Araştırma Çıktıları | Scopus
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Item Efficacy and Safety of Intravenous Colistin in Very Low Birth Weight Preterm Infants(Adis, 2018) Ilhan O.; Bor M.; Ozdemir S.A.; Akbay S.; Ozer E.A.Background: Given the severity and high mortality of multidrug-resistant Gram-negative bacilli (MDR-GNB) infections, the use of colistin will increase in patients with MDR-GNB infection. Objective: This study aims to assess the efficacy and safety of intravenous colistin in very low birth weight (VLBW; birth weight < 1500 g) preterm infants. Methods: We retrospectively analyzed the medical records of patients who received colistin between June 2016 and December 2017. The patients were assigned to two groups: the VLBW group and the non-VLBW group. Both groups were evaluated for response to treatment and adverse effects. Results: In total, 66 infants who received colistin therapy were included; of these, 28 infants were VLBW. All of our patients received standard colistin treatment of 5 mg/kg per day in three doses and the median duration of colistin treatment was 14 days. No significant differences were observed between the groups with respect to the efficacy of colistin (defined as showing microbiological clearance in control cultures and the absence of mortality during treatment) (89.3 vs 86.8%, p > 0.99). Serum magnesium and potassium levels were significantly lower in the VLBW group than in the non-VLBW group during colistin therapy (magnesium, 1.30 vs 1.70 mg/dL, p < 0.001; potassium, 3.6 vs 4.6 mEq/L, p < 0.001). Acute kidney injury was observed in four infants in the VLBW group and one in the non-VLBW group, without significant differences (p = 0.15). Conclusions: Colistin administration appears to be efficacious in VLBW infants; however, renal function tests and serum electrolytes should be monitored more closely in these infants during treatment. © 2018, Springer Nature Switzerland AG.Item Demographic and Clinical Characteristics of Patients with Sustained and Switching Treatments Using Biological and Targeted Synthetic Disease-Modifying Antirheumatic Drugs: A Multicenter, Observational Cross-Sectional Study for Rheumatoid Arthritis(Adis, 2022) Ataman S.; Sunar I.; Bodur H.; Melikoglu M.A.; Cay H.F.; Capkin E.; Akgul O.; Cevik R.; Gogus F.; Kamanli A.; Yurdakul F.G.; Gurer G.; Yagci I.; Rezvani A.; Duruoz M.T.Introduction: Rheumatoid arthritis is a chronic inflammatory disease with different disease activity grades. Several registries have been designed to determine the appropriate regimens of disease-modifying antirheumatic drugs to obtain sustained clinical remission. We examined epidemiological and clinical characteristics of rheumatoid arthritis patients using a clinical registry database (BioSTaR) and analyzed the differences in patients with sustained and switched therapies. Methods: A multicenter, observational cross-sectional study for rheumatoid arthritis was performed between February 2019 and September 2020 using the BioStaR-RA registry. Demographic and clinical characteristics were prospectively recorded into a specifically designed electronic database. The patients were divided into three groups due to the heterogeneity of the study cohort. Patients were grouped as Group I (Initial; within the first 6 months of treatment with biological/targeted synthetic drugs), Group ST (Sustained Treatment; any first drug lasting for at least 6 months without any change), and Group S (Switch; any switching to another drug). Comparative analysis was performed between sustained treatment (Group ST) and drug switching (Group S) groups. Results: The study included a total of 565 patients. The mean age was 53.7 ± 12.8 years, and the majority were female (80.4%). There were 104, 267, and 194 patients in Groups I, ST, and S, respectively. Erosive arthritis and hematological extra-articular involvement were more frequently detected in Group S than Group ST (p = 0.009 and p = 0.001). The patients in Group S had significantly higher disease activity scores (DAS28-CRP, CDAI, and SDAI) (p = 0.025, p = 0.010, and p = 0.003). There were significantly more patients with moderate disease activity in Group S (p < 0.05). Conclusions: The groups with sustained treatment and switching included patients with different disease activity status, although higher disease activity was determined in switchers. Overall, moderate disease activity and remission were the most common disease activity levels. Lower disease activity scores, lower hematologic manifestations, better functional status, and lesser radiographic damage are associated with sustained treatment. © 2021, The Author(s).Item Comparative Efficacy of Biologic Disease-Modifying Anti-Rheumatic Drugs for Non-Radiographic Axial Spondyloarthritis: A Systematic Literature Review and Bucher Indirect Comparisons(Adis, 2023) Akkoç