Drugs - Real World Outcomes最新文献

{"title":"Three-Year Interim Results from a Post-Marketing Surveillance Study of Patients with Migraine Treated with Fremanezumab in South Korea.","authors":"Dayoung Seo, Manho Kim, Mi Ji Lee, Min Kyung Chu, Soo-Jin Cho, Heui-Soo Moon, Tae-Jin Song, Soohyun Cho, Byung-Kun Kim, Gabriela Kivelevitch","doi":"10.1007/s40801-026-00566-6","DOIUrl":"10.1007/s40801-026-00566-6","url":null,"abstract":"<p><strong>Background: </strong>There is limited real-world evidence on the safety and effectiveness of fremanezumab in South Korea.</p><p><strong>Objective: </strong>We aimed to evaluate the safety and effectiveness of fremanezumab as a preventive migraine treatment in adults with migraine in real-life clinical practice in South Korea.</p><p><strong>Methods: </strong>A 6-year, non-interventional, prospective, post-marketing surveillance study conducted in up to 60 clinics and hospitals in South Korea from July 2021 to 2027. Eligible participants are aged ≥ 18 years, have a formal migraine diagnosis, and are receiving fremanezumab for the first time. The primary endpoint is the proportion of new adverse events, including serious adverse events, from first administration of fremanezumab to the 12-week observation period or discontinuation. Secondary endpoints include the mean change from baseline to week 12 in average monthly migraine days (MMD), proportion of participants achieving a ≥ 50% reduction in MMD, and the Patient Global Impression of Change (PGIC) scale at week 12. We present an interim analysis of data collected up to the third year of this study.</p><p><strong>Results: </strong>As part of the overall study, this 3-year interim analysis included data from 14 sites, with 1230 participants for safety and 1096 for effectiveness analyses (mean age: 46.1 years, standard deviation: 13.7; episodic/chronic migraine: 45.2%/54.8%; mean disease duration: 6.9 years [standard deviation 8.2]). Adverse events were reported by 17.6% of participants; the most common were injection-site reactions (5.7%); serious adverse events were infrequent (1.0%). After 12 weeks of treatment, mean change from baseline in MMD was - 7.8 ± 8.1 days (episodic migraine: - 3.4 ± 4.5 days, chronic migraine: - 11.4 ± 8.7 days), all p < 0.0001; 56.5% of participants (episodic migraine: 55.0%, chronic migraine: 57.7%) achieved a ≥ 50% reduction in MMD. Most participants (87.0%) rated treatment as effective on the PGIC scale.</p><p><strong>Conclusions: </strong>Fremanezumab was well tolerated and effective for migraine prevention in Korean adults in a real-world setting. These results support the use of fremanezumab in routine clinical practice across South Korea.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"363-371"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148396457","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":"Pre-existing Comorbidities as Potential Risk Modifiers for New-Onset Myocarditis and Pericarditis following mRNA COVID-19 Vaccination in Males Aged 18-30 in the United States: A Disproportionality Analysis using VAERS Spontaneous Reporting Data.","authors":"Mohammed Salah Salem, Yola Moride, Bernard Bégaud","doi":"10.1007/s40801-026-00568-4","DOIUrl":"10.1007/s40801-026-00568-4","url":null,"abstract":"<p><strong>Background: </strong>Rare cases of myocarditis and pericarditis following mRNA coronavirus disease-19 (COVID-19) vaccination have been reported, primarily among males under 30 years of age. Although the underlying mechanisms remain unclear, cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, and obesity have been hypothesized as potential contributors. Using the Vaccine Adverse Event Reporting System (VAERS), this study investigated whether these comorbidities were disproportionately reported among young adult males with myocarditis or pericarditis following mRNA COVID-19 vaccination compared with vaccinated and general populations. Additionally, this study represents a novel application of disproportionality principles in spontaneous reporting databases to explore, beyond signal detection, the factors that might be associated with the occurrence of an adverse event.