International journal of clinical pharmacology and therapeutics最新文献

{"title":"Antihypertensive drug-induced adverse events in patients aged 80 years and older: A retrospective analysis using the Japanese Adverse Drug Event Report Database.","authors":"Riku Matsushima, Masayuki Hashiguchi, Tsuyoshi Shiga","doi":"10.5414/CP204943","DOIUrl":"10.5414/CP204943","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate major antihypertensive drugs associated with adverse events (AEs) in patients aged ≥ 80 years using the Japanese Adverse Drug Event Report (JADER) database.</p><p><strong>Materials and methods: </strong>We utilized the JADER database (April 2004 - September 2023). Patients aged ≥ 80 years who were taking angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), dihydropyridine calcium channel blockers (CCBs), β-blockers, and thiazide/thiazide-like diuretics as \"suspected agents\" were included. Eight AEs were extracted for analysis. Adjusted reporting odds ratios (aRORs) and 95% confidence intervals (CIs) were calculated using sex as a covariate.</p><p><strong>Results: </strong>The highest aROR for syncope/loss of consciousness was associated with β-blockers (2.57 (95% CI 1.84 - 3.58)), followed by CCBs (2.56 (95% CI 1.95 - 3.36)). Only CCBs showed a significant associated with falls (1.58 (95% CI 1.10 - 2.27)). The highest aROR for bradycardia was associated with β-blockers (18.20 (95% CI 15.64 - 21.18)). The highest aROR for renal failure was for diuretics (2.71 (95% CI 1.83 - 4.02)), followed by ACEIs/ARBs (2.26 (95% CI 1.97 - 2.58)). Electrolyte abnormalities had the greatest aROR for hyperkalemia with ACEIs/ARBs (15.34 (95% CI 13.70 - 17.18)) and for hypokalemia and hyponatremia with diuretics (15.72 (95% CI 11.30 - 21.87), 27.40 (20.27 - 37.0)). Only CCBs showed a significant associated with edema (4.00 (95% CI 2.32 - 6.91)).</p><p><strong>Conclusion: </strong>This study, which employed the JADER database, identified specific AEs associated with drug use in patients aged ≥ 80 years. These AEs included syncope/loss of consciousness associated with β-blockers or CCBs as well as falls and edema associated with CCBs.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"304-311"},"PeriodicalIF":0.9,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147270904","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":"Systemic bismuth absorption and safety of the gastric mucosal protective bismuth potassium citrate, administered as granules and tablets in healthy Chinese and validation of a new, ICP-MS bismuth assay.","authors":"Xiaozhi Lv, Junyan Wu, Suiwen Ye, Quansheng Wang, Shuguang Gan, Jianbin Pi, Yongjian Xiong, Nan Zhang","doi":"10.5414/CP204626","DOIUrl":"10.5414/CP204626","url":null,"abstract":"<p><strong>Background: </strong>The mucosal protective agent, bismuth potassium citrate, is used for treatment of chronic gastritis and gastric stress conditions, including heartburn and acid reflux.</p><p><strong>Objectives: </strong>1) To establish and validate a new inductively coupled mass spectrometry (ICP-MS) analytical method for the determination of bismuth metal in human plasma; and 2) to determine the systemic absorption and safety characteristics of bismuth following the administration of bismuth potassium citrate granules (test drug) and bismuth potassium citrate tablets (reference drug) in healthy Chinese subjects.</p><p><strong>Materials and methods: </strong>A single-center, randomized, open-label, two-drug, single-dose, two-cycle, double-crossover pharmacokinetics study was carried out in a cohort of 24 healthy adult subjects in the fasting state. Subjects meeting the inclusion criteria were randomly assigned to the first cycle in ascending order of screening number obtained prior to dosing. The randomization table assigned subject either to the TR-group (test-reference cycle) or the RT group (reference-test cycle) where each group contained a total of 12 subjects. Subjects recruited but not completing the study, or in whom the data sets were incomplete, were not replaced. Using this study design, all subjects received a single dose of both preparations in the fasting state whereby 12 subjects received the drugs in the order RT and 12 subjects in the order TR, with a washout period of 7 days between each drug administration cycle, respectively.