International journal of clinical pharmacology and therapeutics最新文献

{"title":"Effect of AST-120 treatment discontinuation and serum albumin on free and bound indoxyl sulphate in end-stage kidney disease.","authors":"Takuya Yoshida, Masayuki Tsujimoto, Haruno Fujioka, Yuko Irie, Sachiyo Kawakami, Saki Nakatani, Ayako Iso, Ayaka Sugiyama, Mizuho Miyake, Kazumi Sumino, Rie Tanaka, Tomoko Oda, Taku Furukubo, Satoshi Izumi, Tomoyuki Yamakawa, Tetsuya Minegaki, Kohshi Nishiguchi","doi":"10.5414/CP203027","DOIUrl":"10.5414/CP203027","url":null,"abstract":"<p><strong>Objective: </strong>To examine the effects of the oral uremic toxin absorbent AST-120 on the concentration of free and protein-bound indoxyl sulphate (IS) and to assess the effects of serum albumin in end-stage kidney disease (ESKD) patients undergoing hemodialysis.</p><p><strong>Materials and methods: </strong>The study enrolled 37 ESKD patients who initiated hemodialysis at the Shirasagi Hospital. Serum free and bound IS concentrations were measured before the first of 4 hemodialysis sessions and after the last hemodialysis 7 days later. The cohort contained a subgroup of patients in whom AST-120 treatment (6 g/day) was discontinued immediately prior to the first hemodialysis and a subgroup not treated with AST-120. Clinical characteristics were obtained from electronic medical records.</p><p><strong>Results: </strong>Discontinuation in AST-120 treatment prior to dialysis resulted in marked but highly variable increases in IS concentrations, measured 7 days later, where the efficiency of dialysis of IS was dependent on the serum albumin concentration.</p><p><strong>Discussion: </strong>The observation that the percentage change in IS concentration was significantly higher after discontinuation of AST-120 compared to those not receiving AST-120 was unexpected as was the finding of a high inter-patient variability in IS concentrations before and after hemodialysis. The effects of a discontinuation in AST-120 administration can be interpreted as a rebound in the systemic absorption of indole precursors, but the source of variability in IS concentrations was unclear. Although there are important limitations in this investigation, the report presents valid and valuable data on free and albumin-bound IS concentrations during hemodialysis and AST-120 treatment as well as measurements of serum albumin concentrations in the group of largely elderly subjects.</p><p><strong>Conclusion: </strong>AST-120 in ESKD patients has profound effects on the disposition of IS. There are important sources of variability having a possible marked effect on the concentration of IS in patients with chronic kidney disease. Discontinuing AST-120 treatment before hemodialysis, a practice in Japan to avoid the \"off-label\" administrations of the agent, will result in high and variable concentrations of uremic toxins such as IS. The consequences of this effect will include progression of the disease and the occurrence of cardiovascular and neurological degeneration.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"181-193"},"PeriodicalIF":0.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145989330","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}

{"title":"The guanylate cyclase stimulator vericiguat: Insights and adverse events from a FAERS-based pharmacovigilance study.","authors":"Jia Tang, Bing Lv, Jingchun Han, Kehan Li, Qianying Li, Yuan Hu","doi":"10.5414/CP204875","DOIUrl":"10.5414/CP204875","url":null,"abstract":"<p><strong>Background: </strong>Since its approval by the U.S. Food and Drug Administration in January 2021, vericiguat, a novel soluble guanylate cyclase stimulator, has been increasingly utilized in the treatment of heart failure with reduced ejection fraction. However, comprehensive long-term safety data on vericiguat in large populations are lacking.</p><p><strong>Objective: </strong>This study analyzed the adverse events reported to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to assess the safety profile of vericiguat.</p><p><strong>Materials and methods: </strong>We selected four algorithms to evaluate the signals of adverse events related to vericiguat: Multi-item Gamma Poisson Shrinker, Bayesian Confidence Propagation Neural Network, Proportional Reporting Ratio, and Reporting Odds Ratio.</p><p><strong>Results: </strong>We conducted a retrospective analysis of the FAERS database from January 19, 2021, to December 31, 2024, encompassing 6, 981, 085 reports. Among these, 1,863 adverse events from 886 reports were identified with vericiguat as the primary suspect. After applying all four algorithms at the preferred term level, 64 preferred terms were recognized, encompassing 853 signals. The most common adverse events, such as hypotension, dizziness, dyspepsia, and anemia, were consistent with findings of clinical trials. Additionally, we identified new adverse events, including gastrointestinal hemorrhage and renal impairment.</p><p><strong>Conclusion: </strong>Our analysis provides a comprehensive safety assessment of vericiguat. Most of these results align with findings from previous studies. In addition, our data revealed several new adverse events. This study provides valuable insights that can inform future research and clinical practice.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"144-153"},"PeriodicalIF":0.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145855874","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}

