International Journal Of Clinical Pharmacology And Therapeutics[JOURNAL]
Sun
200 papers
Methotrexate and folic acid supplementation in rheumatoid arthritis: A Japanese claims database and 538,985 patients from April 2015 to November 2020.
Takabatake K, Takeda M, Nakamura M … +5 more , Kawabe K, Hanaoka S, Hayashi H, Sahashi Y, Ooba N
Int J Clin Pharmacol Ther · 2026 Jul · PMID 42390075 · Publisher ↗
OBJECTIVES: To assess the use of laboratory monitoring, folic acid supplementation, and folinate calcium therapy in patients with rheumatoid arthritis (RA) receiving first-line methotrexate (MTX) according to the 2019 Ja...
OBJECTIVES: To assess the use of laboratory monitoring, folic acid supplementation, and folinate calcium therapy in patients with rheumatoid arthritis (RA) receiving first-line methotrexate (MTX) according to the 2019 Japan College of Rheumatology safety updates and using a large Japanese claims database (DeSC). MATERIALS AND METHODS: Patient data for the period 2015 - 2020 were retrieved from the database, and patients were identified who had presented with active disease. The number of patients commencing with MTX treatment and receiving concomitant disease-modifying antirheumatic drug and folic acid supplementation were determined together with information on recommended laboratory testing (blood tests, serum creatinine, chest radiography, and KL-6) in the year prior to MTX initiation. The impact of the 2019 Japan College of Rheumatology guidelines was assessed by comparing the extent of folic acid supplementation before and after publication of the guidelines. RESULTS: Of the 1,574 patients identified with active RA, 919 (58.4%) started MTX. Folic acid was co-administered in 85.1% of MTX users, with no significant change in supplementation rates before and after the introduction of the 2019 guidelines (81.8 vs. 82.2%, p = 0.56), indicating that these safety protocols were already well-established. Baseline blood tests were carried out in 99.8% and chest radiography in 69.2% of patients. After commencing MTX treatment, the monitoring of serum creatinine (87.2 vs. 93.7%, p < 0.05) and KL-6 (15.2 vs. 28.4%, p < 0.05) increased significantly. The frequency of chest radiography decreased to 56.0% (p < 0.05), reflecting a shift toward more sensitive diagnostic tools in clinical practice. No patients required folinate calcium rescue therapy. CONCLUSION: MTX prescribing and monitoring in RA is generally carried out in accordance with clinical guidelines. Although folic acid supplementation is recommended and widely implemented, ~ 20% of patients do not receive it. Monitoring is generally carried out rigorously, but safety data indicate that these measures should receive more attention in high-risk elderly populations who were probably under-represented in this study.
Cardiac arrest in an adolescent following an overdose of antidepressants comprising sertraline, quetiapine fumarate, and lamotrigine: Case report.
Zheng L, Zhang L, Wang F … +3 more , Jiang Y, Lv F, Li G
Int J Clin Pharmacol Ther · 2026 Jul · PMID 42390074 · Publisher ↗
Antidepressant overdose is a prevalent method of self-harm in patients with depression including bipolar disorder. According to the published literature, typical adverse effects are seizures, prolonged QT intervals, and...
Antidepressant overdose is a prevalent method of self-harm in patients with depression including bipolar disorder. According to the published literature, typical adverse effects are seizures, prolonged QT intervals, and arrhythmias, with cardiotoxicity primarily observed in adults. This paper reports the first documented case of an 11-year-old adolescent with depression who ingested a massive overdose comprising sertraline (60 tablets at 50 mg, giving a total dose of 3 g), quetiapine fumarate (50 tablets at 100 mg giving a total dose of 5 g) and lamotrigine (120 tablets at 25 mg giving a total dose of 3 g). At ~ 4 hours post ingestion, the patient developed hypoxemia, hypotension, persistent seizures, resulting in cardiac arrest. This case report offers critical insights into the clinical management of such cases involving pediatric populations.
Recombinant human growth hormone in pediatric patients using the FAERS database: Safety profile and update for the period 2004 - 2024.
Tu L, Jiang H, Liu J … +4 more , Lin Y, Wang S, Tu Y, Hong Q
Int J Clin Pharmacol Ther · 2026 Jul · PMID 42390073 · Publisher ↗
OBJECTIVE: To investigate safety signals associated with recombinant human growth hormone (rhGH) using the FDA Adverse Event Reporting System (FAERS) and make recommendations for its application. BACKGROUND: rhGH is wide...
