Drugs - Real World Outcomes最新文献

{"title":"The Effectiveness of the Safety Communication for Concurrent Benzodiazepine-Opioid Therapy: A Retrospective Real-World Analysis.","authors":"Raseel Alroba, Ohoud Almadani, Dalal Alqahtani, Maha Aldoughaim, Adel Alrwisan","doi":"10.1007/s40801-025-00532-8","DOIUrl":"https://doi.org/10.1007/s40801-025-00532-8","url":null,"abstract":"<p><strong>Background: </strong>In 2018, Saudi Food and Drug Authority (SFDA) issued a safety communication concerning the potential risk of respiratory depression related to concurrent use of benzodiazepines and opioids. This study aims to evaluate the impact of this safety communication on clinical practice by examining trends in prescribing both medications concurrently pre- and post-safety communication date.</p><p><strong>Methods: </strong>A multicenter retrospective cohort study utilizing data from the Real-world Evidence Research Network comprised adult (≥ 18 years old) users of benzodiazepines and opioids from 2016 throughout 2020. This study employed an interrupted time series analysis using an Autoregressive Integrated Moving Average (ARIMA) model to examine changes in concurrent benzodiazepine and opioid use in Saudi Arabia (SA) before and after the safety communication date. Sensitivity analyses were conducted to assess the reliability of the findings.</p><p><strong>Results: </strong>A total of 43,906 episodes of concurrent use of benzodiazepines and opioids were identified for 32,035 patients. Comparing concurrent use of benzodiazepines and opioids pre- and post-safety communication, we observed a slight decrease, from 22.5% (22,846 of 101,538 episodes) to 20.4% (21,096 of 103,409 episodes). The result from our selected model, ARIMA, revealed that the estimated step change was 9.3 in prescriptions (95% CI - 154.5 to 173.2) while the estimated change in slope was - 1.7 prescriptions per month (95% CI - 29.4 to 26.1).</p><p><strong>Conclusions: </strong>In this study, we observed no significant changes in frequencies and trends in concurrent prescriptions of benzodiazepines and opioids before and after the safety communication. This highlights the need for continuous assessment of risk minimization strategies in achieving the targeted outcome.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147467339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Prospective, Multicenter, Single-arm, Phase IV Study to Assess the Safety and Effectiveness of a Fixed-Dose Combination of Pregabalin Prolonged Release and Etoricoxib in Patients with Chronic Low Back Pain with a Neuropathic Component.","authors":"Sandesh Sahebrao Patil, Brijesh Jerambhai Patel, Bhavsar Neel Mahendrabhai, C L Nawal, B Valya, K Sanjeev Kumar, Pandurang Wattamwar, Rana Kaushikkumar Ramanlal, Swagat Shah, Mandodari Rajurkar, Supriya Sonowal, Dipak Patil, Pravin Ghadge, Suyog Mehta","doi":"10.1007/s40801-026-00543-z","DOIUrl":"https://doi.org/10.1007/s40801-026-00543-z","url":null,"abstract":"<p><strong>Background and objective: </strong>Nearly two-thirds of patients with acute low back pain progress to chronic low back pain (CLBP). It is likely to be due to the involvement of both nociceptive and neuropathic pain mechanisms. Therefore, this study evaluated the safety and effectiveness of a fixed-dose combination (FDC) of pregabalin prolonged release (PR) and etoricoxib in patients with CLBP with a neuropathic component.</p><p><strong>Methods: </strong>This single-arm, phase IV study was conducted at nine hospitals across India. Patients with CLBP received an FDC of pregabalin PR 75 mg and etoricoxib 60 mg. The primary endpoint was safety, evaluated by the incidence of adverse events (AEs) and serious AEs. The secondary endpoint was effectiveness, assessed by change in the numeric rating scale (NRS), Roland-Morris Disability Questionnaire (RDQ) and visual analog scale (VAS) scores, and proportion of patients using rescue medication.