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PURPOSE: Acromegaly and neuroendocrine tumors are rare diseases that, under certain conditions, can be treated with somatostatin analogs. The aim was to determine the prescription patterns of somatostatin analogs in a group of patients with acromegaly and neuroendocrine tumors affiliated with the Colombian Health System. METHODS: A retrospective study. A cohort of patients from a drug dispensing database that collected all prescriptions of long-acting somatostatin analogs (octreotide, lanreotide, pasireotide). Sociodemographic variables, clinical variables (diagnosis and comorbidities) and pharmacological therapy variables (dose, changes, persistence of use, comedications) were considered. RESULTS: A total of 213 patients were identified, including 139 (65.3%) with acromegaly and 74 (34.7%) with neuroendocrine tumors. There was a predominance of women (58.7%) and a mean age of 59.7 ± 14.5 years. The most commonly used medications were lanreotide autogel (n = 107; 50.2%), octreotide LAR (n = 102; 47.9%) and pasireotide LAR (n = 4; 1.9%). During follow-up, 11.3% of patients experienced modifications of therapy, with a mean duration from the beginning of treatment to the change in medication of 25 ± 15.9 months. A total of 48.9% of the patients with acromegaly and 87.1% of individuals with neuroendocrine tumors received maximum approved doses of the drug. CONCLUSION: Patients with acromegaly and neuroendocrine tumors in Colombia are mainly women and are most frequently treated with lanreotide autogel for acromegaly and with octreotide LAR for neuroendocrine tumors. In addition, a high proportion are managed with maximum doses of long-acting somatostatin analogs.

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Resumen Introducción: la promoción de la salud psicofísica y la seguridad del uso responsable de los antihipertensivos es una necesidad para mejorar la calidad y esperanza de vida del paciente. Objetivo: indagar la relación de factores de riesgo que influyen en la farmacoseguridad del uso de antihipertensivos en un grupo de adultos mayores con enfermedad cardiovascular. Metodología: estudio cuantitativo exploratorio transversal descriptivo. Se aplicó el instrumento Sistema de Dispensación para usuarios Crónicos en validación a 45 adultos mayores entre 50 y 88 años con diagnóstico clínico de enfermedad cardiovascular durante 2015. Resultados: el ANOVA multifactorial con el paquete estadístico IBM SPSS 2016, evidenció relación estadística alta F (1) = 27,43; p< 0,001 entre los factores de riesgo, la no adherencia e ineficacia del uso antihipertensivo. El análisis comparativo de la diferencia de media entre la no adherencia al tratamiento y la media de la farmacoterapia eficaz e ineficaz, reveló una diferencia muy alta t (1) = 421.59, p< 0,001. Conclusiones: Este estudio muestra la necesidad de fomentar la práctica cotidiana de la promoción de la salud al adulto mayor, a fin de lograr una presión arterial estable y la prevención de algún evento y/o problema relacionado al uso del antihipertensivo que pueda incidir en el efecto terapéutico y en el bienestar del paciente.

Abstract Introduction: The promotion of psychophysical health and the safety of the responsible use of antihypertensive drugs, is a necessity to improve the quality and life expectancy of the patient. Objective: To explore the relationship of risk factors that influence the pharma security for the use of antihypertensive drugs by a group of older adults with cardiovascular disease. Methodology: Descriptive cross-sectional exploratory quantitative study. The Dispensing System for Chronic Users instrument was applied during 2015 in validation to 45 older adults with a clinical diagnosis of cardiovascular disease aged between 50 and 88 years old. Results: The multifactorial ANOVA with the statistical package IBM SPSS 2016, showed a high statistical relationship F (1) = 27.43; p< 0.001 between risk factors, non-adherence and ineffectiveness of antihypertensive use. The comparative analysis of the mean difference between non-adherence to treatment and the mean of effective and ineffective pharmacotherapy, revealed a very high difference t (1) = 421.59, p< 0.001. Conclusions: This study shows the need to encourage the daily practice of health promotion in the elderly, in order to achieve a stable blood pressure and the prevention of any event and/or problem related to the use of anti-hypertensive drugs that may affect the therapeutic effect and on the well-being of the patient.

