Real‐world effectiveness and safety of oral semaglutide in people living with type 2 diabetes: A nationwide multicentre retrospective observational study (<scp>ENDO<sup>2</sup>S‐RWD</scp>)

Moreno‐Pérez, Oscar; Reyes‐Garcia, Rebeca; Modrego‐Pardo, Inés; Doulatram‐Gamgaram, Viyey Kishore; Cases, Carlos Casado; Guillen‐Morote, Cristina; Mendoza, Nieves Arias; Tejera‐Pérez, Cristina; Cárdenas‐Salas, Jersy; Martínez‐Fuster, Sandra; Lardiés‐Sánchez, Beatriz; Márquez‐Pardo, Rosa; Pinés, Pedro; Fernández‐García, José Carlos; ,

doi:10.1111/dom.15431

Cited by 6 publications

(4 citation statements)

References 22 publications

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“…Trying to compare the results of the present work with those of RCT trials, it appears that the relatively small series of data obtained are in line with the RCT observations in terms of both efficacy and safety. Considering other real-world studies on T2D patients, in reference to glycemic control, in the present work, the HbA1c reduction at 6 months (−0.68%) was comparable to that shown in the ENDO2S-RWD [21] (−0.7%HbA1c) and in a recent study by Frazer and colleagues [22] (−0.8%). Limiting the comparison to the Italian evidence available, the present cohort reached the greatest glycemic efficacy (−0.3% and −0.4%) [23,24]; conversely, a more effective glycemic control was reported by the IGNITE study [18] (−0.9%), the PIONEER REAL Switzerland [19] (−0.91%), and in a cohort of Japanese T2D patients [20] (−1.24%).…”

Section: Discussionsupporting

confidence: 88%

“…Indeed, gastrointestinal side effects were experienced by 13.5% of patients, leading to treatment discontinuation in the 20.8% of cases; thus, gastrointestinal illness represents the primary reason for treatment interruption. The discontinuation rate observed in the present study is slightly higher than that observed in both the PIONEER program and the available observational studies with oral semaglutide [ 18 , 19 , 20 , 21 , 22 , 23 , 24 ].…”

Section: Discussioncontrasting

confidence: 80%

“…In reference to body weight, we observed a weight loss at 6 months of −2.63 kg. A variability in the extent of weight loss emerged in the literature, with some authors reporting larger reductions (from −3.7 to −4.85 kg) [ 19 , 21 , 24 ] and others showing a modest efficacy on body weight improvement (from −1.4 4 kg to −2 kg) [ 20 , 23 ]. In some studies, data on weight loss were omitted [ 18 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

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Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Baldassarre,

Di Dalmazi,

Coluzzi

et al. 2024

JCM

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Background/Objectives: Semaglutide is the unique once-daily oral glucagon-like receptor agonist presently available. Aims of this study were to describe clinical characteristics of patients with type 2 diabetes (T2D) initiating oral semaglutide, to assess its effects on glycemic control, body weight (BW) and its tolerability in routine clinical practice. Methods: Electronic medical records from two Italian diabetes clinics were evaluated. Mean glycated hemoglobin (HbA1c) and BW were assessed in adults with T2D before and 6 months after oral semaglutide prescription. Treatment discontinuation and safety data were reported. Results: A total of 192 patients initiating oral semaglutide (44% female) presented a mean age of 66 years, a diabetes duration of 10 years, HbA1c of 7.9% and a BW of 82.6 kg. Almost 50% of patients were obese. Mean HbA1c and BW changes from baseline to follow up were −0.7% and −2.6 kg, respectively. Greater HbA1c reduction was observed in patients with baseline HbA1c ≥ 8% and with diabetes duration <5 years. The composite endpoint of HbA1c ≤7% and a weight loss ≥5% was achieved in 22.5% of the participants. A total of 40 patients (20.8%) discontinued treatment: 26 because of gastrointestinal adverse events, and 10 due to limited effectiveness in lowering HbA1c and/or BW. Conclusions: In a real clinical setting, patients initiating oral semaglutide showed suboptimal metabolic control, short diabetes duration and obesity; a significant improvement in HbA1c and BW was achieved mainly in patients with a more recent diabetes diagnosis, supporting the use of oral semaglutide in the early phase of the disease.

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Section: Discussionsupporting

confidence: 88%

Section: Discussioncontrasting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

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Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Baldassarre,

Di Dalmazi,

Coluzzi

et al. 2024

JCM

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“…Given the global supply chain issues for subcutaneous GLP1RAs, oral semaglutide could also be an option. Real-world data show that it is effective and safe in an unselected population, with one-third reaching WL >10% and near two-thirds achieving HbA1c <7% [ 60 ].…”

Section: Therapeutic Translation: Dysfunctional Adipose Tissue Approa...mentioning

confidence: 99%

Are we ready for an adipocentric approach in people living with type 2 diabetes and chronic kidney disease?

