Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naïve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012.

BACKGROUND: Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients. METHODS: A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians. RESULTS: Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm3) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk. CONCLUSIONS: The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. TRIAL REGISTRATION: Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.

[Clinical relevance of drug interactions between nonsteroidal antiinflammatory drugs (NSAIDs) and antihypertensives]. / Relevancia clínica de las interacciones medicamentosas entre antiinflamatorios no esteroideos y antihipertensivos.

OBJECTIVE: To establish the clinical relevance of drug interactions between nonsteroidal antiinflammatory drugs (NSAIDs) and antihypertensives, based on the interaction severity and probability of occurrence. DESIGN: Systematic review. DATA SOURCES: A PubMed/Medline search was made using the MeSH terms: NSAIDs, Antihypertensive drugs, and Drug interactions. DATA EXTRACTION: Articles between 2002 and 2012, human studies, in Spanish and English and full text access were included. Found articles were included and some of the references used in this works. Studies with in vitro methods, effects on ocular hypertension and those who do not consider the interaction NSAIDs, antihypertensives were excluded. For the selection of the papers included three independent reviewers were involved. We used a tool for data extraction and for assess of the interaction clinical relevance. RESULTS: Nineteen of 50 papers found were included. There were identified 21 interactions with pharmacodynamic mechanism, classified by their clinical relevance in level-2 high risk (76.2%) and level-3 medium risk (23.8%). In addition, evidence of 16 combinations of no interaction were found. CONCLUSIONS: Some NSAIDs may attenuate the effectiveness of antihypertensive drugs when used concurrently, especially with angiotensin converting enzyme inhibitors, diuretics, beta blockers and angiotensin receptorsii blockers. There was no evidence of effect modification of calcium channel antagonists, especially dihydropyridine, by concurrent use of NSAIDs.

Patrones de prescripción de medicamentos para la diabetes mellitus tipo 2 en cinco departamentos de Colombia, en 2014 / Patterns of Medicine Prescriptions for Diabetes Mellitus Type 2 in five Departments of Colombia in 2014 / Padrões de prescrição de medicamento para a Diabetes Mellitus tipo 2 em cinco departamentos da Colômbia em 2014

Resumen Objetivos: Describir los patrones de prescripción de los medicamentos para la diabetes mellitus tipo 2 (DM2) y comorbilidades de pacientes atendidos en cinco instituciones prestadoras de servicios de salud de Colombia. Metodología: Estudio descriptivo transversal, en el cual se revisaron las historias clínicas de 5098 pacientes con DM2, atendidos en centros de atención ambulatoria ubicados en cinco ciudades colombianas entre el 1.º de enero y el 31 de diciembre de 2014. Cada uno de los pacientes con DM2 tenía al menos dos consultas ambulatorias registradas durante el periodo de estudio. La recolección de la información se hizo mediante una encuesta electrónica. Para la categorización de los medicamentos se usaron las guías nacionales e internacionales para el tratamiento de la diabetes. El análisis de los datos fue realizado utilizando el programa IBM SPSS® Statistics versión 21. Resultados: El medicamento de más frecuente prescripción fueron las biguanidas (59 %) y las sulfonilureas (28 %). La prescripción de inhibidores de la dipeptidil peptidasa-4 fue 7 % y la frecuencia de prescripción de agonista del receptor del péptido similar al glucagón tipo 1 (AR GLP-1) fue de 2 %. El medicamento con mayor frecuencia de prescripción como monoterapia fueron las biguanidas (22 %). La combinación más frecuente fue biguanida y las sulfonilureas (21 %), seguida de biguanida e insulina (10 %), y otras combinaciones. El 27 % pacientes con DM2 no recibió ningún tratamiento farmacológico para la diabetes. Con respecto a los medicamentos para comorbilidades, el 52 % de los pacientes utiliza al menos un tipo de antihipertensivo, el 39 % usa al menos un tipo de hipolipemiante y el 35 % utiliza ácido acetilsalicílico. Conclusiones: Las biguanidas fueron el medicamento con mayor frecuencia de prescripción, seguido de las sulfonilureas. Uno de cada cuatro pacientes no tenía registro de prescripción de medicamentos. El uso de ácido acetilsalicílico como prevención del riesgo cardiovascular fue menor al esperado.

