International Journal of Clinical Pharmacy最新文献

{"title":"Cardiovascular toxicities associated with vascular endothelial growth factor receptor tyrosine kinase inhibitors: a pharmacovigilance study based on FDA adverse event reporting system.","authors":"Yao Zhang, Junge Deng, Jize Wang","doi":"10.1007/s11096-025-01962-8","DOIUrl":"10.1007/s11096-025-01962-8","url":null,"abstract":"<p><strong>Background: </strong>Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) are widely used in the treatment of various cancers. However, post-marketing evidence regarding their cardiovascular toxicities remains limited.</p><p><strong>Aim: </strong>This pharmacovigilance study aimed to comprehensively evaluate the association between VEGFR-TKIs and cardiovascular toxicities in cancer patients.</p><p><strong>Method: </strong>We retrieved and analyzed cardiovascular toxicity reports related to VEGFR-TKIs from the FDA Adverse Event Reporting System (FAERS). Disproportionality analyses were performed using the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC), and empirical Bayes geometric mean (EBGM) to detect safety signals of cardiovascular toxicities associated with VEGFR-TKIs.</p><p><strong>Results: </strong>A total of 12,726 cancer patients experienced cardiovascular toxicities associated with VEGFR-TKI treatment. All eleven VEGFR-TKIs were associated with cardiovascular toxicities, with hypertension being the most consistently reported event across all agents. Among them, cabozantinib was associated with the highest number of cardiovascular events, whereas lenvatinib exhibited the strongest signal. Notably, lenvatinib was associated with cardiac failure (ROR = 2.521, PRR = 2.479, IC = 1.308, EBGM = 2.476) and cardiomyopathy (ROR = 2.801, PRR = 2.788, IC = 1.476, EBGM = 2.782); sunitinib with cardiac failure (ROR = 2.745, PRR = 2.693, IC = 1.426, EBGM = 2.687) and cardiomyopathy (ROR = 3.020, PRR = 3.004, IC = 1.584, EBGM = 2.997); ponatinib with cardiomyopathy (ROR = 3.393, PRR = 3.372, IC = 1.752, EBGM = 3.368); and vandetanib with Torsade de pointes/QT prolongation (ROR = 27.930, PRR = 26.101, IC = 4.703, EBGM = 26.051).</p><p><strong>Conclusion: </strong>VEGFR-TKIs were associated with cardiovascular toxicities, particularly hypertension. Notably, lenvatinib and sunitinib were associated with cardiac failure and cardiomyopathy, ponatinib with cardiomyopathy, and vandetanib with Torsade de pointes and QT prolongation. Future prospective studies are warranted to further clarify the causal relationships between these agents and cardiovascular toxicities.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1467-1474"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540120","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":"Comparative effectiveness of potassium-competitive acid blockers and proton pump inhibitors in dual antiplatelet therapy patients: a nationwide cohort study.","authors":"Yu Jeong Lee, Nam Kyung Je","doi":"10.1007/s11096-025-01895-2","DOIUrl":"10.1007/s11096-025-01895-2","url":null,"abstract":"<p><strong>Background: </strong>Proton pump inhibitors (PPIs) are widely used in combination with dual antiplatelet therapy (DAPT) to reduce the risk of gastrointestinal bleeding; however, some PPIs may interfere with clopidogrel metabolism through CYP2C19 inhibition. Potassium-competitive acid blockers (P-CABs) have emerged as alternatives to PPIs, although their effectiveness in patients receiving DAPT have not been sufficiently explored.</p><p><strong>Aim: </strong>This study aimed to compare the effectiveness of PPIs and P-CABs in preventing cardiovascular events and gastrointestinal bleeding among patients receiving DAPT after coronary stent implantation.</p><p><strong>Method: </strong>A retrospective cohort design was employed using nationwide claim data from South Korea. The study included patients who received aspirin-clopidogrel DAPT with PPI or P-CAB for a minimum of 60 days. After applying propensity score matching (PSM) at a 1:1 ratio, survival analysis was conducted. The primary outcome was a composite of acute myocardial infarction, ischemic stroke, revascularization, and in-hospital mortality. Secondary outcomes involved the individual components of the composite outcome and gastrointestinal bleeding.</p><p><strong>Results: </strong>The initial cohort included 39,234 patients in the PPI group and 3,434 in the P-CAB group. After 1:1 PSM, 3,434 patients were included in each group. No statistically significant differences were observed between the PPI and P-CAB groups for the primary outcome (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.68-1.07; p = 0.167) and gastrointestinal bleeding (HR, 1.36; 95% CI, 0.76-2.42; p = 0.3).