Evidence map›Paper›PMID 28965312›Full record

ArticleClinical drug investigation2018

A Comparison of Adverse Drug Reaction Profiles in Patients on Antiretroviral and Antitubercular Treatment in Zimbabwe.

Josiah T Masuka, Precious Chipangura, Priscilla P Nyambayo, Andy Stergachis, Star Khoza

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Josiah T MasukaPharmacovigilance and Clinical Trials Division, Medicines Control Authority of Zimbabwe, 106 Baines Avenue, Harare, Zimbabwe.
Precious ChipanguraPharmacovigilance and Clinical Trials Division, Medicines Control Authority of Zimbabwe, 106 Baines Avenue, Harare, Zimbabwe.
Priscilla P NyambayoPharmacovigilance and Clinical Trials Division, Medicines Control Authority of Zimbabwe, 106 Baines Avenue, Harare, Zimbabwe.
Andy StergachisSchools of Pharmacy and Public Health, University of Washington, Box 357631, Seattle, WA, 98105, USA.
Star KhozaDepartment of Clinical Pharmacology, College of Health Sciences, University of Zimbabwe, P O Box A178, Avondale, Harare, Zimbabwe. skhoza@medsch.uz.ac.zw.

Funding

Global Fund to Fight AIDS, Tuberculosis and Malaria GF-OIG-13-012
6 · The paper itself

Abstract

introductionFew studies describe the adverse drug event profiles in patients simultaneously receiving antiretroviral and anti-tubercular medicines in resource-limited countries.

objectivesTo describe and compare the adverse drug reaction profiles in patients on highly active antiretroviral therapy only (HAART), HAART and isoniazid preventive therapy (HHART), and HAART and antitubercular treatment (ATTHAART).

methodsWe analysed individual case safety reports (ICSRs) for patients on antiretroviral therapy and antitubercular treatment submitted to the national pharmacovigilance centre during the targeted spontaneous reporting (TSR) programme from 1 September 2012 through 31 August 2016. All reports considered certain, probable or possible were included in the analysis.

resultsA total of 1076 ICSRs were included in the analysis. Most of the reports were from the HAART only group (n = 882; 82.0%), followed by patients on HHART (n = 132; 12.3%), and ATTHAART (n = 62; 5.7%). The ATTHAART (35.5%) and HHAART (34.1%) had a higher frequency of hepatic disorders than the HAART group (5.0%) (p < 0.0001). A higher frequency of rash was reported in the HHAART (35.6%) and HAART groups (29.4%) than the ATTHAART group (14.5%) (p = 0.011). Peripheral neuropathy occurred more frequently in the ATTHAART group (19.3%) than other groups (p = 0.001) while Stevens-Johnson syndrome (14.7%; p < 0.001), gynaecomastia (18.2%; p < 0.001), and lipodystrophy (4.5%; p = 0.012) occurred more frequently in the HAART group. The HHAART group was associated with a higher frequency of psychosis (4.5%; p = 0.002).

conclusionAntiretroviral therapy was associated with a higher frequency of Stevens-Johnson syndrome, gynaecomastia, and lipodystrophy. Co-administration of antiretroviral and antitubercular medicines was associated with a higher frequency of drug-induced liver injury and peripheral neuropathy. Similarly, co-administration of isoniazid preventive therapy and antiretroviral drugs was associated with a higher risk for psychosis. There is a need to carefully manage TB/HIV co-infected patients, due to the higher risk of adverse drug reactions which may lead to poor treatment adherence and outcomes.

Indexed as

AdolescentAdultAgedAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveAntitubercular AgentsChemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsExanthemaFemaleHIV InfectionsHumansLipodystrophyMaleMiddle AgedPeripheral Nervous System DiseasesAnti-HIV AgentsAntitubercular Agents

Identifiers

PMID28965312

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