We aimed to evaluate antiepileptic drug treatment persistence and adherence in paediatric epilepsy patients and investigate the association between medication‐taking behaviours and clinical outcome. Methods. Medical and prescription records of newly treated paediatric epilepsy patients, aged 1–18 years who initiated antiepileptic drug monotherapy in a tertiary teaching hospital, were retrospectively reviewed. The rates of overall treatment, non‐persistence, a treatment gap >60 days, and adherence, as measured by a medication possession ratio ≥0.8, were assessed. The relationship between non‐adherence and clinical outcome, defined as an emergency department visit or hospitalisation due to seizure‐related reasons, was analysed. Results. A total of 1,172 patients met the inclusion criteria. The proportion of patients who were both persistent and adherent at one year was 70.14% and decreased to 56.83% at two years. Patients who started an antiepileptic drug at one year of age, took older generation antiepileptic drugs as the initial treatment, and those diagnosed with localized seizures were less likely to be adherent to and persistent with overall antiepileptic drug treatment. Patients who were non‐adherent to antiepileptic drug treatment were at an increased risk of hospitalisation or emergency department visits for seizure‐related reasons (adjusted HR 2.10, 95% CI 1.25–3.55). Conclusions. This large population study shows that 70% of paediatric epilepsy patients were persistent with and adherent to antiepileptic drugs after one year of treatment and confirms that non‐adherence to antiepileptic drug treatment is an important factor in seizure‐related clinical outcome.
BackgroundNutritional support is critical for preterm infants in the neonatal intensive care unit (NICU). A multidisciplinary nutritional support team (NST) that focuses on providing optimal and individualized nutrition care could be helpful. We conducted a thorough evaluation of clinical and nutritional outcomes in a tertiary NICU following the implementation of an NST.MethodsThis study used a retrospective approach with historical comparisons. Preterm neonates < 30 weeks gestational age or weighing < 1250 g were enrolled. Clinical and nutritional outcomes were compared before and after the establishment of the NST. Medical records were reviewed, and clinical and nutritional outcomes were compared between the two groups.ResultsIn total, 107 patients from the pre-NST period and 122 patients from the post-NST period were included. The cumulative energy delivery during the first week of life improved during the post-NST period (350.17 vs. 408.62 kcal/kg, p < 0.001). The cumulative protein and lipid deliveries also significantly increased. The time required to reach full enteric feedings decreased during the post-NST period (6.4 ± 5.8 vs. 4.7 ± 5.1 days, p = 0.016). Changes of Z-score in weight from admission to discharge exhibited more favorable results in the post-NST period (−1.13 ± 0.99 vs.−0.91 ± 0.74, p = 0.055), and the length of ICU stay significantly decreased in the post-NST period (81.7 ± 36.6 vs. 72.2 ± 32.9 days, p = 0.040).ConclusionsNST intervention in the NICU resulted in significant improvements in the provision of nutrition to preterm infants in the first week of life. There were also favorable clinical outcomes, such as increased weight gain and reduced length of ICU stay. Evaluable data remain sparse in the NICU setting with premature neonatal populations; therefore, the successful outcomes identified in this study may provide support for NST practices.Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-016-0648-0) contains supplementary material, which is available to authorized users.
BackgroundErlotinib is a drug used for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. Severe hepatotoxicity was observed in 4% to 31% of patients receiving erlotinib treatment prompting delay or termination of treatment. Only a few factors related to hepatotoxicity of erlotinib have been reported. No study has investigated the role of concomitant medications and erlotinib-induced hepatotoxicity. The aim of this study was to investigate the association between erlotinib-induced hepatotoxicity and various factors including concomitant medications in patients with NSCLC and pancreatic cancer.MethodsFrom January 2014 to June 2017, a retrospective study was conducted in patients with NSCLC and pancreatic cancer, who were treated with erlotinib. Various data were reviewed, including sex, age, body weight, height, body surface area (BSA), underlying disease, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), smoking history, erlotinib dose, EGFR mutation, and concomitant drugs.ResultsThe incidence of grade 2 or higher hepatotoxicity in the study group of patients was 17.2%. Multivariate analysis showed a 2.7-fold increase in hepatotoxicity with the concomitant use of CYP3A4 inducers. In NSCLC patients, co-administration of H2-antagonist/PPI increased hepatotoxicity 3.5-fold. Among the demographic factors, liver metastasis and age ≥ 65 years were significant risk factors in all study patients and NSCLC patients, respectively; the attributable risks for liver metastasis and age were 46.3% and 71.8%, respectively. Subgroup analysis using pancreatic cancer patients yielded marginally significant results with CYP3A4 inducers and erlotinib-induced hepatotoxicity. Liver metastasis and CYP3A4 inducers also shortened time to hepatotoxicity 2.1 and 2.3-fold, respectively.ConclusionsOur study showed that concomitant use of CYP3A4 inducers and H2-antagonist/PPI, liver metastasis, and age ≥ 65 were associated with erlotinib-induced hepatotoxicity. Thus, close monitoring of liver function is recommended, especially in patients using CYP3A4 inducers and anti-acid secreting agents.