</p><p><strong>Methods: </strong>An observed-versus-expected analysis was conducted using reports of myocarditis or pericarditis following mRNA COVID-19 vaccination among males aged 18-30 recorded in VAERS between 2021 and 2022. The prevalence of hypertension, diabetes, dyslipidemia, and obesity among reported cases was compared with prevalence estimates derived from epidemiological studies of vaccinated populations and national population statistics. In addition, disproportionality analyses were performed using comparator groups consisting of reports associated with other vaccines and other adverse events following immunization (AEFIs) within VAERS.</p><p><strong>Results: </strong>A total of 859 eligible reports of myocarditis/pericarditis following mRNA COVID-19 vaccination were identified among males aged 18-30. The prevalence of hypertension, diabetes, dyslipidemia, and obesity was 0.35%, 0.58%, 0.81%, and 1.75%, respectively and was significantly lower than those reported in vaccinated and prepandemic general populations. In disproportionality analyses, myocarditis/pericarditis reports following mRNA vaccination showed higher prevalence of dyslipidemia and obesity, but lower prevalence of hypertension, compared with selected VAERS comparator groups. However, absolute comorbidity prevalence remained low across all groups.</p><p><strong>Conclusions: </strong>No evidence of a modifying role for hypertension, diabetes, dyslipidemia, or obesity was observed for the increased reporting of myocarditis/pericarditis among young adult males following mRNA COVID-19 vaccination. Despite the limitations inherent to spontaneous reporting systems, this study highlights a novel application of disproportionality-based approaches within VAERS to explore potential risk modifiers of vaccine-related adverse events in a hypothesis-generating manner.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"409-419"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148430061","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":"Assessment of Potential Drug-Drug Interactions and Associated Factors Among Pulmonary Inpatients in a Tertiary Care Hospital: A Cross-Sectional Study.","authors":"Nim Bahadur Dangi, Hari Prasad Sapkota, Gobinda Kandel, Krishna Prasad Sapkota","doi":"10.1007/s40801-026-00563-9","DOIUrl":"10.1007/s40801-026-00563-9","url":null,"abstract":"<p><strong>Background: </strong>Potential Drug-drug interactions (pDDIs) are a significant cause of adverse drug events and can compromise treatment outcomes, especially in hospitalized patients who are prescribed multiple medications. Pulmonary patients are especially vulnerable due to polypharmacy and the presence of multiple co-morbid conditions. This study aimed to determine the prevalence of pDDIs and identify associated risk factors among hospitalized pulmonary patients.</p><p><strong>Methods: </strong>A cross-sectional study was conducted among pulmonary patients admitted to a tertiary care hospital in Nepal between July 2024 and December 2025. Patients with a hospital stay of ≥ 24 h and receiving two or more medications were included. Data on socio-demographics, clinical conditions, and medications were collected using a structured form. pDDIs were identified using Lexicomp and IBM Micromedex. Descriptive statistics, bivariate analysis, and binary logistic regression were performed using SPSS V16, with p < 0.05 considered statistically significant.</p><p><strong>Results: </strong>Out of 377 patients who met the inclusion criteria, Lexicomp and Micromedex identified 36.1% and 19.9% pDDIs, respectively. A moderate agreement was observed between Lexicomp and Micromedex in identifying pDDIs (Cohen's Kappa = 0.547). Micromedex classified most interactions as major (53.33%), while Lexicomp classified 66.18% as major severity; however, these classifications were based on screening databases and not confirmed clinical adverse events. Polypharmacy, longer hospital stays, presence of co-morbidities, alcohol consumption, and advanced age were significantly associated with an increased risk of pDDIs.</p><p><strong>Conclusion: </strong>pDDIs are prevalent among hospitalized pulmonary patients and are closely linked to polypharmacy and complex clinical profiles. Routine medication review and the use of drug interaction screening tools are essential to minimize the risk of harmful interactions.