</p><p><strong>Conclusion: </strong>Both PPIs and P-CABs appear to be viable options for acid suppression in patients undergoing DAPT, with no significant differences in cardiovascular or gastrointestinal outcomes.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1204-1214"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673277","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":"Establishment and validation of a predictive nomogram for voriconazole-associated liver injury in lung transplant patients.","authors":"Wenwen Du, Wenqian Chen, Dan Zhang, Shu Li, Bo Li, Xianbo Zuo, Pengmei Li, Xiaoxing Wang","doi":"10.1007/s11096-025-01946-8","DOIUrl":"10.1007/s11096-025-01946-8","url":null,"abstract":"<p><strong>Introduction: </strong>Voriconazole serves as a cornerstone antifungal therapy for lung transplant (LTx) patients; however, its use is associated with a notable risk of hepatotoxicity.</p><p><strong>Aim: </strong>This study aimed to identify potential prognostic factors and develop a robust prediction nomogram for voriconazole-associated liver injury (VALI) in this population.</p><p><strong>Method: </strong>This retrospective observational study included 97 LTx patients treated with voriconazole between 2017 and 2024. Patients were randomly divided into a training cohort and a validation cohort, with a ratio of 75:25. Voriconazole blood concentrations were measured, and genetic polymorphisms related to voriconazole metabolism were analyzed. Potential prognostic factors associated with VALI were identified by using univariate and multivariate Cox proportional hazard models. The nomogram was evaluated by C-index, calibration curve and clinical utility.</p><p><strong>Results: </strong>The overall incidence of VALI was 30.9%. In the multivariate analysis, voriconazole concentration (HR 1.318, 95% CI 1.052-1.650, p = 0.016), voriconazole dose (HR 1.005, 95% CI 1.001-1.008, p = 0.006), concomitant mycophenolate mofetil (MMF) use (HR 0.320, 95% CI 0.116-0.885, p = 0.028), and rs4244285 polymorphism (HR 2.466, 95% CI 0.936-6.498, p = 0.068) were identified as independent predictive factors for VALI. The C-indexes of the nomogram were 0.807 (95% CI 0.725-0.889) for the training cohort and 0.82 (95% CI 0.681-0.959) for the validation cohort. Furthermore, the nomogram demonstrated excellent calibration and clinical applicability. Receiver operating characteristic (ROC) curve analysis determined the voriconazole cut-off trough concentration for hepatotoxicity stratified by MMF use. Stratified analysis indicated that the optimal voriconazole trough thresholds for minimizing VALI risk were 2.8 ng/mL in MMF users (AUC 0.769, p < 0.001) and 2.6 ng/mL in non-users (AUC 0.795, p = 0.011).</p><p><strong>Conclusion: </strong>This study highlights the significance of therapeutic drug monitoring for voriconazole in stratifying the risk probability of VALI among LTx patients. Additionally, we have established a predictive nomogram to aid clinicians and pharmacists in assessing the likelihood of VALI following voriconazole administration in this patient population. However, before clinical implementation, external validation in independent cohorts and prospective utility studies are imperative to confirm the generalizability and clinical efficacy of this model.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1416-1426"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642518","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":"Real-world safety of deucravacitinib: insights from the Food and Drug Administration Adverse Event Reporting System.","authors":"Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu","doi":"10.1007/s11096-025-01896-1","DOIUrl":"10.1007/s11096-025-01896-1","url":null,"abstract":"<p><strong>Background: </strong>Deucravacitinib, a selective inhibitor of TYK2 kinase, has been recently approved for the treatment of moderate to severe plaque psoriasis. Although the safety of deucravacitinib has been observed in clinical trials, its safety in the real world remains to be fully understood.</p><p><strong>Aim: </strong>The purpose of this study was to analyze post-marketing adverse events (AEs) associated with deucravacitinib using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to better understand its safety in real-world conditions.</p><p><strong>Method: </strong>This study performed a retrospective analysis of AEs associated with deucravacitinib from the FAERS database, spanning from the third quarter of 2022 to the second quarter of 2024. AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, Version 27.0). Disproportionality analysis was conducted using several statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network. Additionally, time-to-onset analyses and sensitivity analyses were performed to provide a comprehensive assessment.