International Journal Of Clinical Pharmacology And Therapeutics[JOURNAL]
Sun
200 papers
Association between incretin-related drugs and fractures in patients treated with pioglitazone: A pharmacovigilance study using the FDA Adverse Event Reporting System.
Ohyama K, Abe N, Okamoto T … +1 more , Hori Y
Int J Clin Pharmacol Ther · 2026 Jan · PMID 41122011 · Publisher ↗
OBJECTIVE: 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...
OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: Our results suggest that incretin-related drugs, especially GLP-1RAs, reduce the risk of fractures in patients treated with diabetes medications such as pioglitazone.
Recurrent corticosteroid-resistant cytomegalovirus infection complicating ulcerative colitis responding to antiviral treatment: Case report.
Ayadi S, Ghithia N, Trad N … +4 more , Mensi A, Belhadj Mabrouk E, Mouelhi L, Dabbeche R
Int J Clin Pharmacol Ther · 2026 Jan · PMID 41122010 · Publisher ↗
Cytomegalovirus is a common opportunistic infection that often affects individuals with impaired immune function. It may present with a variety of clinical manifestations. Treatment for ulcerative colitis (UC) usually re...
Cytomegalovirus is a common opportunistic infection that often affects individuals with impaired immune function. It may present with a variety of clinical manifestations. Treatment for ulcerative colitis (UC) usually requires immunosuppressants and steroids, increasing patients' susceptibility to cytomegalovirus infection. We report the case of a 53-year-old female patient with corticosteroid-resistant UC and recurrent cytomegalovirus infection. The patient had exacerbations, and the diagnosis of cytomegalovirus infection was confirmed through serology and detection of high levels of cytomegalovirus DNA in biopsies using quantitative polymerase chain reaction (PCR). After requiring intravenous ganciclovir, the patient improved. However, she had further relapses requiring treatment with foscarnet, with marked improvement in symptoms and endoscopic results. This case shows the importance of evaluating acute cytomegalovirus infections in patients with corticosteroid resistance. Quantitative PCR appears to be a valuable tool in guiding treatment decisions. In addition, the case is evidence for the satisfactory efficacy of foscarnet in managing cytomegalovirus infections.
Evidence that testosterone gel does not increase the risk of cardiovascular disease: A Mendelian randomization study of 337,159 European users.
He XY, Jia ZN, Zhang BY … +6 more , Wu JZ, Wang ZZ, Zhao HP, Yang ZX, Song R, Xu Q
Int J Clin Pharmacol Ther · 2026 Jan · PMID 41122009 · Publisher ↗
BACKGROUND AND OBJECTIVES: 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,...
BACKGROUND AND OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: The study findings suggest that testosterone treatment does not significantly increase the risk of developing cardiovascular disease.
Evidence that mycophenolate mofetil is a safe and effective immunosuppressive in the treatment of autoimmune hepatitis and Evans syndrome: Case report.
Trad N, Mensi A, BelHadj Mabrouk E … +5 more , Zaimi Y, Ayadi S, Mouelhi L, Said Y, Dabbeche R
Int J Clin Pharmacol Ther · 2026 Feb · PMID 41122008 · Publisher ↗
BACKGROUND: Autoimmune hepatitis (AIH) is a chronic immunoinflammatory liver disease frequently associated with extrahepatic autoimmune disorders. Evans syndrome (ES) is a rare chronic autoimmune condition characterized...
BACKGROUND: Autoimmune hepatitis (AIH) is a chronic immunoinflammatory liver disease frequently associated with extrahepatic autoimmune disorders. Evans syndrome (ES) is a rare chronic autoimmune condition characterized by the simultaneous presence of autoimmune hemolytic anemia and immune thrombocytopenia. Its association with AIH is uncommon, and standardized management guidelines are lacking. CASE REPORT: We report the case of a 35-year-old patient diagnosed concurrently with type 1 AIH and ES. The initial response to oral corticosteroid therapy and azathioprine was favorable, with improvements in liver function and hematological parameters. However, during follow-up, the patient experienced multiple relapses despite receiving adequate doses of azathioprine, indicating treatment failure. Due to the unsatisfactory response to first-line therapy, mycophenolate mofetil (MMF) was initiated, resulting in sustained biochemical remission and hematological improvement with good tolerance. CONCLUSION: MMF may be an effective and well-tolerated therapeutic option for treating type 1 AIH associated with ES. However, further studies and international collaboration are necessary to establish standardized management protocols.