OBJECTIVE: To investigate safety signals associated with recombinant human growth hormone (rhGH) using the FDA Adverse Event Reporting System (FAERS) and make recommendations for its application. BACKGROUND: rhGH is widely used in the management of pediatric growth disorders, but a comprehensive evaluation of its safety in pediatric populations is limited. MATERIALS AND METHODS: Adverse event (AE) reports involving patients under 18 years of age where rhGH was the primary suspect (PS) drug were retrieved from the FAERS database for the period beginning the first quarter of 2004 to the end of the third quarter of 2024. The reports were standardized and duplicate reports removed. Disproportionality analysis of AE signals was conducted using four complementary methods, namely i) reporting odds ratio (ROR), ii) proportional reporting ratio (PRR), iii) Bayesian confidence propagation neural network (BCPNN), and iv) empirical Bayesian geometric mean (EBGM). RESULTS: A total of 33,888 AE reports were retrieved and analyzed. Disproportionality analysis identified 167 positive signals across 19 System Organ Classes (SOCs), the most frequently of which was "Investigations," and the most common preferred term (PT) was "Arthralgia". In addition to confirmed AEs, several endocrine-related signals were also recognized including a) fluctuations in thyroid-stimulating hormone, b) increase in unbound concentrations of thyroxine, c) type 1 diabetes mellitus, d) low concentrations of high-density lipoprotein, and e) abnormal body odor. CONCLUSION: A comprehensive safety profile was established for rhGH when used in pediatric populations and comprising several newly identified potential AE signals. The findings underscore the importance of surveillance to mitigate risks and ensure the safe clinical use of rhGH.
The triple neuromodulatory-immunomodulatory axis.
Woodcock-Kloberdanz BG
Int J Clin Pharmacol Ther · 2026 Jun · PMID 42376906 · Publisher ↗
Abstract loading — click title to view on PubMed.
Novel intravenous human IVIG in patients with secondary immunodeficiency: Interim analysis of a multicenter, prospective, non-interventional study.
Bauhofer A, Aigner S, Borte S
Int J Clin Pharmacol Ther · 2026 Jun · PMID 42290269 · Publisher ↗
OBJECTIVE: To evaluate the effectiveness, safety, and tolerability of Yimmug, a novel, highly purified, 10% human plasma-based intravenous immunoglobulin (IVIG) preparation, in patients with secondary immunodeficiency (S...
OBJECTIVE: To evaluate the effectiveness, safety, and tolerability of Yimmug, a novel, highly purified, 10% human plasma-based intravenous immunoglobulin (IVIG) preparation, in patients with secondary immunodeficiency (SID) under real-world conditions. MATERIALS AND METHODS: This interim analysis is based on data from a multicenter, prospective, non-interventional study conducted with out-patients in Germany. Effectiveness was assessed by changes in (i) serum IgG levels, (ii) severe infection rates, (iii) clinical symptoms, and (iv) patient-reported quality of life (QoL) at three treatment intervals (after 3, 12, and 24 IVIG infusions) compared to baseline. Safety was evaluated through documentation of adverse events (AEs), including adverse drug reactions (ADRs), while tolerability was assessed by investigators. RESULTS: A total of 119 SID patients received 726 IVIG infusions at a median (IQR) dose of 0.3 (0.2 - 0.3) g/kg over a median (IQR) duration of 1.4 (0.4 - 2.9) years, with a median interval of 30.1 days between infusions. Serum IgG trough levels increased, with the proportion of patients achieving IgG ≥ 6 g/L rising from 30.3% at baseline to 66.7% after both 12 and 24 infusions. The mean annual rate of infections requiring antibiotics decreased from 2.3 at baseline to 0.0 after 3 and 12, and to 0.4 after 24 infusions, respectively. The new IVIG was well tolerated, and patients' clinical symptoms and QoL improved during treatment. AEs were reported in 20 (16.8%) patients, with 41 events in total, while ADRs occurred in 9 (7.6%) patients, with 16 events. Serious AEs (SAEs) occurred in 4 (3.4%) patients, involving 5 events, but no serious ADRs (SADRs) were reported. CONCLUSION: This interim analysis shows that the risks are minor compared to the benefits of this novel IVIG preparation in the management of SID.
Network meta-analysis of bisphosphonates in the treatment of bone metastases from breast cancer.
Zhang LW, Huang A, Ma HF … +1 more , Shen J
Int J Clin Pharmacol Ther · 2026 Jun · PMID 42290268 · Publisher ↗
OBJECTIVE: Through a network meta-analysis, this study aimed to systematically evaluate the efficacy and safety of bisphosphonates in reducing skeletal-related events in patients with bone metastases from breast cancer,...
