Adalimumab for maintenance therapy for one year in Crohn's disease: results of a Latin American single-center observational study

Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn's disease patients are scarce. The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn's disease patients. Retrospective, single-center, observational study of a Brazilian case series of Crohn's disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤ 4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05). Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033). Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

Regulatory issues on pharmacovigilance in Latin American countries

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.

Lipid levels in the second year of life among HIV-infected and HIV-exposed uninfected Latin American children

Background: Dyslipidemia is observed among older children and adults with HIV. We examined nonfasting cholesterol and triglycerides in two groups of 12-23-month-old Latin American children - HIV-infected vs. HIV-exposed but uninfected (HEU). Methods: HIV-infected and HEU children in Latin America and Jamaica were enrolled in an observational cohort. Eligibility for this analysis required having cholesterol and triglyceride results available during the second year of life. Results: HIV-infected (n = 83) children were slightly older at the time of lipid testing than the HEU (n 681). Forty percent of the HIV-infected children were on protease inhibitor-based antiretroviral therapy (ART); 41% were not on ART. There was no statistically significant difference in mean cholesterol concentrations (mg/dl) by HIV status; however, the HIV-infected children had higher mean triglyceride concentrations. The prevalence of high cholesterol (>200 mg/dl) and high triglycerides (>110 mg/dl) was higher among the HIV-infected vs. HEU. Among the HIV-infected children, mean cholesterol and triglyceride concentrations varied by ART. Children receiving no ART had a significantly lower mean cholesterol concentration. Those receiving protease inhibitor-containing ART had a significantly higher mean triglyceride concentration compared to the other two antiretroviral regimen groups. Conclusion: A greater proportion of HIV-infected children at 12-23 months have hyperlipidemia when compared to HEU children, with the highest triglyceride concentrations observed among those receiving protease inhibitor-containing ART, and the lowest cholesterol levels among those not receiving ART. Implications of these findings will require continued follow-up of HIV-infected children who initiate therapy early in life. (C) 2012 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins

Advancing the management of primary immunodeficiency diseases in Latin America: Latin American Society for Immunodeficiencies (LASID) Initiatives

Primary immunodeficiency diseases (PIDD) are associated with significant morbidity and mortality and result in a significant public health burden. This is in part due to the lack of appropriate diagnosis and treatment of these patients. It is critical that governments become aware of this problem and provide necessary resources to reduce this impact on health care systems. Leading physicians in their respective countries must be supported by their own governments in order to implement tools and provide education and thus improve the diagnosis and treatment of PIDD. The Latin American Society of Primary Immunodeficiencies (LASID) has initiated a large number of activities aimed at achieving these goals, including the establishment of a PIDD registry, development of educational programmes and guidelines, and the introduction of a PIDD fellowship programme. These initiatives are positively impacting the identification and appropriate treatment of patients with PIDD in Latin America. Nevertheless, much remains to be done to ensure that every person with PIDD receives proper therapy. (C) 2011 SEICAP. Published by Elsevier Espana, S.L. All rights reserved.

Birth weight, current body mass index, and insulin sensitivity and secretion in young adults in two Latin American populations

Background and aims: Although studies have shown association of birth weight (BW) and adult body mass index (BMI) with insulin sensitivity in adults, there is limited evidence that BW is associated with insulin secretion. We assessed the associations between BW and current BMI with insulin sensitivity and secretion in young Latin American adults. Methods and results: Two birth cohorts, one from Ribeirao Preto, Brazil, based on 1984 participants aged 23-25 years, and another from Limache, Chile, based on 965 participants aged 22-28 years were studied. Weight and height at birth, and current fasting plasma glucose and insulin levels were measured. Insulin sensitivity (HOMA%S) and secretion (HOMA%beta) were estimated using the Homeostatic Model Assessment (HOMA2). Multiple linear regression analyses were carried out to test the associations between BW and adult BMI z-scores on log HOMA%S and log HOMA%beta. BW z-score was associated with HOMA%S in the two populations and HOMA%beta in Ribeirao Preto when adult BMI z-score was included in the model. BW z-score was associated with decreasing insulin secretion even without adjusting for adult BMI, but only in Ribeirao Preto. BMI z-score was associated with low HOMA%S and high HOMA%beta. No interactions between BW and BMI z-scores on insulin sensitivity were shown. Conclusions: This study supports the finding that BW may affect insulin sensitivity and secretion in young adults. The effect size of BW on insulin status is small in comparison to current BMI. (C) 2010 Elsevier B.V. All rights reserved.

Latin American women's experiences with medical abortion in settings where abortion is legally restricted.

El aborto está legalmente restringido en la mayoría de América Latina donde 95 % de los 4.4 millones de abortos que se realizan anualmente son inseguros. El aborto con medicamentos es el uso de una droga o una combinación de drogas para interrupir el embarazo. Mifepristona seguida de misoprostol constituye el regimen más efectivo y recomendado. En los lugares donde no está disponible la mifepristona, se utiiza misoprostol solo. El aborto con medicamentos ha transformado radicalmente la práctica del aborto a nivel mundial, y particularmente en los contextos legalmente restrictivos. En América Latina, desde hace más de dos décadas, las mujeres utilizan el misoprostol para autoinducirse abortos. Este artículo resume los hallazgos de una revisión bibliográfica sobre las experiencias de las mujeres con el aborto con medicamentos en países latinoamericanos donde el aborto voluntario es ilegal. Las experiencias personales de las mujeres con el aborto con medicamentos son diversas y varían según el contexto, la edad, la historia reproductiva, el nivel socioeconómico y el conocimiento acerca del aborto con medicamentos así como las circunstancias físicas, emocionales y sociales que rodean el embarazo. Pero fundamentalmente, las experiencias están determinadas por la posibilidad de las mujeres de acceder a: 1) un aborto clandestino realizado bajo supervisión médica, o 2) información completa y precisa acerca del aborto con medicamentos, Otros factores clave incluyen el acceso a recursos económicos y apoyo emocional. Las mujeres valoran la seguridad y efectividad del aborto con medicamentos así como la privacidad que ofrece y la posibilidad de tener cerca a su pareja, amiga/o, o persona de su confianza durante el proceso. Las mujeres perciben al aborto con medicamentos como menos doloroso, más fácil, más seguro, más práctico, menos costoso, más natural y menos traumático que otros métodos abortivos. Que sea auto-inducido y que evite el procedimiento quirúrgico también son señalados como ventajas. Las principales desventajas identificadas son que es doloroso y que lleva tiempo para que se complete. Otros aspectos evaluados negativamente incluyen los efectos secundarios, el sangrado prolongado, la posibilidad de que no sea efectivo, y el hecho de que algunas mujeres eventualmente deban solicitar atención médica en una institución donde sean sancionadas por haberse practicado un aborto y hasta denunciadas a la policía.

JETRO and Japan's Postwar Export Promotion System: Messages for Latin American Export Promotion Agencies

This paper tries to explain how the Japanese postwar export promotion system worked and what kind of roles JETRO played in this system. Two case studies of JETRO's successful export promotion activities were also introduced. The paper also points out the themes to be solved by the TPO (Trade Promotion Organizations). Finally the paper shows four advices for Latin American Export Promotion Agencies, based upon JETRO's postwar experiences.