International journal of clinical pharmacology and therapeutics最新文献

{"title":"Empagliflozin and hydralazine-isosorbide dinitrate combination therapy improves outcomes in black patients with heart failure.","authors":"Padmamalini Baskaran, Mohammed Aldhaeefi, Anahita Asaadi, Morgan Jones, Emmanuel King, Dhakrit Rungkitwattanakul, La'Marcus Wingate","doi":"10.5414/CP204854","DOIUrl":"https://doi.org/10.5414/CP204854","url":null,"abstract":"<p><strong>Background: </strong>Black patients experience a disproportionately high incidence of heart failure with reduced ejection fraction (HFrEF), where vasodilators serve as a key therapeutic strategy.</p><p><strong>Materials and methods: </strong>A retrospective cohort study based on medical records of Black patients with HFrEF and an ex vivo analysis of mouse thoracic aorta stimulated with empagliflozin (empa) and hydralazine-isosorbide dinitrate (H-ISDN).</p><p><strong>Results: </strong>The combination synergistically activated cyclic guanosine monophosphate (cGMP) production in the ex vivo thoracic aorta and improved kidney function, reduced brain natriuretic peptide (BNP), and lowered mortality compared to H-ISDN alone in HFrEF patients.</p><p><strong>Conclusion: </strong>Empa + H-ISDN offered superior benefits in Black patients with HFrEF, possibly by reducing oxidative stress and enhancing nitric oxide (NO) bioavailability.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953288","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":"Cabotegravir pharmacokinetics in Asians with and without HIV.","authors":"Kelong Han, Ahmed A Abulfathi, Rashmi S Mehta, Romina A Nand, Mark A Marzinke, Raphael J Landovitz, Ronald D D'Amico, Alex R Rinehart, William R Spreen, Susan L Ford","doi":"10.5414/CP204849","DOIUrl":"10.5414/CP204849","url":null,"abstract":"<p><strong>Objective: </strong>Cabotegravir is approved for HIV treatment (with rilpivirine) and prevention. The established cabotegravir population pharmacokinetic (PPK) model included 1.2% Asian participants. We aimed to compare cabotegravir pharmacokinetics between Asian and non-Asian populations and across Asian countries.</p><p><strong>Materials and methods: </strong>Cabotegravir concentrations were collected from Asian participants in phase 1 and 3 studies. The applicability of the PPK model to Asian populations was validated by predicting the observed concentrations not included in model-building. Cabotegravir post-hoc pharmacokinetic parameters (long-acting absorption rate constant, weight-normalized apparent clearances and volumes of distribution) and exposures (trough and peak concentrations) following monthly and every-2-month regimens were estimated by fitting the PPK model to observed data. Non-Asian participants from the previous PPK dataset (1,697 males; 564 females) were used as comparator. Cabotegravir exposures in Asian and non-Asian were compared via simulations.</p><p><strong>Results: </strong>2,034 cabotegravir concentrations were collected from 162 Asian males (assigned male at birth) in China (n = 47), Japan (n = 17), Korea (n = 25), Thailand (n = 53), and Vietnam (n = 20), and 35 concentrations from 2 Asian females (assigned female at birth) in Korea. Cabotegravir pharmacokinetic parameters were similar between Asian and non-Asian participants. Cabotegravir exposures in Asian populations largely overlapped with but tended to be higher than non-Asian populations, suggesting similar efficacy. Cabotegravir exposures in Asian and non-Asian populations remained below the safety threshold, suggesting similar safety profiles. Cabotegravir pharmacokinetic parameters and exposures were similar across Asian countries.</p><p><strong>Conclusion: </strong>No dose adjustment is recommended for Asian populations with and without HIV. Cabotegravir pharmacokinetic data from any Asian country/region may guide pharmacokinetic evaluation and regulatory considerations across Asian regions.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"427-431"},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12378465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540132","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":"Anti-neurodegenerative treatment in Alzheimer's disease: Multifaceted mechanisms of action of berberine.","authors":"Dandan Song, Congmin Zhang","doi":"10.5414/CP204725","DOIUrl":"10.5414/CP204725","url":null,"abstract":"<p><strong>Background: </strong>Berberine, a traditional Chinese medicine, has demonstrated significant therapeutic influences in treating diabetes, obesity, and diarrhea, among other conditions. It has exhibited potential therapeutic benefits for various neurodegenerative diseases, namely, Alzheimer's disease (AD), Huntington's disease (HD), and Parkinson's disease (PD).