| Adverse drug reactions to antiretroviral therapy (ART): an experience of spontaneous reporting and intensive monitoring from ART centre in India. | |
| | |
MedLine Citation:
|
PMID: 20066675 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
PURPOSE: To assess the nature, severity, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for antiretroviral ADRs. METHODS: Enrolled ambulatory patients were intensively monitored for ADRs. Spontaneously reported ADRs by clinicians were also included. 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. Bivariate analysis and subsequently multivariate logistic regression were used to identify the risk factors for ADRs. Data from spontaneous reporting was assessed using Bayesian neural network method for possible ADR signals. RESULTS: Monitoring by active surveillance indentified 159 (52.82%) ADRs from 400 patients. One hundred and forty-two (47.17%) reactions were spontaneously reported. Anaemia and vomiting were the most commonly observed ADRs. The ADRs were severe in 10.9% of cases. A total of 88% ADRs were definitely/probably preventable. Use of Zidovudine+Lamivudine with Nevirapine or Efavirenz, CD4 <200 cells/microl, female gender, tuberculosis and illiteracy were observed as risk factors for ADRs by bivariate analysis. Concurrent tuberculosis was the only influential risk factor for development of ADRs identified by multivariate logistic regression. CONCLUSION: Prevalence of ADRs in intensively monitored patients was found to be 39.7%. Tuberculosis in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretrovirals in India, ADRs to antiretrovirals require monitoring and reporting. |
| | |
Authors:
|
Retty Rajan Modayil; Anand Harugeri; Gurumurthy Parthasarathi; Madhan Ramesh; Rajendra Prasad; Vasudeva Naik; Vamadeva Giriyapura |
Related Documents
:
|
17391745 - Prospective study of smoking and tuberculosis in india. 16553505 - Do angiotensin-converting enzyme inhibitors or angiotensin ii receptor blockers decreas... 12056515 - Pneumonia in multiple injured patients: a prospective controlled trial on early predict... 17533205 - Community-associated methicillin-resistant staphylococcus aureus skin and soft tissue i... 9086635 - An assessment of disaster risk and its management in thailand. 12579625 - Measuring health-related quality of life in women with urogenital dysfunction: the urog... |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Pharmacoepidemiology and drug safety Volume: 19 ISSN: 1099-1557 ISO Abbreviation: Pharmacoepidemiol Drug Saf Publication Date: 2010 Mar |
Date Detail:
|
Created Date: 2010-03-02 Completed Date: 2010-05-18 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9208369 Medline TA: Pharmacoepidemiol Drug Saf Country: England |
Other Details:
|
Languages: eng Pagination: 247-55 Citation Subset: IM |
Affiliation:
|
JSS College of Pharmacy, JSS University, Mysore 570 015, India. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adolescent Adult Adverse Drug Reaction Reporting Systems / statistics & numerical data* Ambulatory Care Anti-HIV Agents / adverse effects* Bayes Theorem Educational Status Female HIV Infections / complications, drug therapy* Humans India / epidemiology Logistic Models Male Middle Aged Multivariate Analysis Risk Factors Severity of Illness Index Sex Factors Tuberculosis / complications Young Adult |
| Chemical | |
Reg. No./Substance:
|
0/Anti-HIV Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: First trimester aneuploidy screening in the presence of a vanishing twin: implications for maternal ...
Next Document: Determination of amitraz and 2,4-dimethylaniline residues in honey by using LC with UV detection and...