OBJECTIVE: Through a network meta-analysis, this study aimed to systematically evaluate the efficacy and safety of bisphosphonates in reducing skeletal-related events in patients with bone metastases from breast cancer, providing clinical guidance for treatment selection. MATERIALS AND METHODS: Randomized controlled trials (RCTs) on bisphosphonate therapy for bone metastases in breast cancer were retrieved from PubMed, Cochrane, and Embase databases from inception to January 2025. Statistical analyses were performed using Stata software. RESULTS: 22 studies involving 14,934 patients were included. The bisphosphonates evaluated were pamidronate, zoledronate, clodronate, and ibandronate. Regarding the reduction of pathological fractures, the efficacy ranking was clodronate > ibandronate > pamidronate > zoledronate. Significant differences were found between clodronate and pamidronate (OR = -1.41, 95% CI: -2.78 to -0.04) and between clodronate and zoledronate (OR = -1.44, 95% CI: -2.85 to -0.04). For hypercalcemia reduction, zoledronate was more effective than clodronate and pamidronate, though differences were not statistically significant (p > 0.05). In terms of safety, ibandronate showed fewer adverse reactions than clodronate and zoledronate, with a significant difference between ibandronate and zoledronate (OR = -1.14, 95% CI: -1.99 to -0.28). CONCLUSION: Clodronate was most effective in reducing pathological fractures, zoledronate was superior in controlling hypercalcemia, and ibandronate demonstrated the best safety profile. Further clinical studies are warranted to clarify the comparative advantages of each bisphosphonate and support individualized treatment decisions.
Pharmacokinetic and bioequivalence study of apremilast tablets in healthy Chinese subjects under fasting and fed conditions.
Lu P, Yao F, Wang J … +4 more , He Y, Liang J, Zhai X, Liu G
Int J Clin Pharmacol Ther · 2026 Jun · PMID 42290267 · Publisher ↗
Apremilast is a pioneering oral selective phosphodiesterase-4 inhibitor for the treatment of psoriasis. To evaluate and compare the pharmacokinetic properties and bioavailability of apremilast tablets manufactured by Nan...
Apremilast is a pioneering oral selective phosphodiesterase-4 inhibitor for the treatment of psoriasis. To evaluate and compare the pharmacokinetic properties and bioavailability of apremilast tablets manufactured by Nanjing Haijing Pharmaceutical Company (Nanjing, China) with apremilast tablets certified by Celgene Europe B.V. (Utrecht, The Netherlands), we conducted a randomized, open-label, single-dose, two-period, crossover study in healthy Chinese subjects under fasted and fed conditions. Eligible subjects were randomly assigned to receive reference or test apremilast tablets in the first treatment period and the other formulation in the second period. Serial blood samples were collected for pharmacokinetic analysis. Adverse events were recorded. A total of 28 healthy subjects were enrolled in the fasting cohort and 36 subjects in the fed cohort. The 90% confidence intervals of the geometric mean ratios of the test to reference formulations were 91.56 - 106.18% for C, 96.08 - 108.18% for AUC, and 96.02 - 107.67% for AUC in the fasting cohort, and 95.15 - 107.05% for C, 105.13 - 113.45% for AUC, and 104.80 - 111.91% for AUCin the fed cohort, all of which were within the bioequivalence range of 80.00 - 125.00%. There were no serious adverse events. The results showed that the test and reference apremilast tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions.
Pirfenidone and nintedanib in fibrosing interstitial lung disease: A retrospective study based on a regional university hospital data registry and literature review.
Sans-Pola C, Boy R, Villar A … +6 more , Ojanguren I, Simeón-Aznar CP, Guillen-Del-Castillo A, Vancells G, Agustí A, Danés I
Int J Clin Pharmacol Ther · 2026 Jun · PMID 42233448 · Publisher ↗
AIMS: To evaluate the effectiveness and tolerability of pirfenidone and nintedanib in idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. MATERIALS AND METHODS: The study was retrospective and monocentr...