{"title":"Cardiotoxicity associated with antifungal agents: A pharmacovigilance analysis of the FDA Adverse Event Reporting System.","authors":"Dongnan Cao, Chunyan Wei, Yanling Yuan, Bin Wu","doi":"10.5414/CP204897","DOIUrl":"10.5414/CP204897","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to analyze the cardiotoxicity associated with antifungal agents based on data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).</p><p><strong>Materials and methods: </strong>We extracted and evaluated cardiac adverse events (CAEs) linked to antifungals in the FAERS database (2004 - 2023). Signal strength for five antifungal classes was assessed using the reporting odds ratio (ROR) and information component (IC).</p><p><strong>Results: </strong>Among 50,603 cases, triazoles, polyenes, and imidazoles showed significant associations with Torsade de Pointes (TdP)/QT prolongation (QTP), with fluconazole exhibiting the strongest link (ROR: 11.96, 95% CI: 10.62 - 13.46; IC: 2.19, 95% CI: 1.92 - 2.44). Triazoles were notably connected to arrhythmias, particularly itraconazole (ROR: 3.31, 95% CI: 2.88 - 3.79; IC: 1.67, 95% CI: 1.20 - 2.11). Fluconazole also demonstrated strong associations with conduction defects (ROR 6.44, 95% CI 5.60 - 7.39; IC 2.65, 95% CI 2.16 - 3.08) and ventricular tachyarrhythmias (ROR 9.09, 95% CI 7.84 - 10.54; IC 3.15, 95% CI 2.60 - 3.58). Notably, only itraconazole showed significant signals for cardiac failure (ROR 4.04, 95% CI 3.52 - 4.64; IC 1.96, 95% CI 1.48 - 2.40) and cardiomyopathy (ROR 6.34, 95% CI 5.04 - 7.96; IC 2.64, 95% CI 1.79 - 3.30). In contrast, echinocandins did not exhibit significant CAE signals.</p><p><strong>Conclusion: </strong>These findings highlight that azoles and polyenes show substantial associations with CAEs, particularly for TdP/QTP and arrhythmias. Itraconazole showed a significant association with cardiac failure and cardiomyopathy, while the signal for isavuconazole was weaker than for other triazoles. No significant cardiotoxicity signals were detected for echinocandins.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"103-114"},"PeriodicalIF":0.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722533","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}

