroids and colchicine in Colombia.

BACKGROUND: To date, there is no specific antiviral therapy for severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) that causes Coronavirus disease 2019 (Covid-19). Since there is no specific therapy against SARS-CoV2, current efforts aim to prevent contagion through public health measures and develop a protective vaccine. While waiting for the latter, it is necessary to evaluate the drugs that at least, in initial studies, suggested some degree of utility in the management of Covid-19 or its complications. The main objective of the study was to describe the clinical manifestations and outcomes of patients with severe Covid-19 Pneumonia treated with corticosteroids and colchicine. MATERIALS AND METHODS: A cross sectional study of 301 adult patients with Covid-19 Pneumonia confirmed by Real-Time Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-CoV2), Berlin protocol, who required hospitalization in three hospitals in Antioquia, Colombia. Patients were treated according to the institutional protocol (from March 20, 2020 to June 30, 2020) with corticosteroid if the patient required supplemental oxygen. From July 1, 2020, the management protocol changed with the addition of colchicine to all patients admitted to the institutions. The treatment was supervised and monitored by the same specialist in Infectology of the institutions. We describe the clinical manifestations and outcomes of the patients who received these treatments. The information of the patients was analyzed according to the outcome of interest (alive/dead) with univariate, bivariate, and multivariate measures to adjust the variables that presented statistical association. RESULTS: All patients had pneumonia documented by chest computed tomography with ground glass images and presented an alveolar pressure/inspired oxygen fraction (PaFi) less than 300. Three hundred one patients were included, 240 (79.7%) received corticosteroids, within these 145 (48.2%) received colchicine also, and the remaining 61 (20.3%) patients did not receive corticosterioids or colchicine. Mortality in the group that received colchicine was lower compared to the group that did not receive it (9.6 vs 14.6%, p-value = 0.179). CONCLUSIONS: Treatment with corticosteroids and colchicine for managing patients with severe Covid-19 Pneumonia was associated with low mortality at the hospital level. Randomized, placebo-controlled studies are required to evaluate the effect of corticosteroids and colchicine on complications or death from Covid-19.

Other causes of intestinal obstruction actino-mycetoma - a case report and literature review / Outras causas de obstrução intestinal por actinomicetoma - relato de caso e revisão da literatura

Abstract Introduction: Actinomycosis is a rare infectious disease that affects abdominal organs and simulates oncological disease, hardly ever presents itself as a cause of intestinal obstruction. Symptoms: A 43 years old, male patient with two months of left abdominal pain associated to a growth and an 8 kg weight loss, no fever or bowel habit disruption. Interventions: A colonoscopy and an abdominal scanography. Results: A solid heterogeneous 7 × 3.8 cm mass localized in the splenic flexure of the colon with infiltration of its walls and its surrounding fat. Colon cancer was considered as the first diagnostic possibility. During hospitalization, the patient was taken to an emergency exploratory laparotomy, due to an acute abdominal pain with bowel obstruction symptoms. Histopathological diagnosis: Actinomycetoma. Conjoint continuous monitoring with the infectious disease attending, abdominal US and observation did not show new growths. Weight gain and progressive return to daily life was obtained within 8 weeks. Conclusion: In low income countries, intestinal actinomycosis should be considered in the differential diagnosis of abdominal masses and chronic inflammatory processes, patient prognosis with proper management is excellent.

Resumo Introdução: A actinomicose é uma doença infecciosa rara que acomete órgãos abdominais, simula doença oncológica e dificilmente causa de obstrução intestinal. Sintomas: Paciente do sexo masculino, 43 anos, com quadro de dor abdominal esquerda por dois meses, associado ao surgimento de massa e perda de peso de 8 kg, sem febre ou alterações dos hábitos intestinais. Intervenções: Colonoscopia e uma tomografia computadorizada abdominal. Resultados: Observou-se massa sólida heterogênea de 7 × 3,8 cm localizada na flexão esplênica do cólon, com infiltração de suas paredes e gordura adjacente. Câncer de cólon foi a primeira possibilidade diagnóstica considerada. Durante a internação, o paciente foi submetido a uma laparotomia exploradora de emergência, devido a uma dor abdominal aguda com sintomas de obstrução intestinal. Diagnóstico histopatológico: Actinomicetoma. Monitoramento contínuo em conjunto com o tratamento da infecção, ultrassom abdominal e observação; não foram observados novos crescimentos. Ganho de peso e retorno progressivo à vida diária foram observados por oito semanas. Conclusão: Em países de baixa renda, a actinomicose intestinal deve ser considerada no diagnóstico diferencial de massas abdominais e processos inflamatórios crônicos; com manejo adequado, o prognóstico é excelente.