AIMS: To evaluate the effectiveness and tolerability of pirfenidone and nintedanib in idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. MATERIALS AND METHODS: The study was retrospective and monocentric based on patients treated between 2015 and 2020 at the Vall d'Hebron University Hospital, the largest public hospital complex in Catalonia, Spain. Effectiveness and tolerability, including the relative change in forced vital capacity (FVC) assessed at 12 months, were evaluated using data for patients with interstitial lung disease retrieved from a registry and the medical records. RESULTS: Antifibrotics were administered to 55 patients: 34 (61.8%) with IPF, 14 (25.5%) with progressive pulmonary fibrosis (PPF), 5 (9.1%) with systemic sclerosis-associated interstitial lung disease (SSc-ILD), and 2 (3.6%) with post-COVID-19 fibrosis. Median age was 69.9 years; 78.2% were male. The median duration of nintedanib and pirfenidone treatment at study end was 12.1 (interquartile range (IQR) 6.9 - 22.8) and 27.6 months (IQR 10.4 - 58.7), respectively. Treatment was discontinued due to toxicity in 48.5% of patients treated with nintedanib and 18.2% of those treated with pirfenidone. At 1 year, 62% of patients with IPF, 64% of those with PPF, and all patients with SSc-ILD were still receiving antifibrotic therapy, and the median change from baseline in FVC was -2% (IQR from -7.1 to 7.2), -9.9% (from -25.4 to -1.6), and -3.3% (from -18.7 to 16.3), respectively. CONCLUSION: Antifibrotic therapy using pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis provides significant stabilization of the disease measured using the change in FVC at 12 months. Treatment withdrawal was mostly attributable to poor tolerance to nintedanib.
Prolonged cholinergic toxidrome with markedly low cholinesterase activity after exposure to emamectin benzoate emulsion: A case report.
Chubachi H, Kitazume N, Momo K … +1 more , Kamagata H
Int J Clin Pharmacol Ther · 2026 May · PMID 42210851 · Publisher ↗
Emamectin benzoate emulsion is a macrocyclic lactone insecticide that is not classified as an organophosphate or carbamate. We report the case of a man in his 80s with chronic kidney disease and cardiovascular comorbidit...
Emamectin benzoate emulsion is a macrocyclic lactone insecticide that is not classified as an organophosphate or carbamate. We report the case of a man in his 80s with chronic kidney disease and cardiovascular comorbidities who ingested emamectin benzoate emulsion. On day 2, he presented with abdominal pain, diarrhea, and marked sialorrhea; his vital signs were stable; however, his serum cholinesterase (ChE) had markedly declined (18 U/L). The patient was discharged with supportive care. From day 3, watery diarrhea recurred and neurobehavioral symptoms progressed. On day 5, he presented with pinhole miosis and further ChE suppression (2 U/L). Therefore, atropine was administered, and the patient was transferred for close monitoring. After discharge (day 8), miosis and sialorrhea persisted, and ChE remained low for weeks. Findings suggestive of tubular injury were observed during follow-up. The patients' symptoms resolved gradually, with ChE partially recovering by days 75 - 95. This case underscores the need for serial reassessment and structured follow-up after pesticide exposure, even when the patient appears stable at the initial presentation.
Pharmacokinetic evaluation of two oral formulations of chlorpromazine in healthy subjects.
Min HJ, Hwang JG, Choi YS … +1 more , Park MK
Int J Clin Pharmacol Ther · 2026 May · PMID 42163632 · Publisher ↗
Chlorpromazine is a first-generation antipsychotic agent that exerts its therapeutic effects primarily by antagonizing dopamine D2 receptors. This randomized, open-label, single-dose, two-period, two-sequence crossover s...
Chlorpromazine is a first-generation antipsychotic agent that exerts its therapeutic effects primarily by antagonizing dopamine D2 receptors. This randomized, open-label, single-dose, two-period, two-sequence crossover study was conducted to evaluate the pharmacokinetic bioequivalence of two oral formulations of chlorpromazine 100 mg: Neomazine tablets (Whan In Pharmaceutical Co., Ltd.) and Chlorpromazine HCl tablets (Myung In Pharmaceutical Co., Ltd.). A total of 70 subjects were randomized, and 61 completed both treatment periods. Blood samples were collected at predefined intervals up to 72 hours post dose to assess pharmacokinetic parameters, including maximum plasma concentration (C) and the area under the plasma concentration-time curve to the last measurable concentration (AUC). Safety was assessed through monitoring of adverse events (AEs), clinical laboratory tests, vital signs, physical examinations, and 12-lead electrocardiograms. The geometric mean ratios (90% confidence intervals) for C and AUC were 1.0490 (0.9534 - 1.1542) and 0.9941 (0.9261 - 1.0671), respectively, falling within the accepted bioequivalence range of 0.80 - 1.25. Among the 70 subjects who received at least 1 dose, 116 AEs were reported in 48 individuals; all were mild in intensity and resolved without sequelae, and no serious AEs occurred. These findings confirm the pharmacokinetic bioequivalence and favorable tolerability of the two formulations under fasting conditions in healthy adults and support the use of Neomazine as a therapeutically equivalent and clinically interchangeable alternative to Chlorpromazine HCl.
Development of a pain intensity estimation model in breast cancer survivors using quantile regression: A nationwide claims-based cohort study.