N.; Arteaga C.H.; Auteri S.E.; Betts M.; Fahrbach K.; Kim M.; Kiri S.; Neupane B.; Gaffney K.; Mease P.J.Introduction: Biologic disease-modifying anti-rheumatic drugs (bDMARDs), including certolizumab pegol (CZP), are effective treatment options for the management of non-radiographic spondyloarthritis (nr-axSpA). In the absence of head-to-head comparisons in nr-axSpA, we conducted a systematic literature review (SLR) and indirect treatment comparison (ITC) to better understand the comparative efficacy of CZP vs. other bDMARDs. Methods: Literature searches were conducted in October 2020 in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials in patients with nr-axSpA who had failed at least one non-steroidal anti-inflammatory drug and were treated with bDMARDs. Outcomes of interest included the Assessment of Spondyloarthritis international Society (ASAS), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI) and Disease Activity Index (BASDAI), and spinal pain score. Comparative efficacy was examined using a series of Bucher ITCs in subgroups matched by prior exposure to bDMARDs, disease duration, baseline C-reactive protein (CRP) levels/magnetic resonance imaging (MRI) status, and timepoints, to ensure comparability between studies. Results: At 12–16 weeks, treatment with CZP was significantly more likely to achieve ASAS20/40 response and ASDAS-inactive disease status vs. etanercept (ETN), ixekizumab (IXE), and secukinumab (SEC). CZP showed statistically significant improvement in BASDAI, BASFI, and total spine pain score over adalimumab (ADA), ETN, and IXE, and in BASFI over SEC. Among patients with objective signs of inflammation (OSI; elevated CRP levels and/or inflammation on MRI at baseline), CZP had a statistically significant advantage over ETN and SEC (with or without loading dose) in achieving ASAS40, whereas the comparisons with other bDMARDs did not show any statistically significant differences. Conclusion: In the overall matched population, CZP performed significantly better than most comparators in improving the clinical outcomes. Among patients with OSI, CZP was found to be superior to SEC (in the MRI−/CRP + and MRI + /CRP− subgroups) and ETN (in the MRI + /CRP− subgroup) and it was comparable to golimumab and IXE across the different OSI subgroups. © 2023, The Author(s).Item Effect of Individual Patient Characteristics and Treatment Choices on Reliever Medication Use in Moderate-Severe Asthma: A Poisson Analysis of Randomised Clinical Trials(Adis, 2024) van Dijkman S.C.; Yorgancıoğlu A.; Pavord I.; Brusselle G.; Pitrez P.M.; Oosterholt S.; Fumali S.; Majumdar A.; Della Pasqua O.Introduction: Even though increased use of reliever medication, including short-acting beta agonists (SABA), provides an indirect measure of symptom worsening, there have been limited efforts to assess how different patterns of reliever use correlate with symptom control and future risk of exacerbations. Here, we evaluate the effect of individual baseline characteristics on reliever use in patients with moderate-severe asthma on regular maintenance therapy with fluticasone propionate (FP) or combination therapy with fluticasone propionate/salmeterol (FP/SAL) or budesonide/formoterol (BUD/FOR). Methods: A drug-disease model describing the number of 24-h puffs and overnight occasions was developed with data from five clinical studies (N = 6212). The model was implemented using a nonlinear mixed effects approach and a Poisson function, considering clinical and demographic baseline characteristics. Goodness of fit and model predictive performance were assessed. Heatmaps were created to summarise the effect of concurrent baseline factors on reliever utilisation. Results: The final model accurately described individual patterns of reliever use, which is significantly increased with time since diagnosis, smoking, higher Asthma Control Questionnaire (ACQ-5) score and higher body mass index (BMI) at baseline. Whilst the number of puffs decreases slowly after an initial drop relative to the start of treatment, exacerbating patients utilise significantly more reliever than those who do not exacerbate. The mean effect of FP/SAL (median dose: 250/50 μg BID) on reliever use was slightly higher than that of BUD/FOR (median dose: 160/4.5 μg BID), i.e. a 75.3% vs 69.3% reduction in reliever use, respectively. Conclusions: The availability of individual-level patient data in conjunction with a parametric approach enabled the characterisation of interindividual differences in the patterns of reliever use in patients with moderate-severe asthma. Taken together, individual demographic and clinical characteristics, as well as exacerbation history, can be considered an indicator of the degree of asthma control. High SABA reliever use suggests suboptimal clinical management of patients on maintenance therapy. © The Author(s) 2024.