Abstract Objetive: to describe the patterns of medicine prescriptions for diabetes mellitus type 2 (dm2) and the comorbidity of patients in five health care institutions in Colombia. Methodology: descriptive cross-sectional study carried out checking the medical records of 5098 patients with dm2 treated at the outpatient service centers in five Colombian cities between January 1 and December 31 of 2014. Each patient with dm2 had a record of at least two outpatient appointments registered during the time of this study. The information was collected through electronic surveys. National and international guides on diabetes treatment were used to categorize the medications. The spss® 21 software was used to analyze the data. Results: the most frequently prescribed medications were biguanides (59%) and sulfonylureas (28%). The prescription of inhibitors for Dipeptidyl peptidase-4 was 7% and the frequency of prescription of glucagon-like peptide-1 receptor agonists (ar glp-1) was 2%. The medication with the highest frequency of prescription as monotherapy were biguanides (22%). The most frequent combination was biguanide and sulfonylureas (21%). The second most frequent combination was biguanide with insulin (10%), and other combinations. 27% of patients with dm2 did not receive any pharmacological treatment for diabetes. Regarding the medicines for comorbidity, 52% of patients use at least one type of antihypertensive drug, 39% use at least one type of hypolipidemic drug and 35% uses acetylsalicylic acid. Conclusions: biguanides were the most frequently prescribed medication, sulfonylureas came after. One in four patients did not have a record of medicine prescription. The prescription of acetylsalicylic acid to prevent cardiovascular risk was lower than expected.

Resumo Objetivo: descrever os padrões de prescrição dos medicamen tos para a Diabetes Mellitus tipo 2 (dm2) e de comorbilidades de pacientes atendidos em cinco instituições de serviço de saú de da Colômbia. Metodologia: estudo descritivo transversal, no qual revisaram-se as histórias clínicas de 5098 pacientes com dm2, atendidos em centros de atendimento ambulatorial localizados em cinco cidades colombianas, entre 1 de janeiro e 31 de dezembro de 2014. Cada paciente com dm2 tinha pelo menos duas consultas ambulatoriais registradas durante o pe ríodo do estudo. A informação coletou-se através de inquérito eletrônico. Para a categorização dos medicamentos, utiliza ram-se os guias nacionais e internacionais para o tratamento da diabete. A análise dos dados realizou-se utilizando o progra ma spss® 21. Resultados: os medicamentos de prescrição mais frequente foram biguanidas (59%) e as sulfoniluréias (28%). A prescrição de inibidores da dipeptidil peptidase IV foi 7% e a frequência de prescrição de agonista do receptor do péptido si milar ao glucagão tipo 1 (ar glp-1) foi de 2%. O medicamento com mais frequência de prescrição como monoterapia foi as biguanidas (22%). A combinação mais frequente foi biguanida e sulfoniluréias (21%). A segunda combinação mais frequente foi biguanida com insulina (10%), e outras combinações. 27% dos pacientes com dm2 não recebeu tratamento farmacológi co nenhum para a diabetes. Respeito dos medicamentos para comorbilidades, 52% dos pacientes utiliza pelo menos um tipo de anti-hipertensivo, 39% utiliza pelo menos um tipo de hi polipemiante e 35% utiliza ácido acetilsalicílico. Conclusões: as biguanidas foram o medicamento com mais frequência de prescrição, e depois as sulfoniluréias. Um de quatro pacientes não rinha registro de prescrição de medicamentos. O uso de ácido acetilsalicílico como prevenção do risco cardiovascular foi menor do que se esperava.

Relevancia clínica de las interacciones medicamentosas entre antiinflamatorios no esteroideos y antihipertensivos / Clinical relevance of drug interactions between nonsteroidal antiinflammatory drugs (NSAIDs) and antihypertensives

OBJETIVO: Establecer la relevancia clínica de las interacciones medicamentosas reportadas entre antiinflamatorios no esteroideos (AINE) y antihipertensivos basándose en la gravedad y la probabilidad de ocurrencia de la interacción. DISEÑO: Revisión sistemática. Fuentes de datos: Se realizó una búsqueda en PubMed/Medline utilizando los términos Mesh: NSAIDs, Antihypertensive drugs y Drug interactions. Extracción de datos Se incluyeron publicaciones entre 2002 y 2012 de estudios en humanos, en español e inglés y con acceso a texto completo. Fueron incluidos los artículos que la búsqueda arrojó y algunas de las referencias usadas en dichos trabajos. Fueron excluidos los trabajos con métodos in vitro, con efectos sobre la hipertensión ocular y aquellos que no consideraran la interacción AINE-antihipertensivos. Para la selección de los trabajos incluidos participaron 3 revisores independientes. Se usó una herramienta especialmente diseñada para la extracción de datos y análisis de la relevancia clínica de la interacción. RESULTADOS: Se incluyeron 19 artículos de los 50 encontrados. Allí se identificaron 21 interacciones de mecanismo farmacodinámico, clasificadas por su relevancia clínica en nivel 2 (riesgo alto; 76,2%) y nivel 3 (riesgo medio; 23,8%). Adicionalmente se encontró evidencia de 16 combinaciones que no presentaron interacción. CONCLUSIONES: Algunos AINE pueden disminuir la efectividad del tratamiento antihipertensivo cuando se utilizan simultáneamente con antihipertensivos, en especial con inhibidores de la enzima conversora de angiotensina, diuréticos, bloqueadores beta y antagonistas de los receptores de angiotensina. No se encontró evidencia de la modificación del efecto de los antagonistas de los canales de calcio, especialmente dihidropiridínicos, por el uso simultáneo con AINE