</p><p><strong>Results: </strong>Of 231 screened patients, 185 met eligibility criteria and were enrolled. During the 8-week study, four patients were lost to follow-up, and one withdrew consent. Out of the 19 AEs reported, 18 were treatment-emergent AEs (TEAEs), which occurred in 13 (7.18%) patients. Dizziness, cough, pruritus, and rash were the most common TEAEs. All TEAEs were mild or moderate, and no serious TEAEs or discontinuations due to TEAEs occurred in the study. Statistically significant improvements were observed at week 8 compared with baseline in NRS scores (- 3.4 ± 1.69; p < 0.0001), RDQ scores (- 7.3 ± 3.42; p < 0.0001), and VAS scores (- 32.1 ± 15.33; p < 0.0001). The need for rescue medication decreased over time, with only 34 (18.89%) patients requiring it at week 8 compared with 121 (66.85%) at baseline.</p><p><strong>Conclusion: </strong>The FDC of pregabalin PR and etoricoxib was found to be safe, well tolerated, and effective in reducing pain intensity and improving quality of life in patients with CLBP with a neuropathic component. Thus, this FDC can be a potential alternative for managing CLBP with a neuropathic component.</p><p><strong>Trial registration number: </strong>CTRI/2022/05/042521 [Registered on: May 12, 2022] https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njg1ODg=&Enc=&userName.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147431500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Opioid Utilization in Older Adults with Rheumatoid Arthritis before and after Initiating Biological or Targeted Synthetic Disease-Modifying Antirheumatic Drugs.","authors":"Yinan Huang, Shadi Bazzazzadehgan, Liang-Yuan Lin, Omkar Ghodke, Sebastian Bruera, Kaustuv Bhattacharya, Sujith Ramachandran, John P Bentley, Sandeep K Agarwal, Yi Yang","doi":"10.1007/s40801-025-00537-3","DOIUrl":"10.1007/s40801-025-00537-3","url":null,"abstract":"<p><strong>Introduction: </strong>Opioid use is common in rheumatoid arthritis (RA) for pain management; however, evidence of opioid-associated adverse events is increasing. While biological (b) or targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) improve functional outcomes such as pain, little is known about their impact on opioid utilization patterns. This study investigated opioid utilization before and after b/tsDMARD initiation and assessed effect modification by sex.</p><p><strong>Methods: </strong>Using 5% Medicare claims data from 2012 to 2020, this cohort study included older adults (≥ 65 years) with RA who initiated b/tsDMARDs (first prescription = index date), and had continuous Medicare Parts A, B, and D, but not Part C enrollment, during 12 months before and after initiation. The outcomes of interest were any opioid use and long-term opioid therapy (LTOT). McNemar's test was performed to compare outcomes before and after b/tsDMARD initiation. Sex-based differences in changes in opioid use after b/tsDMARD initiation were also evaluated.</p><p><strong>Results: </strong>The study cohort included 3585 individuals with RA initiating b/tsDMARDs; most were female (75.87%) with a mean (SD) age of 73.15 (5.99) years. Following b/tsDMARD initiation, any opioid use decreased significantly from 2094 (58.41%) to 2017 (56.26%) (p = 0.015). However, LTOT use increased significantly from 733 (20.45%) to 900 (25.10%) (p < 0.001), following b/tsDMARD initiation. No evidence of sex differences in the association between b/tsDMARD initiation and opioid utilization was identified.</p><p><strong>Conclusions: </strong>Initiating b/tsDMARDs was associated with a modest reduction in any opioid use. However, LTOT use in RA remained persistently high. The impact of different b/tsDMARD initiation on opioid utilization patterns needs further investigation.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"51-61"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145818348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health Equity Concerns in People with Sickle Cell Disease and Recurrent Vaso-Occlusive Crises: Results from an International Survey Study.","authors":"Adriana Boateng-Kuffour, Lauren Lilly, Jennifer Drahos, Melanie Calvert, Ashley Valentine, Anthony Mason, Nanxin Li, Zahra Pakbaz, Farrukh Shah, Nick Ainsworth, Antony P Martin","doi":"10.1007/s40801-025-00531-9","DOIUrl":"10.1007/s40801-025-00531-9","url":null,"abstract":"<p><strong>Background: </strong>Vaso-occlusive crises (VOCs) are a hallmark of sickle cell disease (SCD). Individuals with SCD often report stigma and negative healthcare provider (HCP) attitudes when seeking treatment. This study examines health equity concerns and perceived barriers to care among adults with recurrent VOCs.