International journal of clinical pharmacology and therapeutics最新文献

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Skin adhesion of a newly developed, bioequivalent rotigotine patch formulation in comparison to the originator product: Results of a multi-center, randomized, crossover trial in patients with Parkinson's disease. 新开发的生物等效罗替戈汀贴剂与原研产品的皮肤粘附性对比:针对帕金森病患者的多中心随机交叉试验结果。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-07 DOI: 10.5414/CP204672
Wolfgang H Jost, Maggie Wang, Gabriel Wauer, Annika Dax, Ralph-Steven Wedemeyer, Barbara Schug, André Warnke, Ana Leblanc, Bjoern Schurad
{"title":"Skin adhesion of a newly developed, bioequivalent rotigotine patch formulation in comparison to the originator product: Results of a multi-center, randomized, crossover trial in patients with Parkinson's disease.","authors":"Wolfgang H Jost, Maggie Wang, Gabriel Wauer, Annika Dax, Ralph-Steven Wedemeyer, Barbara Schug, André Warnke, Ana Leblanc, Bjoern Schurad","doi":"10.5414/CP204672","DOIUrl":"https://doi.org/10.5414/CP204672","url":null,"abstract":"<p><strong>Objectives: </strong>To demonstrate adequate skin adhesion of a new once-daily rotigotine transdermal patch (ROT-TDS) compared to the originator product (reference) in patients with Parkinson's disease (PD).</p><p><strong>Materials and methods: </strong>Pharmacokinetic bioequivalence (PK BE) was assessed with the 4 mg/24h patches in healthy adults in a single-/multiple-dose, crossover trial. The trial investigating skin adhesion in PD patients (stable dose ≥ 8 mg/day rotigotine) was performed with the 8 mg/24h patches as a multiple-dose, crossover trial (4 alternating once-daily patch applications). Skin status (seborrhea, sweating) was characterized at screening. Adhesion was assessed 5 minutes after application and 5 minutes before removal of each patch. Systemic safety and skin irritation/sensitization were monitored.</p><p><strong>Results: </strong>ROT-TDS was bioequivalent to the reference product in the PK BE trial in 48 randomized healthy subjects. In the skin adhesion trial in 43 randomized PD patients, the cumulative mean percentage of adhesion (90% CI) at the end-of-dosing interval was 92.948% (90.156 - 95.740%) for ROT-TDS and 90.471% (87.574 - 93.367%) for the reference. For ROT-TDS, 80.23% of patches were ≥ 90% adhered at the end-of-dosing interval, while this was the case for 67.44% of the reference patches. Safety and skin tolerability of both products were comparable; the most frequent treatment-related adverse event was application-site pruritus for both treatments at comparable extent.</p><p><strong>Conclusion: </strong>ROT-TDS - with shown BE to the originator reference product - displayed similar safety and local tolerability as the reference product in patients with PD. The results show a trend to improved skin adhesion of the new patch compared to the reference in the target population.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial. 空腹条件下健康受试者服用阿法替尼二马来酸盐片剂两种制剂的生物等效性研究:一项随机、开放标签、单剂量、交叉试验。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204514
Yanping Liu, Lang Lü, Man Xu, Juanmin Tao, Yuping Ning, Yan Shi, Yanfen Dong, Qingqing Cao, Jun Ma, Yan Qiu
{"title":"Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial.","authors":"Yanping Liu, Lang Lü, Man Xu, Juanmin Tao, Yuping Ning, Yan Shi, Yanfen Dong, Qingqing Cao, Jun Ma, Yan Qiu","doi":"10.5414/CP204514","DOIUrl":"10.5414/CP204514","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the bioequivalence of two different afatinib dimaleate formulations in healthy Chinese subjects under fasting conditions and to assess their pharmacokinetic and safety profiles.