Lee J, Chan A, Cho J … +1 more , Seo HJ
Int J Clin Pharmacol Ther · 2026 May · PMID 42163631 · Publisher ↗
OBJECTIVE: In patients in whom pain cannot be objectively evaluated, achieving high compliance with symptom management is challenging. This study aimed to estimate pain-related factors and pain intensity in patients with...
OBJECTIVE: In patients in whom pain cannot be objectively evaluated, achieving high compliance with symptom management is challenging. This study aimed to estimate pain-related factors and pain intensity in patients with breast cancer according to prescription history of analgesics. MATERIALS AND METHODS: Pain intensity was rated according to low, moderate, and high cumulative analgesic consumption score (CACS). CACS-based quantile regression analysis was performed considering sociodemographic (age, income, and disease duration), index-related (body mass index (BMI) and Charlson Comorbidity Index (CCI)), and surgery- and treatment-related variables. RESULTS: In the mild pain group (Q1), age (≥ 50 years; β = 0.5803) and BMI (≥ 25; β = 0.7062) -affected the pain estimate. In the moderate-pain group (Q2), age (≥ 50 years; β = 1.0380), BMI (≥ 25; β = 0.9011), CCI (≥ 3; β = 0.6106) and radiation therapy (yes; β = 0.5652) affected pain intensity. In the severe-pain group (Q4), age (≥ 50 years; β = 7.002), BMI (≥ 25; β = 6.2800), CCI (≥ 3; β = 3.4480), lymph node dissection (yes; β = 2.4420), and lymphedema (yes; β = 4.6580) affected pain estimate. CONCLUSION: Among patients with breast cancer, older age, longer disease duration, higher BMI and CCI, prior lymph node dissection, and lymphedema presence may contribute to more severe pain symptoms. These findings may pave the way for the development of preemptive pain intervention for patients with breast cancer.
Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is effective and safe in the treatment of hyperlipidemia in chronic kidney disease stage 3 - 4.
Zhu H, Chang Y, Jin Q
Int J Clin Pharmacol Ther · 2026 May · PMID 42112700 · Publisher ↗
AIMS: To evaluate the efficacy and safety of evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in chronic kidney disease (CKD). BACKGROUND: Dyslipidemia is common in patients with CKD and con...
AIMS: To evaluate the efficacy and safety of evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in chronic kidney disease (CKD). BACKGROUND: Dyslipidemia is common in patients with CKD and contributes to their elevated cardiovascular risk. However, evidence regarding the lipid-lowering efficacy and renal safety of PCSK9 inhibitors in CKD stages 3 - 4 is limited. MATERIALS AND METHODS: A cohort of 200 patients with stage 3 - 4 CKD and hyperlipidemia were administered evolocumab in a single-center retrospective study. Lipid parameters including low-density lipoprotein cholesterol (LDL-C), renal function (estimated glomerular filtration rate, serum creatinine, blood urea nitrogen), and liver enzymes were assessed at baseline and at 3, 6, and 12 months follow-up. Subgroup and multivariate analyses were performed to determine factors associated with LDL-C reduction. Publicly available transcriptomic resources were consulted to provide biological parameters regarding tissue-specific PCSK9 expression. RESULTS: After 12 months, LDL-C was significantly decreased (-56.3 ± 10.5%) compared to baseline where the reduction in stages 3 and stage 4 CKD were similar. Non-high-density lipoprotein (HDL-C) and total cholesterol also declined significantly, but here were no significant changes in HDL-C and triglycerides. Renal function showed no significant deterioration, and no hepatotoxicity or clinically significant adverse events occurred. Baseline LDL-C and age were independent predictors of LDL-C reduction. Public transcriptomic data indicated that PCSK9 expression is predominantly enriched in liver tissue but remains minimal in renal tissues and across major renal cell types, providing biological evidence to explain the preserved renal function observed in this cohort. CONCLUSION: Evolocumab is an effective agent for lowering LDL-C levels and has a satisfactory short-term renal and hepatic safety in this cohort with similar effects across CKD subgroups. The low renal expression of PCSK9 may partly explain its renal safety. These results support the use of evolocumab as a practical and well-tolerated lipid-lowering option for CKD patients who need intensive LDL-C control.
Fondaparinux to treat cerebral venous sinus thrombosis complicated by heparin-induced thrombocytopenia during puerperium: A case report and literature review.
Qi M, Feng X, Jiang L … +5 more , Wu C, Zhang X, Guo P, Wang N, Xu Y
Int J Clin Pharmacol Ther · 2026 May · PMID 42112699 · Publisher ↗
BACKGROUND: Cerebral venous sinus thrombosis (CVST) occurring during the puerperium is a rare yet life-threatening condition. The management of CVST becomes more complex when complicated by heparin-induced thrombocytopen...
