Blood glucose related adverse drug reaction of antitumor monoclonal antibodies: a retrospective analysis using Vigibase

Abstract On the increasing prevalence of using mAbs (monoclonal antibodies) in cancer therapy and the severe risk of hyperglycemia, we aimed to analyze the main clinical ADRs of mAbs, with a focus on adverse hyperglycemic events associated with currently clinically used mAbs. mAbs as well as target information were selected from Martinadale book and published articles. Drug approving information was collected from each government website, and ADR statistic data were collected from VigibaseR, comparing with Adverse Event Reporting System of US FDA. Top 10 mAbs were classified within listing in total ADR records, ADRs per year, hyperglycemic ADR records. Vigibase data were updated onto 15 Feb 2019. 20 mAbs were analyzed with 263217 ADR reports, wherein 16751 records on Metabolism and nutrition disorders and 1444 records on Glucose metabolism disorders. The geographic, age, gender distributions and annual ADR report numbers were listed respectively. Of the top 10, Rituximab, Bevacizumab and Nivolumab were on the top 3 in total ADR record and hyperglycemic record. Top 3 record results were similar in Vigibase and FDA database. It is of increasing importance for clinicians to be aware of early detection, patient management, or drug selection strategies when using mAbs, particularly within the high glycemic risk-reported mAbs, to improve the efficacy and tolerability of mAbs regiment and optimize patient outcomes.

Thyroid volume in patients with glucose metabolism disorders / Volume da tiroide em pacientes com alterações do metabolismo da glicose

Objective Thyroid volume and the prevalence of thyroid nodules are higher in patients with insulin resistance. A relationship between thyroid volume and glucose metabolism disorders (GMD) has not as yet been clarified. The present retrospective study aimed to investigate the association between GMD and thyroid volume. Subjects and methods: We investigated the data of 2,630 patients who were evaluated for thyroid biopsy in our hospital. The study population included 602 patients with GMD, 554 patients with diabetes mellitus (DM) and 1,474 patients with normal glucose metabolism as a control group. We obtained the levels of serum thyroid stimulating hormone (TSH) and the thyroid volumes of those patients retrospectively. Results The median ages for the control group, GMD group and DM group were 55 (15‐91) years, 60 (27‐97) years, and 65 (27‐91) years respectively and there was a statistically significant difference between the groups with regard to age and gender (p<0.001). Levels of TSH were similar in all groups. The median total thyroid volumes for patients with DM and GMD were significantly higher than that of the control group [22.5 (3‐202) mL, 20.2 (4‐190) mL, and 19.2 (3‐168) mL respectively, p≤0.001 for all parameters]. Also the median total thyroid volume for patients with DM was significantly higher than that of the GMD group (p<0.001). According to the correlation analysis, thyroid volume was significantly correlated with age (r=0.92, p<0.001) and TSH (r=0.435, p<0.001). Age, gender, TSH levels, GMD and DM diagnosis were independently correlated with thyroid volume. Conclusion The thyroid gland is one of the target tissues of metabolic disorders. We reported a positive correlation between GMD/type 2 DM and thyroid volume. Further controlled, prospective, randomized studies on this subject are required to gain more information. .

