THU283 Oral Semaglutide, Effectiveness, Safety And Tolerability In Real Life: A Short-term Retrospective Observational Study
Authors: Moreno-Perez Oscar , Guillen-Morote Cristina , Argüello Thalía , Soriano Carmen , SantaCruz Elisa , Lopez-Mondejar Pedro , Navarro-Hoyas Clara , Sanchez-Ortiga Ruth , Sanchez-Pacheco Myriam , Modrego-Pardo Ines , Miguel Pico Antonio 
Published: October 2023

Disclosure: O. Moreno-Perez: None. C. Guillen-Morote: None. T. Argüello: None. C. Soriano: None. E. SantaCruz: None. P. Lopez-Mondejar: None. C. Navarro-Hoyas: None. R. Sanchez-Ortiga: None. M. Sanchez-Pacheco: None. I. Modrego-Pardo: None. A.M. Pico: None.

Introduction: Oral semaglutide (oSEMA) is the first and only oral aRGLP1 currently available on the market. Given its recent commercialization, there is little real-life evidence on its effectiveness, safety, and tolerability. Primary objective: to evaluate the effectiveness (HbA1c, Weight, Blood Pressure, Albumin Creatinine Ratio (ACR)) safety and tolerability of oSEMA 3-6 months after the start of treatment in the real world clinical practice. Secondary objective: to describe the main indications of oSEMA in real life. Material and methods: short-term retrospective observational study of all patients with oSEMA prescription in two health departments between November 2021 and November 2022. Statistical approach: descriptive analysis (median [IQR]); Wilcoxon test - paired data for evaluate changes in main outcomes and logistic regression to determine associations between provider speciality and short-term non-adherence. Ethics committee approval Ref.: 2022-0386. Results: 170 patients were included in these preliminary data. The median age was 63 [55.0 -70.0] years, with male predominance (60.5%), initial weight of 95 [83-112]kg and BMI 36.03 [31.04-39.34] Kg/m2. Median T2D evolution was 8 [2.0-12.0] years, 27.3% have an established CVD and 14% DKD. Prior therapy for T2D: 11% GLP1 receptor agonists (RA), 25.6% DPP4 inhibitors, 47.1% SGLT-2 inhibitors and 22.7% under insulin therapy. The oSEMA provider specialties were mainly: endocrinology (ENDO) 39.2%, primary physician (PCare) 35.7% and cardiology (CAR) 20.9%. At the time of this analysis, the maintenance dose was 7 mg in 98.4% of patients. The changes in the main clinical outcomes at 3-6 months of follow-up were: HbA1c 7.8 [6.9-8.6]% vs 6.9 [6.2-7.7]%, p= 0.0001; weight 95.5 [81-112] Kg vs 90 [74.5-105.2]Kg, p= 0.0001; ACR (baseline ACR subpopulation &gt; 30) 57 [39. 5- 110.9] mg/g vs. CAC 37.0 [14.5-58.0], p=0.005; SBP 135 [125-150] mmHg vs. SBP 121.5 [109.50-31.00], p= 0.028. Treatment was discontinued in 23.8% of cases (ENDO 14%, PCare 26, CAR 30%). Having the index prescription ordered by ENDO were associated with lower odds of non-adherence (OR 0.48[0.22-1.05], p = 0.06). The most frequent causes of oSEMA discontinuation were the lack of continuity of care after hospitalization (renewal / titration) (10.5%) and digestive intolerance (8.7%). Conclusions: Oral SEMA at medium doses is effective in the short term with 1% reductions in HbA1c, 5% weight loss and a significant reduction in microalbuminuria. Oral SEMA is usually started in obese PLWT2D naïve to aRGLP1, with inadequate metabolic control and without CV disease. No serious adverse events have been recorded. Mistakes in the transition from hospital discharge to primary care were the cause of almost 50% of short-term non-adherence.

Presentation: Thursday, June 15, 2023