Resumo Introdução: a promoção da saúde psicofísica e a segurança do uso responsável dos anti-hipertensivos é uma necessidade para melhorar a qualidade e esperança de vida do paciente. Objetivo: achar a relação de fatores de risco que influem na confiança nos fármacos dos pacientes que usam anti-hipertensivos em um grupo de adultos maiores com doença cardiovascular. Metodologia: estudo quantitativo exploratório transversal descritivo. Aplicou-se o instrumento Sistema de Dispensação para usuários Crónicos em validação a 45 adultos maiores entre 50 e 88 anos com diagnóstico clínico de doença cardiovascular durante 2015. Resultados: o ANOVA multifatorial com o pacote estatístico IBM SPSS 2016, evidenciou relação estatística alta F (1) = 27,43; p< 0,001 entre os fatores de risco, a não aderência e ineficácia o uso anti-hipertensivo. A análise comparativa da diferença de média entre a não aderência ao tratamento e a média da farmacoterapia eficaz e ineficaz, revelou uma diferença muito alta t (1) = 421.59, p< 0,001. Conclusões: Este estudo amostra a necessidade de fomentar a prática cotidiana da promoção da saúde ao adulto maior, a fim de obter uma pressão arterial estável e a prevenção de algum evento e/ou problema relacionado ao uso do anti-hipertensivo que possa incidir no efeito terapêutico e no bem-estar do paciente.

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Introducción: El nimotuzumab es un anticuerpo monoclonal empleado en el tratamiento de pacientes con tumor cerebral. Dada su novedad se justifica la realización de estudios de farmacovigilancia que avalen su seguridad. Objetivo: Caracterizar los eventos adversos relacionados con este medicamento en la práctica médica habitual. Métodos: Se realizó un estudio descriptivo y transversal de 41 pacientes con tumor cerebral primario tratados con nimotuzumab en el Departamento de Ensayos Clínicos del Hospital Provincial Docente Saturnino Lora Torres de Santiago de Cuba, desde mayo de 2017 hasta abril de 2019. Resultados: En la serie se identificaron 31 eventos adversos, de los cuales 17 eran conocidos y 14 desconocidos. Predominaron la cefalea (80,5 %), la debilidad en miembros inferiores (48,8 %) y la fosfatasa alcalina elevada (41,5 %). Cabe destacar que el total de los efectos no deseados se consideraron ligeros, según su intensidad; reversibles, según sus resultados y sin cambios, según la actitud respecto al medicamento. Conclusiones: Las características de los eventos adversos encontrados se asemejan a las descritas en otros estudios que también avalan la seguridad del fármaco.

Introduction: The nimotuzumab is a monoclonal antibody used in the treatment of patients with cerebral tumor. The realization of pharmaco surveillance studies that guaranteed its security is justified given its new features. Objective: To characterize the adverse events related to this medicine in the habitual medical practice. Methods: A descriptive and cross-sectional study of 41 patients with primary cerebral tumor treated with nimotuzumab in the Clinical Trial Department of Saturnino Lora Torres Teaching Provincial Hospital was carried out in Santiago de Cuba, from May, 2017 to April, 2019. Results: In the series 31 adverse events were identified, of which 17 were known and 14 were unknown. There was a prevalence of the headache (80.5 %), weakness in lower members (48.8 %) and the high alcaline phosphatase (41.5 %). It is necessary to highlight that all the non wanted effects were considered light according to the intensity; reversible, according to the results and without changes, according to the attitude regarding the medicine. Conclusions: The characteristics of the adverse events that were found resemble to those described in other studies that also guarantee the security of the drug.