</p><p><strong>Methods: </strong>A prospective survey was conducted from May to November 2022 in the US, UK, France, Germany, and Italy. Adults (≥ 18 years) with recurrent VOCs completed a health equity survey and patient-reported outcome measures (PROMs) at month 6. Participants were categorized as experiencing either unfair or fair treatment based on their response to whether they reported ever having been treated unfairly by an HCP due to their race or ethnicity. PROMs were scored, and analyses included Pearson's Chi-squared test and two-sample t-tests.</p><p><strong>Results: </strong>Among 110 participants, most were female (75.5%), Black/African American (93.5%), and US residents (59.1%). In the past year, 66.7% had ≥ 4 VOCs, and 85.3% used opioids. Most (68.6%) believed they would receive better care if they were of a different race/ethnicity, and 64.7% felt HCPs did not believe their symptoms. About 30% waited > 60 min for emergency department check-in, with additional delays before treatment. Key barriers included reported HCP lack of empathy (58.9%) and SCD knowledge (55.9%). Pain significantly impacted daily activities, with all outcomes worse in the Unfair treatment group.</p><p><strong>Conclusions: </strong>Findings highlight significant health equity concerns and barriers to care for adults with SCD and recurrent VOCs, underscoring unmet needs and the humanistic burden in this population.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"29-40"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145563022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Experience with Selexipag in Patients with Pulmonary Arterial Hypertension: Treatment Patterns and Outcomes across Baseline Risk Strata (SPHERE and EXPOSURE Studies).","authors":"Pilar Escribano Subias, Murali M Chakinala, Kelly M Chin, Eva-Maria Didden, Gurinderpal Doad, Harrison W Farber, Sean Gaine, Anna R Hemnes, Kristin B Highland, Tobias J Lange, Vallerie McLaughlin, Audrey Muller, Mohammad Rahman, Tatiana Remeňová, Stefan Söderberg, Apoorva Venkatesh, Nick H Kim","doi":"10.1007/s40801-025-00536-4","DOIUrl":"10.1007/s40801-025-00536-4","url":null,"abstract":"<p><strong>Background: </strong>Treatment strategies for pulmonary arterial hypertension (PAH) depend on patients' 1-year mortality risk; however, real-world practices and outcomes remain inadequately described.</p><p><strong>Objective: </strong>We aimed to investigate real-world experience with selexipag, an oral selective prostacyclin I2 receptor agonist used to treat PAH.</p><p><strong>Methods: </strong>This analysis of two large, prospective, observational studies: SPHERE (NCT03278002; USA; completed) and EXPOSURE (EUPAS19085; Europe and Canada; ongoing, data cutoff November 2021) included adults newly initiating selexipag with follow-up available.</p><p><strong>Results: </strong>Of 1366 selexipag users, 894 met eligibility criteria. At selexipag initiation, the median (Q1-Q3) age was 61 (48-70) years and the time since diagnosis was 2.7 (0.8-7.4) years. Most patients initiated selexipag within triple oral combination therapy (67%) with WHO-FC III symptoms (61%). During a median 10.8 (Q1-Q3: 3.3-18.6) months of selexipag exposure, 388 (43%) patients discontinued selexipag, mostly as a result of tolerability (n = 173, 19%) and death (n = 69, 8%). The median individualised dose was 800 μg twice-daily (n = 742). One-year mortality risk at selexipag initiation (assessable for 591 patients using a four-strata method): 22% were low-risk, 40% intermediate-low, 29% intermediate-high, and 9% high-risk. From low to high risk: 86%, 73%, 57% and 45% were free from all-cause hospitalisation at 1 year, and 1-year survival was 100%, 96%, 91%, and 59%, respectively.</p><p><strong>Conclusions: </strong>Despite current guidelines, over half of patients started selexipag almost 3 years after diagnosis, and 38% were already intermediate-high or high risk of 1-year mortality. Lower hospitalisation rates and better survival were observed for selexipag-treated patients in the low and intermediate-low risk groups versus higher risk groups.