Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F22%3A10435402" target="_blank" >RIV/00216208:11110/22:10435402 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=phmcKuV3Qx" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=phmcKuV3Qx</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s13300-021-01180-1" target="_blank" >10.1007/s13300-021-01180-1</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results

Popis výsledku v původním jazyce

Plain Language Summary People with type 2 diabetes require glucose-lowering drugs to attain and maintain blood glucose control, with many eventually requiring injectable therapies. iGlarLixi combines two injectable therapies (basal insulin glargine and a glucagon-like peptide-1 receptor agonist, lixisenatide) into a single fixed-ratio daily injection and has previously been shown to provide robust improvements in blood glucose control. However, previous studies have not assessed the potential effect that simultaneous use of sodium-glucose co-transporter-2 inhibitor (SGLT2i) therapy may have on iGlarLixi therapy. This is of interest because SGLT2is are a widely used oral blood-glucose-lowering therapy that also have a beneficial effect in people with type 2 diabetes who have cardiovascular or kidney disease or have risk factors for the development or progression of these conditions. Therefore, this study assessed whether there were relevant differences in terms of blood glucose control and safety when initiating iGlarLixi in people treated with SGLT2i versus initiating iGlarLixi in people not receiving SGLT2i. Results showed that iGlarLixi provided similarly good glucose control and safety profiles, regardless of whether SGLT2is were used or not, thereby supporting the simultaneous use of these two therapies. Introduction iGlarLixi, the once-daily fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, robustly improves glycaemic control in adults with type 2 diabetes irrespective of previous treatment [oral antihyperglycaemic drugs (OADs), basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs)]. Sodium-glucose co-transporter-2 inhibitors (SGLT2is) are a recommended treatment option for people with type 2 diabetes with cardiovascular disease, kidney disease and/or heart failure because of their cardio- and renoprotective benefits. Herein, we assessed the effects of concomitant iGlarLixi and SGLT2i therapy. Methods We conducted subgroup analyses according to SGLT2i use in: (1) adults with suboptimally controlled type 2 diabetes on GLP-1 RAs and OADs switching to iGlarLixi in the 26-week LixiLan-G randomised controlled trial (RCT; NCT02787551) and (2) adults switching to or adding iGlarLixi in a 6-month, retrospective real-world evidence (RWE) observational study using data from the US Optum-Humedica electronic medical records database. Changes in HbA(1c) and hypoglycaemia prevalence and event rates were assessed. Results There were no major differences in baseline characteristics for those who initiated iGlarLixi while already using SGLT2i (n = 346) and those initiating iGlarLixi without concomitant SGLT2i therapy (n = 1285). HbA(1c) reductions from baseline to time of assessment and hypoglycaemia prevalence and event rates were similar for iGlarLixi users regardless of SGLT2i therapy. Conclusion Evidence from an RCT and an RWE analysis supports the efficacy/effectiveness and safety of iGlarLixi when used concomitantly with SGLT2i.

Název v anglickém jazyce

Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results

Popis výsledku anglicky

Plain Language Summary People with type 2 diabetes require glucose-lowering drugs to attain and maintain blood glucose control, with many eventually requiring injectable therapies. iGlarLixi combines two injectable therapies (basal insulin glargine and a glucagon-like peptide-1 receptor agonist, lixisenatide) into a single fixed-ratio daily injection and has previously been shown to provide robust improvements in blood glucose control. However, previous studies have not assessed the potential effect that simultaneous use of sodium-glucose co-transporter-2 inhibitor (SGLT2i) therapy may have on iGlarLixi therapy. This is of interest because SGLT2is are a widely used oral blood-glucose-lowering therapy that also have a beneficial effect in people with type 2 diabetes who have cardiovascular or kidney disease or have risk factors for the development or progression of these conditions. Therefore, this study assessed whether there were relevant differences in terms of blood glucose control and safety when initiating iGlarLixi in people treated with SGLT2i versus initiating iGlarLixi in people not receiving SGLT2i. Results showed that iGlarLixi provided similarly good glucose control and safety profiles, regardless of whether SGLT2is were used or not, thereby supporting the simultaneous use of these two therapies. Introduction iGlarLixi, the once-daily fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, robustly improves glycaemic control in adults with type 2 diabetes irrespective of previous treatment [oral antihyperglycaemic drugs (OADs), basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs)]. Sodium-glucose co-transporter-2 inhibitors (SGLT2is) are a recommended treatment option for people with type 2 diabetes with cardiovascular disease, kidney disease and/or heart failure because of their cardio- and renoprotective benefits. Herein, we assessed the effects of concomitant iGlarLixi and SGLT2i therapy. Methods We conducted subgroup analyses according to SGLT2i use in: (1) adults with suboptimally controlled type 2 diabetes on GLP-1 RAs and OADs switching to iGlarLixi in the 26-week LixiLan-G randomised controlled trial (RCT; NCT02787551) and (2) adults switching to or adding iGlarLixi in a 6-month, retrospective real-world evidence (RWE) observational study using data from the US Optum-Humedica electronic medical records database. Changes in HbA(1c) and hypoglycaemia prevalence and event rates were assessed. Results There were no major differences in baseline characteristics for those who initiated iGlarLixi while already using SGLT2i (n = 346) and those initiating iGlarLixi without concomitant SGLT2i therapy (n = 1285). HbA(1c) reductions from baseline to time of assessment and hypoglycaemia prevalence and event rates were similar for iGlarLixi users regardless of SGLT2i therapy. Conclusion Evidence from an RCT and an RWE analysis supports the efficacy/effectiveness and safety of iGlarLixi when used concomitantly with SGLT2i.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Diabetes Therapy

ISSN

1869-6953

e-ISSN

1869-6961

Svazek periodika

13

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

205-215

Kód UT WoS článku

000729210900001

EID výsledku v databázi Scopus

2-s2.0-85120902896