Integrative treatment of the motor neuron disease amyotrophic lateral sclerosis, efficacy of pharmacotherapy, traditional Chinese medicine and importance of respiratory support, life-style, and gastrostomy-assisted nutrition: A review.
Jing W, Shan Y, Wu H … +7 more , Li T, Tang H, Sun Y, Napattharin V, Loong S, Qin B, Pan W
Int J Clin Pharmacol Ther · 2025 · PMID 41090678
Currently, there are no effective treatments for amyotrophic lateral sclerosis (ALS), a chronic progressive neurodegenerative disease. Although the etiology of ALS is unknown, it is thought that factors such as diet, the...
Currently, there are no effective treatments for amyotrophic lateral sclerosis (ALS), a chronic progressive neurodegenerative disease. Although the etiology of ALS is unknown, it is thought that factors such as diet, the environment, and lifestyle habits play a role. The pathogenesis of ALS includes alterations in glutamate neurotransmission, oxidative stress, mitochondrial dysfunction. Drugs such as riluzole, edaravone, dextromethorphan/quinidine combinations, and the administration of tofersen by injection are approved treatment options for ALS although a number of other agents are being examined in clinical trials. Despite these developments, the availability of effective treatment options is limited. This review summarizes the etiology and pathogenesis of ALS and describes treatments in detail as an integrative medicine approach and including traditional Chinese medicine together with the importance of the timing for interventions, precautions necessary for noninvasive ventilator and gastrostomy surgery, and precautions for dealing with respiratory issues with the overall aim of providing state-of-the-art clinical recommendations for the care and therapy of ALS patients.
Treatment of polycystic ovary syndrome with QUF7 and mechanism of action: Evidence from network pharmacology analysis that hydroxynaringenin, quercetin, and kaempferol modulate the estrogen receptor gene.
He Y, Hu W, Wang F … +2 more , Zhao L, Qu F
Int J Clin Pharmacol Ther · 2025 · PMID 41090677
OBJECTIVE: This study aims to investigate the clinical effectiveness and underlying pharmacological processes of a patented formulation derived from Chinese herbal medicine (CHM), named Qu's formula 7 (QUF7), in addressi...
OBJECTIVE: This study aims to investigate the clinical effectiveness and underlying pharmacological processes of a patented formulation derived from Chinese herbal medicine (CHM), named Qu's formula 7 (QUF7), in addressing polycystic ovary syndrome (PCOS). MATERIALS AND METHODS: A retrospective analysis of clinical data was performed involving 225 patients diagnosed with PCOS. We categorized the subjects into two distinct groups: one receiving combined oral contraceptives (COCs) and the other undergoing QUF7 treatment. After treatment, the menstrual cycles and sex hormone levels of the two groups were evaluated. Moreover, an integrative pharmacology approach was utilized to explore the principal components, cardinal targets, and potential mechanisms associated with the QUF7 prescription in the treatment of PCOS. RESULTS: After treatment, patients in the QUF7 group exhibited a significant alteration in their menstrual periods and a pronounced decrease in blood luteinizing hormone (LH) levels compared to the COCs group (p < 0.05). The analysis of network pharmacology revealed a total of 332 intersecting targets associated with QUF7 and PCOS, and findings from molecular docking analyses indicated that 6-hydroxynaringenin has a robust affinity for estrogen receptor 1 (ESR1). The Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis evaluation indicated that the advanced glycation end product (AGE)-AGE receptor (RAGE) and phosphatidylinositol 3-kinase-protein kinase B (PI3K-AKT) signaling pathways are the most probable underlying mechanisms. CONCLUSION: QUF7 modulates endocrine levels and improves ovulation in PCOS patients and possibly exerts multi-targeted effects by mediating the signaling pathways of AGE-RAGE and PI3K-AKT.