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OBJECTIVES: We sought to determine the relationship between in-hospital mortality and the neutrophil-to-lymphocyte ratio (NLR) in patients with ST-elevation myocardial infarction (STEMI) undergoing with pharmaco-invasive strategy (PIS). BACKGROUND: Increased levels of white blood cells have been associated with adverse clinical outcomes in patients with (STEMI). NLR has recently emerged as a potent and more specific prognostic marker in predicting short- and long-term mortalityin patients undergoing primary percutaneous coronary intervention. This association has never been reported in patients managed with PIS. METHODS: Between March 2010 and October 2016, 1860 STEMI patients managed with PIS were consecutively included in a dedicated database. The study population was divided into tertiles based on the admission NLR values (lower: <4.0, intermediate: 4.0 to <7.3, and upper: ≥7.3). Co-primary endpoints were in-hospital mortality and MACE (death, non-fatal reinfarction or stent thrombosis). RESULTS: Patients in the upper NLR tertile had significantly higher in-hospital mortality (9.0% vs. 4.8% versus. 1.8%, p < 0.001) and MACE (11.6% vs. 8.0% versus 2.9%, p < 0.001) than patients with intermediate or low NLR. By multivariable logistic regression analysis, the upper NLR tertile was an independent predictor of MACE (odds radio [OR] 4.19, 95% confidence interval [95% CI] 2.23-7.88, p < 0.001) and in-hospital mortality [OR 3.32, 95% CI 1.19-9.28, p = 0.02]. CONCLUSION: High NLR values were independently associated with in-hospital MACE and death in STEMI patients submitted to a PIS. NLR might be a simple and useful risk stratification tool in this high-risk population.

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El SARS-CoV-2, agente causal de la actual pandemia de la COVID-19, va sufriendo mutaciones como consecuencia de su ciclo evolutivo, lo que ha originado diferentes variantes genéticas, que han sido agrupadas en dos categorías: preocupante (alfa o británica, beta o sudafricana, gamma o brasileña y delta o india) y de interés (lamdba, mu, épsilon, eta, iota, kappa, zeta, theta); estas conllevan implicaciones clínicas en la transmisibilidad, virulencia y resistencia del SARS-CoV-2 a la inmunidad natural y adquirida, lo que representa un serio desafío para los servicios de salud en todo el mundo. En este artículo se describen dichas variantes genéticas, con énfasis en su probable impacto clínico, y además se plantea la posibilidad de que aparezcan otras, como fenómeno natural en la evolución de los virus.

The SARS-CoV-2, causal agent of the COVID-19 current pandemic, is suffering mutations as a consequence of its evolutive cycle, what has originated different genetic variants that have been grouped in two categories: worrying (alpha or British, beta or South African, gamma or Brazilian and delta or Indian) and of interest (lamdba, mu, epsilon, eta, iota, kappa, zed, theta); these categories bear clinical implications in the transmissibility, virulence and resistance from SARS-CoV-2 to the natural and acquired immunity, what represents a serious challenge in health services worldwide. These genetic variants are described in this work, with emphasis in its probable clinical impact, and the possibility that other variants could appear is also explained, as natural phenomenon in the evolution of viruses.

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RESUMEN Objetivo: Identificar las características clínicas de los pacientes con gota y la forma de utilización de los medicamentos antigotosos en Colombia. Métodos: Estudio de corte transversal en el que se analizaron 310 historias clínicas de pacientes atendidos en el último trimestre del 2016 y que recibieron un medicamento antigotoso. Se identificaron variables sociodemográficas, clínicas, farmacológicas, comorbilidades y paraclínicas. Para cada medicamento antigotoso se determinó si el uso fue según las recomendaciones aprobadas por la Federal Drug Administration (FDA). Se realizaron análisis descriptivos, bivariados y multivariados. Resultados: Se evaluaron pacientes de 14 diferentes ciudades de Colombia, con un predominio masculino del 70,3% (n = 218) y una mediana de edad de 64 arios (RIC: 26-94 arios). El antigotoso más frecuentemente utilizado fue alopurinol (n = 255; 82,3%), seguido de colchicina (n = 54; 17,4%). Los diagnósticos hallados como indicación fueron: hiperuricemia (n = 181; 58,4%), gota (n = 34; 11%), artritis gotosa (n = 28; 9%). El 74,5% (n = 231) de las prescripciones tenía un uso aprobado según la FDA, especialmente alopurinol en el manejo de gota e hiperuricemias, mientras que colchicina se encontró siendo utilizada en indicaciones no aprobadas (n = 44; 81,4%). Las comorbilidades más frecuentes fueron hipertensión (68,4%) y dislipidemia (55,8%). Conclusiones: Los pacientes con gota en tratamiento farmacológico tienen una elevada frecuencia de comorbilidades cardiovasculares, y están siendo tratados con alopurinol para la prevención a largo plazo, mientras que una menor proporción recibe colchicina que comúnmente es utilizada para indicaciones no aprobadas por las agencias reguladoras.