Despite the high prevalence of potential drug–drug interactions in pediatric intensive care units, their clinical relevance and significance are unclear. We assessed the characteristics and risk factors of clinically relevant potential drug–drug interactions to facilitate their efficient monitoring in pediatric intensive care units. This retrospective cohort study reviewed the medical records of 159 patients aged <19 years who were hospitalized in the pediatric intensive care unit at Seoul National University Hospital (Seoul, Korea) for ≥3 days between August 2019 and February 2020. Potential drug–drug interactions were screened using the Micromedex Drug-Reax® system. Clinical relevance of each potential drug–drug interaction was reported with official terminology, magnitude of severity, and causality, and the association with the patient’s clinical characteristics was assessed. In total, 115 patients (72.3%) were exposed to 592 potential interactions of 258 drug pairs. In 16 patients (10.1%), 22 clinically relevant potential drug–drug interactions were identified for 19 drug pairs. Approximately 70% of the clinically relevant potential drug–drug interactions had a severity grade of ≥3. Exposure to potential drug–drug interactions was significantly associated with an increase in the number of administrated medications (6–7 medications, p = 0.006; ≥8, p<0.001) and prolonged hospital stays (1–2 weeks, p = 0.035; ≥2, p = 0.049). Moreover, clinically relevant potential drug–drug interactions were significantly associated with ≥8 prescribed drugs (p = 0.019), hospitalization for ≥2 weeks (p = 0.048), and ≥4 complex chronic conditions (p = 0.015). Most potential drug–drug interactions do not cause clinically relevant adverse outcomes in pediatric intensive care units. However, because the reactions that patients experience from clinically relevant potential drug–drug interactions are often very severe, there is a medical need to implement an appropriate monitoring system for potential drug–drug interactions according to the pediatric intensive care unit characteristics.
What is known and objective The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use. Methods A retrospective study was performed by using an electronic medical record and anticoagulation clinical data from 600 patients who received edoxaban from 1 March 2016 to 16 July 2017 at a tertiary teaching university hospital. The appropriateness of edoxaban use was assessed using eight criteria based on drug use evaluation criteria developed by the American Society of Health‐System Pharmacists drug use evaluation guidelines, details in Korea Food and Drug Administration approval of edoxaban. Clinical outcomes were evaluated between the appropriately prescribed and inappropriately prescribed groups regarding the incidence of thrombosis and bleeding episodes. Results and discussion After excluding 86 patients due to the inability to assess renal function, 514 were eligible. Appropriate use was found in 294 patients (57.2%). The most frequent inappropriate use of edoxaban was dose adjustment (60.8%) in accordance with the dosing recommendation in patients with renal insufficiency (creatinine clearance [CrCl] of 15‐50 mL/min) and a low body weight of <60 kg. Moreover, there were three cases of edoxaban use in patients with prosthetic heart valves and moderate‐to‐severe mitral stenosis, and 15 cases of non‐valvular atrial fibrillation in patients with CrCl >95 mL/min in whom edoxaban use is not recommended. Furthermore, we found that the factors related to the appropriateness of edoxaban use were <60 kg body weight (adjusted odds ratio [OR]: 0.310; confidence interval [CI]: 0.197‐0.488) and CrCl <50 mL/min (adjusted OR: 0.629; CI: 0.404‐0.980). There were 45 events (8.75%) of any bleeding, 9 (1.8%) of stroke/transient ischaemic attack (TIA) and four events (0.8%) of deep vein thrombosis (DVT)/pulmonary embolism (PE). However, there was no difference between the appropriately prescribed group (294 patients) and inappropriately prescribed group (220 patients) in the incidence of bleeding events (27 [9.2%] vs 18 [8.2%]), stroke/TIA (7 [2.4%] vs 2 [0.9%]) and DVT/PE (2 [0.7%] vs 2 [0.9%]), respectively. What is new and conclusion Although edoxaban has a broad therapeutic window that does not require routine monitoring, it should be cautiously used in patients with renal insufficiency (CrCl <50 mL/min) and body weight <60 kg.
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