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Comparative risk of genital infections associated with sodium-glucose co-transporter-2 inhibitors

Chintan V Dave¹, Sebastian Schneeweiss¹, Elisabetta Patorno¹

¹Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Diabetes, Obesity & Metabolism

|September 13, 2018

Abstract:

The extent to which sodium-glucose co-transporter-2 (SGLT2) inhibitors increase the risk of genital infections in routine clinical care, compared with other antidiabetic medications, is not clear, or whether the increased risk is consistent across gender or age subgroups, within individual SGLT2 agents, or if it is more pronounced at a particular time after treatment initiation. We conducted a retrospective cohort study using two US commercial claims databases (2013-2017). In the primary analysis, 1:1 propensity score-matched cohorts of female and male subjects with type 2 diabetes mellitus initiating SGLT2 versus dipeptidyl peptidase-4 inhibitors were created. The outcome was a composite of genital candidal infections, vaginitis or vulvovaginitis in women, and genital candidal infections, balanitis, balanoposthitis, phimosis or paraphimosis in men. Among propensity score-matched cohorts of 129 994 women and 156 074 men, the adjusted hazard ratio (HR) and excess risk per 1000 person-years for SGLT2 versus DPP-4 inhibitors was 2.81 (95% confidence interval [CI], 2.64, 2.99) and 87.4 (95% CI, 79.1, 96.2) respectively for women, and was 2.68 (95% CI, 2.31, 3.11) and 11.9 (95% CI, 9.3-15.0) for men. Findings were similar in the SGLT2 inhibitor versus GLP-1 agonist comparison, more pronounced in the subgroup of patients aged ≥60 (HR, 4.45 [95% CI, 3.83-5.17] in women and 3.30 [95% CI, 2.56-4.25] in men), and no meaningful difference across individual SGLT2 inhibitors was identified. This increase in risk was evident in the first month of treatment initiation and remained elevated throughout the course of therapy. SGLT2 inhibitors were associated with an approximately 3-fold increase in risk of genital infections.

Insights

Sodium-glucose co-transporter-2 (SGLT2) inhibitors significantly increase the risk of genital infections in patients with type 2 diabetes. This risk is approximately threefold higher compared to other antidiabetic drugs and is consistent across genders and treatment durations.

Area of Science:

Endocrinology
Infectious Diseases
Pharmacovigilance

Background:

Sodium-glucose co-transporter-2 (SGLT2) inhibitors are widely used for type 2 diabetes mellitus (T2DM).
Genital infections are a known potential side effect of SGLT2 inhibitors, but the magnitude of risk in real-world clinical settings is not fully established.
Understanding the risk profile across different patient subgroups and treatment durations is crucial for clinical decision-making.

Purpose of the Study:

To quantify the risk of genital infections associated with SGLT2 inhibitors compared to other antidiabetic medications.
To investigate whether this risk varies by gender, age, specific SGLT2 agent, or time since treatment initiation.
To assess the consistency of the increased risk over the course of therapy.

Main Methods:

Retrospective cohort study utilizing two large US commercial claims databases (2013-2017).
Propensity score matching was employed to create comparable cohorts of patients initiating SGLT2 inhibitors versus dipeptidyl peptidase-4 (DPP-4) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists.
A composite outcome of genital infections was defined for both men and women.

Main Results:

SGLT2 inhibitors were associated with a nearly threefold increased risk of genital infections compared to DPP-4 inhibitors (HR 2.81 in women, 2.68 in men).
The risk was more pronounced in patients aged 60 and older (HR 4.45 in women, 3.30 in men).
The increased risk was observed from the first month of treatment and persisted throughout the study period, with similar findings compared to GLP-1 agonists.

Conclusions:

SGLT2 inhibitors are associated with a substantially increased risk of genital infections in patients with type 2 diabetes mellitus.
This risk is consistent across genders and individual SGLT2 agents but is higher in older adults and remains elevated throughout treatment.
Clinicians should be aware of this risk when prescribing SGLT2 inhibitors, particularly in vulnerable patient populations.

Read full analysis

Keywords:

SGLT2 inhibitor antidiabetic drug pharmacoepidemiology type 2 diabetes

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