Drugs - Real World Outcomes最新文献

{"title":"Omeprazole and Risk of Hypertension: Analysis of Existing Literature and the WHO Global Pharmacovigilance Database.","authors":"Merhawi Bahta, Natnael Russom, Amon Solomon Ghebrenegus, Yohana Tecleab Okubamichael, Mulugeta Russom","doi":"10.1007/s40801-024-00441-2","DOIUrl":"10.1007/s40801-024-00441-2","url":null,"abstract":"<p><strong>Introduction: </strong>The association between omeprazole and hypertension is poorly documented. The summary of product characteristics of omeprazole approved by major regulators did not mention hypertension as an adverse drug event. Triggered by a locally reported case, this study was conducted to assess the possible causal relationship between omeprazole and hypertension.</p><p><strong>Methods: </strong>Globally reported cases of hypertension following use of omeprazole submitted to the World Health Organization global database, VigiBase, were retrieved on 5 March 2024 and analyzed descriptively. Besides this, a literature search was made to identify preclinical, clinical, and epidemiological information on the association between omeprazole and hypertension or increased blood pressure using different data sources. Relevant information, gathered from different data sources, was finally systematically organized into an Austin Bradford-Hill causality assessment framework to assess the causal relationship between omeprazole and hypertension.</p><p><strong>Results: </strong>VigiBase indicated a total of 1043 cases of hypertension related to omeprazole from 36 different countries. In the global database, a statistical signal was triggered (IC₀₂₅: 0.12) on association of omeprazole and hypertension. From the 1043 cases, 65.0% and 10.6% were reported as 'serious' and 'fatal', respectively. Hypertension resolved following withdrawal of omeprazole in 85 cases and recurred after re-introduction of the suspect drug in 14 cases. In 225 cases, omeprazole was the only suspected drug, while in 122 cases, omeprazole was the sole drug administered. When only these 122 cases were considered, 29 cases had positive dechallenge, four cases were with positive rechallenge and the median time-to-onset was 2 days. Literature search identified a possible biological mechanism and some experimental evidence that indicates omeprazole could possibly cause hypertension.</p><p><strong>Conclusion: </strong>Currently available totality of evidence suggests there is a possible causal relationship between omeprazole and hypertension. Hence, it is recommended to monitor and report any incidence of hypertension related to omeprazole, and further epidemiological studies are recommended to corroborate the suggested causal association.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"735-744"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141436676","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":"Assessing the Costs of Intravenous Push Waste in Intraoperative Areas Through Observation: A Multi-site Study.","authors":"John B Hertig, Les Louden, Blake Shay, Armando Soto, Garrett Robbins, Tatyana Kornilova, Prachi Arora","doi":"10.1007/s40801-024-00456-9","DOIUrl":"10.1007/s40801-024-00456-9","url":null,"abstract":"<p><strong>Introduction: </strong>The costs associated with proper disposal, management, and regulatory compliance of controlled substances in healthcare systems are substantial. In the context of the current opioid crisis, and given the high abuse potential of controlled substances, it is imperative that waste is minimized and waste procedures are followed to ensure safe disposal of controlled substances. This study aims to quantify the costs associated with fentanyl, hydromorphone, morphine, midazolam, and ketamine waste in intraoperative areas through a multi-site observational analysis.</p><p><strong>Methods: </strong>The study used an observational design across various hospital procedural and post-procedural units in the Southwest Florida region of the United States. Automated and non-automated workflows for wasting controlled substances were compared. As with a previous study conducted by Hertig et al., waste was evaluated as (1) the quantity (mg/μg) of medication disposed defined as 'pharmaceutical waste' or 'product waste' (PW); and (2) workforce time associated with the waste disposal process defined as 'workforce time waste' (WTW). Secondary measures include workforce costs associated with the waste disposal process. The product waste analysis was conducted between October and December 2023. The workforce time waste analysis was examined over a 10-day period in January and February 2024. A yearly extrapolation model was applied to cost data.