The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin, versus dual therapy with dapagliflozin or saxagliptin plus metformin, was compared in a post hoc analysis of three randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/day plus saxagliptin 5 mg/day. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/day or dapagliflozin 10 mg/day received add-on dapagliflozin 10 mg/day or saxagliptin 5 mg/day, respectively. After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens. Urinary tract infections were more common with sequential than with concomitant add-on therapy; genital infections were reported only with sequential add-on of dapagliflozin to saxagliptin plus metformin. Hypoglycaemia incidence was <2.0% across all analysis groups. In conclusion, safety and tolerability of triple therapy with dapagliflozin, saxagliptin and metformin, as either concomitant or sequential add-on, were similar to dual therapy with either agent added to metformin.
Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: post hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin
Del Prato, Stefano
;
2018-01-01
Abstract
The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin, versus dual therapy with dapagliflozin or saxagliptin plus metformin, was compared in a post hoc analysis of three randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/day plus saxagliptin 5 mg/day. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/day or dapagliflozin 10 mg/day received add-on dapagliflozin 10 mg/day or saxagliptin 5 mg/day, respectively. After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens. Urinary tract infections were more common with sequential than with concomitant add-on therapy; genital infections were reported only with sequential add-on of dapagliflozin to saxagliptin plus metformin. Hypoglycaemia incidence was <2.0% across all analysis groups. In conclusion, safety and tolerability of triple therapy with dapagliflozin, saxagliptin and metformin, as either concomitant or sequential add-on, were similar to dual therapy with either agent added to metformin.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.