</p><p><strong>Results: </strong>AE reports from 1573 individuals were analyzed, revealing a total of 2895 AEs. Most of these events occurred within the first month of treatment. The primary AEs were associated with skin and subcutaneous tissue disorders, as well as infections and infestations. The study confirmed several known common AEs, including acne (n = 172, ROR 75, PRR 70.61, EBGM 69.14, IC 6.11), folliculitis (n = 51, ROR 62.45, PRR 61.37, EBGM 60.25, IC 5.91), and herpes zoster (n = 18, ROR 6.46, PRR 6.43, EBGM 6.42, IC 2.68), and identified some unexpected AEs such as urticaria (n = 36, ROR, PRR 5.27, EBGM 5.27, IC 2.4), skin burning sensation (n = 42, ROR 21.84, PRR 21.54, EBGM 21.41, IC 4.42), and myalgia (n = 26, ROR 3.93, PRR 3.9, EBGM 3.9, IC 1.96).</p><p><strong>Conclusion: </strong>Our study confirms the known AEs associated with deucravacitinib and identifies several potential AEs. These findings provide preliminary safety data for the practical use of deucravacitinib.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1215-1223"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811319","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":"Evaluating an integrated clinical pharmacist model in a geriatric day hospital: a prospective single-centre observational study.","authors":"Ine Simal, Andreas Capiau, Anton De Spiegeleer, Anja Velghe, Nele Van Den Noortgate, Mirko Petrovic, Annemie Somers","doi":"10.1007/s11096-025-01934-y","DOIUrl":"10.1007/s11096-025-01934-y","url":null,"abstract":"<p><strong>Background: </strong>Drug-related problems (DRPs) are prevalent in geriatric patients and associated with poor health outcomes. Clinical pharmacists (CPs) play a key role in optimising medication use, yet the benefits of CP interventions in collaboration with the geriatrician in a geriatric day hospital setting remain underexplored.</p><p><strong>Aim: </strong>This study aimed to: (1) evaluate CP activities at a geriatric day hospital by analysing (a) identified DRPs and recommendations, and (b) the prevalence of potentially inappropriate medications (PIMs), including Fall-Risk Increasing Drugs (FRIDs), at admission/discharge; and (2) examine the acceptance and implementation rates of CPs' recommendations by the attending geriatrician.</p><p><strong>Method: </strong>All patients that visited the day hospital during 25 non-consecutive days were invited to participate. DRPs and corresponding CPs' recommendations were categorised and analysed. PIMs were identified retrospectively using the Ghent Older People's Prescriptions community Pharmacy Screening-tool version 2.</p><p><strong>Results: </strong>Ninety-nine patients were included (median age: 85 years, 72.7% female). The most frequently identified DRP was 'no indication'. Drugs used for the nervous system were mostly involved. CPs proposed 251 recommendations (median: two per patient), which most frequently concerned 'stop therapy'. The acceptance rate was 80.1%, of which 73.1% were implemented immediately. The PIM prevalence decreased from 91.8% on admission to 87.6% at discharge (p < .001). The median number of FRIDs was two at both timepoints.</p><p><strong>Conclusion: </strong>CPs can have a valuable role in the interdisciplinary team at a geriatric day hospital. Regularly reevaluating the appropriate use of drugs used for the nervous system, and initiating judicious deprescribing is recommended.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1375-1383"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215747","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":"Sedative co-medication patterns across frailty states in people with HIV: a network-based study.","authors":"Henry Ukachukwu Michael, Marie-Josée Brouillette, Robyn Tamblyn, Lesley K Fellows, Nancy E Mayo","doi":"10.1007/s11096-025-01963-7","DOIUrl":"10.1007/s11096-025-01963-7","url":null,"abstract":"<p><strong>Introduction: </strong>People with HIV are living longer, but frailty may increase vulnerability to adverse drug interactions, particularly with sedative medications.</p><p><strong>Aim: </strong>To describe sedative co-medication patterns across frailty states using network-based analysis, and to identify key medications driving interaction complexity.</p><p><strong>Method: </strong>This cross-sectional study analyzed 321 participants using sedatives from the Positive Brain Health Now Cohort (mean age: 53 years), categorized as robust (30.2%), prefrail (47.0%), or frail (22.7%). Sedative use was classified using the Sedative Load Model, and frailty was assessed with a modified Fried Frailty Phenotype. Co-medication networks were constructed for robust, prefrail, and frail groups, with metrics such as Neighborhood Shift Scores (NESH) and ΔBetweenness used to evaluate network dynamics. Edge-level Observed-to-Expected ratios highlighted significant drug pairings and interaction risks.