Interchangeability among carbamazepine formulations: the impact over epilepsy patients

Abstract The treatment of epilepsy is complex and a matter of concern is the interchangeability among different formulations available for antiepileptic drugs. To evaluate the effects of interchangeability among carbamazepine formulations on patients with epilepsy. This is a prospective cohort study that included adult outpatients diagnosed with epilepsy and under pharmacological treatment with carbamazepine. Before switching the brand/manufacturer, the "Interchangeable Pharmaceutical Product in the Treatment of Epilepsies" questionnaire was applied. The questionnaires "Adverse Events Profile" and Quality of Life in Epilepsy-31, so as the plasma carbamazepine concentrations, were evaluated before and after the brand/ manufacturer switch. Physical-chemical tests aiming to assess tablets quality were performed in accordance with the Brazilian Pharmacopoeia 5th edition. The study population was composed by 14 patients (mean age: 44.6 years), with 10 of females. From those interviewed, 10 had no knowledge about the three antiepileptic drugs formulations available. The frequency of adverse event "problems with skin" incresead (p=0.023) and "upset stomach" decreased (p=0.041) after the changeover. The adverse events profile was associated with only two quality of life domains: "energy/fatigue" (p=0.048) and "total score" (p=0.018). Divergent results between generic and reference formulations were observed in purity-water test (reference: 1.96%, generic: 4.84%) and dissolution test, in which the generic formulation presented 66.27 to 85.77% of carbamazepine dissolved after the third level. Conclusions: Objective differences before and after the brand/manufacturer switch were not observed, in spite of patients' perceptions. Despite that, more studies in the field are necessary, especially on the interchangeability among generic antiepileptics, in order to better elucidate switching consequences on patients' life.

Prevalência de síndrome metabólica em mulheres acima de 40 anos de Divinópolis-MG / Prevalence of metabolic syndrome in women aged 40-59 years using two international criteria Prevalencia del síndrome metabólico en las mujeres de 40-59 años utilizando 2 criterios internacionales

Avaliar prevalência da síndrome metabólica (SM) em mulheres comparando critérios internacionais. Métodos: Estudo descritivo transversal envolvendo 93 mulheres, com idade entre 40 a 59 anos, acompanhadas em Unidades Básicas eProgramas de Saúde da Família de Divinópolis-MG. Foram realizadas avaliações clínicas, antropométricas e bioquímicas. Para o diagnóstico de SM foram empregados critérios internacionais: Adult Treatment Panel IIIof the National Cholesterol Education Program (NCEP/ATP III) e International Diabetes Federation (IDF), que utilizam a presença de três ou mais dos seguintes parâmetros alterados: circunferência da cintura (CC), triglicerídeos (TG), HDL,pressão arterial e glicemia. Resultados: 54 mulheres entre 40 a 49 anos (58,7%) e 39 entre 50 a 59 anos (41,3%). Parâmetro individual mais alterado foi CC para ambos os critérios. De acordo com NCEP/ATP III, 40,8% das participantes foram diagnosticadas com SM e 53,7% pelo IDF. Faixa etária de 50-59 apresentou maior prevalência de SM para ambos critérios. Demonstrou-se aumento de risco para SM com tabagismo, diabetes e hipertensão em ambos os critérios. Boa concordância entre os critérios da NCEP ATP III e IDF (k=0,74). Conclusão: IDF foi o critério com maior prevalência para SM e a faixa etária de 50-59 foi a mais crítica...

To evaluate the prevalence of metabolic syndrome (MS) in women compared to international criteria. Methods: Crosssectional descriptive study involving 93 women, aged 40 to 59 years, accompanied in Basic Units and Family HealthPrograms in Divinópolis-MG. Clinical, anthropometric and biochemical assessments were performed. Two International criteria were employedfor the diagnosis of MS: Adult Treatment Panel III of the National Cholesterol Education Program(NCEP/ATP III) and International Diabetes Federation (IDF), which use the presence of three or more of the following altered parameters: waist circumference (WC), triglycerides (TG), HDL, blood pressure and blood glucose. Results: 54women aged 40-49 years (58.7%) and 39 aged 50-59 (41.3%). The most altered individual parameter was the WC for both criteria. According to NCEP/ATP III, 40.8% of participants were diagnosed with MS and 53.7% by IDF. The age group 50-59 showed a higher prevalence of MS for both criteria. Increased risk for MS was demonstrated with smoking, diabetes and hypertension in both criteria. There was agreement between the criteria of NCEP/ATP III and IDF (k = 0.74). Conclusion: IDF criteria was most prevalent for SM and the age group of 50-59 was the most critical...

