Support for lixisenatide in type 2 diabetes patients with renal impairment
medwireNews: Results of a post-hoc analysis suggest that the efficacy of lixisenatide is not compromised among patients with type 2 diabetes who have mild or moderate renal impairment.
Markolf Hanefeld (GWT-Technical University Dresden, Germany) and colleagues categorized participants from nine trials in the GetGoal program into groups based on baseline creatinine clearance (CC). They found that glycated hemoglobin (HbA1c), 2-hour postprandial plasma glucose (PPG), and fasting plasma glucose (FPG) were “comparably reduced” with lixisenatide versus placebo treatment among patients across all CC categories.
HbA1c levels were reduced by 0.52% among patients with normal renal function (CC≥90 mL/min), and by a respective 0.50% and 0.85% among those with mild (CC=60–89 mL/min) and moderate (CC=30–59 mL/min) renal impairment with lixisenatide versus placebo treatment.
The corresponding reductions in 2-hour PPG were 4.78, 5.08, and 6.81 mmol/L, and those for FPG were 0.70, 0.48, and 0.78 mmol/L.
In a meta-analysis, there was no significant difference in lixisenatide-associated HbA1c reductions for patients with normal renal function versus mild or moderate impairment, and for patients with mild versus moderate impairment. Similarly, the team observed no significant differences between these groups for 2-hour PPG and FPG reductions.
These results suggest that “baseline renal status does not affect efficacy outcomes in lixisenatide- versus placebo-treated patients,” write the authors in Diabetes, Obesity and Metabolism.
However, they note that “[a]s the included trials had exclusion criteria based on renal function, there was a lack of patients with severe renal impairment in the present analysis.”
The most common adverse events in all renal function groups were gastrointestinal, and there was a significantly lower incidence of overall gastrointestinal adverse events and nausea/vomiting among patients with normal renal function versus those with mild renal impairment. However, there was no significant difference in the incidence of these adverse events between patients with normal renal function and those with moderate renal impairment. The incidence of hypoglycemia was “similar” in all patient groups.
“These findings indicate that lixisenatide dose adjustment is not required in patients with [type 2 diabetes] with mild or moderate renal impairment,” say Hanefeld and colleagues, although they caution that the trials included in their post-hoc analysis “were of varying design, specifically with regard to duration and treatment regimen,” and that the effects of lixisenatide treatment on diabetic nephropathy were not investigated.
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