</p><p><strong>Results: </strong>Pharmacokinetic parameters (concentration maximum (C_max), AUC_0-t, and area under the concentration-time curve to infinity (AUC_0-∞) were analyzed using a linear mixed-effects model after natural log transformation. The lower limit of the 90% confidence intervals for the geometric mean ratio (test preparation/reference preparation) were below 100%, and the bioavailability of the test formulation (granules) was markedly superior to that for the reference formulation (tablets) where values for C_max, AUC_0-t, and AUC_0-∞ after natural log transformation were 5.44, 12.82, 10.86, 22.44, and 13.79%, 27.42%, respectively. The systemic absorption of bismuth metal from the granules was not greater than that for the tablets.</p><p><strong>Conclusion: </strong>Although the bioavailability of the granules was markedly superior to tablets, the systemic absorption of bismuth metal from the two formulations was similar, and there was no evidence for a difference in the safety characteristics.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"324-334"},"PeriodicalIF":0.9,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147511955","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":"Epidemiological characteristics of severe skin adverse reactions caused by immune checkpoint inhibitors based on case reports.","authors":"Su-Na Tang, Xiao-Wen Ma, Xiao-Yan Zhang, Na-Na Zhang, Fei Wang, Feng-Lin Ye, Na-Na Chen, Ping Yang, Ning-Ning Zhu","doi":"10.5414/CP204826","DOIUrl":"10.5414/CP204826","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the epidemiological characteristics of severe cutaneous adverse reactions (cirAEs) induced by immune checkpoint inhibitors (ICIs) and to provide evidence for the rational clinical use of ICIs and pharmacovigilance for cutaneous toxicities.</p><p><strong>Materials and methods: </strong>We systematically searched the PubMed, MEDLINE, EMBASE, CNKI, and Wanfang databases using keywords including \"immune checkpoint inhibitors,\" \"cutaneous adverse reactions,\" \"cutaneous toxicity,\" \"induced,\" and \"case,\" and their combinations to identify detailed case reports on cirAEs. Data on patient demographics (sex and age), primary cancer type, ICI use, time to cirAE onset, cirAE severity grading, and reaction classification were extracted. Descriptive statistics, co-occurrence analysis of clinical manifestations, and the Apriori algorithm were employed to analyze cirAE patterns.</p><p><strong>Results: </strong>The analysis included a total of 120 articles involving 126 patients (male: 80; female: 46) with a mean age of 63.05 ± 11.85 years. The highest incidence was observed in patients aged 60 - 69 years. The primary cancers were predominantly non-small cell lung cancer and melanoma. Programmed death 1 (PD-1) inhibitors were the most commonly used therapeutic agents. The median time to onset was 15 - 28 days. Most cases were classified as severe Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).</p><p><strong>Conclusion: </strong>Healthcare professionals must remain vigilant for severe cirAEs and ensure timely diagnosis and management to safeguard patient safety during ICI therapy.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"231-241"},"PeriodicalIF":0.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046512","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":"Low-dose lamotrigine co-administration decreases quetiapine plasma concentrations: Effect of <i>UGT2B7</i>-161C>T polymorphism in Japanese patients with depression.","authors":"Takeshi Suzuki, Goyo Nagai, Kazuo Mihara, Yoko Tomori, Shoko Kagawa, Akifumi Nakamura, Kenji Nemoto, Tsuyoshi Kondo","doi":"10.5414/CP204879","DOIUrl":"10.5414/CP204879","url":null,"abstract":"<p><strong>Objectives: </strong>Previous findings showing that lamotrigine co-administration decreases serum quetiapine concentrations were based solely on group comparisons using therapeutic drug monitoring databases. The present prospective study examined the effects of lamotrigine co-administration on plasma quetiapine concentrations in Japanese patients with depression and in relation to polymorphisms of UGT1A2 and UGT2B7, enzymes responsible for lamotrigine metabolism.</p><p><strong>Materials and methods: </strong>14 patients with depression were recruited in the study. They had been treated with immediate-release quetiapine 200, 400, or 700 mg/d. Lamotrigine was co-administered in all patients over a period of 8 weeks where the final doses of lamotrigine were 75 mg/d in 2 subjects taking valproate and 100 mg/d in 12 subjects not taking valproate. Blood samples were collected before and 2, 4, and 8 weeks after commencing lamotrigine co-administration. Quetiapine and lamotrigine concentrations in plasma were measured using LC/MS/MS. The genotypes of the <i>UGT1A4</i> 142T>G, <i>UGT2B7</i>-161C>T, and <i>UGT2B7</i> 372A>G polymorphisms were identified using real-time PCR analysis.