Personalized management of acenocoumarol dosage using eGFR: Analysis of INR data in a cohort of 204 patients.
Farandzha D, Velchev V, Hazarbasanov D
Int J Clin Pharmacol Ther · 2025 Dec · PMID 41065070 · Full text
BACKGROUND: Acenocoumarol is a widely used vitamin K antagonist, particularly in European countries. While age and body metrics are known to influence dose requirements, the role of renal function in guiding acenocoumaro...
BACKGROUND: Acenocoumarol is a widely used vitamin K antagonist, particularly in European countries. While age and body metrics are known to influence dose requirements, the role of renal function in guiding acenocoumarol dosage remains underexplored. AIMS: The primary aim of this study was to investigate the relationship between renal function and the weekly dose of acenocoumarol required to maintain therapeutic international normalized ratio (INR) levels. MATERIALS AND METHODS: We analyzed 425 INR measurements from 204 adult patients receiving acenocoumarol, stratified by target INR ranges of 2.00 - 3.00 and 2.50 - 3.50. Renal function was assessed using the body surface area (BSA)-adjusted chronic kidney disease-epidemiology (CKD-EPI) 2021 formula. Weekly acenocoumarol doses were evaluated in relation to age, sex, estimated glomerular filtration rate (eGFR), and body size. RESULTS: Patients with lower eGFR and older age required significantly lower weekly doses of acenocoumarol. In the INR 2.00 - 3.00 group, males required higher doses than females, correlating with both greater body size and higher eGFR. However, in the INR 2.50 - 3.50 group, males and females received the same median dose despite differing body metrics, mirroring their similar renal function. A positive correlation was found between BSA-adjusted eGFR and weekly dose, particularly when eGFR exceeded 90 mL/min (Spearman r = 0.48, p = 0.0001). CONCLUSION: Renal function, as measured by BSA-adjusted eGFR, is a critical determinant of acenocoumarol dose requirements. These findings support the inclusion of renal function in future acenocoumarol dose calculators and emphasize the importance of individualized dosing strategies.
Amyotrophic lateral sclerosis rehabilitation management and non-pharmacological symptomatic treatment: A review.
Shan Y, Jing W, Zhang H … +4 more , Liu Y, Wei S, Wu F, Pan W
Int J Clin Pharmacol Ther · 2026 Jan · PMID 41065069 · Publisher ↗
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 a...
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.
The Enhanced Games with doping permitted and Hulk Hogan.
Woodcock-Kloberdanz BG
Int J Clin Pharmacol Ther · 2025 Nov · PMID 41058603 · Publisher ↗
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Association of antibiotic treatment for second-trimester GBS with reduced miscarriage risk: Probiotic intervention shows no benefit.
Guo ML, Chen YN, Fang JH … +1 more , Qi WH
Int J Clin Pharmacol Ther · 2025 Dec · PMID 40964782 · Publisher ↗
OBJECTIVE: To investigate the colonization rate of group B (GBS) during the second trimester of pregnancy, the correlation between GBS infection and miscarriage as well as the impact of intervention on pregnancy outcome...
