No difference in CV autonomic neuropathy with dapagliflozin vs. glimepiride
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Adults with type 2 diabetes experienced no difference in cardiovascular autonomic neuropathy measures or B-type natriuretic peptide levels after 12 weeks of dapagliflozin therapy vs. 12 weeks of glimepiride, according to trial data.
“In this pilot crossover study, we evaluated the effect of dapagliflozin compared with glimepiride on measures of CV autonomic neuropathy and heart function in patients with type 2 diabetes on prior metformin monotherapy,” Lynn Ang, MBBS, an assistant professor of internal medicine at the University of Michigan Medical School, and colleagues wrote in a study published in the Journal of Diabetes and Its Complications. “After 12 weeks of treatment with each drug, there were no significant differences in either the low-frequency to high-frequency power ratio, the primary outcome measure reflecting the sympathetic/parasympathetic balance, or any of the other indices of CV autonomic neuropathy, including standardized CV autonomic reflex tests and heart rate variability.”
Researchers conducted a randomized, two-period crossover trial with 41 adults with type 2 diabetes on metformin monotherapy who were not meeting the American Diabetes Association’s recommended glycemic targets and were followed at University of Michigan outpatient clinics. Participants were randomly assigned to 5 mg dapagliflozin (Farxiga, AstraZeneca) for 4 weeks, with the dose increasing gradually up to 10 mg during 8 weeks, or 2 mg glimepiride daily for 4 weeks, with a gradual dose increase to 4 mg for 8 weeks. After a 2-week washout period, participants switched to the opposite therapy for 12 weeks. Standardized CV autonomic reflex tests and heart rate variability studies were assessed through continuous ECG recordings at baseline and 12 weeks for each therapy. Low-frequency to high-frequency power ratio was the primary outcome in the trial, with other changes in CV autonomic reflex tests, heart rate variability studies and B-type natriuretic peptide levels serving as secondary outcomes.
In both unadjusted and adjusted analyses, no difference was observed in low-frequency to high-frequency power ratio from baseline to 12 weeks between the two medications. There was also no significant difference in any of the secondary outcomes measured in CV autonomic reflex tests and heart rate variability studies or in B-type natriuretic peptide levels. There were also no difference or interactions between sex and treatment for any CV autonomic neuropathy measures.
Participants had declines in HbA1c with both drugs, although there was a greater reduction observed with glimepiride compared with dapagliflozin (median change, –0.6% vs. 0.15%; P = .033). Participants lost a mean 2.75 kg of body weight while on dapagliflozin, whereas those taking glimepiride had a mean weight gain of 1.79 kg (P < .001).
The researchers noted that the short treatment duration and small sample size of participants were both important limitations in the trial.
“Larger and longer prospective studies in patients with more advanced disease will likely help further elucidate the relationship between SGLT2 inhibitors and CV autonomic neuropathy,” the researchers wrote.
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