No dosage adjustment is required for Onglyza in mild renal impairment; however, in moderate to severe impairment a reduced dose of 2.5mg once daily is recommended. Renal function should be monitored prior to initiation of therapy and periodically thereafter. A new 2.5mg tablet has been launched to facilitate dosing in moderate or severe renal impairment.
Caution is advised in patients with severe renal impairment and use in patients with end-stage renal disease (ESRD) requiring dialysis is not recommended.
Approval for the licence extension was based on the results of a 12-week randomised controlled study, which showed that saxagliptin 2.5mg is a well-tolerated treatment option for patients with inadequately controlled type II diabetes and renal impairment.
The 12-week study involved 170 adults with type II diabetes, HbA1c 7-11% and creatinine clearance <50ml/minute who were randomised to saxagliptin 2.5mg once daily or placebo. Significantly greater reductions in HbA1c from baseline to week 12 were observed in the saxagliptin group than in the placebo group (adjusted mean treatment difference -0.42% [p=0.007]).
Saxagliptin was generally well tolerated with a similar incidence of hypoglycaemia in the saxagliptin and placebo groups (20% vs 22.4%, respectively). The proportion of patients experiencing an adverse effect was greater among those with severe renal impairment or ESRD than among those with moderate impairment.
Further Information: AstraZeneca