OBJECTIVE: To investigate the colonization rate of group B (GBS) during the second trimester of pregnancy, the correlation between GBS infection and miscarriage as well as the impact of intervention on pregnancy outcomes. MATERIALS AND METHODS: 228 GBS-positive pregnant women at 14 - 28 weeks of gestation were divided into 3 groups according to their preferences to receive medical intervention: group A (antibiotic group, n = 54) received oral antibiotic, group B (probiotic group, n = 96) received oral probiotic, and group C (non-intervention group, n = 78) received no drug treatment. 300 GBS-negative pregnant women were selected voluntarily and randomly as the control group (group D). The incidence of miscarriage-related conditions, negative conversion rate of GBS were compared between the 4 groups. Perinatal outcomes were compared between the GBS persistent positive and negative groups. RESULTS: GBS colonization rate was 14.7%. The incidence of threatened miscarriage and miscarriage in group A were 1.85 and 1.85%, both of which were lower than those in group B at 21.9 and 6.3%, and group C at 33.3 and 7.7%, with all differences being statistically significant (p < 0.05). The incidence of threatened miscarriage and miscarriage in group B and group C were significantly higher than those in group D at 3.3 and 2.7% (p < 0.05). The negative conversion rate of GBS in group A was significantly higher than that in group C (14.8 vs. 2.7%, p < 0.05). There was a difference in the incidence of fetal distress, premature delivery, premature rupture of the fetal membrane, chorioamnionitis, and neonatal infection between the continuously positive and negative pregnant women (p < 0.05). CONCLUSION: GBS colonization rate was 14.7% in the second trimester of pregnancy. GBS infection can increase the risk of threatened miscarriage and miscarriage as well as the risk of adverse pregnancy outcomes. Early intervention with antibiotics can increase the negative conversion rate of GBS, reduce the incidence of threatened miscarriage and miscarriage, and ameliorate the adverse outcome of pregnancy. The effect of probiotic intervention on the negative conversion of GBS was insignificant.
Analgesia using sufentanil and sufentanil plus dexmedetomidine following cesarean section and effect on placental hypoxia-inducible factors.
Lv X, Lin X, Ma L
Int J Clin Pharmacol Ther · 2025 Dec · PMID 40964781 · Publisher ↗
OBJECTIVE: To investigate the analgesic effect of sufentanil plus dexmedetomidine following cesarean section and to determine its influence on placental hypoxia-inducible factors. MATERIALS AND METHODS: A cohort of 150 p...
OBJECTIVE: To investigate the analgesic effect of sufentanil plus dexmedetomidine following cesarean section and to determine its influence on placental hypoxia-inducible factors. MATERIALS AND METHODS: A cohort of 150 puerperae who underwent prenatal examinations and cesarean section in our hospital were randomized into a control group (n = 75) and a study group (n = 75). Anesthesia and analgesia were carried out using sufentanil alone in the control group and sufentanil plus dexmedetomidine in the study group. Measurements were made before anesthesia (T0), 5 minutes (T1) and 10 minutes (T2) after anesthesia, and immediately after delivery (T3) and after the end of surgery (T4). RESULTS: Mean arterial pressure (MAP) and heart rate (HR) decreased in both groups at T1 - T4 compared with T0, but were higher in the study group compared to the control group (p < 0.05). The visual analogue scale (VAS) score, and levels of substance P (SP), neuropeptide Y (NPY) and malondialdehyde (MDA) in the study group were lower than those in the control group (p < 0.05). The beginning and duration of labor and the dose of analgesics within the 48-hour observation period were all lower in the study group compared to the control group (p < 0.05). CONCLUSION: Sufentanil plus dexmedetomidine can effectively maintain hemodynamic stability during cesarean section without marked changes in placental hypoxia-inducible factors and oxidative stress responses and has a limiting effect on the secretion of pain mediators.
Ocrelizumab use before pregnancy and neonatal B-cell depletion: A case report.
Eleftheriou G, Sangiovanni A, Butera R … +6 more , Gallo M, Giampreti A, Faraoni L, Cirronis M, Contessa MG, Bacis G
Int J Clin Pharmacol Ther · 2025 Dec · PMID 40905577 · Publisher ↗
Ocrelizumab is a recombinant humanized IgG1 monoclonal antibody that depletes B lymphocytes by binding their surface antigen CD20 and is approved for the relapsing forms of multiple sclerosis (MS). Several studies report...
Ocrelizumab is a recombinant humanized IgG1 monoclonal antibody that depletes B lymphocytes by binding their surface antigen CD20 and is approved for the relapsing forms of multiple sclerosis (MS). Several studies report that in utero exposure to ocrelizumab is not associated with an increased risk of malformations, and very few cases of neonatal B-cell count depletion are described after therapy ending shortly before conception or during early pregnancy. We report the first case of transient and complete neonatal B-cell depletion, while conception took place 3 months after the last administration.