</p><p><strong>Results: </strong>The findings revealed substantial costs linked to both PW and WTW, emphasizing the financial burden of controlled substance waste. Study data validated previous literature describing the extent of fentanyl, hydromorphone, and morphine waste while documenting significant amounts of midazolam and ketamine waste. The combined annual waste cost for the two study hospitals was estimated at US$56,557, with workforce time accounting for 36%-50% of this total cost.</p><p><strong>Conclusion: </strong>This study provides vital insights into the financial and operational impact of medication waste in procedural and post-procedural areas, supporting ongoing efforts to minimize waste, ensuring the safe and effective use of controlled substances. Future research should explore the impact of medication waste across diverse healthcare settings and the cost implications associated with pharmacy professionals in the waste compliance process.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"635-645"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589042/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399692","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 Evidence of User Experience with Microenemas for Relief of Constipation.","authors":"Stefanie Rasche, Christer Spegel, Katarina Lundh","doi":"10.1007/s40801-024-00444-z","DOIUrl":"10.1007/s40801-024-00444-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Constipation is a commonly reported gastrointestinal complaint. Research on this widespread condition focuses mainly on clinical trials for chronic constipation with less emphasis on patient experience and nonchronic situations. Sufferers report that constipation interferes with daily activities and quality of life. It is likely that this is common among all sufferers of constipation, regardless of how often the condition is experienced.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This work explored attitudes and perceptions of people who experience occasional constipation and self-treat with over the counter products, particularly Microlax&lt;sup&gt;®&lt;/sup&gt; microenemas.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this retrospective study, real-world data were collected from 1635 respondents from France and Russia who experienced occasional constipation. Participants completed a questionnaire about their experiences with occasional (not chronic) constipation and perceptions of over the counter treatments of oral laxatives, suppositories, and Microlax microenemas. Questions focused on comfort, quality of life, ease of use, and reliability of these treatments. Participants had used the microenema for treatment of occasional constipation within 3 months of study participation. Occasional constipation was based on the Rome IV diagnostic criteria for adults and babies. Data were analyzed across the total population of all groups, then by subgroup. Success criteria were defined as of at least 70% agreement with the statements scoring ≥ 7 on the scale of 0-10. The proportion of respondents agreeing with the individual statements was calculated using the denominator for the total sample within each group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study shows that experiencing even occasional bouts of constipation negatively affect quality of life and well-being. Participants (women aged 25-54 years, older men, and women aged 60-80 years) reported that it severely limited daily life and activities and caused negative emotions and embarrassment. Pregnant women and mothers with babies showed great concern that constipation indicated a serious and painful condition and was bad for their babies. Participants agreed that using Microlax microenema provided greater ease of use, comfort, reliability, and safety than oral laxatives and rectal suppositories.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Sufferers of occasional constipation report that these bouts interfere with their daily lives and reduce quality of life, similar to what is reported for those with chronic constipation based on existing literature. The microenema, Microlax, showed benefits in the relief of occasional constipation compared with oral laxatives and rectal suppositories. Trepidation about using the microenema, experienced before using it, was greatly reduced after the first and subsequent uses. Microlax microenema enabled users to regain the feeling of control and provided positive impacts on ","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"659-667"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589039/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153432","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 Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study.","authors":"Bruno Fautrel, Yoram Bouhnik, Carine Salliot, Franck Carbonnel, Mathurin Fumery, Christophe Bernardeau, Yves Maugars, Mathurin Flamant, Fabienne Coury, Ben Braithwaite, Salima Hateb, Janet Addison","doi":"10.1007/s40801-024-00459-6","DOIUrl":"10.1007/s40801-024-00459-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There is a need for published data on real-world use of SB5, an adalimumab (ADL) biosimilar approved in Europe in 2017, on the basis of evidence from pre-clinical and analytic data as well as phase I and III clinical studies demonstrating equivalent efficacy and comparable pharmacokinetics, safety and immunogenicity profiles as the reference ADL.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The purpose of this study was to estimate patient persistence on SB5 at 12 months post-initiation using clinical and healthcare claims data from the French Système National des Données de Santé (national healthcare claims database, SNDS) in addressing data gaps.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;PERFUSE is a 12-month, observational, multi-centre cohort study of patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases (IMIDs) who initiated routine SB5 treatment between October 2018 and October 2020, either as their first ADL (naïve) or transitioning from another ADL (switched). Clinical data, including disease activity scores, C-reactive protein levels, and dosing information, were collected as available from patient records captured during routine visits to specialist physicians. Persistence data were supplemented with data from the French national healthcare claims database (SNDS). Analyses of clinical data were descriptive, while persistence was assessed using a Kaplan-Meier survival analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Overall, 911 patients were included: 507 from rheumatology centres [116 with rheumatoid arthritis (RA), 78 psoriatic arthritis (PsA), and 313 ankylosing spondylitis (AS)] and 404 from gastroenterology centres [316 with Crohn's disease (CD) and 88 ulcerative colitis (UC)]. Among naïve patients, 12-month remission/low activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, increasing significantly from baseline for all indications (p &lt; 0.05). Switched patients' remission rates remained stable between baseline and month 12 (M12) for all indications (p &gt; 0.05). Persistence (95% CI) at M12 among naïve patients was 59% (46.5, 68.8) for RA, 65% (49.7, 77.1) for PsA, 56% (48.3, 62.6) for AS, 70% (63.0, 75.7) for CD, and 42% (30.7, 53.1) for UC, compared to 60% (42.7, 73.7) for RA, 57% (37.3, 72.1) for PsA, 55% (45.8, 64.0) for AS, 63% (53.4, 71.7) for CD, and 56% (27.2, 77.6) for UC among switched patients. No significant differences were observed between naïve and switched patients (p &gt; 0.05). SNDS pairing provided information on 68 of the 132 patients (52%) who were lost to follow-up in the clinical database, of whom 57 (84%) were confirmed persistent at M12 and 11 (16%) non-persistent. Primary treatment failure (naïve patients) and patient decision (switched patients) were the most common reasons stated for treatment discontinuation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;SB5 provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"573-591"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388851","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":"Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events.","authors":"Colleen M Kingsbury, Ivori Zvorsky, Kevin Spelman","doi":"10.1007/s40801-024-00454-x","DOIUrl":"10.1007/s40801-024-00454-x","url":null,"abstract":"<p><strong>Background: </strong>There is a growing interest in products featuring hemp extracts and a demand for more data regarding their safety. To date, there is a paucity of published data on the safety of these products.</p><p><strong>Methods: </strong>A retrospective analysis of postmarketing surveillance data collected in the United States on full spectrum hemp extract (FSHE) products manufactured by Charlotte's Web (CW) was conducted over an 18-month period (January 2019 to July 2020). The frequency of adverse events (AEs) and serious adverse events (SAEs) was assessed by analyzing AE reports against the estimated number of consumers who purchased products and the total number of products sold.