'Centro de Investigaciones y Publicaciones Farmaceuticas (CIPF)'
Abstract
Objective: To assess the incidence, severity pattern,
causality, predictability and preventability of adverse
drug reactions (ADRs) and to identify risk factors for
adverse drug reactions in highly active antiretroviral
therapy.
Methods: Enrolled patients were intensively
monitored for ADRs to highly active antiretroviral
therapy. Predictability was assessed based on
history of previous exposure to the drug or literature
incidence of ADRs. Preventability was assessed
using Schumock and Thornton criteria and severity
was assessed using modified Hartwig and Siegel
scale. Multivariate logistic regressions were used to
identify the risk factors for ADRs.
Results: Monitoring of 130 retropositive patients by
active pharmacovigilance identified 74 ADRs from
57 patients. Anemia and hepatotoxicity were the
most commonly observed ADRs. The organ system
commonly affected by ADR was red blood cell
(21.4%).The ADRs were moderate in 77% of cases.
Type A reactions (77%) were more common. A total
of 10.8% ADRs were definitely preventable. The
incidence rate of ADRs (65.9%) was highest with
Zidovudine + Lamivudine + Nevirapine combination.
A total of 84% interruptions to highly active
antiretroviral therapy were due to toxicity. CD4 less
than 200 cells/ìl, female gender and tuberculosis
were observed as risk factors for ADRs.
Conclusion: Incidence of ADRs in intensively
monitored patients was found to be 43.8%. Anemia
in HIV patients is an influential risk factor for
occurrence of ADRs. With the increasing access to
antiretroviral in India, clinicians must focus on early
detection and prevention of ADRs to highly active
antiretroviral therapy.Objetivo: Evaluar la incidencia, gravedad,
causalidad y preventabilidad de las reacciones
adversas medicamentosas (RAM) e identificar los
factores de riesgo de esas RAM en terapias de
antiretrovirales altamente activos.
Metodos: Se monitorizo intensamente a los
pacientes incluidos a la busqueda de RAM. La
predecibilidad se evaluo con base en la historia de
exposiciones previas al medicamento o a la
incidencia de RAM en la literatura. La
preventabilidad se valoro usando los criterios de
Schumock y Thornton y la gravedad se evaluo
utilizando la escala modificada de Hartwig y
Siegel. Se utilizaron regresiones logisticas
multivariadas para identificar los factores de riesgo
de RAM.
Resultados: La monitorizacion retrospectiva de 130
pacientes mediante farmacovigilancia activa
identifico 74 RAM de 57 pacientes. Anemia y
hepatotoxicidad fueron las RAM mas comunmente
observadas. El sistema comunmente afectado por
las RAM fueron las celulas rojas sanguineas
(21,4%).
Las RAM fueron moderadas en el 77% de los
casos. Las reacciones tipo A fueron las mas
comunes. Un total del 10,8% de RAM fueron
definitivamente prevenibles. La incidencia de RAM
mas alta fue con la combinacion Zidovudina
+ Lamivudina + Nevirapina. Un 84% de las
interrupciones de terapias
antiretrovirales altamente activas fue debido a la
toxicidad. Se observaron como factores de riesgo
de RAM un CD4 en menos de 200 cel, el genero
femenino y la tuberculosis.
Conclusion: La incidencia de RAM en pacientes
intensivamente monitorizados fue del 43,8%. La
anemia en pacientes con VIH es u7n factor d e
riesgo de influencia en la aparicion de RAM. Con
el creciente uso de antiretrovirales en India, los
clinicos deben centrar la atencion en la deteccion
temprana y la prevencion de RAM de terapias
antiretrovirales altamente activos