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.
Baykara B, Bedir Demirdag T, Ozpinar S … +2 more , Polat M, Tapisiz A
Int J Clin Pharmacol Ther · 2026 Feb · PMID 40888215 · Publisher ↗
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Empagliflozin and hydralazine-isosorbide dinitrate combination therapy improves outcomes in Black patients with heart failure.
Baskaran P, Aldhaeefi M, Asaadi A … +4 more , Jones M, King E, Rungkitwattanakul D, Wingate L
Int J Clin Pharmacol Ther · 2025 Nov · PMID 40888214 · Publisher ↗
BACKGROUND: Black patients experience a disproportionately high incidence of heart failure with reduced ejection fraction (HFrEF), where vasodilators serve as a key therapeutic strategy. MATERIALS AND METHODS: A retrospe...
BACKGROUND: Black patients experience a disproportionately high incidence of heart failure with reduced ejection fraction (HFrEF), where vasodilators serve as a key therapeutic strategy. MATERIALS AND METHODS: 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). RESULTS: 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. CONCLUSION: Empa + H-ISDN offered superior benefits in Black patients with HFrEF, possibly by reducing oxidative stress and enhancing nitric oxide (NO) bioavailability.
Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024).
Gu B, Lv B, Tang J
Int J Clin Pharmacol Ther · 2025 Nov · PMID 40888213 · Publisher ↗
OBJECTIVE: Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin rem...
OBJECTIVE: Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin remain limited. This study analyzes voclosporin-associated AEs using FDA Adverse Event Reporting System (FAERS) data. MATERIALS AND METHODS: AEs with voclosporin as the primary suspected (PS) drug were extracted from the FAERS database, covering the period from the first quarter of 2021 to the second quarter of 2024. Disproportionality analysis, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was used to analyze AE signals. RESULTS: We identified 3,785 reports of AEs associated with voclosporin as PS, encompassing a total of 10,795 AEs. After applying 4 disproportionality algorithms, 6 system organ classes (SOCs) and 88 preferred terms (PTs) were detected, respectively. AEs with the strongest signal intensities included: glomerular filtration rate decreased, urine protein/creatinine ratio increased, hypertension, diarrhea, headache, and blood potassium increased. The median onset time for AEs was 56 days (interquartile range 4 - 208 days), with ~ 43% of AEs occurring within the first month of commencing voclosporin therapy. CONCLUSION: Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug's labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information.
Expression of the genes QPRT, RAB26, and SRPRB in cancer tissue from patients with triple-negative breast cancer as a biomarker for diagnosis, pharmacotherapy strategy, and survival: Evidence from bioinformatic database analysis.
Liu Y, Zeng Y
Int J Clin Pharmacol Ther · 2025 Dec · PMID 40888212 · Publisher ↗
OBJECTIVE: To screen differentially expressed genes (DEGs) in triple-negative breast cancer (TNBC) by bioinformatic methods and explore their relationship between TNBC prognosis and related biological functions. MATERIAL...
OBJECTIVE: To screen differentially expressed genes (DEGs) in triple-negative breast cancer (TNBC) by bioinformatic methods and explore their relationship between TNBC prognosis and related biological functions. MATERIALS AND METHODS: Microarray dataset GSE65194 was downloaded from Gene Expression Omnibus (GEO) database. The whole TNBC-related datasets were downloaded from The Cancer Genome Atlas (TCGA) database. After screening DEGs in R software, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses were performed to predict the function of these DEGs. The survival curve examination of the DEGs was performed based on TCGA database and Kaplan-Meier plotter website. In addition, the gene-drug interaction network was explored using the Comparative Toxicogenomics Database (CTD). RESULTS: A total of 2,496 up-regulated and 142 down-regulated DEGs were revealed in GEO database and TCGA database simultaneously. The GO and KEGG analysis revealed enrichment in regulation of nucleobase, nucleoside, nucleic acid metabolism, DNA binding, and integrin family cell surface interactions. Furthermore, up-regulation of quinolinate phosphoribosyl transferase (), member RAS oncogene family (), and SRP receptor subunit beta () were significantly associated with survival in TNBC patients. CONCLUSION: , , and may be three potential novel prognostic biomarkers for TNBC and will provide potential guidance value for future research on TNBC.
