EPIC (yaşlı, ayaktan kardiyak hastalarda polifarmasi ve potansiyel ilaç-ilaç etkileşimlerinin epidemiyolojisi) çalışmasının temel, tasarım ve metodolojisi

Objective: The aim of this study is to assess the prevalence of polypharmacy, inappropriate drug use, and drug-drug interactions (DDIs) in elderly patients presenting at outpatient cardiology clinics in Turkey. Methods: The EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study will be an observational, real-world, multicenter study conducted to evaluate DDIs and polypharmacy in elderly cardiac outpatients. All consecutive patients (aged >= 65 years) admitted to outpatient cardiology clinics between July 30, 2018 and July 30, 2019 who provide written, informed consent will be enrolled. A total of approximately 5000 patients are to be enrolled in this non-interventional study. All of the data will be collected at one point in time and current clinical practice will be evaluated (ClinicalTrials.gov NCT03370523). Result: Patient demographics, comorbid disease characteristics, laboratory test results, and details of medication use will be collected using self-reports and medical records. The severity of comorbid disease will be recorded and scored according to Charlson Comorbidity Index (CCI) and patients will be divided into 3 groups: mild, those with a CCI score of 1-2; moderate, those with a CCI score of 3-4; and severe, those with a CCI score of >= 5. Polypharmacy will be defined as the use of 5 or more medications at one time. DDIs will be determined using the Lexicomp Online drug interaction screening tool and potentially inappropriate medications will be defined based on the 2015 update of the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Severe drug interactions will be defined as those in category D or X. Conclusion: EPIC will be the first large-scale study in Turkey to evaluate polypharmacy, potentially inappropriate medications, and DDIs in elderly cardiac outpatients in a real-world clinical setting.Amaç: Türkiye’deki kardiyoloji polikliniklerine başvuran yaşlı hastalarda polifarmasi prevalansını, uygunsuz ilaç kullanımını ve ilaç-ilaç etkileşimlerini (İİE) değerlendirmek. Yöntemler: EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) çalışması kardiyoloji polikliniklerine başvuran yaşlı hastalarda polifarmasi ve İİE’nin değerlendirileceği, gerçek yaşam verilerini aktaran, çok merkezli ve gözlemsel bir çalışma olarak tasarlandı. Çalışmaya; 30 Temmuz 2018 ve 30 Temmuz 2019 tarihleri arasında farklı kardiyoloji polikliniklerine başvuran, aydınlatılmış onam formunu imzalayan, 65 yaş ve üzeri, kadın ve erkek, ardışık 5000 hastanın dahil edilmesi planlandı. Hastalarla ilgili tüm verilerin tek bir ziyarette alınması ve verilerin değerlendirilmesi planlandı (ClinicalTrials.gov numarası NCT03370523). Bulgular: Hastalara ait demografik veriler, komorbid hastalık durumları, laboratuvar test sonuçları ve ilaç bilgileri hasta beyanları ve medikal kayıtlar yoluyla toplanacaktır. Komorbid hastalıklar kaydedilecek ve komorbid hastalıkların ciddiyeti Charlson komorbidite indeksi’ne (CKİ) göre hastalar 3 gruba ayrılacaktır: CKİ skoru 1–2 olanlar hafif, CKİ skoru 3–4 olanlar orta, CKİ skoru ≥5 olanlar ciddi. Polifarmasi aynı hastanın bir kerede 5 ve üzeri ilaç kullanması olarak tanımlanacaktır. İİE Lexicomp® çevrimiçi ilaç etkileşimi tarama aracı ile kontrol edilecek, potansiyel uygunsuz ilaç kullanımı 2015 Beers kriterlerine göre tanımlanacaktır. D ve X kategorisindeki etkileşimler ciddi ilaç etkileşimi olarak sınıflandırılacaktır. Sonuç: EPIC çalışması kardiyoloji polikliniklerine başvuran yaşlı hastalarda polifarmasi, İİE ve potansiyel uygunsuz ilaç kullanımı konularında gerçek yaşam verilerini ayrıntılı olarak aktaran ilk büyük çaplı çalışma olacaktır

Guideline-adherent therapy for stroke prevention in atrial fibrillation in different health care settings: Results from ramses study

Objective No studies have been conducted in Turkey to compare the quality of stroke prevention therapies provided in different healthcare settings in patients with atrial fibrillation (AF). Therefore, we aimed to evaluate possible differences between secondary (SH) and tertiary hospital (TH) settings in the effectiveness of implementing AF treatment strategies. Methods Baseline characteristics of 6273 patients with non-valvular AF enrolled in the RAMSES (ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies in Turkey) study were compared. Results Of the study population, 3312 (52.8%) patients were treated in THs and 2961 (47.2%) patients were treated in SHs. Patients treated in the SH setting were older (70.8 ± 9.8 vs. 68.7 ± 11.4 years, p < 0.001), had a lower socioeconomic status, had a higher CHA2DS2VASc and HASBLED scores (3.4 ± 1.4 vs. 3.1 ± 1.7, p < 0.001 and 1.7 ± 1.0 vs. 1.6 ± 1.1, p < 0.001 respectively), and had more comorbidities than patients treated in THs. Inappropriate oral anticoagulant use was more prevalent in SHs than THs (31.4% vs. 25.6%, p < 0.001). When over- and undertreatment rates were compared among hospital types, overtreatment was more prevalent in THs (7.6% vs. 0.9%, p < 0.001) while undertreatment was more common in SHs (30.5% vs. 17.9%, p < 0.001). Conclusion This study demonstrates the marked disparity between patient groups with AF presenting at SHs and THs. The use of guideline-recommended therapy is not adequate in either type of centre, overtreatment was more prevalent in THs and undertreatment was more prevalent in SHs