Browsing by Author "Turk, Ugur Onsel"

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Baseline Clinical Characteristics of Patients from the Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in TüRkiye Study
(Kare Publ, 2026) Yavuz, Veysel; Turk, Ugur Onsel; Arslan, Ugur; Kocabas, Umut; Akgun, Didar Elif; Coner, Ali; Kurşun, Mustafa; Uguz, Berat
Objective: A post-authorization safety study with a prospective design focusing on the safety of edoxaban treatment in Türkiye has not yet been conducted. The Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in TüRkiye (ETAF-TR) study was designed to evaluate the safety and effectiveness of edoxaban treatment in atrial fibrillation (AF). The baseline results of the ETAF-TR study describe the demographic, clinical, and laboratory characteristics of the study population. Method: The ETAF-TR study (NCT04594915) is a prospective, national, multicenter, observational, post-authorization safety study conducted in 50 outpatient cardiology clinics. Results: Overall, 1,053 patients with AFtreated with edoxaban forstroke prevention were enrolled in the study between August 2020 and May 2022. The mean age of the study population was 70.1 +/- 11.3 years, and 59.0% of the patients were female. Mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >= 75 years, Diabetes, Stroke/TIA/thromboembolism, Vascular disease, Age 65-74 years, Sex category) and HAS-BLED scores (Hypertension, Abnormal renal/ liver function, Stroke, Bleeding history/predisposition, Labile INR, Elderly, Drugs/alcohol) were 3.5 and 1.6, respectively. Of the 1,053 patients, 843 (80.1%) received standard-dose edoxaban and 210 (19.9%) received reduced-dose edoxaban. Of the 1,053 patients, 38 (3.6%) had off-label use of edoxaban therapy. Among the remaining 1,015 patients, 834 (82.2%) received an appropriate dose of edoxaban and 181 (17.8%) received an inappropriate dose of edoxaban according to the Summary of Product Characteristics (SmPC) criteria. Conclusion: Edoxaban has been used in a wide spectrum of patients with AF in daily routine practice, with good overall adherence to the SmPC. As the largest national pharmacovigilance study to date, the ETAF-TR study will provide detailed insight into the safety of edoxaban treatment.
Citation - WoS: 13
Citation - Scopus: 14
Real-World Data on Empagliflozin and Dapagliflozin Use in Patients With Heart Failure: the Red-Heart Study
(Wiley Periodicals, Inc, 2024) Kocabaş, Umut; Ergin, Işıl; Yavuz, Veysel; Altın, Cihan; Kaplan, Mehmet; Oztekin, Guelsuem Meral Yilmaz; Dogdus, Mustafa; Turk, Ugur Onsel; Yılmaz Öztekin, Gülsüm Meral
Aims: We aimed to determine the use of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and to identify clinical factors associated with their use in patients with heart failure (HF) in a real-life setting. Methods: Real-world data on Empagliflozin and Dapagliflozin use in patients with HEART failure: The RED-HEART study is a multicentre, cross-sectional and observational study that included HF patients in the outpatient setting regardless of ejection fraction from 19 cardiology centres between August 2023 and December 2023. Results: The study population consisted of 1923 patients with HF, predominantly men (61.2%), with a median age of 66 (range: 19-101) years. Overall, 925 patients (48.1%) were receiving SGLT2is. Among the study population, 22.1% had HF with preserved ejection fraction, 21.5% had HF with mildly reduced ejection fraction, 56.4% had HF with reduced ejection fraction and the use of SGLT2is was 42.0%, 47.9% and 50.6% in each group, respectively (P = 0.012). The use of SGLT2is was 76.6% in patients with HF and diabetes, 19.8% in patients with HF and chronic kidney disease and 26.8% in patients without diabetes and chronic kidney disease (P < 0.001). Higher education level [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.06-3.05; P = 0.027], higher household income (OR: 3.46; 95% CI: 1.27-9.42; P = 0.015), New York Heart Association functional class IV (OR: 2.72; 95% CI: 1.16-6.35; P = 0.021), diabetes (OR: 9.42; 95% CI: 6.72-13.20; P < 0.001), the use of angiotensin receptor-neprilysin inhibitors (ARNis) (OR: 4.09; 95% CI: 2.39-7.01; P < 0.001), the use of mineralocorticoid receptor antagonists (MRAs) (OR: 2.02; 95% CI: 1.49-2.75; P < 0.001), the use of loop diuretics (OR: 1.62; 95% CI: 1.18-2.22; P = 0.003) and the use of thiazide diuretics (OR: 1.72; 95% CI: 1.30-2.29; P < 0.001) were independently associated with the use of SGLT2is. Conversely, atrial fibrillation (OR: 0.63; 95% CI: 0.45-0.88; P = 0.008), chronic kidney disease (OR: 0.53; 95% CI: 0.37-0.76; P = 0.001), the use of dihydropyridine calcium channel blockers (OR: 0.68; 95% CI: 0.48-0.98; P = 0.042) and the use of statins (OR: 0.67; 95% CI: 0.49-0.91; P = 0.010) were independently associated with the non-use of SGLT2is. Conclusions: The RED-HEART study provided comprehensive real-world data about implementing SGLT2is in patients with HF. These results suggest that there is a need for organized action and close collaboration between healthcare providers to improve the implementation of SGLT2is, especially in patients with HF with preserved ejection fraction and chronic kidney disease.