Efficacy and safety of sensor-augmented pump therapy (SAPT) with predictive low-glucose management in patients diagnosed with type 1 diabetes mellitus previously treated with SAPT and low glucose suspend / Eficacia y seguridad del tratamiento con bomba de insulina con sensor (SAPT) con gestión predictiva de la hipoglucemia en pacientes con diagnóstico de diabetes mellitus tipo 1 tratados previamente con SAPT y suspensión por hipoglucemia

Background: Sensor-augmented insulin pump therapy (SAPT) with low-glucose suspend (LGS) is an effective and safe alternative for treating patients with type 1 diabetes mellitus (T1DM). New predictive low-glucose management (PLGM) systems decrease the severity and duration of hypoglycemic events. However, evidence of benefits in patients previously treated with SAPT-LGS is limited. Methods: A prospective before-after study was conducted in patients with T1DM treated with SAPT-LGS, who were switched to the Minimed(R) 640G system with SmartGuard(R) to assess the impact on A1c levels, severe hypoglycemia (SH), hypoglycemia unawareness (HU), and area under the curve (AUC) <70mg/dL after three months of follow-up. Results: Fifty-five patients with T1DM with a mean age of 37.9 (IQR 6, 79) years and a mean baseline A1c level of 7.52±1.11% were enrolled. After three months under PLGM, A1c levels significantly decreased to 7.18±0.91% (p=0.004). SH rate decreased from 2.47 (CI 0.44, 4.90) to 0.87 (CI 0.22, 1.52) events/patient-year (Incidence rate ratio 0.353, 95% CI 0.178, 0.637), AUC <70mg/dL decreased from 0.59±0.76 to 0.35±0.65mg/dL x minute (p=0.030). HU determined by Clarke questionnaire resolved in 23 out of 30 patients (p=0.002). Conclusions: This study suggests that SAPT with PLGM decreases the frequency of SH, HU, exposure to glucose levels below 70mg/dL, and A1c levels. Based on these results, this therapy should be considered in T1DM patients previously treated with SAPT-LGS with persistent SH and HU. Further clinical trials comparing the efficacy and safety of these features are required

Introducción: La terapia con bomba de insulina integrada a sistema de monitoreo continuo con suspensión en hipoglucemia (SAPT-LGS) es una alternativa efectiva y segura para el tratamiento en pacientes con diabetes tipo 1 (DM1). La función de suspensión antes del límite bajo (PLGM) reduce la gravedad y la duración de los eventos hipoglucémicos. Sin embargo, la evidencia del beneficio en pacientes tratados previamente con SAPT-LGS es limitada. Métodos: Se realizó un estudio longitudinal antes y después con pacientes DM1 tratados con SAPT-LGS que se cambiaron al sistema Minimed(R) 640G con SmartGuard(R), con el fin de evaluar el impacto en los niveles de A1c, hipoglucemia severa (HS), hipoglucemia asintomática (HA) y área bajo la curva (AUC) <70mg/dl después de tres meses de seguimiento. Resultados: Se incluyeron 55 pacientes con DM1, de 37.9 (IQR 6, 79) años, A1c basal de 7.52±1.11%. A los 3 meses bajo PLGM, la A1c se redujo significativamente a 7.18%±0.91% (p=0.004). La tasa de HS se redujo de 2.47 (CI 0.44,4.90) a 0.87 (CI 0.22,1.52) eventos/año del paciente (índice de incidencia 0.353 IC 95%, 0.178, 0.637), el AUC <70mg/dl se redujo de 0,59±0,76 a 0,35±0,65mg/dl x minuto (p = 0,030). HA determinado por el cuestionario Clarke resolvió en 23 de 30 pacientes (p=0,002). Conclusiones: Este estudio sugiere que PLGM reduce la frecuencia de HS, HA, la exposición a niveles de glucosa por debajo de 70mg/dl y A1c. Con base a estos resultados, esta terapia debería considerarse en pacientes con DM1 tratados previamente con SAPT-LGS que persisten con HS e HA. Se requieren ensayos clínicos adicionales que comparen la eficacia y la seguridad de estas características

Efficacy and safety of sensor-augmented pump therapy (SAPT) with predictive low-glucose management in patients diagnosed with type 1 diabetes mellitus previously treated with SAPT and low glucose suspend.

BACKGROUND: Sensor-augmented insulin pump therapy (SAPT) with low-glucose suspend (LGS) is an effective and safe alternative for treating patients with type 1 diabetes mellitus (T1DM). New predictive low-glucose management (PLGM) systems decrease the severity and duration of hypoglycemic events. However, evidence of benefits in patients previously treated with SAPT-LGS is limited. METHODS: A prospective before-after study was conducted in patients with T1DM treated with SAPT-LGS, who were switched to the Minimed® 640G system with SmartGuard® to assess the impact on A1c levels, severe hypoglycemia (SH), hypoglycemia unawareness (HU), and area under the curve (AUC) <70mg/dL after three months of follow-up. RESULTS: Fifty-five patients with T1DM with a mean age of 37.9 (IQR 6, 79) years and a mean baseline A1c level of 7.52±1.11% were enrolled. After three months under PLGM, A1c levels significantly decreased to 7.18±0.91% (p=0.004). SH rate decreased from 2.47 (CI 0.44, 4.90) to 0.87 (CI 0.22, 1.52) events/patient-year (Incidence rate ratio 0.353, 95% CI 0.178, 0.637), AUC <70mg/dL decreased from 0.59±0.76 to 0.35±0.65mg/dL x minute (p=0.030). HU determined by Clarke questionnaire resolved in 23 out of 30 patients (p=0.002). CONCLUSIONS: This study suggests that SAPT with PLGM decreases the frequency of SH, HU, exposure to glucose levels below 70mg/dL, and A1c levels. Based on these results, this therapy should be considered in T1DM patients previously treated with SAPT-LGS with persistent SH and HU. Further clinical trials comparing the efficacy and safety of these features are required.