</p><p><strong>Results: </strong>The mean plasma concentration of quetiapine 8 weeks after lamotrigine treatment was significantly lower than that prior to the administration (p < 0.05). The mean percentage reduction in quetiapine concentration was significantly greater in subjects carrying the C/T and T/T genotypes when compared to those carrying the C/C genotype in respect to the <i>UGT2B7</i>-161C>T polymorphism (p < 0.05).</p><p><strong>Conclusion: </strong>The present study provides evidence that low-dose lamotrigine co-administration decreases plasma quetiapine concentrations in Japanese patients with depression and that the magnitude of this effect differs between genotypes of the <i>UGT2B7</i>-161C>T polymorphism.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"242-249"},"PeriodicalIF":0.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147270980","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":"A randomized, open-label, single-dose study to evaluate the safety and pharmacokinetics of two formulations containing 40 mg of fexuprazan in healthy Korean subjects.","authors":"Joon Hur, Jin A Lee, Hyung Park, Yongam Choi, Jihye Chae, Yong-Geun Kwak, Seol Ju Moon, Min-Gul Kim","doi":"10.5414/CP204926","DOIUrl":"10.5414/CP204926","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the pharmacokinetics and safety of two 40-mg fexuprazan formulations.</p><p><strong>Materials and methods: </strong>This study was an open-label, randomized, single-dose, crossover bioequivalence trial in healthy subjects. 24 subjects were randomized to receive either the test formulation, tablet A (40 mg fexuprazan), or the reference formulation, tablet B (40 mg fexuprazan), with crossover administration. Plasma samples were collected up to 48 hours post-dose and analysed for fexuprazan using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). Individual pharmacokinetic parameters were derived by noncompartmental analysis. Safety was evaluated throughout the study.</p><p><strong>Results: </strong>22 subjects completed the study and were included in the pharmacokinetic analysis. Geometric mean values of area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC_t) was 380.17 and 390.33 ng×h/mL for the test and reference formulations, respectively. Geometric mean values of maximum plasma concentration (C_max) were 29.36 and 31.65 ng/mL for the test and reference formulations, respectively. The 90% confidence intervals (CIs) for the test/reference geometric mean ratios of AUC_t and C_max were 0.9098 - 1.0427 and 0.8665 - 0.9931, respectively. All adverse events were mild, and no serious adverse events occurred.</p><p><strong>Conclusion: </strong>The novel 40-mg fexuprazan formulation (tablet A) was demonstrated to be bioequivalent to the initially developed formulation (tablet B), with comparable systemic exposure (AUC) and peak concentration (C_max). Both formulations were well tolerated, with no clinically meaningful differences in adverse event profiles.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"274-282"},"PeriodicalIF":0.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147270928","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":"Hemoglobin A1c levels in patients with type 2 diabetes mellitus receiving oral semaglutide with versus without proton pump inhibitors: An exploratory study.","authors":"Satoru Matsunuma, Yusuke Hirota, Koichi Yoshimoto","doi":"10.5414/CP204899","DOIUrl":"10.5414/CP204899","url":null,"abstract":"<p><strong>Objective: </strong>Oral semaglutide contains salcaprozate sodium, which promotes the opening of epithelial tight junctions and increases gastric pH to prevent its degradation; these actions together improve absorption. Proton pump inhibitors (PPIs) increase gastric pH. However, it is unclear whether PPIs affect the absorption of semaglutide and may therefore enhance the blood glucose lowering effect of semaglutide or affect the reduction of hemoglobin A1c (HbA1c). Therefore, this study investigated differences in HbA1c changes and adverse events between those with and without PPI co-administration.</p><p><strong>Materials and methods: </strong>This single-center retrospective study included patients with type 2 diabetes who received oral semaglutide. Patients were categorized into two groups: those on treatment with PPI (w/PPI) and those not on treatment with PPI (without PPI (w/o PPI)). The primary outcome was the change in HbA1c levels at 52 weeks, while the secondary outcomes included changes at 26 weeks and the incidence of adverse events.