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"499-512"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148316147","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":"Treatment Selection Patterns and Associated Outcomes for Biguanides and SGLT2 Inhibitors in Type 2 Diabetes: A Retrospective Database Study in Japan.","authors":"Ryo Mishima, Daisuke Koide","doi":"10.1007/s40801-026-00567-5","DOIUrl":"10.1007/s40801-026-00567-5","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes mellitus has multiple treatment options and high healthcare costs. In Japan, DPP-4 inhibitors have been widely used, but since 2022 the pharmacotherapy algorithm has shifted: DPP-4 inhibitors and biguanides for BMI < 25 kg/m <math><mmultiscripts><mrow></mrow> <mrow></mrow> <mn>2</mn></mmultiscripts> </math> , and biguanides and SGLT2 inhibitors for BMI <math><mo>≥</mo></math> 25 kg/m <math><mmultiscripts><mrow></mrow> <mrow></mrow> <mn>2</mn></mmultiscripts> </math> . However, real-world factors influencing prescribing decisions between biguanides and SGLT2 inhibitors remain unclear.</p><p><strong>Objective: </strong>This study investigates factors influencing the choice between biguanides and SGLT2 inhibitors in clinical practice. We also compare glycemic efficacy and medication persistence while accounting for baseline characteristics.</p><p><strong>Methods: </strong>This retrospective cohort study used the Millennium Medical Record Database, primarily capturing care from large hospitals. Adults aged <math><mo>≥</mo></math> 18 years who received a first prescription of a biguanide or a SGLT2 inhibitor between July 2019 and April 2023 were included. Patients were categorized as 1st-line or 2nd-line therapy. Confounding was addressed using coarsened exact matching with classification tree modeling. HbA1c changes were analyzed using mixed models for repeated measures, and persistence using Kaplan-Meier methods.</p><p><strong>Results: </strong>A total of 1925 patients were included. In the 1st-line cohort (n = 1440), key selection factors were diuretic use, lipid-modifying agents, and baseline HbA1c. At 24 weeks, HbA1c decreased in both groups (biguanide: -1.37 percentage points, 95% CI -1.48 to -1.26; SGLT2 inhibitor: -1.16 percentage points, 95% CI -1.29 to -1.02); the between-group difference was -0.21 percentage points (95% CI -0.38 to -0.04). Persistence at 48 weeks was 47.0% (95% CI 42.7-51.2) for biguanides and 56.2% (95% CI 51.2-61.2) for SGLT2 inhibitors. In the 2nd-line cohort (n = 485), selection factors were baseline HbA1c, BMI, and diuretic use. HbA1c decreased at 24 weeks (biguanide: -2.26 percentage points, 95% CI -2.47 to -2.05; SGLT2 inhibitor: -1.79 percentage points, 95% CI -2.04 to -1.54); the between-group difference was -0.47 percentage points (95% CI -0.80 to -0.15). Persistence at 48 weeks was 51.8% (95% CI 45.2-58.4) for biguanides and 49.4% (95% CI 40.3-58.6) for SGLT2 inhibitors.</p><p><strong>Conclusions: </strong>In Japanese patients with type 2 diabetes, treatment selection was mainly associated with concomitant cardiovascular medication use. BMI influenced choice, particularly in the 2nd-line setting, but was not the predominant determinant. Biguanides were associated with greater HbA1c reductions. In intention-to-treat analyses, persistence over 48 weeks was higher with SGLT2 inhibitors in the 1st-line cohort, while persistence was comparable in the 2nd-line cohort.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"395-408"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148434961","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":"Feasibility of Reconstructing Survival Outcomes from Unstructured Electronic Medical Records under Japan's Next-Generation Medical Infrastructure Act: A Historical Cohort Study of Atezolizumab in Non-small Cell Lung Cancer.","authors":"Masahiko Nakatsui, Yosuke Nishida, Suguru Nozue, Yukinori Sakata, Mie Azuma, Rika Abe, Rika Okamoto, Yuki Nakagami, Yasushi Okuno","doi":"10.1007/s40801-026-00570-w","DOIUrl":"10.1007/s40801-026-00570-w","url":null,"abstract":"<p><strong>Background and objective: </strong>As the use of real-world evidence (RWE) expands, evaluating whether Japanese real-world data (RWD) can reproduce clinical trial findings is crucial. This study aimed to determine whether pseudonymized medical information collected under the Next-Generation Medical Infrastructure Act could reconstruct a patient cohort comparable to the Japanese subgroup of the OAK trial and to evaluate progression-free survival (PFS) and overall survival (OS) in patients with non-small cell lung cancer (NSCLC) treated with atezolizumab.