</p><p><strong>Materials and methods: </strong>This randomized, open-label, 2-period, crossover, bioequivalence study included 32 healthy Chinese subjects. The subjects were assigned to receive a single 40-mg dose of generic or brand-named afatinib dimaleate tablet. Blood samples were collected pre-dose and up to 120 hours after dosing. Healthy subjects orally took the trial preparation (T) (afatinib maleate tablets developed by Jiangxi Shanxiang Pharmaceutical Co., Ltd., Gan Zhou, China) and the reference preparation (R) (afatinib maleate tablets developed by Boehringer Ingelheim Pharma GmbH & Co., Ingelheim, Germany) under fasting conditions in the appropriate period according to the randomization. We measured the blood concentrations, calculated the pharmacokinetic parameters of the two preparations in the human body, and evaluated whether formulations were bioequivalent. Safety of the preparations in healthy subjects was monitored during the whole trial. Safety assessment was conducted by vital signs, physical examination, laboratory examination, and 12-lead electrocardiogram during the study, i.e., from the time the subject received the test drug to the end of the last visit.</p><p><strong>Results: </strong>Under fasting conditions, the 90% confidence intervals (CIs) of the geometric mean ratios of the test/reference for afatinib dimaleate were 93.34 - 103.92% for AUC<sub>0-t</sub>, 90.26 - 105.52% for C<sub>max</sub>, and 93.49 - 104.05% for AUC<sub>0-∞</sub>.</p><p><strong>Conclusion: </strong>The 90% CI for the geometric mean ratios (test/reference) of C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> were within the range of 80.00 - 125.00%, indicating that the test formulation was equivalent to the reference formulation in healthy Chinese subjects under fasting conditions. Both products were similar in terms of safety.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pulmonary fibrosis insights and therapy targets from disease models and administration of the lipophilic diterpene, sodium tanshinone IIA sulfonate: Review and meta-analysis. 从疾病模型和服用亲脂性二萜--丹参酮 IIA 磺酸钠中了解肺纤维化和治疗目标:综述和荟萃分析。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204622
Li-Ying Peng, Jun-Jun Shi, Yue Liang, Yang Li, Yan Tang, Tuo Kai, Andong Yang, Zi-Yue Xiong
{"title":"Pulmonary fibrosis insights and therapy targets from disease models and administration of the lipophilic diterpene, sodium tanshinone IIA sulfonate: Review and meta-analysis.","authors":"Li-Ying Peng, Jun-Jun Shi, Yue Liang, Yang Li, Yan Tang, Tuo Kai, Andong Yang, Zi-Yue Xiong","doi":"10.5414/CP204622","DOIUrl":"10.5414/CP204622","url":null,"abstract":"<p><p>Pulmonary fibrosis (PF) is a chronic and progressive pulmonary interstitial disease of unknown etiology and is also a sequela in severe patients with the Coronavirus Disease 2019 (COVID-19). Seven databases were systematically searched to evaluate the preclinical evidence of Tanshinone IIA (Tan IIA) on PF. The quality of the included studies was assessed using a 10-item risk of bias tool, and data were analyzed using RevMan 5.3 software. 22 experiments from 12 studies on a total of 248 animals were included. The results showed that PF phenotype, such as fibrotic score, collagen I (Col-I), collagen III (Col-III), hydroxyproline (Hyp), in the group treated with Tan IIA were significantly lower than those in the model group (p < 0.00001). The potential mechanisms of Tan IIA improvement of PF involve reducing inflammation, antioxidation, and suppressing activation of transforming growth factor beta 1 (TGF-β1). The subgroup analysis of different models, different rat species, and different dosage time showed significant reduction in fibrotic scores and Hyp levels with Tan IIA. The preclinical evidence indicated that Tan IIA might be a potent and promising agent for PF, but this conclusion should be further confirmed with more research.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rational use of short-term anorectic drugs for one-year effective treatment of obesity: An analysis of four studies. 合理使用短期厌食症药物,有效治疗肥胖症一年:对四项研究的分析。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204585
Cynthia Galicia-Quintanar, Héctor Isaac Rocha-González, María Elena Sánchez Mendoza, Jesús Arrieta-Valencia, Juan Rodríguez-Silverio, Geovanna Nallely Quiñonez-Bastidas, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Gerardo Reyes-García