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"85-100"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time to Treatment Discontinuation and Cost Effectiveness of Third-Line Therapies in Advanced Colorectal Cancer: Real-World Evidence from the NIH All of Us Research Program.","authors":"Patrick J Kiel, Mark W McGiffin, Todd C Skaar, Michael A Preston","doi":"10.1007/s40801-026-00539-9","DOIUrl":"10.1007/s40801-026-00539-9","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Treatment options for patients with advanced colorectal cancer who progress after standard therapies remain limited, and real-world evidence on treatment durability and economic outcomes in later lines of therapy is needed to inform clinical and policy decision making. This study evaluated real-world outcomes, healthcare utilization, and cost effectiveness of immune checkpoint inhibitors (ICI) compared with regorafenib or trifluridine/tipiracil (Rego/Tri) in third-line (3L) advanced colorectal cancer (CRC), leveraging the nationally distributed NIH All of Us Research Program.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a retrospective cohort cost-utility analysis using All of Us Version 8 Curated Data Repository. Eligible adults (≥ 18 years) with advanced CRC initiated ICI (pembrolizumab, nivolumab ± ipilimumab) or Rego/Tri during 2017-2023. Outcomes included time to treatment discontinuation (TTD), healthcare utilization, costs, and quality-adjusted life years (QALYs; base-case utility = 0.75). Costs were estimated from CMS 2023 schedules (Part B ASP for infused agents, Part D unit costs for orals; inpatient/outpatient fee schedules for non-drug services), applied per cycle and proportionally for partial cycles. Analyses were conducted from the US Medicare payer perspective, with the time horizon limited to observed TTD and no discounting applied (&lt; 1 year). Incremental cost-effectiveness ratios (ICERs), incremental net monetary benefit (INMB), and cost-effectiveness acceptability curves (CEACs) were estimated using nonparametric bootstrapping (1000 replicates). Sensitivity analyses varied utility weights (0.6-1.0).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 82 patients (ICI n = 50; Rego/Tri n = 32), median TTD was significantly longer with ICI (8.0 vs 1.4 months; HR 0.49, 95% CI 0.30-0.79; p = 0.0037). Non-drug utilization costs were not significantly different, but ICI drug costs were higher (US$207,558 vs US$119,805; p = 0.001). Mean total costs were US$476,729 for ICI versus US$264,225 for Rego/Tri (p = 0.018). QALYs were higher for ICI (0.84 vs 0.43; p &lt; 0.001). The ICER was US$518,000 per QALY gained. CEAC analysis demonstrated ~ 0% probability of cost effectiveness at US$150,000/QALY, ~ 50% at US$500,000/QALY, and ~ 80% at ≥ US$1,000,000/QALY. Sensitivity analyses yielded consistent findings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;In this exploratory analysis using the novel NIH All of Us Research Program, ICI therapy was associated with longer treatment duration and greater QALYs but substantially higher costs compared with Rego/Tri. ICI was unlikely to be cost effective at conventional US thresholds but may be favorable at higher willingness-to-pay values. These findings highlight both the promise of leveraging the All of Us Research Program for nationally distributed, demographically diverse pharmacoeconomic research and the challenges of interpreting real-world cost effectiveness in small cohorts. As the datas","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"121-131"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147431483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and Safety of the Novel Selective Urate Reabsorption Inhibitor Dotinurad After Switching from Febuxostat in Patients with Stage B/C Heart Failure.","authors":"Tsutomu Murakami, Yuki Watanabe, Norihito Nakamura, Shigemitsu Tanaka, Yuji Ikari","doi":"10.1007/s40801-025-00526-6","DOIUrl":"10.1007/s40801-025-00526-6","url":null,"abstract":"<p><strong>Background: </strong>Hyperuricemia is a common comorbidity in patients with cardiovascular diseases and chronic kidney disease, often requiring long-term urate-lowering therapy. Febuxostat, a xanthine oxidase inhibitor, has raised cardiovascular safety concerns. Dotinurad, a selective urate reabsorption inhibitor, has emerged as a potential alternative, but clinical evidence in patients with Stage B/C heart failure remains limited.