Sex Differences in Cardiovascular Effectiveness of Newer Glucose‐Lowering Drugs Added to Metformin in Type 2 Diabetes Mellitus
Open accessAbstract
Background Randomized controlled trials showed that newer glucose‐lowering agents are cardioprotective, but most participants were men. It is unknown whether benefits are similar in women. Methods and Results Among adults with type 2 diabetes mellitus not controlled with metformin with no prior use of insulin, we assessed for sex differences in the cardiovascular effectiveness and safety of sodium‐glucose‐like transport‐2 inhibitors ( SGLT ‐2i), glucagon‐like peptide‐1 receptor agonists ( GLP ‐1 RA ), dipeptidyl peptidase‐4 inhibitors, initiated as second‐line agents relative to sulfonylureas (reference‐group). We studied type 2 diabetes mellitus American adults with newly dispensed sulfonylureas, SGLT ‐2i, GLP ‐1 RA , or dipeptidyl peptidase‐4 inhibitors (Marketscan‐Database: 2011–2017). We used multivariable Cox proportional hazards models with time‐varying exposure to compare time to first nonfatal cardiovascular event (myocardial infarction/unstable angina, stroke, and heart failure), and safety outcomes between drugs users, and tested for sex–drug interactions. Among 167 254 type 2 diabetes mellitus metformin users (46% women, median age 59 years, at low cardiovascular risk), during a median 4.5‐year follow‐up, cardiovascular events incidence was lower in women than men (14.7 versus 16.7 per 1000‐person‐year). Compared with sulfonylureas, hazard ratios ( HR s) for cardiovascular events were lower with GLP ‐1 RA (adjusted HR ‐women: 0.57, 95% CI : 0.48–0.68; aHR ‐men: 0.82, 0.71–0.95), dipeptidyl peptidase‐4 inhibitors ( aHR ‐women: 0.83, 0.77–0.89; aHR ‐men: 0.85, 0.79–0.91) and SGLT ‐2i ( aHR ‐women: 0.58, 0.46–0.74; aHR ‐men: 0.69, 0.57–0.83). A sex‐by‐drug interaction was statistically significant only for GLP ‐1 RA ( P =0.002), suggesting greater cardiovascular effectiveness in women. Compared with sulfonylureas, risks of adverse events were similarly lower in both sexes for GLP ‐1 RA ( aHR ‐women: 0.81, 0.73–0.89; aHR ‐men: 0.80, 0.71–0.89), dipeptidyl peptidase‐4 inhibitors ( aHR ‐women: 0.82, 0.78–0.87; aHR ‐men: 0.83, 0.78–0.87) and SGLT ‐2i ( aHR ‐women: 0.68, 0.59–0.78; aHR ‐men: 0.67, 0.59–0.78) (all sex–drug interactions for adverse events P >0.05). Conclusions Newer glucose‐lowering drugs were associated with lower risk of cardiovascular events than sulfonylureas, with greater effectiveness of GLP ‐1 RA in women than men. Overall, they appeared safe, with a better safety profile for SGLT ‐2i than for GLP ‐1 RA regardless of sex.
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Another study demonstrated that GLP-1 RA use was linked to a lower frequency of MACE in women than in men (incidence rate 6.6 per 1000 person-year for females versus 11.9 per 1000 PY for males, p < 0.001).
“A conflicting conclusion was drawn by another study which demonstrated that the use of GLP-1 RAs was linked to a lower frequency of MACE in women than in men (incidence rate: 6.6 per 1000 person-year [PY] for females versus 11.9 per 1000 PY for males, p < 0.001).”
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 [70]
The Results report a stronger reduction in major cardiovascular-event risk for women using GLP-1 RAs than for men, relative to sulfonylureas (adjusted HR 0.57 versus 0.82). The retrieved Results passages do not substantiate the claimed incidence rates of 6.6 and 11.9 per 1,000 person-years; they report a sex-by-drug interaction of P=0.001, not P<0.001. No page number is available in our copy. (LLM, conf=0.82)
Experimental — accuracy not yet measuredWhen comparing sulfonylureas with GLP-1 RAs, the risk of MACE was lower in those treated with GLP-1 RAs.
“Furthermore, when comparing sulfonylureas with GLP-1 RAs, the risk of MACE was found to be lower in those treated with the latter.”
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 [70]
The reduction in MACE risk associated with GLP-1 RA treatment was higher in women than in men (adjusted hazard ratio 0.57 in females vs. 0.82 in males, p = 0.001), suggesting a two-way drug-by-sex interaction.
“An important aspect of this comparative study is that the reduction in risk associated with GLP-1 RA treatment was even higher in women than in men (adjusted hazard ratio in patients treated with GLP-1 RA vs. patients treated with sulfonylurea was 0.57 in females vs. 0.82 in males, p = 0.001), further suggesting a two-way drug-by-sex interaction [70].”
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 [70]
In that large cohort, the enrolled subjects had a low cardiovascular risk, with the majority having no history of cardiovascular disease.
“In addition, the enrolled subjects had a low cardiovascular risk, with the majority having no history of CVD (6.5 % of men and 6.4 % of women had cerebrovascular disease, 2.9 % and 1.5 %, respectively, had a history of myocardial infarction, and 4.7 % and 3.6 %, respectively, had peripheral vascular disease).”
From Real-world sex differences in type 2 diabetes patients treated with GLP-1 receptor agonists (2024) · cites this paper as [23]
In a study of a large cohort of 167,254 subjects with type 2 diabetes not controlled with metformin who were started on a second-line agent, there was a statistically significant sex-by-drug interaction only for GLP-1 RA.
“a study of a large cohort of 167,254 subjects with type 2 diabetes not controlled with metformin who were started on a second-line agent, including SGLT-2i, GLP-1 RA, dipeptidyl peptidase-4 inhibitors (DPP-4i), or sulfonylurea, showed a statistically significant sex-by-drug interaction only for GLP-1 RA”
From Real-world sex differences in type 2 diabetes patients treated with GLP-1 receptor agonists (2024) · cites this paper as [23]
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- Authors
- Raparelli, V., Elharram, M., Moura, C. S., Abrahamowicz, M., Bernatsky, S., Behlouli, H., & Pilote, L.
- Affiliations
- McGill University Health Centre (CA)
- McGill University (CA)
- Research Institute McGill University Health Centre Montreal QC Canada
- Corresponding author
- Pilote, Louise
- ORCID
- Venue
- Journal of the American Heart Association
- Published
- 2020-01-07
- Volume
- 9
- Issue
- 1
- Pages
- e012940-e012940
- ISSN
- 2047-9980 (ISSN-L)
- PMC
- PMC6988160
- OpenAlex
- W2998713219
- Cited by
- 106
- References
- 50
- Citations by year
- 2026: 17 · 2025: 12 · 2024: 17 · 2023: 18 · 2022: 16 · 2021: 14 · 2020: 12
- FWCI
- 11.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Journal of the American Heart Association (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion, other-oa)
- Funders
- Canadian Institutes of Health Research (TD3.137716)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Sex and Gender in Healthcare
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- sex differences, type 2 diabetes, cardiovascular outcomes, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, sulfonylureas, metformin, myocardial infarction, stroke, heart failure, cardiovascular safety, women's cardiovascular health
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Sodium-Glucose Transporter 2 Inhibitors, Heart Disease Risk Factors, Glucagon-Like Peptide-1 Receptor Agonists, Aged, Blood Glucose, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Retrospective Studies, Sex Factors, Biomarkers, Down-Regulation, Databases, Factual, Treatment Outcome, Risk Assessment, Incretins, Dipeptidyl-Peptidase IV Inhibitors
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