Moreno-Pérez,

Reyes-García,

Modrego-Pardo

et al. 2024

Clinical Kidney Journal

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We are entering a new era in the management of adiposity-based chronic disease (ABCD) with type 2 diabetes (T2D) and related chronic kidney disease (CKD). ABCD, T2D and CKD can affect almost every major organ system and have a particularly strong impact on the incidence of cardiovascular disease (CVD) and heart failure. ABCD and the associated insulin resistance are at the root of many cardiovascular, renal and metabolic (CKM) disorders, thus an integrated therapeutic framework using weight loss (WL) as a disease-modifying intervention could simplify the therapeutic approach at different stages across the lifespan. The breakthrough of highly effective WL drugs makes achieving a WL of >10% possible, which is required for a potential T2D disease remission as well as for prevention of microvascular disease, CKD, CVD events and overall mortality. The aim of this review is to discuss the link between adiposity and CKM conditions as well as placing weight management at the centre of the holistic CKM syndrome approach with a focus on CKD. We propose the clinical translation of the available evidence into a transformative Dysfunctional Adipose Tissue Approach (DATA) for people living with ABCD, T2D and CKD. This model is based on the interplay of four essential elements (i.e. adipocentric approach and target organ protection, dysfunctional adiposity, glucose homeostasis, and lifestyle intervention and de-prescription) together with a multidisciplinary person-centred care. DATA could facilitate decision-making for all clinicians involved in the management of these individuals, and if we do this in a multidisciplinary way, we are prepared to meet the adipocentric challenge.

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Real-World Clinical Experience of Oral Semaglutide in a Secondary Diabetes Clinic in the UK: A Retrospective Observational Study

Williams,

Alberts,

Sharaf

et al. 2024

Diabetes Ther

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Introduction:Oral semaglutide improves cardiovascular risk factors in people with type 2 diabetes (T2D) in clinical trials, though real-world evidence is limited. We aimed to determine the real-world impact of oral semaglutide on routinely collected clinical data in our practice. Methods: People with T2D initiated on oral semaglutide in secondary care diabetes clinics at two hospital sites in Wales (United Kingdom) were included. Data were collected on reasons for oral semaglutide initiation and changes in bodyweight, blood pressure, glycemic control, and lipid profiles over follow-up at 3-6 months, and at 6-12 months. Data were collected to determine the safety of oral semaglutide. Results: Seventy-six patients were included, with a median age 59.3 [51.4-67.6] years, and 38 (50.0%) patients were female. The most common reasons for oral semaglutide were need for weight loss and improved glycemia (69.8%), and improved glycemia alone (25.0%). Oral semaglutide associated with significantly reduced bodyweight (− 3.3 kg), body mass index (BMI) (-0.9 kg/m 2 ), glycated hemoglobin (HbA1c) (− 11 mmol/mol), and total cholesterol (− 0.4 mmol/l) by 3-6 months follow-up. At 6-12 months, there was a significant reduction in systolic blood pressure (− 7.0 mmHg), in addition to sustained reductions in other metabolic parameters. By 12 months, 18 (23.6%) patients had discontinued the drug, largely resulting from gastrointestinal disturbance, but there were no serious events in this cohort. Conclusions: Oral semaglutide was effective in improving cardiovascular risk factors in this real-world population living with T2D, and no serious events were identified related to oral semaglutide in this patient group.

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Real‐world effectiveness and safety of oral semaglutide in people living with type 2 diabetes: A nationwide multicentre retrospective observational study (ENDO²S‐RWD)

Abstract: BACKGROUNDType 2 diabetes guidelines recommend glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and/or sodium-glucose co-transporter-2 inhibitors for people living with type 2 diabetes (PLWT2D) with an

Cited by 6 publications

References 22 publications

Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Are we ready for an adipocentric approach in people living with type 2 diabetes and chronic kidney disease?

Real-World Clinical Experience of Oral Semaglutide in a Secondary Diabetes Clinic in the UK: A Retrospective Observational Study

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Real‐world effectiveness and safety of oral semaglutide in people living with type 2 diabetes: A nationwide multicentre retrospective observational study (ENDO2S‐RWD)

Abstract: BACKGROUNDType 2 diabetes guidelines recommend glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and/or sodium-glucose co-transporter-2 inhibitors for people living with type 2 diabetes (PLWT2D) with an

Cited by 6 publications

References 22 publications

Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Are we ready for an adipocentric approach in people living with type 2 diabetes and chronic kidney disease?

Real-World Clinical Experience of Oral Semaglutide in a Secondary Diabetes Clinic in the UK: A Retrospective Observational Study

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Resources

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Real‐world effectiveness and safety of oral semaglutide in people living with type 2 diabetes: A nationwide multicentre retrospective observational study (ENDO²S‐RWD)