Design and development of a mobile app of drug information for people with visual impairment.

BACKGROUND: People with visual impairment presents difficulties to access the labels information of medicines. In this sense, technological tools can contribute to improve access to this information and the appropriate use of medicines in this population. However, currently, in Colombia, there are no tools to facilitate this process. OBJECTIVE: To design and development of a mobile app of drug information for people with visual impairment, which allows them to access information for the appropriate use of medicines. METHODS: A user-centered design process is carried out in four phases was used: a) Identification the needs and barriers for appropriate use of medicines; b) Lifting of requirements, c) Interface design and prototyping, and development of the mobile app, and d) Usability test. RESULTS: The study involved 48 people with visual disability, of which 69% required assistance for the use of medicines. The main barriers identified were access to information and dosing. A total of ten user requirements were identified, based on these and international accessibility standards FarmaceuticApp was designed and developed, incorporating the problems that were identified in the usability test. CONCLUSION: A mobile app of drug information for people with visual impairment using a user-centered design process was designed and developed, highlighting the importance of involving the users and other stakeholders in the design and development m-health technologies. FarmaceuticApp could contribute to the appropriate use of medicines and improve therapeutic adherence, as well as autonomy and independence in people with visual impairment.

[The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2015-2017]. / Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2015-2017.

BACKGROUND: The pharmacokinetics of anti-retrovirals (ARVs) can be modified by other concomitant medicinal products. It is timely to update the interactions between new ARVs and drugs of chronic use to maintain therapeutic success. AIM: To update information about drug interactions in patients with HIV/AIDS on antiretroviral therapy. METHODS: Comprehensive literature review in MEDLINE/PubMed database from January of 2015 to June of 2017, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into levels according to seriously and probability of occurrence. RESULTS: 466 articles were identified; full text was accessed in 444. Of these, 164 provided interactions, which allowed the identification of a total of 534 pairs of drug interactions. The interactions that presented a higher risk of generating safety and effectiveness problems were 308 (57.7%) of level 2 and 35 (6.6%) of level 1. CONCLUSIONS: We identify 534 new pairs of drug interactions, of which 308 (64.2%) are the most clinically relevant.

Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2015-2017 / The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2015-2017

Resumen Introducción: La farmacocinética de los anti-retrovirales (ARVs) puede ser modificada por otros medicamentos de uso concomitante. Es oportuno actualizar las interacciones entre nuevos ARVs y fármacos de uso crónico para mantener un éxito terapéutico. Objetivo: Actualizar información sobre interacciones medicamentosas en pacientes con infección por VIH/SIDA en terapia antiretroviral. Método: Revisión estructurada en MEDLINE/ PubMed utilizando los términos Mesh: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions, entre enero de 2015 y junio de 2017. Fueron seleccionadas publicaciones sobre interacciones medicamentosas en humanos, en inglés o español y con acceso a texto completo. Además, se incluyeron referencias de artículos considerados relevantes. La inclusión de los artículos fue evaluada por tres investigadores independientes y, en caso de requerirlo, por consenso entre ellos. La relevancia clínica se estableció, acorde con la gravedad y probabilidad de ocurrencia de la interacción. Resultados: Se identificaron 466 artículos, se accedió a texto completo a 444. De éstos, 164 aportaron interacciones, lo que permitió identificar un total de 534 parejas de interacciones medicamentosas. Las interacciones que presentaron un mayor riesgo de generar problemas de seguridad y efectividad fueron 308 (57,7%) de nivel 2 y 35 (6,6%) de nivel 1. Conclusiones: Se identifican 534 parejas nuevas de interacciones medicamentosas, de ellas 308 (64,2%) de mayor relevancia clínica.

Background: The pharmacokinetics of anti-retrovirals (ARVs) can be modified by other concomitant medicinal products. It is timely to update the interactions between new ARVs and drugs of chronic use to maintain therapeutic success. Aim: To update information about drug interactions in patients with HIV/AIDS on antiretroviral therapy. Methods: Comprehensive literature review in MEDLINE/PubMed database from January of 2015 to June of 2017, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into levels according to seriously and probability of occurrence. Results: 466 articles were identified; full text was accessed in 444. Of these, 164 provided interactions, which allowed the identification of a total of 534 pairs of drug interactions. The interactions that presented a higher risk of generating safety and effectiveness problems were 308 (57.7%) of level 2 and 35 (6.6%) of level 1. Conclusions: We identify 534 new pairs of drug interactions, of which 308 (64.2%) are the most clinically relevant.

Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2009-2014 / The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2009-2014

Objective: To update information about drug interactions in patients with HIV/AIDS. Methods: Comprehensive literature review in MEDLINE/PubMed database from May of 2009 to December of 2014, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into four levels according to seriously and probability of occurrence. Results: Global, 546 different references were retrieved and 243 were selected. In addition 11 further manuscripts were identified in the references of the included articles. Overall, 935 pairs of drug interactions were identified, 95.7% pharmacokinetic (823 by enzyme induction or inhibition and 67 by changes in bioavailability). Of the 935 pairs of drug interactions, 402(43%) were classified as levels 1 or 2. Conclusions: The most clinically relevant antiretroviral drug interactions are due to pharmacokinetic mechanism, mainly induction or enzyme inhibition, according to previous reviews, the protease inhibitors remain as the antiretrovirals with the highest number of clinical relevant interactions.

Objetivo: Actualizar información sobre interacciones medicamentosas en pacientes con VIH/SIDA. Métodos: Revisión estructurada en MEDLINE/PubMed utilizando los términos Mesh: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions, entre mayo de 2009 y diciembre de 2014. Publicaciones sobre interacciones medicamentosas, en humanos, en inglés o español y con acceso a texto completo fueron seleccionadas. Además, se incluyeron referencias de artículos considerados relevantes. La inclusión de los artículos fue evaluada por tres investigadores independientes y, en caso de requerirlo, por consenso entre ellos. La relevancia clínica se estableció en cuatro niveles, acorde con la gravedad y probabilidad de ocurrencia de la interacción. Resultados: Se identificaron 546 artículos, de los cuales se seleccionaron 273; además, se incluyeron 11 referencias relevantes. Se identificaron 935 parejas de interacciones medicamentosas, 95,7% farmacocinéticas. De este grupo, 823 mediadas por inducción o inhibición enzimática y 67 por cambios en la biodisponibilidad. De las 935 parejas de interacciones, 402 (43%) fueron relevantes clínicamente (niveles 1 o 2). Conclusiones: Las interacciones medicamentosas con anti-retrovirales de mayor relevancia clínica se deben a mecanismos farmacocinéticos, principalmente inducción o inhibición enzimática. Acorde con revisiones previas, los inhibidores de proteasa continúan siendo los anti-retrovirales con mayor número de interacciones relevantes.

Aproximación para establecer y evaluar la relevancia clínica de las interacciones medicamentosas en el tratamiento de pacientes infectados con virus de hepatitis C genotipo 1: Revisión estructurada / A Structured Review of Approaches for Establishing and Evaluating Clinical Relevance of Drug Interactions in Patients with Hepatitis C Virus Genotype 1

Objetivo: establecer y evaluarla relevancia clínica de interacciones medicamentosas en el tratamiento de pacientes con hepatitis C genotipo 1. Método: se realizó una búsqueda en PubMed/MedLine de artículos publicados en inglés y en español, desde el diciembre de 2004 a diciembre de 2014, utilizando los términos Mesh: Hepatitis C AND drug interactions OR herb-drug interactions OR food-drug interactions, de estudios realizados en humanos. Además, la búsqueda se complementó con la revisión, en el mismo período, sobre interacciones de antiretrovirales y hepatitis C en humanos, utilizando los términos Mesh: (Anti-retroviral agents AND Hepatitis C AND drug interactions OR herb-drug interactions OR food-drug interactions). La relevancia clínica de las interacciones medicamentosas se definió y evaluó con base a la probabilidad de ocurrencia y la gravedad de la interacción. Resultados: se identificaron 228 artículos, de los que se pudo acceder al texto completo en 212. De estos, 62 aportaban interacciones, lo que permitió identificar 128 parejas de IM, de las cuales 120 (93,7%) fueron farmacocinéticas y 8 (6,3%) farmacodinámicas. Por su parte, de estas 128 parejas, 2 (1,6%) fueron valoradas de nivel 1: 110 (53,7%) de nivel 2; 16 (7,8%) de nivel 3; y 0 (0%) de nivel 4. Además, se identificaron 78 parejas agrupadas como interacciones con evidencia de ausencia de relevancia clínica. Conclusiones: más del 90% de las interacciones medicamentosas de relevancia clínica son farmacocinéticas asociadas a cambios del metabolismo hepático, el telaprevir fue el medicamento con mayor número de interacciones.