Evaluar la prevalencia de síndrome metabólico (SM) en las mujeres en comparación con los criterios internacionales. Métodos: estudio descriptivo transversal que involucró a 93 mujeres, entre 40 a 59 años, acompañadas por las UnidadesBásicas y Programas de Salud de la Familia de Divinópolis-MG. Se realizaron evaluaciones clínicas, antropométricas ybioquímicas. Para el diagnóstico de SM criterios internacionales se emplearon: del Programa National de Education porCholesterol - Panel de Tratamiento de Adultos III (NCEP/ATP III) y Federación Internacional de Diabetes (IDF), que utilizan la presencia de tres o más de los siguientes parámetros cambiados: circunferencia de la cintura (CC), triglicéridos (TG), HDL, presión arterial y glucosa enla sangre. Resultados: 54 mujeres de 40-49 años (58,7%) y 39 entre los 50 a 59 años (41,3%). Parámetroindividual más alterado fue CC en ambos criterios. Según NCEP/ATP III, el 40,8% de las participantes fueron diagnosticadas con SM y el 53,7% por IDF. Grupo de edadde 50-59 mostraronmayor prevalencia de SM por ambos criterios. Se demostrómayor riesgo de SM con el tabaquismo, la diabetes y la hipertensión arterial en ambos criterios.Hubo bastante concordancia entre los criterios del NCEP/ATP III y IDF (k = 0,74). Conclusión: criterios de IDF fueron más frecuentes para SM y el grupo de edad de 50 a 59 fue el más crítico...

Acetylcholinesterase inhibition starting from extracts of Bauhinia variegata L., Bauhinia var. candida (Aiton) Buch.-Ham., and Bauhinia ungulata L / Inibição de acetilcolinesterase a partir de extratos de Bauhinia variegata L., Bauhinia variegata var. candida (Aiton) Buch.-Ham., e Bauhinia ungulata L

INTRODUCTION: A treatment to the Alzheimer's disease consists inhibition of the acetylcholinesterase, which is responsible for the acetylcholine control in the synapses. METHODS: We have investigated the potential of inhibition of the acetylcholinesterase produced by hexane extracts of leaves, branches, and flowers from three Bauhinia specimens, which is based on the technique of thin layer chromatography and on identifying the organ of the plant that possesses larger concentration of inhibitors. RESULTS: Retention factor analysis shows values of 0.31aA, 0.31aA, and 0.46aB for flowers B. variegata, B. var. candida, and B. ungulata, respectively. CONCLUSIONS: The flower extract of B. ungulata is the most suitable for further studies on this inhibition.

INTRODUÇÃO: Um tratamento para a doença de Alzheimer consiste na inibição da acetilcolinesterase, responsável pelo controle de acetilcolina nas sinapses. MÉTODOS: Nós investigamos o potencial de inibição da acetilcolinesterase produzido por extratos hexânicos de folhas, ramos e flores de três espécimes de Bauhinia, realizado a partir da cromatografia em camada delgada e que órgão possui maior concentração de inibidores. RESULTADOS: Os fatores de retenção apresentaram 0,31aA, 0,31aA e 0,46aB para as flores de B. variegata, B. var. candida e B. ungulata respectivamente. CONCLUSÕES: O extrato de flores de B. ungulata é o mais satisfatório para futuros estudos desta inibição.

Acetylcholinesterase inhibition starting from extracts of Bauhinia variegata L., Bauhinia var. candida (Aiton) Buch.-Ham., and Bauhinia ungulata L.

INTRODUCTION: A treatment to the Alzheimer's disease consists inhibition of the acetylcholinesterase, which is responsible for the acetylcholine control in the synapses. METHODS: We have investigated the potential of inhibition of the acetylcholinesterase produced by hexane extracts of leaves, branches, and flowers from three Bauhinia specimens, which is based on the technique of thin layer chromatography and on identifying the organ of the plant that possesses larger concentration of inhibitors. RESULTS: Retention factor analysis shows values of 0.31aA, 0.31aA, and 0.46aB for flowers B. variegata, B. var. candida, and B. ungulata, respectively. CONCLUSIONS: The flower extract of B. ungulata is the most suitable for further studies on this inhibition.