Drug interactions in hospitalized patients: Critical importance of renal disease and drug monitoring based on data from hospital departments of internal medicine in Serbia.
Drndarević A, Draganov I, Kovačević M … +5 more , Vuksanović M, Janković A, Kalaba A, Miljković B, Vezmar Kovačević S
Int J Clin Pharmacol Ther · 2025 Nov · PMID 40888211 · Publisher ↗
INTRODUCTION: Drug-drug interactions (DDIs) have been associated with adverse drug reactions (ADRs) which can cause hospitalization. The aim of this study was to associate potential DDIs (pDDIs) with potential ADRs upon...
INTRODUCTION: Drug-drug interactions (DDIs) have been associated with adverse drug reactions (ADRs) which can cause hospitalization. The aim of this study was to associate potential DDIs (pDDIs) with potential ADRs upon admission to hospital among patients on five internal medicine wards. MATERIALS AND METHODS: A cross-sectional study was performed on the cardiology, nephrology, endocrinology, gastroenterology, and geriatrics ward. The patients' sociodemographic characteristics, medical history, clinical and laboratory parameters were recorded. RESULTS: In total, 474 patients participated in the study. The mean age was 69.7 ± 12.8 years. We identified 1,949 pDDIs in 389 patients (82.1%), with an average of 5.0 ± 4.7 (range 1 - 34). angiotensin-converting enzyme inhibitors, loop diuretics, aspirin, and β-blockers were most frequently involved in DDIs, and the most common possible adverse outcomes were renal failure, decreased blood pressure, bleeding, and hypoglycemia. Asthma/chronic obstructive pulmonary disease, heart failure, nephrology ward, number of medications, acute myocardial infarction and diabetes were predictive for clinically relevant pDDIs. Elevated urea and serum creatinine levels were associated with pDDIs resulting in possible renal failure. Anticoagulants were associated with Prothrombin time-international normalized ratio levels >3 (6.23; 3.80 - 10.21; p < 0.001), whereas the presence of pDDIs leading to clopidogrel inefficacy was associated with elevated troponin levels (OR 4.03; 1.96 - 8.27; p < 0.001). CONCLUSION: We associated comorbidities with different classes of clinically significant pDDIs and possible outcomes such as renal failure, bleeding, and clopidogrel inefficacy with appropriate laboratory parameters outside the reference range. The pDDI-associated inefficacy of clopidogrel may have caused patient hospitalization due to reinfarction.
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.
Parrot M, Cave J, Pelaez MJ … +3 more , Ghandehari H, Dogra P, Yellepeddi V
Int J Clin Pharmacol Ther · 2025 Dec · PMID 40833045 · Full text
OBJECTIVES: 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, po...
OBJECTIVES: 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. MATERIALS AND METHODS: 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. 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. RESULTS: 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. CONCLUSION: 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.
Epithelial-mesenchymal transition biomarkers in patients with acute exacerbation of COPD are indicative of disease severity, disease progression, and risk of readmission.
Chou X, Zhang Q, Li Y … +4 more , Qiu X, Sha Q, Gu Y, Jiang D
Int J Clin Pharmacol Ther · 2025 Nov · PMID 40833044 · Publisher ↗
AIMS: 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 pulmon...
AIMS: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Exogenous insulin antibody syndrome in type 2 diabetes with diabetic ketoacidosis: A case report and literature review.
Xu M, Xia L, Xiao R … +1 more , Deng D
Int J Clin Pharmacol Ther · 2025 Nov · PMID 40776672 · Publisher ↗
BACKGROUND: 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 exp...
BACKGROUND: 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. CASE REPORT: 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. CONCLUSION: 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.
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