Evidence map›Paper›PMID 26008986›Full record

ArticleDrug safety2015

Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study From Ethiopia.

Woldesellassie M Bezabhe, Luke R Bereznicki, Leanne Chalmers, Peter Gee, Desalew M Kassie, Mekides A Bimirew, Gregory M Peterson

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Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  8. Incidence and Predictors of Severe Adverse Drug Reactions among Patients on Antiretroviral Drugs in Harari Regional State, Eastern Ethiopia.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Woldesellassie M BezabheDivision of Pharmacy, School of Medicine, University of Tasmania, Private Bag 26, Hobart, TAS, 7001, Australia, mwoldesellassie@yahoo.com.
Luke R Bereznicki
Leanne Chalmers
Peter Gee
Desalew M Kassie
Mekides A Bimirew
Gregory M Peterson

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn Ethiopia, the use of antiretroviral therapy (ART) has been scaled up for HIV/AIDS over the past decade. Adverse drug reactions (ADRs) associated with ART pose a unique challenge in the treatment of the infection in this resource-limited setting.

objectivesThe aims of this study were to examine the incidence and nature of ADRs, identify the risk factors associated with the development of ADRs, and assess their impact on treatment outcomes.

methodsA prospective cohort study was conducted in adult patients (≥18 years of age) with HIV/AIDS who commenced ART. All ADRs in the first 12 months of therapy were recorded, and the severity, causality, and preventability assessed. The impact of severe ADRs on self-reported adherence, immunological, and body mass index (BMI) outcomes were assessed.

resultsOf the 211 patients included in the analysis, 181 (85.7 %) experienced at least one ADR and 66 (31.3 %) experienced at least one severe ADR within 12 months of commencing ART (incidence rates for any ADR and severe ADR of 14.8 and 3.2 per 100 person-months, respectively). Logistic regression analysis indicated that taking zidovudine-containing regimens (odds ratio [OR] 4.2, 95 % confidence interval [CI] 2.1-8.4) or being unemployed (OR 2.2, 95 % CI 1.1-4.3) were independent predictors of experiencing severe ADRs. Patients who experienced a severe ADR were less likely (OR 0.4, 95 % CI 0.2-0.9) to be ≥90 % adherent to ART. The mean gain in BMI was significantly lower in patients with severe ADRs after 3 and 12 months of therapy.

conclusionsADRs were common within the first 3 months in patients initiated on ART. Severe ADRs were negatively associated with self-reported adherence and gain in BMI. Measures need to be implemented to routinely monitor for severe ADRs to improve ART adherence and treatment outcomes.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsAnti-Retroviral AgentsBody Mass IndexChi-Square DistributionDrug-Related Side Effects and Adverse ReactionsEthiopiaFemaleHumansIncidenceLogistic ModelsMaleMedication AdherenceOdds RatioPharmacovigilanceProspective StudiesAnti-Retroviral AgentsZidovudine

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.