</p><p><strong>Methods: </strong>We conducted a historical cohort study using the Millennium Medical Record database. Medical information collected between 1 October 2015, and 31 October 2022 was utilized, and the study itself was conducted from September 2023 to February 2024. Patients treated with atezolizumab for NSCLC were identified, and eligibility criteria from the OAK trial were applied. Effectiveness outcomes were extracted from unstructured electronic medical record text by trained abstractors through manual review of the medical records, ensuring robustness of the assessments.</p><p><strong>Results: </strong>A total of 75 patients were analyzed. The median PFS was 3.5 months (95% CI 2.3-8.9), comparable to the 4.2 months (95% CI 2.8-4.4) reported in the OAK trial's Japanese subgroup. Subgroup analyses showed numerical distance, with shorter PFS in patients with advanced stage and poor performance status, consistent with clinical expectations. Median OS was not reached, likely due to censoring from untracked hospital transfers.</p><p><strong>Conclusions: </strong>This study demonstrated the feasibility of extracting PFS from unstructured text in RWD, yielding results comparable to clinical trials. While OS estimation faced challenges due to tracking limitations, future integration with the National Database under the revised law is expected to enhance accuracy, paving the way for using this infrastructure to generate external control arms.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"421-429"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148560930","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":"Drug Utilization Pattern of Proton Pump Inhibitors in Patients with Acid Peptic Disease and Comorbidities in India: A Real-World Electronic Medical Records-Based Study.","authors":"Yogesh Garje, Tanish Modi, Mudit Sabharwal, Sunil Gupta, Rajiv Saikia, Ashwini Satpathy, Shruti Dharmadhikari, Neeraj Markandeywar, Chintan Khandhedia, Amey Mane, Suyog Mehta, Sadhna Joglekar","doi":"10.1007/s40801-026-00544-y","DOIUrl":"10.1007/s40801-026-00544-y","url":null,"abstract":"<p><strong>Background: </strong>Acid peptic disease (APD) is often associated with comorbidities. Choosing a proton pump inhibitor (PPI) is critical in such patients, given the frequent use of multiple concomitant medications in routine clinical practice. This real-world study was planned in India to understand drug utilization and prescription patterns of PPIs in APD patients with comorbidities.</p><p><strong>Objective: </strong>The aim was to evaluate the real-world drug utilization patterns of PPIs and to explore the adherence, effectiveness, and tolerability of pantoprazole in APD patients with comorbidities in India.</p><p><strong>Methods: </strong>This multicenter, retrospective, electronic medical record-based study analyzed data of adult APD patients with comorbidities treated with PPIs at four Indian outpatient clinics (January 2017-December 2020). Patients aged ≥18 years with at least two follow-up visits were included, and outcomes assessed included utilization patterns, adherence, effectiveness, and tolerability.</p><p><strong>Results: </strong>The study included data from 687 patients with APD, who had a mean age of 47.8 years, and 56.6% of them were male. Patients had various comorbidities, and PPIs were co-prescribed with antidiabetics, antiplatelets, antihypertensives, antibiotics, and antithyroid drugs. Pantoprazole was the most commonly prescribed PPI (51.7%), followed by esomeprazole (20.2%), rabeprazole (13.0%), lansoprazole (9.2%), and omeprazole (6.0%). A greater proportion of patients treated with pantoprazole adhered to treatment when compared to other PPIs at follow-up visits. All APD symptoms significantly reduced at follow-up visit 2 compared to baseline across all PPIs (p < 0.05). All PPIs were well-tolerated, with adverse events consistent with their known profiles.