</p><p><strong>Methods: </strong>This single-center retrospective study evaluated 30 patients with Stage B (n = 10) and C (n = 20) heart failure and hyperuricemia who were switched from febuxostat (10, 20, or 40 mg) to dotinurad (0.5, 1.0, or 2.0 mg, respectively), based on the prior febuxostat dose. Laboratory and urinary parameters were assessed at baseline and at follow-up (median 65 days [56-84] after switching).</p><p><strong>Results: </strong>In Stage B heart failure, serum uric acid showed a non-significant trend toward reduction (5.8 [4.4-6.3] to 5.3 [4.8-7.5] mg/dL, p = 0.09), whereas in Stage C heart failure, serum uric acid increased significantly (5.1 [4.6-6.6] to 5.4 [4.8-6.8] mg/dL, p = 0.02). The proportion of patients achieving serum uric acid ≤ 6.0 mg/dL was maintained (Stage B: 60.0 to 50.0%; Stage C: 70.0 to 75.0%). Urinary uric acid excretion increased, while urinary pH remained stable in both groups. The uricosuric effect of dotinurad was evident with or without concomitant use of sodium-glucose cotransporter 2 inhibitors. No adverse events, including cardiovascular events, urolithiasis, or gout flares, were observed.</p><p><strong>Conclusions: </strong>Switching from febuxostat to dotinurad may be effective and safe over the short term in patients with Stage B/C heart failure and hyperuricemia.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"1-6"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145631262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Potentially Inappropriate Medication and Association with Falls During Hospitalisation: An Analysis Based on Electronic Health Records (POLAR_MI project).","authors":"Louisa Redeker, Miriam Kesselmeier, Beate Mussawy, Steffen Grabe, Marietta Rottenkolber, Torsten Thalheim, Florian Schmidt, Thomas Peschel, Alexander Strübing, Daniel Neumann, André Scherag, Markus Loeffler, Sven Schmiedl, Petra Thürmann","doi":"10.1007/s40801-025-00528-4","DOIUrl":"10.1007/s40801-025-00528-4","url":null,"abstract":"<p><strong>Background: </strong>In an ageing population, drug-related problems, including potentially inappropriate medications (PIMs), are increasingly relevant. PIM lists are important tools for improving medication safety in older adults.</p><p><strong>Objective: </strong>As part of the POLAR_MI (POLypharmacy, drug interActions, Risks) project, this study aimed to assess the prevalence of PIM and its association with falls in patients aged ≥ 65 years, based on the methods and processes of the Medical Informatics Initiative Germany.</p><p><strong>Methods: </strong>A retrospective, distributed analysis of electronic health records (EHRs) (2018-2021) was conducted at ten German university hospitals. PIMs were defined using PRISCUS and EU(7)-PIM lists. Falls were identified using documented fractures as a surrogate. Multivariable logistic regression modelling was applied, adjusting for confounders including age, gender, Charlson Comorbidity Index (CCI) and fall-risk-increasing drugs (FRIDs).</p><p><strong>Results: </strong>A total of 166,126 cases (median age: 76 years; 45.8% women) were analysed. According to PRISCUS, 12.8% of cases had at least one PIM, with amitriptyline most common (1.1% of all cases). According to EU(7)-PIM, 45.6% of cases were affected, with apixaban most frequent (8.6%). An association between falls and at least one PIM (PRISCUS: adjusted odds ratio [aOR] 1.21, 95% confidence interval [CI] 0.94-1.55; EU(7)-PIM: aOR 1.01, 95% CI 0.83-1.22) could not be observed. However, FRIDs were associated with falls (PRISCUS: aOR 2.31, 95% CI 1.64-3.27; EU(7)-PIM: aOR 2.43, 95% CI 1.69-3.48).</p><p><strong>Conclusions: </strong>In this large multicentre EHR analysis, PIMs were common in older patients, but an association with an increased likelihood of falls could not be observed. In contrast, the well-known association with FRIDs was confirmed. The ongoing digitalisation of German hospitals enables such large-scale data analyses for risk assessment and supports improvements in patient safety.