Международный эндокринологический журнал 5 (45) 2012
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One-year safety, tolerability and efficacy of vildagliptin in patients with type 2 diabetes and moderate or severe renal insufficiency
Авторы: Kothny W., Shao Q., Groop P.H., Lukashevich V.
Рубрики: Эндокринология
Разделы: Справочник специалиста
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Aim. Assess long-term safety and efficacy of the DPP-4 inhibitor vildagliptin in 369 patients with type 2 diabetes (T2DM) and moderate or severe renal insufficiency (RI).
Methods. Double-blind, randomized, parallel-group, 52-week clinical trial comparing safety and efficacy of vildagliptin (50 mg qd, n = 211) and placebo (n = 158) added to ongoing stable antihyperglycemic treatment, in patients with T2DM and moderate or severe (glomerular filtration rate (GFR) ≥ 30 to < 50 mL/min/1.73m2 and < 30 mL/min/1.73m2) RI.
Results. The study population comprised 122 and 89 patients with moderate RI and 94 and 64 patients with severe RI randomized to vildagliptin and placebo, respectively, with the majority of patients receiving background insulin therapy (72 and 82 % for moderate and severe RI, respectively). After one year, the between-treatment difference in adjusted mean change in A1C was –0.4 ± 0.1 % (p = 0.005) in moderate RI (baseline = 7.8 %) and –0.7 ± 0.2 % (p < 0.0001) in severe RI (baseline = 7.6 %). In patients with moderate RI, similar proportions of patients experienced any AE (84 vs. 85 %), any SAE (21 vs. 19 %), any AE leading to discontinuation (5 vs. 6 %) and death (1 vs. 0 %) with vildagliptin and placebo, respectively. This was also true for patients with severe RI: AEs (85 vs. 88 %), SAEs (25 vs. 25 %), AEs leading to discontinuation (10 vs. 6 %) and death (3 vs. 2 %).
Conclusions. In patients with T2DM and moderate or severe RI, vildagliptin added to ongoing antidiabetic therapy had a safety profile similar to placebo during one-year observation. Further, relative to placebo, a clinically-significant decrease in A1C was maintained throughout one-year treatment with vildagliptin.
Diabetes, Obesity and Metabolism. — June 2012