{"title":"Rational use of short-term anorectic drugs for one-year effective treatment of obesity: An analysis of four studies.","authors":"Cynthia Galicia-Quintanar, Héctor Isaac Rocha-González, María Elena Sánchez Mendoza, Jesús Arrieta-Valencia, Juan Rodríguez-Silverio, Geovanna Nallely Quiñonez-Bastidas, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Gerardo Reyes-García","doi":"10.5414/CP204585","DOIUrl":"10.5414/CP204585","url":null,"abstract":"<p><strong>Background: </strong>Obesity is a complex disease for which pharmacotherapy is often used. Anti-obesity drugs (AODs) are characterized by inducing a variable inter-subject body weight reduction (BWR), the attainment of a plateau after their maximal effect is achieved, and weight regain after drug discontinuation, which complicate individualized treatment of obesity.</p><p><strong>Objective: </strong>This exploratory analysis aimed to compare the first-month body weight reduction in kg (1mo-BWRkg) and tolerance development (moT) of four known interventions with low (placebo), intermediate (phentermine or mazindol monotherapy), and high (5 active ingredients fixed-dose combination) efficacy, as predictors of their 6-month body weight reduction efficacy in percent (6mo-BWR%). In addition, a detailed analysis of the 6-to-12-month BWR follow-up in subjects under orlistat or diet and exercise regimens was performed.</p><p><strong>Materials and methods: </strong>The analysis included 662 adult subjects with obesity. After the construction of average efficacy and weight rebound curves, subjects were grouped into various 1mo-BWRkg, moT, and 6mo-BWR% intervals, or 6-month body weight rebound parameters for further evaluation.</p><p><strong>Results: </strong>The 6mo-BWR% efficacy level of interventions was confirmed, although a general high intersubject variation was observed. 1mo-BWRkg + moT was found as an acceptable predictor of 6mo-BWR%. Between 50 and 80% of the 6-to-12-month follow-up completers maintained at least 5% BWR%.</p><p><strong>Conclusion: </strong>Short-term AODs are useful adjuvants for the 1-year rational treatment of obesity. 1mo-BWRkg + moT is an acceptable parameter to predict the 6mo-BWR% efficacy of these interventions.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetic, bioequivalence, and safety assessments of two brands of 30-mg nifedipine controlled-release formulations in Chinese healthy subjects. 在中国健康受试者中对两种品牌的 30 毫克硝苯地平控释制剂进行药代动力学、生物等效性和安全性评估。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204605
Huan Lu, Fei Zhou, Cuijie Rui, Hen You, Wenhao Zhang, Yaxin Zhang, Juefang Ding, Shunbo Zhao, Qiang Wu
{"title":"Pharmacokinetic, bioequivalence, and safety assessments of two brands of 30-mg nifedipine controlled-release formulations in Chinese healthy subjects.","authors":"Huan Lu, Fei Zhou, Cuijie Rui, Hen You, Wenhao Zhang, Yaxin Zhang, Juefang Ding, Shunbo Zhao, Qiang Wu","doi":"10.5414/CP204605","DOIUrl":"10.5414/CP204605","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to analyze the pharmacokinetic (PK) characteristics, safety, and bioequivalence (BE) of a test (T) preparation of a nifedipine controlled-release tablet and the reference (R) drug (Adalat GTIS) in Chinese study participants in the context of fasting and postprandial states.</p><p><strong>Materials and methods: </strong>An open-label, single-center, randomized, single-dose, two-period study was designed including two separate arms, one with administration under fasting conditions and one with administration under postprandial conditions (high-fat, high-calorie breakfast). After oral administration, the nifedipine concentrations in plasma were quantitatively analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) at regular intervals. Primary PK parameters, including the area under the concentration curve from 0 to infinity (AUC<sub>0-∞</sub>), the area under the concentration profile from 0 to the last measurable concentration time (AUC<sub>0-t</sub>), and maximal measured plasma concentration (C<sub>max</sub>) were log-transformed with BE limits of 80 - 125% to evaluate BE. All adverse events (AEs) were wholly supervised.