Objetivo O volume da tiroide e a prevalência de nódulos tiroidianos são mais altos em pacientes com resistência à insulina. A relação entre o volume da tiroide e os transtornos do metabolismo da glicose (TMG) ainda não foi elucidada. O objetivo do presente estudo retrospectivo foi investigar a associação entre os TMG e o volume da tiroide. Sujeitos e métodos: Analisamos os dados de 2.630 pacientes que foram avaliados para biópsia de tiroide em nosso hospital. A população estudada incluiu 602 pacientes com TMG, 554 pacientes com diabetes melito (DM) e 1.474 pacientes com metabolismo normal da glicose, como grupo controle. As concentrações de hormônio tireoestimulante (TSH) e os volumes da tiroide para esses pacientes foram obtidos de forma retrospectiva. Resultados As idades medianas para o grupo controle, grupo TMG e grupo DM foram 55 (15‐91), 60 (27‐97) e 65 (27‐91) anos, respectivamente, e houve diferença estatisticamente significativa entre os grupos com relação à idade e ao gênero (p<0,001). Os níveis de TSH foram similares em todos os grupos. A mediana do volume total da tiroide para pacientes com DM e TMG foi significativamente maior do que para os pacientes do grupo controle [22,5 (3‐202) mL, 20,2 (4‐190) mL, e 19,2 (3‐168) mL, respectivamente, p≤0,001 para todos os parâmetros]. Além disso, a mediana do volume total da tiroide para pacientes com DM foi significativamente maior do que no grupo TMG (p<0,001). De acordo com a análise de correlação, o volume da tiroide foi significativamente correlacionado com a idade (r=0,92; p<0,001) e TSH (r=0,435; p<0,001). A idade, o gênero, a concentração de TSH e o diagnóstico de TMG e DM se correlacionaram com o volume da tiroide de forma independente. Conclusão A tiroide ...

Síndrome metabólico: prevalencia y factores de riesgo en escolares / Metabolic syndrome: prevalence and risk factor in school age children

El síndrome metabólico (SM) en niños se diagnóstica con la presencia de tres ó más de los siguientes criterios: Obesidad abdominal > p90, presión arterial sistólica y/o diastólica > p95, triglicéridos > p95, HDL-C < p5, según edad y sexo; y alteraciones de la glicemia en ayunas > 100mg/dl. Determinar la prevalencia y los factores de riesgo para síndrome metabólico en los escolares de 6 a 12 años de la Escuela Básica Bolivariana “Moruy” en el Municipio Falcón del Estado Falcón, mayo-agosto 2006. Es un estudio descriptivo, transversal, exploratorio, no experimental, con muestra probabilística de 80 estudiantes de ambos sexos; determinándoles presión arterial, circunferencia abdominal, peso, talla, perfil lipídico y glicemia en ayunas. De la población estudiada, en 13,7 por ciento se evidenció presión arterial elevada, 11,2 por ciento obesidad abdominal, 11,3 por ciento sobrepeso y obesidad corporal, 3,7 por ciento estrías cutáneas, 1,2 por ciento acantosis nigricans, 3,7 por ciento hipertrigliceridemia, 13,7 por ciento HDL-C bajo, 6,2 por ciento alteraciones de la glicemia en ayunas. La prevalencia total de SM fue de un 3.7 por ciento. La totalidad de la población estudiada presentó al menos un factor de riesgo (familiar, perinatal y/o obstétrico y personal) para SM, mientras que la prevalencia de SM se ubicó en 3,7 por ciento.

The metabolic syndrome (MS) in children is diagnosed with the presence of three or more of the following criteria: abdominal obesity > p90, blood pressure systolic/diastolic > p95, triglycerides > p95, HDL-C < p5, according to gender and age, and fasting glucose alterations > 100 mg/dl. Objective: To determine the prevalence and the risks factors for ms in students 6-12 years old of the Bolivarian Basic School “Moruy” in the municipality of Falcón, state of Falcon, Venezuela. Methods: It is a descriptive, transversal, exploratory, not experimental study, with a probabilistic sample of 80 students; the following parameters were measured: blood pressure, waist circumference, weight, size, serum lipids and fasting glucose. Results: 13.7% of the total population presented high blood pressure, 11.2% abdominal obesity, 11.3% were overweigth or presented corporal obesity, cutaneous striates were present in 3.7%, acantosis nigricans in 1.2%, hipertriglyceridaemia in 3.7%, low HDL-C in 13.7%, fasting glucose was elevated in 6.2% and the total prevalence of MS was 3.7%. The total studied population presented at least one risk factor (familiar, perinatal/obstetric and personal) for MS. The total prevalence of MS was 3.7%.