Evidence map›Paper›PMID 32048185›Full record

ArticleDrug safety2020

Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study.

Sieta T de Vries, Petra Denig, Corine Ekhart, Peter G M Mol, Eugene P van Puijenbroek

Open access · hybridAbstract read
In one paragraph

Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
4.8field-weighted citation impact, top 4% 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

36 citing papers in PubMed, 66 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. Article
  5. Cardiovascular contributions to dementia: Examining sex differences and female-specific factors.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Rethinking about Metformin: Promising Potentials.Korean journal of family medicine · 2024
    Article
  11. Exploring Novel Adverse Events of Nefecon.Kidney international reports · 2024
    Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

5 authors at 3 institutions in 1 country.

Sieta T de VriesDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0001-6090-2434
Petra DenigDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-7929-4739
Corine EkhartNetherlands Pharmacovigilance Center Lareb, 's-Hertogenbosch, The Netherlands.ORCID 0000-0002-2252-0467
Peter G M MolDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-4262-3180
Eugene P van PuijenbroekNetherlands Pharmacovigilance Center Lareb, 's-Hertogenbosch, The Netherlands. e.vanpuijenbroek@lareb.nl.ORCID 0000-0002-2236-1398
University Medical Center Groningen · NLNetherlands Pharmacovigilance Centre Lareb · NLUniversity of Groningen · NL

Funding

European Union's Horizon 2020 research and innovation programme 754425ZonMw 849100006
6 · The paper itself

Abstract

introductionIn general, women more often experience metformin-associated adverse drug reactions (ADRs) than men.

objectivesWe aimed to assess whether sex differences in reported ADRs for metformin are observed at different times after initiation, and to explore their concurrence with sex differences in the dose of metformin over time. This may guide future studies in assessing the involved mechanisms of sex differences in metformin-associated ADRs and may guide sex-specific management of ADRs in clinical practice.

methodsThis study has a longitudinal design using data about patients initiating metformin collected by the Dutch National Pharmacovigilance Center Lareb through their Intensive Monitoring program. Patients were asked to complete a web-based questionnaire six times after initiation (i.e., at 2 weeks, 6 weeks and at 3, 6, 9, and 12 months). The outcome variables were the proportion of patients reporting any ADR (primary) and the dose of metformin (secondary). Sex differences in the proportions of ADRs and in the dose were tested at each assessment using Pearson Chi-Squared tests and Wilcoxon rank-sum tests, respectively. Using Bonferroni adjustment for multiple testing, a p value < 0.01 was considered statistically significant.

resultsThe number of included patients was 1712 (40.9% women). Women reported an ADR more often than men, which was statistically significant at the assessment at 2 weeks (34% vs 25%, p < 0.001), and 6 weeks (37% vs 28%, p = 0.001) after initiation. In general, women were reported to be prescribed a lower dose than men, which became statistically significant at the 9-month assessment (p < 0.01).

conclusionsSex differences in reported ADRs were seen in the first weeks after metformin initiation, whereas statistically significant differences in self-reported prescribed dosing were observed after several months. Patients, in particular women, might benefit from being prescribed lower metformin doses at treatment initiation.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsFemaleHumansLongitudinal StudiesMaleMetforminMiddle AgedNetherlandsPharmacovigilanceSex FactorsSurveys and QuestionnairesMetformin

Identifiers

PMID32048185
PMCPMC7165141
OpenAlexW3006443583

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.