</p><p><strong>Results: </strong>The PK profiles of the T and R formulations were comparable to each other under both fasting and postprandial conditions. The 90% confidence intervals (CIs) of the AUC<sub>0-∞</sub>, AUC<sub>0-t</sub>, and C<sub>max</sub> were 92.69 - 106.06%, 93.32 - 107.05%, and 99.53 - 116.71%, respectively, under the fasting state. The 90% CIs of the AUC<sub>0-∞</sub>, AUC<sub>0-t</sub>, and C<sub>max</sub> were 105.05 - 117.40%, 105.43 - 117.82%, and 102.66 - 116.30%, respectively, in the postprandial arm. 47 cases of drug-associated AEs were noted in the entire research.</p><p><strong>Conclusion: </strong>Under both the fasting and postprandial states, the two nifedipine controlled-release formulations were bioequivalent and safe in healthy Chinese subjects.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adequate IVIG dosing is associated with an improved long-term outcome in secondary immunodeficiency: A prospective, non-interventional study. 足够的 IVIG 剂量与继发性免疫缺陷的长期疗效改善有关:一项前瞻性、非干预性研究。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-10-01 DOI: 10.5414/CP204595
Artur Bauhofer, Ümniye Balaban, Sonja Schimo, Monika Mayer, Jörg Schüttrumpf, Stephan Borte
{"title":"Adequate IVIG dosing is associated with an improved long-term outcome in secondary immunodeficiency: A prospective, non-interventional study.","authors":"Artur Bauhofer, Ümniye Balaban, Sonja Schimo, Monika Mayer, Jörg Schüttrumpf, Stephan Borte","doi":"10.5414/CP204595","DOIUrl":"10.5414/CP204595","url":null,"abstract":"<p><strong>Objective: </strong>To assess the safety, tolerability, and effectiveness of the intravenous immunoglobulin (IVIG) Intratect 50 g/L in immunoglobulin replacement therapy (IgRT) in a prospective, large-scale non-interventional study (NIS). The analysis focused upon patients with secondary immunodeficiency (SID), the most frequent indication for IgRT in this NIS.</p><p><strong>Materials and methods: </strong>Patients were enrolled at 123 centers in Germany. Each patient received IVIG as prescribed by the physician, guided by the Summary of Product Characteristics. Data were acquired from medical records and patients' questionnaires.</p><p><strong>Results: </strong>In the NIS, 3,563 patients were documented. The main indication for IgRT was SID (73.2%), followed by primary immunodeficiency (14.7%), immune thrombocytopenia (5.8%), and other indications (6.2%). Among the SID patients, 52.9% were male, mean age was 66.5 years, and most (63.8%) were IVIG-naïve. Their annual infection rate improved from 3.7 before documentation in the NIS to 1.1 during the first year of the study. IgG trough plasma levels increased during treatment (> 6 g/L: 44.5% of SID patients at study entry and 64.8% in long-term treatment) and were associated with a trend toward reduced infection rate (p = 0.08). A 1-year infection analysis showed a significantly lower infection risk in the medium- and high-dose groups than in the low-dose group (p = 0.028 and p = 0.017, respectively). Patients' treatment satisfaction and quality of life improved from baseline. Adverse drug reactions (ADRs) in SID occurred at a low frequency with 0.8% at infusion level. On the patient level, ADRs occurred in 251 (15.3%) SID patients, with chills (7.4%) and pyrexia (0.9%) reported most frequently.</p><p><strong>Conclusion: </strong>Effectiveness, safety, and quality of life confirmed the positive benefit-risk profile of IgRT. Higher IVIG dosages per body weight led to higher IgG plasma trough levels, in turn leading to reduced infection rates. Obese patients may need body-weight-adjusted treatment to reduce the risk of infection.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11425087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retrospective evaluation of medical information for predicting tazobactam/piperacillin-induced liver injury. 对预测他唑巴坦/哌拉西林诱发肝损伤的医疗信息进行回顾性评估。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-24 DOI: 10.5414/CP204588
