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Results of a study of more than 330 patients suggest use of sitagliptin could improve outcomes in patients with diabetes and COVID-19.
Results of study from investigators in Italy suggest sitagliptin (Januvia) could prove useful for improving mortality rates among patients with type 2 diabetes hospitalized with coronavirus disease 2019 (COVID-19).
While the analysis was observational in nature, results of the study indicate initiating patients receiving therapy with sitagliptin were more than 70% less likely to need mechanical ventilation and serve as the basis for a new randomized clinical trial to further understand the effect of sitagliptin in diabetics with COVID-19.
"We think it's reasonable to try sitagliptin if a patient is admitted to the hospital with type 2 diabetes and COVID," said Paolo Fiorina, MD, PhD, a diabetes researcher in the division of nephrology at Boston Children's Hospital and the University of Milan, in a statement. "I'm excited about our findings, because we still have very few therapeutic options for the many diabetic patients affected by COVID."
Driven by a need to identify novel therapeutic approaches for treating various patients groups with COVID-19, Fiorina and a team of colleagues from the University of Pavia in Italy sought to determine whether the DPP-4 inhibitor sitagliptin improved outcomes in diabetic patients. Investigators noted sitagliptin was chosen as debate exists over whether the agent’s mechanism could put patients at a greater risk of severe outcomes or whether the anti-inflammatory effects could reduce incidence of cytokine storm and organ complications.
"We decided to try sitagliptin and collect the data," added Fiorina. "COVID-19 mortality in diabetic patients is high, and the drug is very safe, so we felt there was no reason not to use it."
From 7 academic hospitals in northern Italy, investigators identified 338 consecutive patients with type 2 diabetes and COVID-19 pneumonia admitted between March 1-April 30, 2020. Of these 338 patients, 169 were administered only intravenous insulin and were used as controls. The remaining 169 patients were administered sitagliptin in addition to insulin. Investigators noted there were no significant differences between the study arms in regard to demographic characteristics.
Upon analysis, treatment with sitagliptin at the time of hospitalization was associated with reduced mortality (18% vs 37%; HR, 0.44; 95% CI, 0.29-0.66; P=.0001) and an improvement in clinical outcomes (60% vs 38%; P=.0001). Additionally, results indicated treatment with sitagliptin was associated with an increased number of hospital discharges (120 vs 89; P=.0008) than usual care with intravenous insulin.
In a multivariable analysis, investigators found treatment with sitagliptin was associated with a 77% reduction in mortality odds compared to standard care (OR, 0.23; 95% CI, 0.12-0.46; P=.0001). Compared to those receiving standard care, patients receiving sitagliptin were less likely to need mechanical ventilation (HR, 0.27; 95% CI, 0.11-0.62), need intensive care (HR, 0.51; 95% CI, 0.27-0.95), and less likely to have a worsening of clinical outcomes (25% vs 46%).
A subgroup analysis of patients 70 years of age and older also indicated sitagliptin treated patients had a lower rate of mortality (29% vs 51%) and experienced improved outcomes (HR, 0.54; 95% CI, 0.34-0.85; P=.009) compared to those receiving standard care with intravenous insulin.
In the aforementioned release, Fiorina noted the results of the current study are being used as the basis for a new prospective study enrolling patients in Italy and elsewhere in Europe to further understand the impact of sitagliptin use in patients with type 2 diabetes and COVID-19.
"We must now confirm our findings in a placebo-controlled, prospective study," added Fiorina.
This study, “Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study,” was published in Diabetes Care.