{"title":"Population pharmacokinetics of tofacitinib in patients with active ankylosing spondylitis.","authors":"Shinichi Tsuchiwata, Akiyuki Suzuki, Qiang Wang, Keith Kanik, Lara Fallon, Sujatha Menon","doi":"10.5414/CP204781","DOIUrl":"10.5414/CP204781","url":null,"abstract":"<p><strong>Objective: </strong>To characterize tofacitinib pharmacokinetics (PK) in patients with active ankylosing spondylitis (AS) and estimate the effects of covariates on variability of PK parameters.</p><p><strong>Materials and methods: </strong>Pooled data from two studies in patients with AS who received tofacitinib were analyzed using nonlinear mixed-effects modeling. Tofacitinib PK was described by a one-compartment model parameterized in terms of apparent oral clearance (CL/F), apparent volume of distribution (V/F), and a first-order absorption rate constant (k_a). Covariates evaluated: baseline age, sex, race, creatinine clearance (BCCL), and C-reactive protein for CL/F; baseline age/body weight for V/F.</p><p><strong>Results: </strong>Analysis included 279 patients. The point estimates for CL/F, V/F, and k_a were 27.1 L/hour, 126 L, and 3.07 hour^-1, respectively, in a reference patient. Excluding BCCL, point estimates of area under the concentration-time curve (AUC) over a dosing interval at steady-state and maximum steady-state tofacitinib concentration (C_max) change vs. the reference patient ranged from 98 - 112% and 89 - 115%, respectively. Estimated AUC was 24% higher in a patient with BCCL = 50 mL/min vs. the reference patient (BCCL = 126 mL/min). Point estimates and 90% confidence intervals of the AUC and C_max ratios indicated no major differences in tofacitinib exposure over the range of baseline age/body weight studied, and sex/race.</p><p><strong>Conclusion: </strong>Tofacitinib does not require dose adjustment/restriction for age, body weight, sex, or race based on the differences (< 20%) in exposure relative to a reference patient with AS. The tofacitinib CL/F and BCCL relationship was consistent with known contribution of renal excretion to total tofacitinib clearance.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"57-65"},"PeriodicalIF":0.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12825014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145700909","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}

{"title":"Comparison of vasopressin-first weaning versus norepinephrine-first weaning in critically ill patients.","authors":"Maram Alshreef, Hanin AbaAlkhayl, Qoot Almdainy, Abdulaziz Alshammari, Shahad Alajmi, Shatha Alruwaite, Ebtisam Alqahtani, Reema Almalke, Tagreed Alonazi","doi":"10.5414/CP204891","DOIUrl":"10.5414/CP204891","url":null,"abstract":"<p><strong>Background: </strong>Septic shock is a critical condition requiring vasopressor support and mechanical ventilation. The sequence of vasopressor weaning may affect clinical outcomes, such as mechanical ventilation duration and patient survival.</p><p><strong>Objectives: </strong>This study assesses how vasopressor weaning order affects hemodynamic stability, clinical outcomes, and the length of mechanical ventilation in critically ill septic shock patients.</p><p><strong>Materials and methods: </strong>A retrospective cohort study was conducted at Prince Sultan Military Medical City, Riyadh, Saudi Arabia, from January 2022 to December 2023. Critically ill adult patients receiving intravenous norepinephrine and vasopressin for septic shock and requiring mechanical ventilation were included. Patients were classified into two groups: vasopressin weaned first or norepinephrine weaned first. The duration of mechanical ventilation was the main outcome. These were secondary outcomes: mean arterial pressure (MAP) stability, 30-day and in-hospital mortality, length of stay (LOS) in the intensive care unit and hospital, and rates of reintubation.</p><p><strong>Results: </strong>Among 100 patients (mean age: 65.1 ± 19.7 years; 58% male), vasopressin was weaned first in 47 patients (47%) and norepinephrine first in 53 (53%). Patients extubated while on vasopressors (vasopressin weaned first) had a shorter median duration of mechanical ventilation (4 days) and lower odds of mortality (adjusted OR = 0.30, 95% CI: 0.09 - 0.98; p = 0.046) compared to those weaned off norepinephrine first. No significant differences were observed in reintubation rates or LOS.</p><p><strong>Conclusion: </strong>Weaning vasopressin before norepinephrine may be associated with improved survival and reduced mechanical ventilation duration in septic shock patients, although further research is needed to validate these findings and optimize vasopressor weaning strategies.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"83-91"},"PeriodicalIF":0.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12825015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145677392","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}