</p><p><strong>Results: </strong>A total of 66 patients were included. HbA1c reduction at 52 weeks was significantly greater in the w/PPI group (-1.56 ± 0.37%) than in the w/o PPI group (-1.08 ± 0.76%, p = 0.024). The incidences of adverse events were 24.0% and 31.7% in the w/PPI and w/o PPI groups, respectively (p = 0.502).</p><p><strong>Conclusion: </strong>HbA1c reduction at 52 weeks was significantly greater in the PPI co-administration group than in the group without PPI. Future research should include larger sample sizes and pharmacokinetic studies to clarify the clinical implications and interactions between oral semaglutide and PPIs.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"250-258"},"PeriodicalIF":0.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046625","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":"Prediction of paclitaxel-induced myelosuppression: Validation of a regression model using creatinine clearance and other risk factors obtained retrospectively in hospitalized cancer patients.","authors":"Yang Hai, Yulong Liu","doi":"10.5414/CP204939","DOIUrl":"10.5414/CP204939","url":null,"abstract":"<p><strong>Objective: </strong>To develop a predictive model for paclitaxel (PTX)-induced moderate-to-severe myelosuppression in hospitalized cancer patients and to evaluate its accuracy through cross-validation.</p><p><strong>Materials and methods: </strong>A total of 348 cancer patients treated with PTX at Yingshang County People's Hospital between January 2022 and August 2025 were retrospectively reviewed. Clinical data from 278 patients were used to develop the model, including sex, age, underlying diseases, and baseline laboratory parameters at admission. Multivariate logistic regression was used to identify independent risk factors for moderate-to-severe myelosuppression and to construct the predictive model. The model was evaluated using receiver operating characteristic (ROC) curve analysis. An additional 70 patients were used for cross-validation to assess the model's accuracy.</p><p><strong>Results: </strong>The incidence of PTX-induced moderate-to-severe myelosuppression was 32.37% in the 278-patient cohort. Multivariate analysis identified the following independent predictors: creatinine clearance rate (OR = 3.81, 95% CI: 1.853 - 7.836, p < 0.001), red blood cell count (OR = 2.69, 95% CI: 1.263 - 5.726, p = 0.01), hemoglobin (OR = 6.49, 95% CI: 2.431 - 17.328, p < 0.001), neutrophil count (OR = 3.196, 95% CI: 1.077 - 9.485, p = 0.036), and nutritional status (OR = 2.373, 95% CI: 1.008 - 5.586, p = 0.048). The predictive model incorporating these five factors demonstrated strong performance, achieving an AUC of 0.845, a sensitivity of 75.56%, and a specificity of 78.19%. Furthermore, cross-validation on an independent cohort of 70 patients confirmed a prediction accuracy of 84.29%.</p><p><strong>Conclusion: </strong>The developed predictive model demonstrates strong performance in assessing the risk of PTX-induced moderate-to-severe myelosuppression and may serve as a useful tool for early identification of high-risk patients, supporting clinical decision-making and personalized treatment strategies.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"259-268"},"PeriodicalIF":0.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147581284","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":"Vancomycin-induced acute kidney injury in a type 2 diabetes patient with augmented renal clearance: A case report and dosing strategy implications.","authors":"Liang-Fen Wang, Ju Zhou, Rong Chen","doi":"10.5414/CP204905","DOIUrl":"10.5414/CP204905","url":null,"abstract":"<p><p>Vancomycin-induced acute kidney injury (AKI) is a well-documented adverse effect, particularly in high-risk populations such as patients with type 2 diabetes mellitus (T2DM) and augmented renal clearance (ARC). However, optimal dosing strategies for diabetic patients with ARC remain unclear, increasing the risk of nephrotoxicity. A 36-year-old male with newly diagnosed T2DM (HbA1c 11.6%) and ARC (baseline estimation of glomerular filtration rate (eGFR) 270 - 301 mL/min/1.73m²) developed AKI following high-dose vancomycin therapy (1.5g q8h) for a methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) abscess. Despite initially subtherapeutic trough levels (8.83 μg/mL), the patient experienced AKI (serum creatinine: 195 μmol/L; eGFR 36.1 mL/min) coinciding with a toxic trough level (75.84 μg/mL) on day 7 after vancomycin administration. AKI resolved after vancomycin discontinuation and aggressive hydration. Diabetic patients with ARC are at increased risk of vancomycin-induced AKI, even with subtherapeutic troughs. Close renal function monitoring, individualized dosing, and consideration of AUC-based protocols or alternative antibiotics (e.g., linezolid) are essential for mitigating nephrotoxicity. Further pharmacokinetic studies in this population are warranted to optimize therapeutic outcomes.