</p><p><strong>Conclusion: </strong>This real-world study highlighted utilization patterns of PPIs and demonstrated that all PPIs are effective and well-tolerated in managing APD symptoms in patients with comorbidities. Pantoprazole was the most co-prescribed and preferred PPI amongst the prescribed PPIs. These findings provide real-world insights into how PPIs are utilized in Indian patients with APD and comorbidities and may help clinicians make informed decisions when selecting an appropriate PPI in routine practice.</p><p><strong>Trial registration: </strong>The study was registered in the Clinical Trial Registry of India (CTRI number: CTRI/2021/06/034237).</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"513-524"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147527702","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":"Calcitonin Gene-Related Peptide Monoclonal Antibody Utilization and Treatment Gaps in People with Migraine in Japan: Results from the OVERCOME (Japan) 2nd Study.","authors":"Yoshiki Hanaoka, Tsubasa Takizawa, Ryotaro Ishii, Daisuke Danno, Masayuki Hamakawa, Kaname Ueda, Yoshinori Tanizawa, Satoshi Osaga, Leo J Philip Tharappel, Chie Hashimoto","doi":"10.1007/s40801-026-00571-9","DOIUrl":"10.1007/s40801-026-00571-9","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are an effective preventive treatment for migraine. However, their population-level utilization patterns and treatment gaps are underreported in Japan. This analysis of the ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME [Japan]) 2nd study, evaluated utilization patterns of CGRP mAbs and treatment gaps, and identified factors associated with CGRP mAb treatment experience among CGRP mAb-eligible individuals with migraine in Japan.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This analysis of a nationwide, population-based, cross-sectional online survey included adults with migraine. Respondents were further classified according to CGRP mAb eligibility (based on the guidelines for the promotion of optimal use). Both CGRP mAb-eligible and ineligible individuals were stratified by experience with CGRP mAbs. CGRP mAb-experienced respondents were further stratified into \"current CGRP mAb\" and \"discontinued CGRP mAb\" subgroups. Respondents reported their CGRP mAb utilization pattern, headache perceptions, attitude, and barriers to treatment initiation. Multivariate logistic regression was performed to identify the factors associated with CGRP mAb treatment experience among CGRP mAb-eligible respondents.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among the 19,590 respondents with migraine, 1484 (7.6%) met the eligibility criteria for CGRP mAbs (78 were current CGRP mAb users, 58 discontinued CGRP mAb, and 1348 never used CGRP mAbs), indicating about 90% of CGRP mAb-eligible individuals had never received CGRP mAb therapy. Among the 18,106 CGRP mAb-ineligible respondents, based on the current symptom status at the time of the survey, 110 were current CGRP mAb users, 176 discontinued CGRP mAbs, and 17,820 never used CGRP mAbs. In both the eligibility groups, more CGRP mAb-experienced respondents visited CGRP mAb-prescribable departments (63.6-88.5%). Among the CGRP mAb-eligible current users, most had consulted headache specialists (40.5%), and the proportion of triptan use (ever and current) was also high in these groups (84.6% and 73.1%). Among eligible nonusers (n = 1348), awareness of CGRP mAbs was markedly low (78.0% had never heard of CGRP mAbs), and only 4.2% had been informed about CGRP mAbs by a physician. Eligible nonusers were less likely to discuss treatment goals with physicians and more likely to perceive migraine as an unavoidable condition. Among the eligible respondents, CGRP mAb treatment experience was strongly associated with prior triptan use (OR 9.38 [95% CI 5.94, 14.80]), and consultation at the CGRP mAb-prescribing department (OR 7.20 [95% CI 3.60, 14.37]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;A substantial treatment gap exists in the use of CGRP mAbs among eligible individuals with migraine in Japan. Improving access to specialist care, enhancing patient-physician