{"title":"Pegylated liposomal doxorubicin-induced hand-foot syndrome in a patient with breast cancer: Case report and FAERS database analysis.","authors":"Kejun Qu, Jialan Zhao, Yongli Zhang, Junwei Li","doi":"10.5414/CP204868","DOIUrl":"10.5414/CP204868","url":null,"abstract":"<p><p>Hand-foot syndrome (HFS) is a relatively common, dose-limiting dermatologic toxic reaction associated with multiple chemotherapeutic agents, including pegylated liposomal doxorubicin (PLD). Early symptoms of HFS include erythema, marked discomfort, swelling, and tingling on the palms and soles of the feet, which may progress to blistering and even ulceration in severe cases. We report a case of a breast cancer patient who developed HFS after receiving 3 cycles of PLD. The patient presented with redness, swelling, blistering, ulceration, and exudation in her palms, soles, axillae, groin, and waist. After symptomatic treatment, her HFS symptoms were significantly relieved. At the same time, we have also examined the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data for further reports of the relationship between different anthracyclines and risk of HFS.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"32-37"},"PeriodicalIF":0.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145444771","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}

{"title":"Amyotrophic lateral sclerosis rehabilitation management and non-pharmacological symptomatic treatment: A review.","authors":"Yuetong Shan, Wei Jing, Haihan Zhang, Yizhou Liu, Shangyu Wei, Feifei Wu, Weidong Pan","doi":"10.5414/CP204744","DOIUrl":"10.5414/CP204744","url":null,"abstract":"<p><p>Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that lacks effective treatment options for the prevention of progression. Relieving swallowing difficulties, reducing breathing difficulties, and alleviating muscle spasms are essential to improving the quality of life in patients with ALS. Many symptoms can be treated clinically with medication; however, the evidence level of related research is relatively low. Rehabilitation management can aid in improving various functional impairments and enhancing quality of life. This review introduces and describes the relevant evaluations of rehabilitation and nonpharmacological symptomatic treatment methods for functional disorders from the perspectives of motor and nonmotor symptoms. This review may promote the popularization of ALS rehabilitation management and provide an additional reference for ALS treatment.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"38-46"},"PeriodicalIF":0.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250944","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}

{"title":"Evidence that testosterone gel does not increase the risk of cardiovascular disease: A Mendelian randomization study of 337,159 European users.","authors":"Xin-Yang He, Zhuo-Nan Jia, Bo-Yu Zhang, Jian-Zhao Wu, Zi-Zhao Wang, Hai-Peng Zhao, Zi-Xian Yang, Rui Song, Qian Xu","doi":"10.5414/CP204682","DOIUrl":"10.5414/CP204682","url":null,"abstract":"<p><strong>Background and objectives: </strong>The potential association between testosterone therapy and cardiovascular disease remains a topic of debate. While some studies suggest a link between testosterone treatment and heart disease, definitive evidence for a causal relationship is lacking. This study aimed to investigate the causal relationship between testosterone gel use and cardiovascular disease, including stroke, coronary heart disease, hypertension, and cardiomyopathy, using a two-sample Mendelian randomization (MR) approach.</p><p><strong>Materials and methods: </strong>This study utilized data from Genome-Wide Association Studies and applied MR analysis to assess causal relationships. The primary method was the inverse variance weighted method, with MR-Egger, weighted median, and weighted mode used as complementary methods. Sensitivity analyses were conducted to evaluate the robustness of the results.</p><p><strong>Results: </strong>The inverse variance weighted analysis showed no significant causal link between testosterone gel use and cardiovascular disease risk. Sensitivity analyses revealed no evidence of horizontal pleiotropy or heterogeneity.</p><p><strong>Conclusion: </strong>The study findings suggest that testosterone treatment does not significantly increase the risk of developing cardiovascular disease.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"9-17"},"PeriodicalIF":0.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345185","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}