Takahiro Amemiya, Hiroshi Suzuki
{"title":"Retrospective evaluation of medical information for predicting tazobactam/piperacillin-induced liver injury.","authors":"Takahiro Amemiya, Hiroshi Suzuki","doi":"10.5414/CP204588","DOIUrl":"10.5414/CP204588","url":null,"abstract":"<p><strong>Objective: </strong>Tazobactam/piperacillin is a first-line treatment option for hospital-acquired pneumonia; however, drug-induced liver injury (DILI) is relatively frequently observed with tazobactam/piperacillin in clinical practice. This study aimed to verify the usefulness of available patient data for predicting DILI prior to tazobactam/piperacillin administration.</p><p><strong>Materials and methods: </strong>Tazobactam/piperacillin-treated patients were retrospectively selected and divided into patients with and without DILI. Comparative analysis was performed regarding age, gender, dose, duration of treatment, clinical laboratory values prior to treatment initiation, and the types of organ-specific infections in both groups.</p><p><strong>Results: </strong>Multiple logistic regression analyses indicated that elevated C-reactive protein (odds ratio (OR), 1.284; 95% confidence interval (CI), 1.172 - 1.406; p < 0.001) and high hemoglobin (OR, 1.697; 95% CI, 1.259 - 2.286; p < 0.001) levels prior to the administration of tazobactam/piperacillin were risk factors for DILI in males who received a 4.5-g dose. A predictive model for DILI risk was constructed by combining these test values and analyzed using receiver operating characteristic curves, obtaining 0.910 for the model construction set and 0.845 for the validation set.</p><p><strong>Conclusion: </strong>The development of DILI was predicted with good accuracy in males who received a 4.5-g dose with elevated C-reactive protein and hemoglobin.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identification of factors associated with vancomycin-induced acute kidney injury: A retrospective analysis using the Common Data Model. 识别万古霉素诱发急性肾损伤的相关因素:使用通用数据模型进行回顾性分析。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-24 DOI: 10.5414/CP204646
Sang-In Park, Jung-Kyeom Kim, Uijeong Yu, Ji In Park
{"title":"Identification of factors associated with vancomycin-induced acute kidney injury: A retrospective analysis using the Common Data Model.","authors":"Sang-In Park, Jung-Kyeom Kim, Uijeong Yu, Ji In Park","doi":"10.5414/CP204646","DOIUrl":"10.5414/CP204646","url":null,"abstract":"<p><strong>Objective: </strong>Previous findings on predictors of vancomycin-induced acute kidney injury (AKI) are inconsistent. We aimed to identify the predictors of vancomycin-induced AKI using the Observational Medical Outcome Partnership Common Data Model.</p><p><strong>Materials and methods: </strong>We analyzed data from patients treated with vancomycin between January 1, 2012, and May 31, 2022, who were positive for <i>Staphylococcus aureus</i> and had undergone oxacillin susceptibility tests. After excluding patients without data for vancomycin or baseline serum creatinine levels, 116 patients were included in the final dataset. Data up to the third measured vancomycin concentration were collected for each patient. Logistic regression models were used to estimate the odds ratio and 95% confidence interval for each variable associated with vancomycin-induced AKI.</p><p><strong>Results: </strong>High baseline serum creatinine levels, intensive care unit admission, and concurrent renal disorders were significantly associated with vancomycin-induced AKI. Although high trough levels or area under the curve values were not significantly associated with vancomycin-induced AKI, both were significantly higher in patients with AKI than in those without AKI at the second vancomycin concentration measurement. The proportion with trough levels > 20 mg/L was higher in patients with AKI than in those without AKI at the third measurement.