communication, and increasing awareness of preventive treatme","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"431-450"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148560981","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 PD-1 Inhibitor Rechallenge After Prior Immunotherapy in Patients Aged ≥ 60 Years with Advanced Non-Small-Cell Lung Cancer: A Single-Center Retrospective Study.","authors":"Xiao-Yue Jiang, Xin Li, Hui Huang, Min Pan, Qiu-Qiu Chen, Chun-Qiao Chen","doi":"10.1007/s40801-026-00578-2","DOIUrl":"https://doi.org/10.1007/s40801-026-00578-2","url":null,"abstract":"<p><strong>Background and objectives: </strong>Evidence regarding the effectiveness and safety of PD-1 inhibitor rechallenge in older patients with advanced non-small-cell lung cancer (NSCLC) previously exposed to immunotherapy remains limited. This study evaluated the effectiveness and safety of PD-1 inhibitor monotherapy rechallenge in patients aged ≥ 60 years with advanced NSCLC who had previously received immunotherapy.</p><p><strong>Methods: </strong>This single-center retrospective cohort study included 56 patients aged ≥ 60 years with advanced NSCLC who received PD-1 inhibitor monotherapy rechallenge at the Department of Oncology Radiotherapy at the Guilin People's Hospital between January 2019 and March 2025. Objective response rate (ORR) and disease control rate (DCR) were assessed per RECIST 1.1 criteria. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method. Treatment-related adverse events (TRAEs) were graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</p><p><strong>Results: </strong>In the full analysis population of 56 patients with five non-evaluable patients counted as non-responders, the ORR and DCR were 21.4% and 58.9%, respectively. The median PFS of the 56 older patients with advanced NSCLC receiving PD-1 inhibitors was 3.9 months (95% CI 1.88-5.92) and median OS was 11.3 months (95% CI 4.78-17.82) from rechallenge of PD-1 inhibitors. The safety profile indicated that TRAEs of any grade occurred in 41 patients (73.2%), most commonly fatigue, decreased appetite, rash, hepatic enzyme elevations, pneumonitis, and hypothyroidism. Grade ≥ 3 TRAEs were detected in 15 patients (26.8%). Immune-related TRAEs were generally manageable with corticosteroids and supportive care.</p><p><strong>Conclusion: </strong>PD-1 inhibitor rechallenge showed modest antitumor activity and a generally manageable safety profile in this selected cohort of patients aged ≥ 60 years with advanced NSCLC previously exposed to immunotherapy. Given the small sample size, single-center retrospective design, and potential selection bias, these findings should be considered preliminary and require validation in larger multicenter prospective studies.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148857151","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":"Prospective Real-World Assessment of Pain Relief with Injection-Based Delivery of Etoricoxib (RAPID Study).","authors":"Shiva Shankar Jha, Anoop Dhamangaonkar, Rajkumar Iyengar, Gautam Chakraverty, Kotini Saskar Rao, Abhijeet Mukherji, Sameer Muchhala, Vidhya Natarajan","doi":"10.1007/s40801-026-00576-4","DOIUrl":"https://doi.org/10.1007/s40801-026-00576-4","url":null,"abstract":"<p><strong>Background: </strong>Acute pain is frequently inadequately controlled in routine clinical practice, particularly when oral analgesic administration is delayed or impractical. Intramuscular (IM) etoricoxib offers a parenteral option for rapid pain control; however, prospective real-world evidence across diverse acute pain conditions remains limited.</p><p><strong>Objectives: </strong>The primary objective was to evaluate changes in pain intensity using the Numeric Pain Rating Scale (NPRS) from baseline to predefined post-injection timepoints. Secondary objectives included physician global assessment of pain relief and assessment of tolerability based on reported adverse events. The findings are expected to further strengthen the clinical evidence base for intramuscular (IM) etoricoxib and inform its integration into acute pain management pathways in Indian healthcare settings.