Comparison of safety and tolerability with continuous (exenatide once weekly) or intermittent (exenatide twice daily) GLP ‐1 receptor agonism in patients with type 2 diabetes

Jun 28, 2012Diabetes, obesity & metabolism

Safety and side effects of weekly versus twice-daily exenatide treatment in type 2 diabetes

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Abstract

ExQW was associated with less nausea and vomiting compared to ExBID in patients with type 2 diabetes.

Nausea and vomiting were less frequent with ExQW, peaking at treatment initiation.
Injection-site adverse events were more common with ExQW but decreased over time in both formulations.
No major hypoglycaemia events were reported, with minor hypoglycaemia occurring infrequently and similarly in both groups.
Serious adverse events and discontinuations due to adverse events occurred at similar rates for both ExQW and ExBID.

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AIMS: Exenatide is a glucagon-like peptide-1 receptor agonist shown to improve glycaemic control in patients with type 2 diabetes (T2DM). Intermittent exenatide exposure is achieved with the twice-daily formulation (ExBID), while the once-weekly formulation (ExQW) provides continuous exenatide exposure. This integrated, retrospective analysis compared safety and tolerability of ExQW vs. ExBID in patients with T2DM.

METHODS: Data were pooled from two open-label, randomized, comparator-controlled, trials directly comparing ExQW (N = 277) to ExBID (N = 268). Between-group differences in adverse event (AE) and hypoglycaemia incidences were calculated. Incidence over time and duration of selected AEs (nausea, vomiting, and injection-site-related AEs) were also summarized.

RESULTS: The most common AEs were nausea, diarrhoea, injection-site pruritus, and vomiting. Nausea and vomiting occurred less frequently with ExQW vs. ExBID, peaking at initiation (ExQW) or at initiation and dose escalation (ExBID), and decreasing over time. Few patients discontinued because of gastrointestinal-related AEs. Injection-site AEs were more common with ExQW but decreased over time in both groups. No major hypoglycaemia occurred; minor hypoglycaemia occurred with low incidence in patients not using concomitant sulphonylurea, with no difference between ExQW and ExBID. Serious AEs and discontinuations because of AEs were reported with similar frequency in both groups.

CONCLUSIONS: Both exenatide formulations were generally safe and well-tolerated, with ExQW associated with less nausea and vomiting but more injection-site AEs. Continuous vs. intermittent exposure did not impact the overall tolerability profile of exenatide, with no evidence of prolonged duration or worsened intensities of AEs with continuous exposure.

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Comparison of safety and tolerability with continuous (exenatide once weekly) or intermittent (exenatide twice daily) GLP ‐1 receptor agonism in patients with type 2 diabetes

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