Whether the dual therapy increases the risk of erythrocytosis in a real-world setting remains unclear, however.
A team led by Albany Medical College in New York conducted a retrospective nationwide cohort study of U.S. military veterans with type 2 diabetes (T2D) and baseline hematocrit between 38% and 50% who were prescribed SGLT-2i and/or TRT between March 2013 and October 2022 and had adequate adherence based on the proportion of days covered of more than 80%.
For the study published in the Journal of Endocrinological Investigation, the researchers divided patients into three groups: SGLT-2i only, TRT only, or combination therapy. They then calculated the odds ratio (OR) of new erythrocytosis cases—defined as a hematocrit level of >54% within 365 days of therapy initiation. Factors taken into consideration included baseline hematocrit, age, BMI, obstructive sleep apnea, diuretic use, and smoking status.
The results indicated that 1.4% of the entire cohort of 53,971 patients with T2D developed erythrocytosis. The researchers reported that in unadjusted analyses, the OR of new onset erythrocytosis was higher in the combined SGLT-2i and TRT group compared with the SGLT-2i or TRT group alone (4.99; 95% CI, 3.10-7.71 and 2.91; 95% CI, 1.87-4.31, respectively).
“In the models adjusted for baseline characteristics, patients on combination therapy had significantly higher odds of erythrocytosis compared to those on SGLT-2i (OR 3.80, 95% CI [2.27-6.11]) or TRT alone (OR 2.49, 95% CI [1.51-3.59]),” the authors pointed out. “Testosterone delivery route (topical vs. injectable) did not modify increased odds of erythrocytosis.”
The study team concluded, “For the first time, we demonstrated that in large cohort of patients combined therapy with SGLT-2i and TRT is associated with increased erythrocytosis risk compared with either treatment alone. Given rising prevalence of SGLT-2i use, providers should consider periodic hematocrit assessment in persons receiving both SGLT-2i and TRT.”
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