ABSTRACT Objective: To identify the clinical characteristics of patients with gout, and the prescription patterns of anti-gout medications in Colombia. Methods: Cross-sectional study, that analysed the data from 310 medical records of patients treated in the last quarter of 2016, and who received an anti-gout medication. Sociodemographic, clinical, pharmacological, comorbidities, and paraclinical variables were identified. For each anti-gout drug used, it was determined whether the use was in accordance with Federal Drug Administration (FDA) approved recommendations. Descriptive, bivariate and multivariate analyses were performed. Results: Patients from 14 different cities in Colombia were evaluated, with a male predominance of 70.3% (n = 218) and a median age of 64 years (RIC: 26-94 years). The most frequently used anti-gout medication was allopurinol (n = 255; 82.3%), followed by colchicine (n = 54; 17.4%). The main diagnoses found as an indication were: hyperuricaemia (n=181, 58.4%), gout (n = 34; 11.0%), and gouty arthritis (n = 28; 9.0%). Almost three-quarters (74.5%; n = 231) of the prescriptions had an approved use according to the FDA, especially allopurinol in the management of gout and hyperuricaemia, while colchicine was found to be used in unapproved indications (n = 44, 81.4%). The most frequent comorbidities were hypertension (68.4%) and dyslipidaemia (55.8%). Conclusions: Patients with gout who are under pharmacological treatment have a high frequency of cardiovascular comorbidities. They were being treated with allopurinol for long-term prevention, while a smaller proportion received colchicine, which is often used for indications not approved by regulatory agencies.

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Introducción: El impacto de la prescripción inapropiada de fármacos en el anciano ha llevado al desarrollo de métodos para su reducción en varias partes del mundo. Objetivo: Diseñar y validar los criterios de medicación potencialmente inapropiada en el anciano, adaptados al entorno sociosanitario de Cuba. Métodos: Se realizó una investigación cualitativa, en la cual los criterios fueron validados por medio de la metodología Delphi, por un comité de expertos (especialistas en medicina geriátrica y clínica de diferentes zonas geográficas del país), y se les calculó la consistencia interna mediante el coeficiente alfa de Cronbach. Resultados: Los criterios quedaron estructurados en tres listas: 1) medicación potencialmente inapropiada, medicamento indicado no prescripto, cuando no existe contraindicación para su uso; 2) medicación potencialmente inapropiada independiente del diagnóstico o la condición clínica; 3) medicación potencialmente inapropiada dependiente del diagnóstico o la condición clínica. Conclusiones: Se demostró la validez del contenido y la adecuada consistencia interna de los criterios diseñados para la identificación de medicación potencialmente inapropiada en el anciano.

Introduction: The impact of inappropriate prescription of medication in the elderly has led to the development of methods for its reduction in several parts of the world. Objective: To design and validate the medication approaches potentially inappropriate in the elderly, adapted to the socio-sanitary environment of Cuba. Methods: A qualitative investigation was carried out, in which the approaches were validated by means of the Delphi methodology, by an experts committee (specialists in geriatrics medicine and clinic from different geographical areas of the country), and the internal consistency was calculated by means of the alpha coefficient of Cronbach. Results: The approaches were structured in three lists: 1) potentially inappropriate medication, advised medication non prescribed, when contraindication doesn't exist for its use; 2) medication potentially inappropriate, independent from the diagnosis or clinical condition; 3) potentially inappropriate medication, depending on the diagnosis or clinical condition. Conclusions: The validity of the content and the appropriate internal consistency of the designed approaches for the medication identification potentially inappropriate in the elderly were demonstrated.