</p><p><strong>Results: </strong>Frail individuals exhibited the most interconnected sedative network (graph density: 0.24; average degree: 7.31) followed by prefrail (graph density: 0.18; average degree: 6.67) and robust groups (graph density: 0.13; average degree: 4.61). Medications with high network influence included mirtazapine (robust-to-prefrail: NESH = 2.05; ΔBetweenness = 0.23), gabapentin (robust-to-frail: NESH = 2.46, ΔBetweenness = 0.10), and pregabalin (prefrail-to-frail: NESH = 2.55; ΔBetweenness = 0.71). High-risk sedative pairs in frail individuals included hydromorphone-clonazepam (Observed-to-Expected ratio: 3.07; interaction severity: D), amitriptyline-oxycodone (Observed-to-Expected ratio: 1.92; severity: D), and quetiapine-citalopram (Observed-to-Expected ratio: 2.12; severity: D). Prefrail individuals had intermediate-risk combinations, including clobazam-levetiracetam (Observed-to-Expected ratio: 81.5; severity: C), and gabapentin-hydroxyzine (Observed-to-Expected ratio: 3.58; severity: D). Robust individuals showed fewer and lower-risk patterns, such as amitriptyline-pregabalin (Observed-to-Expected ratio: 4.00; severity: C). Network differences reflect increasing polypharmacy and adverse interaction risks with advancing frailty.</p><p><strong>Conclusion: </strong>Sedative co-medication patterns vary meaningfully across frailty states in people with HIV. Frailty is associated with more complex networks and a greater likelihood of high-risk drug interactions. Medications influencing these patterns can help identify opportunities for safer prescribing. The prefrail stage may offer a timely window for interventions aimed at minimizing polypharmacy and improving safety in middle-aged and older adults with HIV.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1475-1484"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642520","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":"Idiopathic fascicular ventricular tachycardia and verapamil: how to administer a continuous perfusion.","authors":"Alma Feka, Nancy Perrottet, Farshid Sadeghipour","doi":"10.1007/s11096-025-01970-8","DOIUrl":"10.1007/s11096-025-01970-8","url":null,"abstract":"<p><p>Idiopathic fascicular ventricular tachycardia is a rare form of ventricular tachycardia that is treated with verapamil, according to recent European guidelines. However, the authors and the majority of manufacturers only mention bolus intravenous administration of verapamil in these guidelines and in the Summary of Product Characteristics (SmPC), which leaves clinicians uncertain when continuous perfusion is required. This brief comment addresses this issue and suggests a protocol for the preparation and administration of continuous intravenous verapamil perfusion for adult patients.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1544-1545"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799005","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":"Pancreatitis associated with BRAF inhibitors: a disproportionality analysis based on the Food and Drug Administration Adverse Event Reporting System.","authors":"Shoujun Wang, Jinjing Wang, Huahua Zhang, Jiangfeng Wang","doi":"10.1007/s11096-025-01914-2","DOIUrl":"10.1007/s11096-025-01914-2","url":null,"abstract":"<p><strong>Background: </strong>The relationship between the development of pancreatitis and the use of BRAF (B-Raf proto-oncogene, serine/threonine kinase) inhibitors remains incompletely understood, primarily due to the infrequency of such cases.</p><p><strong>Aim: </strong>This study aimed to investigate the association between BRAF inhibitors and pancreatitis, and to describe the clinical characteristics of pancreatitis related to these agents.</p><p><strong>Method: </strong>A disproportionality analysis was conducted using data from the Food and Drug Administration Adverse Event Reporting System between July 2011 and June 2024. The reporting odds ratio (ROR) and information component (IC) were employed to assess the association between BRAF inhibitors and pancreatitis. Additionally, subgroup analysis and time-to-onset analysis were further performed.</p><p><strong>Results: </strong>A total of 169 cases of pancreatitis were identified in association with BRAF inhibitors: 71 cases with vemurafenib, 63 with dabrafenib, and 35 with encorafenib. The median age of patients was 62 years. Vemurafenib, dabrafenib, and encorafenib all showed a positive signal for pancreatitis, with respective RORs and ICs as follows: vemurafenib (ROR 2.46, 95% CI 1.95-3.10; IC = 1.27, 95% CI 0.88-1.56), dabrafenib (ROR 1.56, 95% CI 1.22-2.00; IC = 0.63, 95% CI 0.21-0.93), and encorafenib (ROR 2.59, 95% CI 1.86-3.62; IC = 1.34, 95% CI 0.77-1.74). The shortest median time-to-onset for pancreatitis was observed with vemurafenib (6.5 days), followed by encorafenib (14.0 days) and dabrafenib (129.5 days).