</p><p><strong>Aims: </strong>This study aims to elucidate the mechanism behind berberine pharmacological action in treating AD.</p><p><strong>Materials and methods: </strong>We search the articles published in PubMed and CNKI and summarize the mechanism of berberine in AD.</p><p><strong>Results: </strong>In recent years, as research into the pharmacology of berberine has deepened, researchers have discovered its strong neuroprotective properties. The ability of berberine to enhance cognitive function is thought to result from inhibiting the spread of AD-related proteins, reducing oxidative stress and inflammation, increasing choline levels, and regulating autophagy.</p><p><strong>Conclusion: </strong>This review explores the latest research on berberine in AD, suggesting that berberine and its analogs may offer a promising new approach to treating the condition.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"432-438"},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199034","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":"Primary hypertension in German children and adolescents: Low treatment rates and dominance of ACE inhibitors in an analysis of 7,482 cases for the period 2005 to 2023.","authors":"Jacob Christian Moll, Jens Bohlken, Kerstin Weber, Karel Kostev","doi":"10.5414/CP204857","DOIUrl":"10.5414/CP204857","url":null,"abstract":"<p><strong>Aims: </strong>To investigate prescription patterns in children and adolescents receiving treatment for primary hypertension.</p><p><strong>Materials and methods: </strong>Cumulative prescriptions within the 12-month period before the index date were analyzed for a cohort of 7,482 children and adolescents using Kaplan-Meier curves, stratified according to age group. Associations between age, sex, co-diagnoses, and the likelihood to be treated were evaluated using multivariable Cox regression.</p><p><strong>Results: </strong>The percentage of adolescents, children aged 6 years and above, and children aged up to 5 years receiving antihypertensive therapy was low (15.7% for adolescents, 12.8% for children aged 6 years and above, and 10.3% for children aged up to 5 years). The numbers receiving an angiotensin-converting enzyme (ACE) inhibitor, the most frequently prescribed drug class, were 65.4, 70.3, and 62.8%, and the numbers receiving a β-adrenergic receptor blocker, the second most commonly prescribed drug class were 19.1, 16.7, and 14.0%, respectively. Using multivariable analysis, co-diagnoses for type 1 diabetes mellitus (HR: 2.47; 95% CI: 1.72 - 3.55) and epilepsy (HR: 2.46; 95% CI: 1.74 - 3.47) were significantly correlated with an increased likelihood to receive antihypertensive therapy.</p><p><strong>Conclusion: </strong>The low number of children and adolescents with primary hypertension prescribed antihypertensive therapy is not in accord with current treatment guidelines. The reasons for this discrepancy and the effect it has on long-term cardiovascular outcomes are of considerable concern and need to be investigated.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"405-410"},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540133","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 rare case of septic shock caused by Serratia marcescens in an immunocompetent male adolescent. Comment on: DOI: 10.5414/CP204652 by Mughrab et al.","authors":"Bengisu Baykara, Tugba Bedir Demirdag, Seyma Ozpinar, Meltem Polat, Anil Tapisiz","doi":"10.5414/CP204884","DOIUrl":"https://doi.org/10.5414/CP204884","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953307","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 silica nanoparticle biodistribution using a calibrated physiologically based model: Unbound fraction and elimination rate constants for the kidneys and phagocytosis identified as major determinants.","authors":"Madison Parrot, Joseph Cave, Maria J Pelaez, Hamidreza Ghandehari, Prashant Dogra, Venkata Yellepeddi","doi":"10.5414/CP204837","DOIUrl":"https://doi.org/10.5414/CP204837","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to develop a minimal physiologically based pharmacokinetic (mPBPK) model to predict the biodistribution of silica nanoparticles (SiNPs) and evaluate how variations in surface charge, size, porosity, and geometry influence their systemic disposition.