Natalia Duque1, Esther Artime2, Irene Romera2, Jeremie Lebrec3, Silvia Díaz2, Miriam Rubio2, Antoni Sicras-Mainar4, Enrique Carretero-Anibarro5, Xavier Mundet6, Juan J Gorgojo-Martínez7, Jesús Reviriego2. 1. Departamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain. duque_natalia@lilly.com. 2. Departamento Médico, Lilly Alcobendas, Avda. de la Industria 30, Alcobendas, 28108, Madrid, Spain. 3. HaaPACS GmbH, Schriesheim, Germany. 4. Atrys Health SA, Health Economics and Outcomes Research, Barcelona, Spain. 5. Medicina Familiar y Comunitaria, Unidad de Gestión Clínica Estepa, Sevilla, Spain. 6. Universitat Autonoma de Barcelona, Bellaterra, Spain. 7. Department of Endocrinology and Nutrition, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
Abstract
INTRODUCTION: In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10-15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice. METHODS: In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively. RESULTS: The IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively. CONCLUSION: In real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs.
INTRODUCTION: In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulinglargine (IGlar) U300 required 10-15% more insulin than those receiving IGlarU100. This study sought to determine whether this difference was apparent in real-world practice. METHODS: In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlarU100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlarU100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively. RESULTS: The IGlarU100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlarU300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlarU300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlarU100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively. CONCLUSION: In real-world practice, insulin dose was significantly higher in IGlarU300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlarU300 would result in higher costs.
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