Effectiveness and safety of SGLT-2 inhibitors for renal allograft recipients with post-transplant diabetes mellitus: an open single-center prospective study
M.S. Novikova, S.S. Allazova, L.P. Molina, O.M. Koteshkova, M.B. Antsiferov, O.N. Kotenko, E.M. Shilov
1) Dispensary of the Moscow Healthcare Department, Moscow, Russia;
2) Department of Internal, Occupational Diseases and Rheumatology, Faculty of Preventive Medicine, Sechenov University, Moscow, Russia;
3) City Clinical Hospital No 52 of the Moscow Healthcare Department, Moscow, Russia;
4) Department of Hospital Therapy, Peoples’ Friendship University of Russia, Moscow, Russia
Objective. Evaluation of the safety and efficacy of therapy with sodium glucose cotransporter 2 (SGLT-2) inhibitors in kidney transplant (KT) recipients with post-transplantation diabetes mellitus (PTDM).
Material and methods. An open single-center prospective study of the use of SGLT-2 inhibitors (canagliflozin 300 mg/day or empagliflozin 25 mg/day or dapagliflozin 10 mg/day) and other hypoglycemic agents (metformin, insulin, sulfonylurea, glinides, and dipeptidyl peptidase-4 inhibitors) in various combinations for 24 weeks included 57 KT recipients who underwent transplantation more than a year ago, with a diagnosis of PTDM, with stable kidney function (estimated glomerular filtration rate – eGFR > 30 ml/min/1.73 m2) against the background of immunosuppressive therapy. Patients were divided into groups: the first (experimental) – 12 individuals (11 men) who received SGLT-2 inhibitors in combination with other hypoglycemic drugs, and the second (control) – 45 individuals (23 men) on standard hypoglycemic therapy without SGLT-2 inhibitors.
Results. 57 KT recipients (12 on SGLT-2 inhibitors and 45 on standard hypoglycemic therapy; 33 men) completed the study. 24 weeks after the start of therapy with SGLT-2 inhibitors, statistically significant differences in the first (experimental) group compared with the second (control) were obtained in relation to: glycemic control-∆% fasting plasma glucose -2.34 vs 8.38; ∆P=0.047, ∆% HbA1c -2.02 versus -0.89; ∆P=0.022; anthropometric indicators – ∆% body weight -6.42 versus -1.9; P=0.001, ∆% BMI -5.25 vs. 0.36; P=0.002; hemodynamics – ∆% SBP -2.31 versus 0.00; P=0.000. According to metabolic parameters, a significant change in ∆% uric acid was noted – -23.61 versus -2.86; P=0.041;according to hematological parameters, ∆% erythrocytes was 9.47 versus 2.05; P=0.041.
There were no statistically significant differences between the experimental and control groups in terms of renal allograft function: ∆% eGFR - 9.65 versus - 10.53; P=0.083, ∆% MAU 0.00 versus 0.00; P=0.248. There was no difference in immunosuppressive therapy: the minimum concentration of calcineurin inhibitors (C0) ∆% cyclosoprine 0.00 vs -6.15; P=0.826, ∆% tacrolimus 7.14 vs 0.00; P=0.317. The frequency of side effects did not differ: cases of urinary infection 1/11 (9%) vs. 3/42 (7.1%); P>0.05.
Conclusion. SGLT-2 inhibitors in combination with other antihyperglycemic agents safely improve anthropometric and metabolic parameters in PT recipients with PTDM compared with standard DM therapy without SGLT-2 inhibitors. An increase in the erythrocyte level in the first group was noted.
About the Autors
Maria S. Novikova – Cand.Sci. (Med.), Nephrologist, Endocrinological Dispensary of the Moscow Healthcare Department. Address: 37 Prechistenka st., Moscow, 119034; e-mail: email@example.com.
Sona S. Allazova – Postgraduate Student at the Department of Internal, Occupational Diseases and Rheumatology, Sechenov University, Moscow; e-mail: firstname.lastname@example.org Lyudmila P. Molina – Cand.Sci. (Med.), Cardiologist, Endocrinological Dispensary of the Moscow Healthcare Department. Address: 37 Prechistenka st., Moscow, 119034 Olga M. Koteshkova – Cand.Sci. (Med.), Endocrinologist, Endocrinological Dispensary of the Moscow Healthcare Department. Address: 37 Prechistenka st., Moscow, 119034 Mikhail B. Antsiferov – Dr.Sci. (Med.), Professor, Chief Specialist in Endocrinology of the Moscow Healthcare Department, Chief Physician of the Endocrinological Dispensary of the Moscow Healthcare Department, Moscow; e-mail: email@example.com
Oleg N. Kotenko – Cand.Sci. (Med.), Chief Specialist in Nephrology of the Moscow Healthcare Department, Deputy Chief Physician for Nephrological Care, City Clinical Hospital № 52 of the Moscow Healthcare Department, Moscow; e-mail: firstname.lastname@example.org
Evgeny M. Shilov – Doctor of Medical Sciences, Professor of the Department of Internal, Occupational Diseases and Rheumatology, Sechenov University, Moscow; e-mail: email@example.com