</p><p><strong>Materials: </strong>The mPBPK model was calibrated using in vivo pharmacokinetic data from mice administered aminated, mesoporous, and rod-shaped SiNPs. Human data were collected from clinical trial data from Cornell dots.</p><p><strong>Materials: </strong>The mPBPK model incorporated physiological parameters and nanoparticle-specific characteristics to simulate SiNP biodistribution and was built in Matlab 2024a. Global sensitivity analysis identified influential parameters, including the unbound fraction and elimination rate constants for the kidneys and mononuclear phagocyte system (MPS). The model was extrapolated to predict human pharmacokinetics, with accuracy evaluated using Pearson correlation coefficients. Non-compartmental analysis (NCA) assessed organ-specific accumulation and biodistribution patterns.</p><p><strong>Results: </strong>Global sensitivity analysis revealed that the unbound fraction and elimination rate constants for the kidneys and MPS were major determinants of SiNP biodistribution. NCA indicated that aminated SiNPs initially accumulated in the liver, spleen, and kidneys but redistributed due to their high unbound fraction, while mesoporous SiNPs localized in the lungs. Rod-shaped SiNPs exhibited high lung exposure. The extrapolated model showed high predictive accuracy, with Pearson correlation coefficients of 0.98 for mice and 0.99 for humans.</p><p><strong>Conclusion: </strong>The mPBPK model effectively predicts the pharmacokinetics of diverse SiNPs, offering insights to optimize nanoparticle-based drug delivery systems and facilitating their translation from preclinical models to clinical applications.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953134","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":"Epithelial-mesenchymal transition biomarkers in patients with acute exacerbation of COPD are indicative of disease severity, disease progression, and risk of readmission.","authors":"Xiaohua Chou, Qian Zhang, Yuanqin Li, Xinran Qiu, Qian Sha, Yongli Gu, Daoli Jiang","doi":"10.5414/CP204769","DOIUrl":"https://doi.org/10.5414/CP204769","url":null,"abstract":"<p><strong>Aims: </strong>To explore the association of epithelial-mesenchymal transition (EMT)-related biomarkers with an increase in disease severity/progression leading to readmission with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).</p><p><strong>Materials and methods: </strong>A prospective and observational study was conducted, involving patients admitted for AECOPD. Serum levels of EMT-related biomarkers (E-cadherin, zonula accludens-1 (ZO-1), vimentin and α-smooth muscular actin (α-SMA) were measured at patient admission. The clinical outcomes were 12-month AECOPD-related readmission risk, time to the first AECOPD-related readmission after discharge and number of 12-month AECOPD-related readmissions.</p><p><strong>Results: </strong>A total of 168 patients were included in the study, of whom 54 had at least one readmission for AECOPD during the 12-month follow-up period. Low serum levels of E-cadherin (< 279.7 ng/mL, adjusted odds ratio (aOR) = 9.434, p = 0.000), and high serum levels of vimentin (≥ 263.2 pg/mL, aOR = 7.116, p = 0.008), and α-SMA (≥ 460.8 pg/mL, aOR = 11.653, p = 0.000) were associated with an increased risk of AECOPD-related readmissions. Patients with low serum levels of E-cadherin and high serum levels of α-SMA exhibited the highest risk of AECOPD-related readmission. Additionally, low serum levels of E-cadherin and high serum levels of vimentin and α-SMA were associated with a shorter time to the first AECOPD-related readmission, and an increased number of 12-month AECOPD-related readmissions.</p><p><strong>Conclusion: </strong>Low serum levels of E-cadherin and high serum levels of vimentin and α-SMA are associated with an increase in disease severity/progression leading to AECOPD-related readmissions during a 12-month follow-up period. Moreover, simultaneous evaluation of E-cadherin and α-SMA levels enhances the accuracy in identifying patients who are likely to be re-hospitalized with AECOPD.