OBJECTIVE: To establish the clinical relevance of drug interactions between nonsteroidal antiinflammatory drugs (NSAIDs) and antihypertensives, based on the interaction severity and probability of occurrence. DESIGN: Systematic review. Data sources: A PubMed/Medline search was made using the MeSH terms: NSAIDs, Antihypertensive drugs, and Drug interactions. Data extraction: Articles between 2002 and 2012, human studies, in Spanish and English and full text access were included. Found articles were included and some of the references used in this works. Studies with in vitro methods, effects on ocular hypertension and those who do not consider the interaction NSAIDs, antihypertensives were excluded. For the selection of the papers included three independent reviewers were involved. We used a tool for data extraction and for assess of the interaction clinical relevance. RESULTS: Nineteen of 50 papers found were included. There were identified 21 interactions with pharmacodynamic mechanism, classified by their clinical relevance in level-2 high risk (76.2%) and level-3 medium risk (23.8%). In addition, evidence of 16 combinations of no interaction were found. CONCLUSIONS: Some NSAIDs may attenuate the effectiveness of antihypertensive drugs when used concurrently, especially with angiotensin converting enzyme inhibitors, diuretics, beta blockers and angiotensin receptors II blockers. There was no evidence of effect modification of calcium channel antagonists, especially dihydropyridine, by concurrent use of NSAID

Efectividad y seguridad del esquema genérico lamivudina/zidovudina/efavirenz en pacientes VIH (+). Estudio fase IV y comparación con el mismo esquema de medicamentos innovadores / Effectiveness and safety of generic lamivudine/zidovudine/efavirenz in HIV (+) patients. Phase IV study and comparison with generic and innovator drugs

Antecedentes: El fortalecimiento de la política de productos competidores (genéricos) se puede acompañar de interrogantes sobre la calidad y, por tanto, sobre la efectividad de algunos de estos medicamentos. Los estudios fase IV son una opción válida para valorar la efectividad y seguridad de estos medicamentos. Objetivos: Valorar la efectividad y seguridad del esquema genérico Lamivudina/Zidovudina/Efavirenz en pacientes con VIH/SIDA que no han recibido terapia antirretroviral, que son atendidos en un programa de atención integral ambulatoria especializada, y comparar estos resultados con los datos de eficacia y seguridad reportados en un estudio de referencia (que utiliza el mismo esquema de medicamentos innovadores y fue realizado con pacientes con condiciones similares). Métodos: Se realizó un estudio clínico abierto no controlado del tipo fase IV. Se valoró la efectividad (disminución de carga viral en plasma y aumento de linfocitos CD4+) y seguridad (reacciones adversas) del esquema genérico Lamivudina/Zidovudina/Efavirenz durante 12 meses en pacientes mayores de 18 años VIH (+), que no habían recibido terapia antirretroviral y con indicación para recibirla. Los seguimientos clínicos y el seguimiento farmacoterapéutico fueron utilizados como estrategias de valoración y recolección de datos. Los resultados fueron comparados con los resultados reportados en un estudio referencia, contrastando la hipótesis de no inferioridad de dichos resultados. Resultados: El estudio incluyó 47 pacientes, de los cuales 33 estuvieron presentes hasta el final del estudio. Al año de tratamiento, en 28 pacientes (el 85%) la carga viral (valorada por indetectabilidad de las copias de RNAm viral/mL) alcanzó una disminución estadísticamente significativa, mientras que en 30 pacientes (el 91%) el recuento de linfocitos T-CD4+ mayor a 200 células/mm3 alcanzó un aumento progresivo y estadísticamente significativo. Para la comparación se halló un artículo que cumplió con...