{"title":"Association between incretin-related drugs and fractures in patients treated with pioglitazone: A pharmacovigilance study using the FDA Adverse Event Reporting System.","authors":"Katsuhiro Ohyama, Nonoka Abe, Takumi Okamoto, Yusuke Hori","doi":"10.5414/CP204789","DOIUrl":"10.5414/CP204789","url":null,"abstract":"<p><strong>Objective: </strong>Diabetes mellitus (DM) causes various long-term complications and has, e.g., a direct negative effect on bone metabolism. Pioglitazone, which is used to treat DM, increases the risk of fractures. Reduced bone metabolism in patients with DM substantially impairs their quality of life. Therefore, this study aimed to determine the association of fractures with incretin-related drugs, dipeptidyl peptidase-4 inhibitors (DPP-4Is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs), in patients treated with pioglitazone using a pharmacovigilance database.</p><p><strong>Materials and methods: </strong>Data from the U.S. Food and Drug Administration Adverse Event Reporting System from the first quarter of 2013 to the end of 2019 were analyzed. The reporting odds ratio and information component values were used to evaluate the positive and inverse associations between the abovementioned drugs and fractures.</p><p><strong>Results: </strong>Inverse associations were observed between incretin-related drugs and fractures in patients treated with DPP-4Is (sitagliptin) and GLP-1RAs (dulaglutide, exenatide, and liraglutide). A subgroup analysis revealed inverse associations between fractures and GLP-1RAs (exenatide and liraglutide) in patients treated with pioglitazone.</p><p><strong>Conclusion: </strong>Our results suggest that incretin-related drugs, especially GLP-1RAs, reduce the risk of fractures in patients treated with diabetes medications such as pioglitazone.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"1-8"},"PeriodicalIF":0.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345236","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}

{"title":"Analysis of the clinical characteristics and risk factors for dabigatran-induced bleeding in patients with nonvalvular atrial fibrillation.","authors":"Xiaojuan Wang, Xiaoying Wang, Ya Li, Zhenfeng Yang, Dong Wu","doi":"10.5414/CP204807","DOIUrl":"10.5414/CP204807","url":null,"abstract":"<p><strong>Objective: </strong>To explore the clinical characteristics of dabigatran-induced bleeding and analyze its risk factors in patients with nonvalvular atrial fibrillation (NVAF).</p><p><strong>Materials and methods: </strong>A retrospective analysis was conducted on patients with NVAF who received 110 mg of dabigatran twice daily from January 2020 to March 2023. Patients were divided into a long-term-use group and a first-time-use group on the basis of their duration of medication use. The impact of long-term dabigatran use on coagulation function was analyzed. Furthermore, patients in the long-term-use group were divided into bleeding and nonbleeding subgroups. Multivariate logistic regression analysis was used to determine the risk factors for bleeding. Clinical data such as underlying diseases, concomitant medications, bleeding types, and bleeding sites were collected.</p><p><strong>Results: </strong>A total of 531 cases were collected, including 214 in the long-term-use group and 317 in the first-time-use group. In addition to fibrinogen (p > 0.05), coagulation function indicators, including the prothrombin time, prothrombin time percentage, international normalized ratio, activated partial thromboplastin time, and thrombin time (TT), were greater in the long-term-use group than in the first-time-use group, whereas D-dimer values were significantly lower in the long-term-use group (p < 0.05). A total of 63 bleeding cases were found, with an overall bleeding rate of 11.86%. The bleeding type was BARC type 1 (87.30%), and the bleeding site was mainly gastrointestinal bleeding (77.78%). Multivariate logistic regression analysis revealed that a TT value &gt; 116 s (OR 0.385, 95% CI 0.150 - 0.984; p = 0.038) and the presence of heart failure (OR 0.341, 95% CI 0.133 - 0.875; p = 0.025) were risk factors for bleeding in patients on long-term dabigatran therapy.</p><p><strong>Conclusion: </strong>The probability of bleeding caused by long-term use of dabigatran is relatively high, but it is mainly minor bleeding. The long-term use of dabigatran has an impact on multiple coagulation function indicators. Clinical physicians and pharmacists need to closely monitor patients' TT values and whether they have heart failure and identify high-risk populations for bleeding as early as possible.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"18-27"},"PeriodicalIF":0.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345161","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}