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953310","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":"Exogenous insulin antibody syndrome in type 2 diabetes with diabetic ketoacidosis: A case report and literature review.","authors":"Murong Xu, Li Xia, Rong Xiao, Datong Deng","doi":"10.5414/CP204819","DOIUrl":"10.5414/CP204819","url":null,"abstract":"<p><strong>Background: </strong>Exogenous insulin antibody syndrome (EIAS) is a rare allergic reaction triggered by exogenous insulin. It typically manifests as recurrent hypoglycemia during insulin use. In some cases, patients may also experience significant elevation in their blood glucose levels.</p><p><strong>Case report: </strong>We review a case of type 2 diabetes mellitus complicated by diabetic ketoacidosis. The patient exhibited a significant increase in his blood glucose level and demonstrated a substantial insulin resistance. Only through the administration of a large amount of insulin, it was possible to gradually reduce his blood glucose level. Notably, laboratory examination revealed a significant elevation in the patient's blood insulin autoantibody. Based on these findings, the patient was diagnosed with EIAS and used glucocorticoids during treatment. Subsequently, the patient's required insulin dose decreased significantly, and the blood glucose level was effectively controlled.</p><p><strong>Conclusion: </strong>EIAS can significantly increase blood glucose levels and impair the hypoglycemic effect of insulin. In patients with acute metabolic disorders, such as ketoacidosis, glucocorticoid therapy can be considered.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799031","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":"Rare systemic skin hyperpigmentation associated with osimertinib: A case report.","authors":"Le Li, Lifang Yang, Guanglei Xu, Zhouqian Jiang","doi":"10.5414/CP204768","DOIUrl":"10.5414/CP204768","url":null,"abstract":"<p><p>A patient with advanced small cell lung cancer presented with systemic skin pigmentation, a rare and severe skin adverse reaction during treatment with osimertinib. Osimertinib-induced hyperpigmentation is rarely reported, According to the patient's condition, adverse drug reactions, and drug efficacy, osimertinib was the urgently needed treatment regimen, and 80 mg of osimertinib was continued. Therefore, we hope this case can provide experience for clinicians to identify adverse reactions of the drug and ensure the safety of patients.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742067","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":"Skin toxicity associated with immune checkpoint inhibitors based on the FDA adverse event reporting system 2011 - 2023 data.","authors":"Xiao-Yan Qiu, Zhang-Yong Fu, Ai-Feng Wu","doi":"10.5414/CP204739","DOIUrl":"10.5414/CP204739","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate skin toxicity associated with immune checkpoint inhibitors (ICIs) using data mining and the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).</p><p><strong>Materials and methods: </strong>Data on skin toxicity associated with the use of ICIs were retrieved for the period January 2011 to September 2023. Analysis was done using various methods, including reporting odds ratio (ROR) estimates, proportional reporting ratios (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker estimates (MGPS). Mortality and hospitalization data were also assessed.</p><p><strong>Results: </strong>A total of 8,129 skin toxicity reports concerning \"ICIs\" as the \"primary suspected cause\" were documented, accounting for 18.89% of all reported adverse events. Anti-PD-1 agents showed the highest incidence of skin toxicity, whereas anti-CTLA-4 monotherapy was associated with the most significant changes in ROR, PRR, empirical Bayesian geometric mean (EBGM), and information component (IC) values. The median onset of toxicity was 17 days after commencement of ICI treatment, consistent across sexes, age groups, and ICI types. The highest mortality rate occurred with anti-PD-1 treatment (11.37%), and there was a significant difference in mortality rates between different ICI treatments (monotherapy vs. combination therapy) (p = 0.03).</p><p><strong>Conclusion: </strong>Differences are present between ICI regimens in the pattern of skin toxicity with anti-PD-1 therapies exhibiting the highest incidence of skin toxicity and mortality rates, while anti-CTLA-4 therapies showed the most marked signals.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682608","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}