| アブストラクト | INTRODUCTION: In this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide). METHODS: In this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed. Cohort 2 was subdivided to evaluate the incidence rate of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment in people switched to iGlarLixi from either a GLP-1 RA +/- oral antidiabetic drugs (OADs) or OADs alone (Cohort 2A) or from a GLP-1 RA and long-acting insulin +/- OADs or long-acting insulin +/- OADs (Cohort 2B). RESULTS: Of the 438 people in the iGlarLixi group and 9295 people in the iGlar-100 group in Cohort 1, who had a median follow-up duration of 52 and 44 days, respectively, there were zero and 0.011 (95% CI 0.006-0.018) events per person-year of hospital-treated hypoglycaemia, respectively. Cohort 2A included 201 people each in the GLP-1 RA +/- OADs and OADs alone groups, with a median follow-up duration of 76 and 101 days, respectively, and Cohort 2B included 255 people in the GLP-1 RA and long-acting insulin +/- OADs group and 623 people in the long-acting insulin +/- OADs group, with a median follow-up duration of 73 and 62 days, respectively; no cases of hospital-treated hypoglycaemia or severe hyperglycaemia requiring inpatient treatment were observed. CONCLUSION: Consistent with clinical trials, this post-marketing database study observed that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of prior antidiabetic drug treatment. |
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| ジャーナル名 | Advances in therapy |
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| Pubmed追加日 | 2025/3/9 |
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| 投稿者 | Kaneto, Hideaki; Hatanaka, Makiko; Morimoto, Yukiko; Takahashi, Yoko; Terauchi, Yasuo |
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| 組織名 | Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School,;Kurashiki, Japan.;Post Authorization Regulatory Study, Medical Affairs, Sanofi K.K., Tokyo, Japan.;Real World Evidence Generation Partnering, Medical Affairs, Sanofi K.K., Tokyo,;Japan.;General Medicine Medical, Sanofi K.K., Opera City Tower 3-20-2, Nishi-Shinjuku,;Shinjuku-ku, Tokyo, 163-1488, Japan. Yoko.Takahashi@sanofi.com.;Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama;City University, Yokohama, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40056372/ |
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