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"269-273"},"PeriodicalIF":0.9,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147372731","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":"Impact of extracorporeal membrane oxygenation on antituberculosis drug concentrations: A case study and pharmaceutical care strategies.","authors":"Yidan Xu, Fei Lv, Xing Yu","doi":"10.5414/CP204865","DOIUrl":"10.5414/CP204865","url":null,"abstract":"<p><strong>Background: </strong>Extracorporeal membrane oxygenation (ECMO) provides life support for critically ill tuberculosis (TB) patients. However, during ECMO therapy, significant fluctuations in the plasma concentration of anti-TB drugs occur due to drug adsorption in the ECMO circuit, hemodilution, and metabolic disturbances.</p><p><strong>Materials and methods: </strong>This single-case study monitored the plasma concentration of anti-TB drugs in a TB patient supported by ECMO.</p><p><strong>Results: </strong>The differences in peak plasma concentrations (C_max) measured at the end of ECMO support vs. 7 days after ECMO withdrawal were as follows: isoniazid (66%), linezolid (63%), ethambutol (56%), and levofloxacin (12%).</p><p><strong>Conclusion: </strong>We analyzed ECMO's impact on drug concentrations and implemented therapeutic drug monitoring to optimize therapy. However, this single-case study has inherent limitations; future multi-center studies are warranted to validate these findings.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"219-225"},"PeriodicalIF":0.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933097","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":"Effect of inhaled corticosteroid with oral montelukast and levocetirizine in asthma: A population-based study.","authors":"Myunghee Park, Seong-Dae Woo, Minae Park, Yujin Lee, Hwa Jeong Seo","doi":"10.5414/CP204906","DOIUrl":"10.5414/CP204906","url":null,"abstract":"<p><strong>Introduction: </strong>Asthma is a chronic disease that requires careful management, and its exacerbations can be life-threatening. The aim of this study was to ascertain whether inhaled corticosteroids (ICS)-containing inhaler in combination with oral montelukast and levocetirizine could lessen the exacerbation of asthma in comparison to inhaler alone.</p><p><strong>Materials and methods: </strong>Among 437,915 asthma patients receiving ICS-containing inhaler, 91,122 participants were included. Treatment groups were categorized as (1) ICS-containing inhalers (ICS with or without long-acting β-2 agonist (LABA)), and (2) ICS-containing inhalers used in combination with both oral montelukast and levocetirizine, and (3) severe exacerbation of asthma (visit of emergency room or hospitalization). After 1 : 1 propensity score matching of treatment groups, survival analysis utilizing Cox regression was conducted for estimating the effect of treatment on asthma exacerbation.</p><p><strong>Results: </strong>We found that the inhaler plus montelukast and levocetirizine group exhibited a lower crude incidence rate and was associated with a lower risk of all-cause death and moderate to severe exacerbation. Specifically, the adjusted hazard ratios (HRs) were 0.71 (p = 0.006) for all-cause death, 0.57 (p < 0.001) for moderate exacerbation. For severe exacerbations, the adjusted HRs were 0.59 for emergency room visits and 0.66 for hospitalizations (p = 0.018 and 0.011, respectively), compared to the ICS-only group, demonstrating a statistically significant reduction.</p><p><strong>Conclusion: </strong>Treatment with ICS-containing inhaler plus oral montelukast and levocetirizine was significantly associated with a lower risk of exacerbations in asthma patients. Alongside the growing burden of healthcare utilization and costs in South Korea, consideration of the treatment of ICS with montelukast and levocetirizine may serve as an effective treatment option for patients with severe, uncontrolled asthma, potentially improving disease management and reducing healthcare costs.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"210-218"},"PeriodicalIF":0.9,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917640","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}