Objective: Our objective was to establish and evaluate the clinical relevance of drug interactions in the treatment of patients with hepatitis C genotype 1. Method: We searched for articles published in English and Spanish from December 2004 to December 2014 in PubMed/MedLine. We used the following Medical Subject Headings (MESH): Hepatitis C and drug interactions OR herb-drug interactions OR food-drug interactions studies performed in humans. We conducted an additional complementary search for articles published in the same period about interactions of anti-retroviral and hepatitis C in humans using the following MESH: (Anti-retroviral agents AND Hepatitis C and drug interactions OR herb-drug interactions OR food -drug interactions). The clinical relevance of drug interactions was defined and evaluated based on the probability of occurrence and severity of interaction. Results: We identified 228 articles. Of these, it was possible to read the full text of 212. Of these, 62 contributed interactions which allowed us to identify 128 pairs of drug interactions, of which 120 (93.7%) were pharmacokinetic and 8 (6.3%) pharmacodynamic. Of these 128 pairs, two (1.6%) were rated Level 1: 110 (53.7%) were Level 2, 16 (7.8%) were Level 3, and 0 (0%) were Level 4. In addition, 78 pairs were identified that were grouped as interactions with evidence of absence of clinical significance. Conclusions: More than 90% of clinically relevant drug interactions are pharmacokinetic interactions associated with hepatic metabolism. Telaprevir has the greatest number of interactions.

[The clinical relevance of drug interactions in patients with human immunodeficiency virus infection: update 2009-2014]. / Relevancia clínica de las interacciones medicamentosas en pacientes infectados con el virus de la inmunodeficiencia humana: actualización 2009-2014.

OBJECTIVE: To update information about drug interactions in patients with HIV/AIDS. METHODS: Comprehensive literature review in MEDLINE/PubMed database from May of 2009 to December of 2014, using the Mesh terms: Anti-retroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full text were retrieved. Additionally, citation lists from identified articles were reviewed. The study inclusion was assessed by three independent researchers and by consensus among them when was necessary. Clinical relevance of drug interaction was grouped into four levels according to seriously and probability of occurrence. RESULTS: Global, 546 different references were retrieved and 243 were selected. In addition 11 further manuscripts were identified in the references of the included articles. Overall, 935 pairs of drug interactions were identified, 95.7% pharmacokinetic (823 by enzyme induction or inhibition and 67 by changes in bioavailability). Of the 935 pairs of drug interactions, 402(43%) were classified as levels 1 or 2. CONCLUSIONS: The most clinically relevant antiretroviral drug interactions are due to pharmacokinetic mechanism, mainly induction or enzyme inhibition, according to previous reviews, the protease inhibitors remain as the antiretrovirals with the highest number of clinical relevant interactions.

Randomized clinical trial of lovastatin in HIV-infected, HAART naïve patients (NCT00721305).

BACKGROUND: Evidence suggests that statins may modify the immune response against HIV. The aim was to evaluate the antiretroviral and immunomodulatory effects of lovastatin in HIV-infected patients, naïve for antiretroviral therapy. METHODS: Randomized, double-blinded, placebo-controlled, phase-II clinical trial. Primary outcomes were plasma viral load and circulating CD4+ T cell count, after 6 and 12 months of treatment; secondary outcomes were CD8+ T cell count, expression of activation markers (CD38 and HLA-DR) on T cells, and clinical outcomes. With a power of 90% to detect both a decrease of 0.3 log10 in plasma HIV-1 RNA copies and an increase of 20% in the CD4+ T cell count, we estimated a required sample size of 110 HIV-infected patients (55 per group). The results were analyzed by a model of repeated measurements using Generalized Estimating Equations. RESULTS: Patients were randomized to receive either lovastatin (n = 55) or placebo (n = 57). During the 12-month follow-up, there was no effect of lovastatin either on viral load (estimated average change = 0.157 copies/mL; CI 95% = -0.099 to 0.414), or on the CD4+ T cell count (estimated average change = -26.1 cells/µL; CI 95% = -89.8 to 37.6). Moreover, there were no significant differences in secondary outcomes. CONCLUSIONS: Daily administration of lovastatin (40 mg) for one year in HIV-infected patients, naïve for antiretroviral therapy, had no significant effect on HIV replication, the CD4+ T cell count, or the activation level of T cells. (www.clinicaltrials.gov; ID NCT00721305).

Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study): a phase-II randomized clinical trial.

