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Cited by 61Pharmacovigilance and Adverse Drug ReactionsSex and Gender in HealthcarePharmaceutical Practices and Patient Outcomes

Gender differences in adverse event reports associated with antidiabetic drugs

Open access
Joung, Kyung-In, Jung, Gyu-Won, Park, Han-Heui, Lee, Hyesung, Park, So-Hee, Shin, Ju-Young·2020·Scientific Reports
DOI 10.1038/s41598-020-74000-4PMC PMC7567832
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Abstract

Little is known about gender-specific reporting of adverse events (AEs) associated with antidiabetic drugs. This study was to assess the gender-related difference in AEs reporting associated with antidiabetic agents. The number of antidiabetic drug-AE pairs associated was identified using the Korea Adverse Event Reporting System database. Prevalence of diabetes was estimated using the Health Insurance Review and Assessment Service-National Patients Sample database. Reporting rate per 10,000 people was calculated by dividing drug-AE pairs with the number of antidiabetic drug users by gender. Gender difference was presented with risk ratio (reporting rate ratio) of women to men. Antidiabetic agent-associated AEs were more frequently reported by women than men throughout body organs and drug classes. 13 out of 17 system organ class level disorders with significant gender differences were reported more often by women than men. By drug class, gender-specific reporting rates were observed in most of the drug classes, especially in newer classes such as glucagon-like peptide-1 analog (GLP1-RA), sodium glucose co-transporter-2 inhibitor (SGLT2i), and thiazolidinedione (TZD). Looking into preferred term level for each drug class, women dominated the reports of class-specific AEs of newer antidiabetic drugs such as urinary tract/genital infection (all reported by women) in SGLT2i, edema in TZD (risk ratio (RR) 12.56), and hyperglycemia in insulin users (RR 15.35). Gender differences in antidiabetic-associated AE reporting often attributed to women. Explanations for these different report levels by gender should be further investigated.

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  • Women had a higher probability of experiencing headaches after treatment with GLP-1 RAs compared to men (risk ratio of 7.97).

    “Another interesting finding of this analysis was that women had a higher probability of experiencing headaches after treatment with GLP-1 RAs compared to men (risk ratio of 7.97) [76].”

    From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [76]

    Table 4 in the Results reports a women-to-men risk ratio of 7.97 (95% CI 1.01–62.78) for headache reports associated with GLP-1 RAs. But the Discussion explicitly says reporting rates should not be viewed as a measure of adverse-event risk, so the paper does not establish that women had a higher probability of experiencing headaches. (LLM, conf=0.90)

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  • A study analyzing data from two national Korean databases concluded that females were approximately twice as likely as males to report any adverse events linked to GLP-1 RA use, with a reporting ratio of 2.34.

    “Further exploring this subject, a study analyzing data derived from two national Korean databases concluded that females were approximately twice as likely than males to report any adverse events linked to GLP-1 RA use, with a reporting ratio of 2.34 (reporting ratio: reporting rate of women/reporting rate of men).”

    From Sex Differences in Response to Treatment with Glucagon-like Peptide 1 Receptor Agonists: Opportunities for a Tailored Approach to Diabetes and Obesity Care (2022) · cites this paper as [76]

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Authors
Joung, K.-I., Jung, G.-W., Park, H.-H., Lee, H., Park, S.-H., & Shin, J.-Y.
Affiliations
Sungkyunkwan University (KR)
Corresponding author
Shin, Ju-Young
ORCID
Venue
Scientific Reports
Publisher
Springer Science and Business Media LLC
Published
2020-10-16
Volume
10
Issue
1
Pages
17545-17545
ISSN
2045-2322 (ISSN-L)
DOI
10.1038/s41598-020-74000-4
PMC
PMC7567832
OpenAlex
W3092746703
Cited by
61
References
40
Citations by year
2026: 11 · 2025: 9 · 2024: 16 · 2023: 13 · 2022: 9 · 2021: 3
FWCI
4.40
Type
journal article
Language
en
Open access
Licence
Locations
  • Scientific Reports (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
Korea Health Industry Development Institute (HG18C0068)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Sex and Gender in Healthcare
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
Keywords
gender differences, adverse drug reactions, antidiabetic drugs, pharmacovigilance, women, GLP-1 receptor agonists, SGLT2 inhibitors, thiazolidinediones, insulin, urinary tract infection, edema, hyperglycemia
MeSH terms
Glucagon-Like Peptide-1 Receptor, Sodium-Glucose Transporter 2 Inhibitors, Adult, Aged, Aged, 80 and over, Diabetes Mellitus, Female, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Risk, Sex Factors, Databases, Factual, Adverse Drug Reaction Reporting Systems, Thiazolidinediones, Republic of Korea

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