BACKGROUND: Cerebral venous sinus thrombosis (CVST) occurring during the puerperium is a rare yet life-threatening condition. The management of CVST becomes more complex when complicated by heparin-induced thrombocytopenia (HIT), a prothrombotic adverse effect of heparin therapy. CASE PRESENTATION: A case of puerperium-associated CVST with HIT is presented, in which fondaparinux was utilized as an alternative anticoagulant during the acute phase, followed by rivaroxaban. A multidisciplinary approach was employed, which included hematoma drainage, decompressive craniectomy, and endovascular recanalization. The patient achieved a favorable outcome, with a modified Rankin scale score of 2 at the 3-month follow-up. CONCLUSION: This case highlights the potential safety and efficacy of fondaparinux in the management of CVST with HIT, emphasizing the critical role of a multidisciplinary approach in optimizing patient recovery.
Timing of antimicrobial stewardship intervention and mortality among patients admitted to intensive care unit.
Takuma A, Miura A, Tagami K … +1 more , Momo K
Int J Clin Pharmacol Ther · 2026 May · PMID 42112698 · Publisher ↗
OBJECTIVES: Antimicrobial stewardship is important in the intensive care unit (ICU), where critically ill patients are managed. Herein, we aimed to evaluate the associations between the timing of antimicrobial stewardshi...
OBJECTIVES: Antimicrobial stewardship is important in the intensive care unit (ICU), where critically ill patients are managed. Herein, we aimed to evaluate the associations between the timing of antimicrobial stewardship team (AST) interventions in the ICU and patient mortality and to identify the optimal timing of interventions to improve patient survival. MATERIALS AND METHODS: We retrospectively analyzed the data of patients admitted to the ICU at Showa Medical University Northern Yokohama Hospital (April 2016 - March 2023). The primary outcome was in-hospital mortality; the key exposure was the timing of AST intervention following antimicrobial initiation. Mortality incidence rates per 100 person-days and age-adjusted incidence rate ratios were calculated. RESULTS: Overall, 94 patients were included. Earlier AST intervention after ICU admission was associated with the lowest mortality (incidence rate (IR): 0.205 (95% confidence interval (CI): 0 - 0.512) per 100 person-days). In an age-adjusted analysis, later intervention was associated with a higher mortality incidence rate than earlier intervention (IR ratio (IRR): 5.53 (95% CI: 1.30 - 23.50), p = 0.02). CONCLUSION: Earlier AST intervention after ICU admission was associated with lower mortality in ICU patients. Proactive and timely stewardship efforts are therefore needed in ICUs.
Dulaglutide-associated body odor with dechallenge and rechallenge in a patient with type 2 diabetes.
Marusic S, Staresinic M, Cigrovski Berkovic M
Int J Clin Pharmacol Ther · 2026 May · PMID 42087771 · Publisher ↗
OBJECTIVE: Although uncommon, medications may induce unpleasant body odor, potentially leading to psychosocial distress and reduced treatment adherence. To date, unpleasant body odor has not been recognized as an adverse...
OBJECTIVE: Although uncommon, medications may induce unpleasant body odor, potentially leading to psychosocial distress and reduced treatment adherence. To date, unpleasant body odor has not been recognized as an adverse effect of dulaglutide. We report a novel case of dulaglutide-associated body odor, confirmed by dechallenge and rechallenge. CASE REPORT: A 57-year-old man with a 6-year history of type 2 diabetes mellitus and hypertension was initiated on dulaglutide due to inadequate glycemic control and obesity. Two weeks after treatment initiation, an unpleasant body odor was noted by family members and colleagues. No changes in diet, hygiene practices, or concomitant medications were reported. Dermatological examination and extensive laboratory evaluation excluded infectious, metabolic, and endocrine causes. The odor resolved ~ 10 days after discontinuation of dulaglutide. Upon rechallenge, the odor recurred, confirming a causal relationship. Dulaglutide was permanently discontinued, and treatment was switched to semaglutide, after which the body odor did not recur and glycemic control improved. According to the Naranjo Adverse Drug Reaction Probability Scale, the association was classified as probable. CONCLUSION: This case highlights a rare and previously unreported adverse effect of dulaglutide. Although not medically serious, drug-induced body odor may substantially impair quality of life and treatment adherence.
Pharmocracy via MCC to de-prescribing: The attempted ascent and descent of Everest.
Woodcock-Kloberdanz BG
Int J Clin Pharmacol Ther · 2026 Jun · PMID 42087770 · Publisher ↗
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Gastrointestinal symptoms in Parkinson's disease treated in a controlled trial using traditional Chinese medicine (Jia-Wei-Ji-Chuan-Jian decoction) with network pharmacology analysis of active agents and mechanism of action.
