Evidence map›Paper›PMID 36424607›Full record

ArticleAIDS research and therapy2022

An evaluation of postmarketing reports of hyperglycaemia associated with dolutegravir for treatment of HIV in Eswatini.

Alemayehu L Duga, Sibongile Magongo, Siphesihle Nhlabatsi, Denis O Ladwar, Linda Härmark, Leàn Rolfes

Open access · goldAbstract read
In one paragraph

Article in AIDS research and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
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

9 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
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

6 authors at 4 institutions in 3 countries.

Alemayehu L DugaNational Pharmacovigilance Center, Eswatini Ministry of Health, Matsapha, Eswatini. alexduga4@gmail.com.ORCID 0000-0003-3944-1025
Sibongile MagongoMedicine Regulatory Unit, Eswatini Ministry of Health, Matsapha, Eswatini.
Siphesihle NhlabatsiNational Pharmacovigilance Center, Eswatini Ministry of Health, Matsapha, Eswatini.
Denis O LadwarChemonics Eswatini, Manzini, Eswatini.
Linda HärmarkThe Netherlands Pharmacovigilance Center Lareb, s-Hertogenbosch, The Netherlands.
Leàn RolfesThe Netherlands Pharmacovigilance Center Lareb, s-Hertogenbosch, The Netherlands.
Ministry of Health · SZNetherlands Pharmacovigilance Centre Lareb · NLChildren’s Foundation · GBSouthern Africa Nazarene University · SZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDolutegravir (DTG) is an Integrase Strand Transfer Inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV infection. It is available in a number of pharmaceutical preparations including the fixed-dose combination (TLD) containing tenofovir (300 mg) + lamivudine (300 mg) + dolutegravir (50 mg). In 2018, Eswatini adopted TLD as the preferred first-line HIV treatment regimen for adults and adolescents as per WHO recommendations. From March 2019 to March 2020, the National Pharmacovigilance Center (NPC) in Eswatini received 8 reports of hyperglycaemia associated with the use of DTG. This study was conducted to investigate if Eswatini NPC database included cases suggestive of causality between dolutegravir and hyperglycaemia.

methodA qualitative synthesis of information from the Eswatini national pharmacovigilance database from March 2019 to March 2020 was conducted to investigate a casual association between hyperglycaemia and dolutegravir.

resultsAll reports with dolutegravir containing regimen and suspected Adverse Event of hyperglycaemia in the period of March 2019 to March 2020 were included in the study. Seven of the reports were serious (resulted in hospitalization and one case concerned optic neuritis, leading to blindness). Two patients had a medical history of diabetes while the rest of the patients had never experienced hyperglycaemia before starting dolutegravir. For all the reports, the time to onset of hyperglycaemia ranges from 2-5 months after the initiation of DTG. None of the patients discontinued the use of DTG. All the patients were treated with oral hypoglycaemic medication. In severe cases, patients were treated with intravenous normal saline and ringer lactate as well as rapid-acting insulins. All patients are currently stable on oral hypoglycaemic drugs.

conclusionCases that support causality between dolutegravir containing regimen and hyperglycaemia were found. These cases were mainly serious. Based on these findings it is recommended that healthcare professionals (HCPs) actively screen all patients for risk factors of hyperglycaemia before DTG initiation. In addition, it is important that HCPs are aware of the possible association between DTG and hyperglycaemia.

Indexed as

HIV InfectionsHyperglycemiaAdolescentAdultDolutegravirEswatiniHeterocyclic Compounds, 3-RingHumansDolutegravirHeterocyclic Compounds, 3-RingDolutegravirEswatiniHIV/AIDSHyperglycaemiaPharmacovigilanceSignal

Identifiers

PMID36424607
PMCPMC9694599
OpenAlexW4309918493

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.