Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America.

OBJECTIVE: Our objective was to describe the risk of hospital admission for virologically confirmed dengue (VCD) and the risk of clinically severe hospitalized VCD occurring up to 4 years after the first dose (years 1 to 4) in three randomized clinical trials comparing tetravalent dengue vaccine with placebo. METHODS: The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies. RESULTS: Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42-0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged ≥9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged <9 years, particularly in those aged 2-5 years, there were more hospitalized VCD cases compared with the control participants in Year 3 but not in Year 4. The overall RR in those aged <9 years for Year 1 to Year 4 was 0.786 (95% CI 0.60-1.03), with a higher protective effect in the 6-8 year olds than in the 2-5 year olds. CONCLUSIONS: The overall benefit-risk remained positive in those aged ≥9 years up to year 4, although the protective effect was lower in years 3 and 4 than in years 1 and 2.

[Migraine: implications for work, disability and request for health services in Colombia]. / Migraña: implicaciones laborales, discapacidad y solicitud de servicios de salud en Colombia.

INTRODUCTION: Migraine causes problems of public health and work. OBJECTIVES: To describe the pharmaco economic impact of migraine in Colombia. PATIENTS AND METHODS: The sample group was made up of patients aged between 18 and 65 years diagnosed as having migraine according to the criteria of the International Headache Society. We made a descriptive study of migraine in Colombian patients recruited from five international multicentric clinical trials who responded to a questionnaire on: 1. Frequency of migraine attacks. 2. Days or hours of work lost through migraine. 3. Requests for health services. 4. Occupation of participants. For the statistical analysis we used descriptive techniques of resumption of frequencies, and also non parametric statistics in order to describe how their work was affected. RESULTS: 82% of the patients complained of from one to four migraine attacks per month. 64% considered that migraine had adversely affected between one and twenty hours of work per month. No differences were seen between paid and unpaid work. 15% of the patients lost more than one day of paid work and 36% more than one day of unpaid work in the month prior to the questionnaire. 52% of the patients requested at least one medical consultation for migraine during the year of the questionnaire; 42% consulted the emergency services at least once and 43% did not consult the health services at all. CONCLUSIONS: These epidemiological and socio economic data are important for a rational approach to the implementation of health resources and to assure effective management of the disorder.

Migraña: implicaciones laborales, discapacidad y solicitud de servicios de salud en Colombia / Migraine; implicatiosn for work, disability and request for health services in Colombia

Introducción. La migraña constituye un problema de salud pública y de carácter laboral. Objetivo. Describir el impacto farmacoeconómico de la migraña en Colombia. Pacientes y métodos. La muestra la constituyen pacientes de entre 18 y 65 años con diagnóstico de migraña según los criterios de la International Headache Society.Se trata de un estudio descriptivo de migraña en pacientes colombianos reclutados en ensayos clínicos multicéntricos internacionales, quienes respondieron un cuestionario acerca de: 1. Frecuencia de crisis migrañosas; 2. Días y horas de trabajo perdidos por migraña; 3. Solicitud de servicios de salud; 4. Ocupación de los participantes.El análisis estadístico utilizó técnicas descriptivas de resumen de frecuencias, y también estadísticas no paramétricas con el fin de describir cómo se ve afectado el trabajo. Resultados. El 82 por ciento de los pacientes presentaron entre una y cuatro crisis migrañosas al mes. El 64 por ciento de los pacientes refirieron que la migraña les había afectado negativamente de 1 a 20 horas de trabajo en el último mes. No se encontraron diferencias entre el trabajo remunerado y el no remunerado. El 15 por ciento de los pacientes perdieron más de un día de trabajo remunerado y el 36 por ciento de los pacientes perdieron más de un día de trabajo no remunerado durante el mes previo a la encuesta.Un 56 por ciento de los pacientes solicitaron por lo menos una consulta médica debido a la migraña en el año de la encuesta, el 42 por ciento consultaron por lo menos una vez al servicio de urgencias y el un 43 por ciento nunca consultó a servicios de salud. Conclusiones. Los presentes datos epidemiológicos y socioeconómicos son importantes para proporcionar un enfoque racional para la implementación de recursos de salud y para asegurar un manejo ificaz de la enfermedad (AU)