posted on 25.09.2020, 23:38by Sebastiano Bruno Solerte, Francesca D’Addio, Roberto Trevisan, Elisabetta Lovati, Antonio Rossi, Ida Pastore, Marco Dell’Acqua, Elio Ippolito, Cristiana Scaranna, Rosalia Bellante, Silvia Galliani, Alessandro Roberto Dodesini, Giuseppe Lepore, Francesca Geni, Roberta Maria Fiorina, Emanuele Catena, Angelo Corsico, Riccardo Colombo, Marco Mirani, Carlo De Riva, Salvatore Endrio Oleandri, Reza Abdi, Joseph V. Bonventre, Stefano Rusconi, Franco Folli, Antonio Di Sabatino, Gianvincenzo Zuccotti, Massimo Galli, Paolo Fiorina
Background. Poor outcomes have been reported in patients with
type 2 diabetes and coronavirus disease 2019 (COVID-19), thus it is mandatory
to explore novel therapeutic approaches for this population.
Methods. In a multicenter case-control retrospective observational study, sitagliptin, an oral and highly selective DPP-4 inhibitor, was
added to standard-of-care (e.g.; insulin administration) at the time of
hospitalization in patients with type 2 diabetes who were hospitalized with COVID-19.
Every center also recruited at 1:1 ratio untreated controls matched for age and
gender. All patients had pneumonia and exhibited oxygen saturation lower than 95%
when breathing ambient air, or were receiving oxygen support. The primary
endpoints were discharge from the hospital/death and improvement of clinical
outcomes, defined as an increase in at least two points on a seven-category
modified ordinal scale. Data were
collected retrospectively from patients receiving sitagliptin from March 1 through
April 30, 2020.
Results. Of the 338 consecutive patients with type 2 diabetes and COVID-19 admitted
in Northern Italy hospitals included in this study, 169 were on sitagliptin,
while 169 were on standard-of-care. Treatment with sitagliptin at the time of
hospitalization was associated with reduced mortality (18% vs. 37% of deceased
patients; HR=0.44, 95% CI: 0.29-0.66, p=0.0001), with an improvement in
clinical outcomes (60% vs. 38% of improved patients, p=0.0001) and with a greater
number of hospital discharges (120 vs. 89 of discharged patients, p=0.0008),
compared to patients receiving standard-of-care respectively.
Conclusions. In this multicenter case-control retrospective observational study of
patients with type 2 diabetes admitted to the hospital for COVID-19,
sitagliptin treatment at the time of hospitalization was associated with
reduced mortality and improved clinical outcomes as compared to
standard-of-care treatment. The effects of sitagliptin in patients with type 2 diabetes
and COVID-19 should be confirmed in an ongoing randomized, placebo-controlled
F.D. is supported by a SID Lombardia Grant and by the EFSD/JDRF/Lilly Programme on Type 1 Diabetes Research 2019. P.F. is supported by the Italian Ministry of Health grant RF-2016-02362512 and by the Linea-2 2019 funding from Università di Milano. R.A. is the recipient of the Stepping Strong Innovator Award 116260. We thank the “Fondazione Romeo e Enrica Invernizzi” for extraordinary support. We thank also Mediolanum-farma for providing sitagliptin and Dr. Giorgio Bedogni, statistician, for the support in the data analysis.