BACKGROUND: Highly active antiretroviral therapy produces a significant decrease in HIV-1 replication and allows an increase in the CD4 T-cell count, leading to a decrease in the incidence of opportunistic infections and mortality. However, the cost, side effects and complexity of antiretroviral regimens have underscored the immediate need for additional therapeutic approaches. Statins exert pleiotropic effects through a variety of mechanisms, among which there are several immunoregulatory effects, related and unrelated to their cholesterol-lowering activity that can be useful to control HIV-1 infection. METHODS/DESIGN: Randomized, double-blinded, placebo controlled, single-center, phase-II clinical trial. One hundred and ten chronically HIV-1-infected patients, older than 18 years and naïve for antiretroviral therapy (i.e., without prior or current management with antiretroviral drugs) will be enrolled at the outpatient services from the most important centres for health insurance care in Medellin-Colombia. The interventions will be lovastatin (40 mg/day, orally, for 12 months; 55 patients) or placebo (55 patients). Our primary aim will be to determine the effect of lovastatin on viral replication. The secondary aim will be to determine the effect of lovastatin on CD4+ T-cell count in peripheral blood. As tertiary aims we will explore differences in CD8+ T-cell count, expression of activation markers (CD38 and HLA-DR) on CD4 and CD8 T cells, cholesterol metabolism, LFA-1/ICAM-1 function, Rho GTPases function and clinical evolution between treated and not treated HIV-1-infected individuals. DISCUSSION: Preliminary descriptive studies have suggested that statins (lovastatin) may have anti HIV-1 activity and that their administration is safe, with the potential effect of controlling HIV-1 replication in chronically infected individuals who had not received antiretroviral medications. Considering that there is limited clinical data available on this topic, all these findings warrant further evaluation to determine if long-term administration of statins may benefit the virological and immunological evolution in HIV-1-infected individuals before the use of antiretroviral therapy is required. TRIAL REGISTRATION: Registration number NCT00721305.

Respuesta: Relevancia clínica de las interacciones medicamentosas / Reply: Clinical significance of drug interactions

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[Clinical relevance of drug interactions]. / Interacciones medicamentosas: aproximación para establecer y evaluar su relevancia clínica.

The identification, prevention, and solution of drug interactions are a critical aspect to achieved desired pharmacotherapy goals. The purpose of this review was to organize information about drug interactions, and to develop an approach to identify and evaluate drug interactions considered clinically relevant. Data for this review were identified by search of MEDLINE and PubMed and references cited in relevant articles. <> plus <>, <> or <> were searched in titles or in abstracts. Only papers published in English and Spanish from January of 1996 to June of 2006 and in humans were reviewed. We reviewed the type and mechanism of drug interactions, and we highlight those associated to changes in the systemic clearance or in the bioavailability. So, we provide an approach to evaluate and use the clinical relevance of drug interactions complemented with a classification based on the severity and probability of its occurrence.

Interacciones medicamentosas: aproximación para establecer y evaluar su relevancia clínica / Clinical relevance of drug interactions

La identificación, prevención y tratamiento de las interacciones medicamentosas clínicamente relevantes son aspectos fundamentales en la farmacoterapia. En este trabajo se ha pretendido sistematizar la información y desarrollar una propuesta para establecer y evaluar la relevancia clínica de las interacciones medicamentosas. Se realizó una revisión bibliográfica en Medline y PubMed, y en las referencias de los artículos considerados relevantes. En los títulos y resúmenes de los artículos se buscó el término «interacciones medicamentosas» combinado con «relevante clínicamente», «relevancia clínica» o «relevante significativamente». Se incluyeron las publicaciones realizadas en humanos, en inglés o español, entre enero de 1996 y junio de 2006. Se presentan el tipo y mecanismo de las interacciones medicamentosas, especialmente las asociadas a cambios en el aclaramiento sistémico y en la biodisponibilidad; se propone una secuencia de pasos a seguir para establecer la relevancia clínica de las interacciones y una clasificación basada en la gravedad y probabilidad de aparición

The identification, prevention, and solution of drug interactions are a critical aspect to achieved desired pharmacotherapy goals. The purpose of this review was to organize information about drug interactions, and to develop an approach to identify and evaluate drug interactions considered clinically relevant. Data for this review were identified by search of MEDLINE and PubMed and references cited in relevant articles. «Drug interactions» plus «clinical relevance», «clinically relevant» or «significantly relevant» were searched in titles or in abstracts. Only papers published in English and Spanish from January of 1996 to June of 2006 and in humans were reviewed. We reviewed the type and mechanism of drug interactions, and we highlight those associated to changes in the systemic clearance or in the bioavailability. So, we provide an approach to evaluate and use the clinical relevance of drug interactions complemented with a classification based on the severity and probability of its occurrence