Tıp Fakültesi / Faculty of Medicine

Permanent URI for this collectionhttps://hdl.handle.net/11727/1403

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    Vaccination in Individuals with Multiple Sclerosis - Part I
    (2023) Cinar, Bilge Piri; Tuncer, Asli; Bilge, Nuray; Bunul, Sena Destan; Gozubatik Celik, Rabia Gokcen; Ciftci, Eda Derle; Genc, Gencer; Karaman, Bedriye; Kilic, Ahmet Kasim; Sariteke, Alp; Seferoglu, Meral; Tiftikcioglu, Bedile Irem; Tunc, Abdulkadir; Uncu, Gulgun; Yavas, Irfan; Yetkin, Mehmet Fatih; Efendi, Husnu; Siva, Aksel; 0000-0001-6900-4702
    Multiple sclerosis (MS) is an autoimmune and demyelinating disease of the central nervous system. It is a chronic disease, and in the evaluation of all other health and vital processes, decisions should be made by considering the disease process and the drugs used by the patient. Since vaccination can be performed at every stage of life, from childhood to adulthood, immune system activity, except where it is characteristic of the vaccine, should be reviewed in patients with MS. In this review, the applications of different vaccines in individuals with MS are discussed in two separate sections.
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    Efficacy and Safety of the Proposed Bevacizumab Biosimilar BAT1706 Compared with Reference Bevacizumab In Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study
    (2023) Chen, Likun; Rangel, Jose David Gomez; Cil, Timucin; Li, Xingya; Cicin, Irfan; Shen, Yihong; Liu, Zhihua; Ozyilkan, Ozgur; Igor, Bondarenko; Chen, Jun; Oleksandr, Kostiuk; Chen, Zhendong; Zhang, Helong; Fu, Ziyi; Dong, Qingfeng; Song, Shuqiang; Yu, Jin-Chen; Zhang, Li; 37935428
    Background: BAT1706 is a proposed biosimilar of bevacizumab (Avastin (R)). We aimed to compare the efficacy and safety of BAT1706 with that of EU-sourced reference bevacizumab (EU-bevacizumab) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).Methods: Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU-bevacizumab plus paclitaxel and carboplatin (EU-bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU-bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU-bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75-1.33 (China National Medical Products Administration requirements), or 0.73-1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of -0.12 to 0.15 (EMA requirements).Results: In total, 649 randomized patients (BAT1706, n = 325; EU-bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU-bevacizumab arms (48.0% and 44.5%, respectively). The ORR(18 )risk ratio of 1.08 (90% CI: 0.94-1.24) and the ORR(18 )risk difference of 0.03 (95% CI: -0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU-bevacizumab. The safety profile of BAT1706 was consistent with that of EU-bevacizumab and no new safety signals were observed.Conclusion: In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU-bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.
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    The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction >= 40%: A Population-Based Cohort Study (Nebivolol-TR Study)
    (2022) Altin, Cihan; Okyay, Kaan; Kocaba, Umut; Coner, Ali; https://orcid.org/0000-0001-6134-8826; https://orcid.org/0000-0002-5711-8873; 36317659; AAK-7355-2020; ABD-7321-2021
    Background: This study aimed to assess the safety and tolerability of nebivolol in hypertensive patients with coronary artery disease and left ventricular ejection fraction >= 40% in a Turkish cohort. Methods: A total of 1015 hypertensive patients and coronary artery disease with left ventricular ejection fraction >= 40% were analyzed from 29 different centers in Turkey. Primary outcomes were the mean change in blood pressure and heart rate. Secondary outcomes were to assess the rate of reaching targeted blood pressure (<130/80 mmHg) and heart rate (<60 bpm) and the changes in the clinical symptoms (angina and dyspnea). Adverse clinical events and clinical outcomes including cardiovascular mortality, cardiovascular hospital admissions, or acute cardiac event were recorded. Results: The mean age of the study population was 60.3 +/- 11.5 years (male: 54.2%). During a mean follow-up of 6 months, the mean change in blood pressure was -11.2 +/- 23.5/-5.1 +/- 13.5 mmHg, and the resting heart rate was -12.1 +/- 3.5 bpm. Target blood pressure and heart rate were achieved in 76.5% and 37.7% of patients. Angina and functional classifications were improved by at least 1 or more categories in 31% and 23.2% of patients. No serious adverse events related to nebivolol were reported. The most common cardiovascular side effect was symptomatic hypotension (4.2%). The discontinuation rate was 1.7%. Cardiovascular hospital admission rate was 5% and hospitalization due to heart failure was 1.9% during 6 months' follow-up. Cardiovascular mortality rate was 0.1%. Conclusion: Nebivolol was well tolerated and safe for achieving blood pressure and heart rate control in hypertensive patients with coronary artery disease and heart failure with preserved or mildly reduced ejection fraction.