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"15-27"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145548703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in Adverse Event Reports of Dipeptidyl Peptidase-4 Inhibitor-Associated Pemphigoid in Japan.","authors":"Akina Takami, Gen Terashima, Takumi Tajima, Koki Yamashita, Ataru Igarashi","doi":"10.1007/s40801-025-00535-5","DOIUrl":"10.1007/s40801-025-00535-5","url":null,"abstract":"<p><strong>Background: </strong>Dipeptidyl peptidase-4 (DPP-4) inhibitors are widely used as a first-line therapy for type 2 diabetes in Japan. Precautions of the package inserts for ethical drugs containing DPP-4 inhibitors were revised for pemphigoid between 2016 and 2018.</p><p><strong>Study design and methods: </strong>This is a retrospective study that investigated the number of DPP-4 inhibitor-associated pemphigoid events using the Japanese Adverse Drug Event Report and its estimated annual incidence rate using a nationwide claims database to assess the trend in reported DPP-4 inhibitor-associated pemphigoid events after the release of the revised precautions in Japan.</p><p><strong>Results: </strong>We identified 2175 DPP-4 inhibitor-associated pemphigoid events in 2069 case reports. The most common suspected DPP-4 inhibitor was vildagliptin (45.3%), followed by teneligliptin (17.5%), sitagliptin (16.0%), and linagliptin (11.0%). The number of DPP-4 inhibitor-associated pemphigoid events increased from 30 in 2015 to 373 in 2016, reaching a peak of 412 in 2018. Although the estimated annual incidence rate did not exceed 50 per 1,000,000 patients mostly, it exceeded 100 per 1,000,000 for vildagliptin in 2016 and 2018.</p><p><strong>Conclusions: </strong>The number of reported DPP-4 inhibitor-associated pemphigoid events increased after the revised precautions of package inserts for DPP-4 inhibitors were released.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"101-110"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Age and Gender Heterogeneity in Adverse Drug Reactions Associated with Hemp Use: Evidence from the FDA Pharmacovigilance Data in the Last Two Decades.","authors":"Chengwen Teng, Jun Wu, Jing Yuan, Z Kevin Lu","doi":"10.1007/s40801-026-00542-0","DOIUrl":"10.1007/s40801-026-00542-0","url":null,"abstract":"<p><strong>Background: </strong>Hemp-derived products are increasingly used for medical and wellness purposes following legalization, yet systematic safety data remain limited.</p><p><strong>Objective: </strong>We aimed to identify the most common adverse drug reactions associated with hemp use and to evaluate age- and gender-specific differences in risk.</p><p><strong>Methods: </strong>We analyzed adverse event reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) from 1 January, 2004 to 30 June, 2025. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) for hemp-associated adverse drug reactions were calculated.</p><p><strong>Results: </strong>Among 19,345,024 FAERS reports, 1712 involved hemp products. The most frequently reported adverse drug reactions included fatigue (180), nausea (152), diarrhea (138), headache (126), dizziness (119), pain (119), anxiety (115), dyspnea (86), arthralgia (82), vomiting (82), insomnia (79), depression (76), weight decreased (70), asthenia (68), feeling abnormal (68), fall (67), decreased appetite (60), pain in extremity (60), seizure (60), and somnolence (58). Seizures (ROR 6.76, 95% CI 5.22-8.75), anxiety (ROR 5.15, 95% CI 4.26-6.22), and depression (ROR 4.13, 95% CI 3.28-5.19) were most strongly associated with hemp. Older adults exhibited higher RORs for diarrhea, dizziness, arthralgia, asthenia, fall, decreased appetite, and pain in extremity, whereas younger adults showed stronger associations with fatigue, nausea, headache, pain, anxiety, dyspnea, vomiting, insomnia, depression, weight decreased, feeling abnormal, seizure, and somnolence. Women demonstrated higher RORs across nearly all adverse drug reactions except seizures, which were more strongly associated with men.</p><p><strong>Conclusions: </strong>Use of hemp-derived products are associated with adverse drug reactions, including serious neurological and psychiatric events, with marked heterogeneity by age and gender.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"145-152"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13003082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}