Lower GI Events With Insulin Glargine + Lixisenatide vs. Lixisenatide Alone
This article is written live from the American Association of Clinical Endocrinologists (AACE) 2017 Annual Meeting in Austin, TX. MPR will be reporting news on the latest findings from leading experts in endocrinology. Check back for more news from AACE 2017.
At the AACE 2017 Annual Meeting, study authors from the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences reported that treatment with iGlarLixi (insulin glargine 100U/mL + lixisenatide) resulted in a lower rate of gastrointestinal (GI) adverse events vs. Lixi (lixisenatide) alone.
In the Phase 3 LixiLan clinical program, iGlarLixi demonstrated low rates of nausea, vomiting, and diarrhea, resulting in very low rates of discontinuation. Jennifer Truijillo, PharmD, and colleagues performed a post-hoc analysis to determine the frequency and timing of GI adverse events in 2 trials comparing iGlarLixi in patients with type 2 diabetes uncontrolled on oral antidiabetics and/or basal insulin vs. iGlar alone or Lixi alone.
Study authors obtained data on nausea, vomiting, and diarrhea from the LixiLan-O and LixiLan-L studies for the analysis.
The data showed 11.7% of patients treated with iGlarLixi experienced nausea, vomiting, or diarrhea in the LixiLan-O trial and 9.6% of patients in the LixiLan-L trials, compared with 27.5% of Lixi-treated patients in LixiLan-O and 4.7% of iGlar-treated patients in LixiLan-O and 1.4% of iGlar-treated patients in LixiLan-L trials. From Day 60 to study end (~210 days), the percentage of patients with onset of GI adverse events was 7.7% (LixiLan-O) and 4.1% (LixiLan-L) for iGlarLixi; 6.9% (LixiLan-O) for Lixi; and 3.2% (LixiLan-O) and 2.2% (LixiLan-L) for iGlar.
After Day 80, new reports of nausea, vomiting, or diarrhea were 3.4%, 1.1%, and 3.0% for iGlarLixi vs. 2.6%, 1.3%, and 2.6% for Lixi, respectively, in LixiLan-O. GI adverse events were mostly mild to moderate in severity; there was 1 report of a severe event in LixiLan-L and none in LixiLan-O.
In LixiLan-O, the median duration of nausea was 5.0 days with iGlarLixi, 7.5 days with Lixi, and 2.0 days with iGlar; the median duration of vomiting was 1.0 day, 3.0 days, and 2.0 days, respectively; and the median duration of diarrhea was 3.5 days, 3.0 days, and 2.0 days, respectively. In LixiLan-L, the median duration of nausea was 6.0 days with iGlarLixi vs. 3.0 days with iGlar; the median duration of vomiting was 2.0 days with iGlarLixi vs. 1.0 day with iGlar; and the median duration of diarrhea was 2.5 days with iGlarLixi vs. 2.0 days with iGlar.
The incidence of GI adverse events with iGlarLixi therapy appeared to be mostly transient with most occurring during the initial 8-week titration period. "As expected, the overall proportion of patients with GI AEs was higher with iGlarLixi than with iGlar, but lower than with Lixi; this may be due to the slow increase in Lixi dose in the fixed-ratio iGlarLixi combination," added Dr. Truijillo.
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