</p><p><strong>Conclusion: </strong>Our findings revealed that underlying renal disease and intensive care unit admission are more significantly associated with vancomycin-induced AKI than vancomycin pharmacokinetic parameters or dosage, likely due to vancomycin concentration-based dosage adjustment in clinical settings. Our findings may help develop strategies for reducing the incidence of vancomycin-induced AKI; however, further prospective studies are essential.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of uric acid elevation between aspirin-ticagrelor and aspirin-clopidogrel during dual antiplatelet therapy. 阿司匹林-替卡格雷与阿司匹林-氯吡格雷双重抗血小板治疗期间尿酸升高的比较。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-18 DOI: 10.5414/CP204606
Sojin Park, Sangah Chi, Jeong Hoon Yang, Myungsook Min, Ju-Young Shin
{"title":"Comparison of uric acid elevation between aspirin-ticagrelor and aspirin-clopidogrel during dual antiplatelet therapy.","authors":"Sojin Park, Sangah Chi, Jeong Hoon Yang, Myungsook Min, Ju-Young Shin","doi":"10.5414/CP204606","DOIUrl":"https://doi.org/10.5414/CP204606","url":null,"abstract":"<p><strong>Objective: </strong>This study investigated whether serum uric acid levels are more elevated in the aspirin-ticagrelor group than in the aspirin-clopidogrel group. Materials and Materials and methods: We conducted a retrospective cohort study with patients between 2013 and 2020. Baseline and maximum serum uric acid levels within a 6-month follow-up period were analyzed to determine the increase in both groups.</p><p><strong>Results: </strong>A total of 41,877 patients were enrolled. A statistically significant elevation of serum uric acid levels was found in the aspirin-ticagrelor group compared to the aspirin-clopidogrel group (odds ratio (OR; 95% confidence interval (CI)) = 1.36 (1.15 - 1.60), p < 0.001). Kidney dysfunction and diuretic use were also identified as risk factors for uric acid elevation.</p><p><strong>Conclusion: </strong>Monitoring serum uric acid levels is recommended during aspirin-ticagrelor therapy, especially in patients with kidney dysfunction or those using diuretics.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142286330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A case of a geriatric patient with thrombocytopenia after partial recovery from COVID-19. 一例从 COVID-19 部分康复后出现血小板减少的老年病人。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2024-09-06 DOI: 10.5414/CP204664
Yukako Hayashi, Kenji Momo, Mutsumi Ando, Hiroaki Koya, Tsutomu Nagai, Kazuki Shinmura, Issei Tokimatsu, Yasushi Akutsu, Masahiro Kurosawa
{"title":"A case of a geriatric patient with thrombocytopenia after partial recovery from COVID-19.","authors":"Yukako Hayashi, Kenji Momo, Mutsumi Ando, Hiroaki Koya, Tsutomu Nagai, Kazuki Shinmura, Issei Tokimatsu, Yasushi Akutsu, Masahiro Kurosawa","doi":"10.5414/CP204664","DOIUrl":"10.5414/CP204664","url":null,"abstract":"<p><p>The global emergence of -COVID-19 has prompted rapid therapeutic and vaccine advancements; however, clinical evidence remains limited. With around a 50% fatality rate for COVID-19 patients with acute respiratory distress syndrome (ARDS), early intervention is crucial. This report details a severe case of post-COVID-19 thrombocytopenia in a 79-year-old man and emphasizes its critical nature. Despite negative initial COVID-19 test results, subsequent positive results led to treatment initiation, and severe thrombocytopenia persisted resulting in bleeding complications and death. Recognized as a hematological manifestation of COVID-19, thrombocytopenia in this geriatric patient highlights the need for extended post-COVID-19 monitoring and management. This underscores the importance of vigilance and timely intervention, especially in vulnerable populations, and emphasizes the need for further research to understand the intricate relationship between COVID-19 and thrombocytopenia.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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