Real-World Evaluation of Once-Weekly Subcutaneous Semaglutide in Patients with Type 2 Diabetes Mellitus in Spain (SEMA-RW Study).

Fecha de publicación: 03/08/2024 Fecha Ahead of Print: 03/08/2024

Autores de IIS La Fe

Juan Francisco Merino Torres

Autor

Participantes ajenos a IIS La Fe

Caballero Mateos I
García de Lucas MD
Doulatram-Gamgaram VK
Moreno-Moreno P
Jimenez-Millan AI
Botana-López M
Soto-Gónzalez A
Fernández-García JC
Morales-Portillo C

Grupos

Unidad Mixta de Investigación en Endocrinología, Nutrición y Dietética clínica

Leader

Juan Francisco Merino Torres

Abstract

Although, in randomized clinical trials, once-weekly subcutaneous semaglutide (OW s.c.) has demonstrated superior efficacy in comparison with placebo and active controls in terms of glycemic control and body weight reduction in patients with type 2 diabetes mellitus (T2DM), these results need to be confirmed in a real-world (RW) setting. An RW ambispective study (6 months retrospective and 6 months prospective) was conducted in 10 tertiary hospitals in Spain. We evaluated changes in HbA1c and body weight in patients with T2DM treated with semaglutide OW s.c. Additionally, we analyzed different subgroups of patients treated with semaglutide OW s.c. as an add-on to glucose-lowering therapy. A total of 752 patients with a mean age of 60.2 years, a mean HbA1c level of 8.5%, a mean body weight of 101.6 kg, and a mean T2DM duration of 10 years were included. At 12 months, compared with baseline, there was a mean difference of -2.1% in HbA1c levels (p < 0.001) and a mean difference of 9.2 kg in body weight (p < 0.001). Moreover, there were statistically significant differences (p < 0.001) between baseline and month 12 in both HbA1c and body weight in the four subgroups receiving semaglutide OW s.c. as an add-on to glucose-lowering therapy. Semaglutide OW s.c. was well tolerated, with gastrointestinal disorders being the most commonly reported side effects. In this RW study, 12 months of treatment with semaglutide OW s.c. in patients with T2DM was associated with significant and clinically relevant improvements in glycemic control and weight loss, regardless of the glucose-lowering therapy received, and the overall safety profile was positive.

Datos de la publicación

ISSN/ISSNe:: 2072-6643, 2072-6643
Tipo:: Article
Páginas:: -
DOI:: 10.3390/nu16152545
Factor de Impacto:: 1,287 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Filiaciones

Caballero Mateos I:: Endocrinology and Nutrition Department, Virgen Macarena University Hospital and Vithas Hospital, 41009 Sevilla, Spain
García de Lucas MD:: Internal Medicine Department, Hospital Costa del Sol, 29603 Marbella, Spain
Doulatram-Gamgaram VK:: Department of Endocrinology and Nutrition, Regional University Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Faculty of Medicine, University of Malaga, 29016 Malaga, Spain
Moreno-Moreno P:: Endocrinology and Nutrition Department, Reina Sofía University Hospital, 14004 Córdoba, Spain
Jimenez-Millan AI:: Endocrinology and Nutrition Department, University Hospital, 11510 Puerto Real, Spain
Botana-López M:: Endocrinology and Nutrition Department, Lucus Augusti University Hospital, 27003 Lugo, Spain
Merino-Torres JF:: Endocrinology and Nutrition Department, La Fe University Hospital, 46026 Valencia, Spain
Soto-Gónzalez A:: Endocrinology and Nutrition Department, A Coruña University Hospital Complex, 15006 A Coruña, Spain
Fernández-García JC:: Department of Endocrinology and Nutrition, Regional University Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Faculty of Medicine, University of Malaga, 29016 Malaga, Spain
Morales-Portillo C:: Endocrinology and Nutrition Department, Virgen Macarena University Hospital and Vithas Hospital, 41009 Sevilla, Spain