</p><p><strong>Methods: </strong>This multicenter, noncomparative, prospective observational study was conducted across 68 sites in India. Adults with acute painful conditions prescribed Nucoxia® 90 mg IM etoricoxib as part of routine care were enrolled. Pain intensity was assessed using the Numeric Pain Rating Scale (NPRS) at baseline and predefined post-injection timepoints. The primary endpoint was change in NPRS score from baseline to 60 min post-injection. Effectiveness was additionally evaluated using the Global Physician Assessment. Safety outcomes included injection-site reactions and adverse events.</p><p><strong>Results: </strong>A total of 418 patients were included (364 inpatients; 54 outpatients), with a mean age of 46.0 ± 10.9 years; 69.6% (291/418) were male. Low back pain (36.1%) was the most common indication. Among inpatients, mean NPRS scores decreased from 7.6 ± 1.5 at baseline to 3.3 ± 2.3 at 60 min (p < 0.001), with sustained improvement to 0.3 at 24 h; 88.7% (323/364) were pain free at 24 h. Among outpatients, mean NPRS scores declined from 6.1 ± 1.6 to 0.8 ± 1.5 at 60 min, with 70.4% (38/54) reporting complete pain relief (p < 0.001). Physicians reported marked or moderate improvement in 82.3% (344/418) of patients. Adverse events were infrequent, reported by 2.5% of patients with available safety data (9/360).</p><p><strong>Conclusions: </strong>IM etoricoxib was associated with rapid and sustained pain reduction and demonstrated a favorable tolerability profile across a range of acute pain conditions in Indian clinical practice.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789387","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":"Trends in First-Time Symptomatic Antidementia Drug Dispensations to Home-Dwelling People in Norway: A Nationwide Register-Based Study.","authors":"Torunn Gudmestad Øvrebø, Anita L Sunde, Arvid Rongve, Svein Reidar Kjosavik, Ingvild Dalen, Ragnhild Oesterhus","doi":"10.1007/s40801-026-00547-9","DOIUrl":"10.1007/s40801-026-00547-9","url":null,"abstract":"<p><strong>Background: </strong>Symptomatic antidementia drugs can influence cognitive symptoms. According to Norwegian dementia guidelines, general practitioners (GPs) are responsible for assessing, treating, and following up on dementia, with extended assessments provided by specialist healthcare in more complicated cases and for patients under 65 years of age.</p><p><strong>Objective: </strong>The aim of this study was to investigate trends in first-time antidementia drug dispensations to home-dwelling people aged 60 years and older in Norway (2006-2020), and to analyse whether a GP issued the first prescription.</p><p><strong>Methods: </strong>This repeated annual cross-sectional study utilized data from the Norwegian Prescribed Drug Registry (NorPD). Age- and sex-stratified incidence rates of antidementia drugs (ATC N06D) dispensed by Norwegian pharmacies between January 1, 2006, and December 31, 2020, were analysed. The Norwegian GP Registry was linked with NorPD to identify if the prescriber worked as a GP at the time of the first antidementia prescription.</p><p><strong>Results: </strong>In this study, 66,886 individuals received a novel antidementia drug dispensation. The incidence rates of first-time antidementia drug dispensations showed an overall declining trend during the study period. Females accounted for 61.1% of first-time dispensations, with the highest incidence rates observed in the 80-84-years age group across both sexes. Across all age groups, female patients were more likely than male patients to receive their first antidementia prescription from a GP. Patient age had a notable influence on prescriber type, with older people more often receiving their first prescription from a GP compared with younger people.</p><p><strong>Conclusions: </strong>There was a declining trend in the annual incidence rate of antidementia drug dispensations to home-dwelling people. Older age and female sex were associated with an increased likelihood of receiving a first-time symptomatic antidementia drug prescription from a GP.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"159-169"},"PeriodicalIF":2.0,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287347/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580615","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}