Loong SK, Wu F, Liu Y … +5 more , Voratunyakit N, Wei S, Li W, Li R, Pan W
Int J Clin Pharmacol Ther · 2026 Jul · PMID 42084228 · Publisher ↗
BACKGROUND: Gastrointestinal symptoms in Parkinson's disease (PD), in particular chronic constipation, are common and are treated in China using the traditional Chinese medicine (Jia-Wei-Ji-Chuan-Jian decoction) (JWJCJ))...
BACKGROUND: Gastrointestinal symptoms in Parkinson's disease (PD), in particular chronic constipation, are common and are treated in China using the traditional Chinese medicine (Jia-Wei-Ji-Chuan-Jian decoction) (JWJCJ)). However, information on therapeutic targets and the underlying mechanism is limited. MATERIALS AND METHODS: A total of 72 PD patients with constipation attending Departments of Neurology in Shanghai, China (Shanghai Pudong New Area Gongli Hospital and Shuguang Hospital Affiliated to Shanghai University) were recruited into the study and allocated to a Treatment group (n = 36) and a Control group (n = 36). Patients in the Control group received a combination treatment comprising anti-Parkinson agents (Western drug regimen) with the addition of a traditional Chinese patent medicine (Huang-Xing Run-Chang Tablets*) over a period of 5 weeks, whereas patients in the Treatment group received the same anti-PD Western drug regimen together with the JWJCJ decoction, also for a period of 5 weeks. An evaluation using clinical efficacy scores was carried out together with network pharmacology analysis. Identified drug targets for JWJCJ using the traditional Chinese medicine Swiss Target Prediction database (TCMSP) and disease targets for chronic constipation in PD were obtained from Genecards and the OMIM database. Therapeutic targets for JWJCJ in the treatment of chronic constipation were identified by intersecting drug targets and disease targets. GO functional enrichment analysis, KEGG pathway analysis, and disease association analysis were carried out using the DAVID database and visualized using Cytoscape 3.9.1 software. RESULTS: CSS efficacy scores in the Treatment group were higher than that in the Control group (88.57 vs. 52.94%, p < 0.001). No significant differences were seen prior to treatment in the CSS, PDQ-39 and MDS-UPDRS scores and the corresponding total scores for the two groups. After treatment, CSS values for patients in the Treatment group were higher than values before treatment (p < 0.01). Network pharmacology analysis identified 172 active components, 9,542 drug targets, and 421 intersecting target genes for JWJCJ. PPI analysis identified 10 main and possibly key targets for JWJCJ in the treatment of chronic constipation. KEGG analysis identified 198 signaling pathways, where pathways in cancer, specific cancer pathways such as prostate cancer and non-small cell lung cancer, lipid and atherosclerosis, hepatitis B, and the AGE-RAGE signaling pathway in diabetic complications were among the pathways most significantly enriched. These findings are evidence that the active ingredients in JWJCJ in the treatment of chronic constipation in PD mainly target TP53, SRC, AKT1, PIK3R1, and PIK3CA. CONCLUSION: The efficacy of JWJCJ in treating chronic constipation in PD involves the targets SRC, PIK3R1, JUN, TP53, STAT3, PIK3CA, EGFR, ESR1, MAPK1, and AKT1 domains. These findings provide theoretical basis for the clinical application of JWJCJ decoction in the treatment of chronic constipation in PD.
Polypharmacy and hyperpolypharmacy in elderly (≥ 65 years) pacemaker recipients: Prevalence and association with frailty, physical activity, adherence, and healthcare utilization in a prospective single-center study.
Costa M, António N, Félix C … +6 more , Jordão I, Paiva P, Guimarães J, Fernandes D, Gonçalves L, Parente F
Int J Clin Pharmacol Ther · 2026 Jul · PMID 42057633 · Publisher ↗
OBJECTIVES: To quantify polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs) in pacemaker recipients aged ≥ 65 years and to assess associations with frailty (FRAIL), physical activity (IPAQ), medication adherence...