</p><p><strong>Conclusion: </strong>This study reveals a significant reporting association between BRAF inhibitors and the development of pancreatitis, with a higher risk observed in the early stage of treatment.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1296-1304"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between sodium-glucose cotransporter 2 inhibitors and cancer: a systematic review and meta-analysis of randomized active-controlled trials.","authors":"Bo Xu, Bo Kang, Shaoqian Li, Jixiang Chen, Jiecan Zhou","doi":"10.1007/s11096-025-01924-0","DOIUrl":"10.1007/s11096-025-01924-0","url":null,"abstract":"<p><strong>Background: </strong>The effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors on cancer incidence compared to other hypoglycemic drugs remains unclear.</p><p><strong>Aim: </strong>This systematic review and meta-analysis was designed to investigate the association of SGLT2 inhibitors with cancer compared to active comparators.</p><p><strong>Method: </strong>A systematic search was conducted up to March 11, 2024 across Web of Science, PubMed, and ClinicalTrials.gov, and included trials with a follow-up period of at least 52 weeks. The Mantel-Haenszel statistical method was utilized, applying risk ratio (RR) and 95% confidence intervals (CI) for binary variables.</p><p><strong>Results: </strong>Twenty trials covering 16,399 type 2 diabetes mellitus patients were included. Median follow-up duration was 1.0 (1.0) years. The effect of SGLT2 inhibitors on the overall risk of cancer was neutral compared to active comparators (RR 1.00; 95%CI 0.71-1.40; p = 0.99; moderate certainty of evidence). SGLT2 inhibitors did not have a significant impact on breast cancer, endometrial/uterine cancer, gastrointestinal cancer, prostate cancer, renal cancer, or respiratory cancer. Subgroup analysis indicated a significant reduction in the risk of gastrointestinal cancer with SGLT2 inhibitors compared to metformin (RR 0.23; 95%CI 0.06-0.95; p = 0.04). SGLT2 inhibitors potentially increased gastrointestinal cancer risk relative to sulfonylureas (RR 3.52; 95%CI 0.91-13.64; p = 0.07).</p><p><strong>Conclusion: </strong>SGLT2 inhibitors showed neutral cancer risk in T2DM patients but may reduce gastrointestinal cancer versus metformin, guiding tailored therapy based on patient risk profiles.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1121-1131"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144007184","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":"Peripheral neuropathy associated with immunomodulatory drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database.","authors":"Chunhong Liang, Xueyan Zhang, Lijuan Zhou, Weiquan Zhang, Leifeng Liang, Di Xiao, Pingzhi Peng","doi":"10.1007/s11096-025-01925-z","DOIUrl":"10.1007/s11096-025-01925-z","url":null,"abstract":"<p><strong>Background: </strong>Peripheral neuropathy requires early detection and intervention.</p><p><strong>Aim: </strong>This study aimed to examine the association between immunomodulatory medications (IMiDs; thalidomide, lenalidomide, and pomalidomide) and peripheral neuropathy.</p><p><strong>Method: </strong>OpenVigil 2.1 was used to retrieve data associated with IMiDs and peripheral neuropathy from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using the reporting odds ratio (ROR) and information components (IC) with a 95% credibility interval. Peripheral neuropathy signals were further prioritized using a rating scale.</p><p><strong>Results: </strong>We found 645 cases of peripheral neuropathy in 19,622 adverse event reports for thalidomide, 4849 cases in 197,866 adverse event reports for lenalidomide, and 933 cases in 40,582 adverse event reports for pomalidomide. Based on the clinical priority assessment, peripheral neuropathy was identified as having moderate clinical priority for the three immunomodulatory drugs (priority score = 6). In plasma cell myelomas, more peripheral neuropathy was reported for thalidomide [4.24% vs. 2.51%; ROR = 1.72 (1.42, 2.08); IC = 0.23 (0.05, 0.41)] and lenalidomide [2.71% vs. 1.06%, ROR = 2.59 (2.29, 2.91); IC = 0.14 (0.08, 0.20)] than in non-plasma cell myelomas. Peripheral neuropathy signals were detected in age groups 51-74, 63-74, and 51-62 for lenalidomide, thalidomide, and pomalidomide, respectively. No disproportionate gender differences were detected.</p><p><strong>Conclusion: </strong>Our study indicated that the risk of peripheral neuropathy varied among patients with different indications and age subgroups for the same IMiD. Further investigation is required to verify these risk signals.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1324-1332"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110513","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}