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Resumen Varón de 33 años con antecedentes de convulsiones febriles y discapacidad intelectual moderada grave, inició a los 2 años convulsiones tanto focales como generalizadas atónicas diarias, que ocasionaron traumas faciales. Debido a la farmacorresistencia se implantó un estimulador del nervio vago, con respuesta parcial al mismo. Durante su seguimiento, se hizo diagnóstico de enfermedad celíaca. Al realizar una tomografía de encéfalo se evidenciaron calcificaciones piriformes occipitales bilaterales, estableciéndose el diagnostico de enfermedad celiaca, epilepsia y calcificaciones cerebrales. Se le indicó dieta libre de gluten y continuar el tratamiento farmacológico, logrando de esta manera una reducción de las crisis.

Abstract A 33-year-old man with a history of febrile seizures and moderate-severe intellectual disability began, at 2 years, both focal and generalized daily atonic seizures, which caused facial trauma. Due to drug resistance, a vagus nerve stimulator was implanted, with partial response to it. During his follow-up, he was diagnosed with celiac disease. When performing a brain tomography, bilateral occipital pyriform calcifications were evidenced, establishing the diagnosis of celiac disease, epilepsy and cerebral calcifications. A gluten-free diet was indicated and pharmacological treatment continued, thus achieving a reduction in seizures.

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A 33-year-old man with a history of febrile seizures and moderate-severe intellectual disability began, at 2 years, both focal and generalized daily atonic seizures, which caused facial trauma. Due to drug resistance, a vagus nerve stimulator was implanted, with partial response to it. During his follow-up, he was diagnosed with celiac disease. When performing a brain tomography, bilateral occipital pyriform calcifications were evidenced, establishing the diagnosis of celiac disease, epilepsy and cerebral calcifications. A gluten-free diet was indicated and pharmacological treatment continued, thus achieving a reduction in seizures.

Varón de 33 años con antecedentes de convulsiones febriles y discapacidad intelectual moderada grave, inició a los 2 años convulsiones tanto focales como generalizadas atónicas diarias, que ocasionaron traumas faciales. Debido a la farmacorresistencia se implantó un estimulador del nervio vago, con respuesta parcial al mismo. Durante su seguimiento, se hizo diagnóstico de enfermedad celíaca. Al realizar una tomografía de encéfalo se evidenciaron calcificaciones piriformes occipitales bilaterales, estableciéndose el diagnostico de enfermedad celiaca, epilepsia y calcificaciones cerebrales. Se le indicó dieta libre de gluten y continuar el tratamiento farmacológico, logrando de esta manera una reducción de las crisis.

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BACKGROUND: In 2020 Colombia may expect to have close to 231,700 patients with neovascular age-related macular degeneration (ARMD). Treatment of neovascular ARMD involves the sequential Intra-vitreal injections of anti-vascular endothelial growth factor (anti-VEGF therapy) medications. The efficacy and safety of anti-VEGF therapy on a treat-and-extend (T&E) dosing scheme are similar when ranibizumab or aflibercept are administered. Objective : A cost-minimization analysis from the payer`s perspective in Colombia projects treatment expenses of anti-VEGF therapy using aflibercept or ranibizumab on T&E regimens for the treatment of neovascular ARMD. Methods : A model projects the expenses of the compared treatment regimens for two and five-year periods beginning on February 2020. The model used information from clinical trials, case series and meta-analyses on the compared treatment regimens, demographic, epidemiologic and economic data originated from the Colombian government sources. A 3% discount rate was applied. Results : Projected cost differences in favor of ranibizumab after two and five-year treatment periods beginning February 2020 could be close to U.S. $ 4,861 and U.S $ 7,241 per treated eye, respectively. If all patients with unilateral and bilateral neovascular ARMD in Colombia were to receive appropriate anti-VEGF therapy for two years, the projected expected cost difference in favor of ranibizumab could be close to U.S. $ 462,717,092 dollars. Conclusion : Within the Colombian healthcare setting anti-VEGF therapy on a T&E regimen utilizing ranibizumab for neovascular ARMD may be cost-saving compared with employing aflibercept. Despite cost favorability, ranibizumab should not be the only therapeutic option since in clinical practice alternatives are required.

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