OBJECTIVES: To quantify polypharmacy (≥ 5 drugs) and hyperpolypharmacy (≥ 10 drugs) in pacemaker recipients aged ≥ 65 years and to assess associations with frailty (FRAIL), physical activity (IPAQ), medication adherence (MAT), and healthcare utilization over 6 months. BACKGROUND: Polypharmacy is common in elderly patients with cardiac devices, but prospective data from European pacemaker clinics on frailty, physical activity, adherence, and prescribing quality are limited. MATERIALS AND METHODS: Prospective, single-center observational study in a Portuguese tertiary pacemaker outpatient clinic (n = 104). Participants (≥ 65 years) were assessed at enrolment and at 3 and 6 months. FRAIL, IPAQ, and MAT were recorded at each timepoint. Healthcare utilization was defined as emergency department visits and/or hospital admissions. STOPP/START v3 was applied descriptively at 6 months. RESULTS: Mean age was 79.1 ± 7.5 years; 69.2% were men. Polypharmacy and hyperpolypharmacy were present in 49.0% and 38.5% at enrolment and 47.5% and 43.4% at 6 months. A higher number of chronic medications was associated with higher FRAIL scores, lower IPAQ scores and more frequent healthcare utilization, whereas MAT scores remained uniformly high. Cardiovascular drugs, diuretics, and proton-pump inhibitors (PPIs) were the most frequently used classes. STOPP/START identified potentially inappropriate medications (notably PPIs and benzodiazepines) and prescribing omissions according to START (notably cardiovascular therapies). CONCLUSION: Polypharmacy and hyperpolypharmacy are frequent and persistent in elderly pacemaker recipients and are associated with frailty, lower physical activity and higher healthcare utilization. Structured medication review during routine follow-up may help identify PIMs and PPOs and optimize pharmacotherapy.
Inflammatory cytokines, autoantibodies and salivary gland function in Sjögren's syndrome: Effects of T. wilfordii as Hook F medical wine and Tripterygium glycosides tablets.
Yu X, Chu P, Yu C … +1 more , Zhao L
Int J Clin Pharmacol Ther · 2026 Apr · PMID 42021716 · Publisher ↗
OBJECTIVE: This study was conceived to compare the clinical efficacy of Tripterygium wilfordii Hook F (TWHF) medical wine and Tripterygium glycoside tablets (TGTs) in patients with primary Sjögren's syndrome (pSS), mainl...
OBJECTIVE: This study was conceived to compare the clinical efficacy of Tripterygium wilfordii Hook F (TWHF) medical wine and Tripterygium glycoside tablets (TGTs) in patients with primary Sjögren's syndrome (pSS), mainly focusing on inflammatory markers, autoantibody profiles, and salivary gland function. MATERIALS AND METHODS: In this prospective, randomized controlled trial, 90 pSS patients were enrolled and randomly assigned into a TWHF medical wine group (Observation) or TGTs group (Control), receiving either TWHF medical wine (8 mL, twice daily) or TGTs (10 mg, 3 times daily) for 12 weeks. Primary outcomes included unstimulated whole saliva (UWS) flow rate, EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and positivity rates of anti-SSA/SSB antibodies. Secondary outcomes included subjective symptom scores (EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)), serum IgG levels, and safety profiles. RESULTS: Baseline characteristics were comparable between the two groups. After 12 weeks, the Observation group showed significantly greater improvements in UWS and ESSDAI scores. The positive rates of anti-SSA and anti-SSB had decreased in both groups, with a more pronounced decline observed in the observation group, though between-group differences were not statistically significant. ESSPRI scores and IgG levels were significantly reduced in both groups, with more pronounced changes in the Observation group. No severe adverse events occurred, and both treatments were well tolerated with comparable safety profiles. CONCLUSION: TWHF medical wine is more effective than TGTs in improving salivary gland function, systemic disease activity, and immunological profiles in pSS patients, with comparable safety. These results suggest that TWHF medical wine is a suitable alternative treatment for primary Sjögren's syndrome.
Prospects for solving difficulties in steroid withdrawal and management supplementing tranilast and roxithromycin in corticosteroid-dependent atopic dermatitis.
Horiuchi Y
Int J Clin Pharmacol Ther · 2026 Jul · PMID 41925113 · Publisher ↗
Intractable cases of atopic dermatitis often exhibit recurrent exacerbations, with the primary treatment being topical steroids. However, prolonged use of steroids can lead to steroid addiction or iatrogenic disease. Wit...
Intractable cases of atopic dermatitis often exhibit recurrent exacerbations, with the primary treatment being topical steroids. However, prolonged use of steroids can lead to steroid addiction or iatrogenic disease. Withdrawal from steroids once the condition becomes uncontrollable is known to be challenging. Herein, we explore the strategies for overcoming steroid addiction and mitigating its adverse effects. One approach involves combining the anti-allergic drug tranilast, which inhibits mast cell degranulation, with the unique macrolide antibiotic roxithromycin, known for its T helper type 2 (Th2) suppressive effect. Moreover, we examine the methods for managing steroid-dependent atopic dermatitis, a condition that poses significant challenges in terms of withdrawal.
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