</p><p><strong>Results: </strong>During the 18-month period, approximately 646,391 consumers purchased 1,939,172 products and 431 AEs were reported by 304 individuals. The estimated percentage of consumers who reported at least one adverse event was 0.05%. The percentage of AEs per products sold was 0.02%. Most AEs (98.14%) reported were Grade 1 (i.e., asymptomatic or causing mild symptoms), as classified by the Common Terminology Criteria for Adverse Events. Seven AEs were classified as serious, and the percentage of SAEs per products sold was 0.0004%. None of the reported SAEs were classified as a Grade 4 or Grade 5 (i.e., life threatening or fatal).</p><p><strong>Conclusions: </strong>Approximately 0.05% of consumers who purchased the CW FSHE products from January 2019 to July 2020 reported an adverse event. The percentage of AEs and SAEs per products sold was 0.02% and 0.0004%, respectively. These data demonstrate that CW FSHE products appear to be well tolerated at recommended doses.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"669-678"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343631","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":"Comparison of the Safety of Aspirin Monotherapy and Aspirin and P2Y12 Inhibitor Combination Therapy in Patients Post Coil Embolization During Admission: A Cross-Sectional Study Using a Nationwide Inpatient Database.","authors":"Hiroshi Magara, Yuri Nakamura, Takuaki Tani, Shinobu Imai, Anna Kiyomi, Kensuke Yoshida, Kiyohide Fushimi, Munetoshi Sugiura","doi":"10.1007/s40801-024-00464-9","DOIUrl":"10.1007/s40801-024-00464-9","url":null,"abstract":"<p><strong>Background: </strong>Some aspects regarding the use of antiplatelet agents after coil embolization for subarachnoid hemorrhage during admission remain unclear. This study used diagnostic procedure combination (DPC) data to investigate the safety and prognostic effects of aspirin monotherapy and aspirin and P2Y12 inhibitor combination therapy on bleeding events.</p><p><strong>Methods: </strong>This cross-sectional study used Japanese DPC data to assess patients who were hospitalized with subarachnoid hemorrhage and received aspirin monotherapy and aspirin and P2Y12 inhibitor combination therapy between April 2016 and March 2020 (n = 4421). The aspirin monotherapy (A group, n = 2848) and aspirin and P2Y12 inhibitor combination therapy (AP group, n = 1573) groups were compared. The primary and secondary endpoints were the incidence of bleeding events and proportion of patients with a modified Rankin Scale (mRS) score ≤ 2 at discharge, respectively. Data was analyzed using multivariable adjusted logistic regression (significance level, 5%).</p><p><strong>Results: </strong>The adjusted odds ratio in AP group, with A group as the reference, for bleeding events and the proportion of patients with mRS score ≤ 2 at discharge were 0.97 (95% confidence interval [95% CI]: 0.75-1.26, p = 0.839) and 1.09 (95% CI: 0.92-1.29, p = 0.302), respectively.</p><p><strong>Conclusions: </strong>There are no differences in the incidence of bleeding events or good clinical outcomes (mRS score ≤ 2 at discharge) between aspirin monotherapy and aspirin and P2Y12 inhibitor combination therapy.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"679-689"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544249","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":"A Pharmacovigilance Study on Psychotropic Agent-Induced Urinary Retention Using the Japanese Adverse Drug Event Report Database.","authors":"Shusuke Uekusa, Keika Mogi, Yuki Ota, Yuki Hanai, Kohei Kitagawa, Takashi Yoshio, Kazuhiro Matsuo","doi":"10.1007/s40801-024-00465-8","DOIUrl":"10.1007/s40801-024-00465-8","url":null,"abstract":"<p><strong>Introduction: </strong>Psychotropic drugs have been reported to cause urinary retention (UR) via anticholinergic and other mechanisms. However, UR has not received much attention because of its non-fatal symptoms. We investigated the occurrence of UR associated with psychotropic drugs using the Japanese Adverse Drug Event Report (JADER) database.</p><p><strong>Methods: </strong>Using the JADER database, we calculated reporting odds ratios for UR for 74 psychotropic drugs. Multivariate logistic regression analysis was used to adjust for the effects of sex, underlying disease, and age on UR. Variable selection included forced entry for sex, age, benign prostatic hyperplasia (BPH), depression, and backward-forward stepwise selection for each drug.</p><p><strong>Results: </strong>A total of 887,704 cases were reported, of which 4653 (0.52%) had UR. In terms of sex, 0.79% (3401/429,372 cases) and 0.43% (1797/415,358 cases) of male and female patients had UR. In terms of age, 0.31% (892/288,676 cases) and 0.68% (3463/506,907 cases) of patients aged < 60 years and 60 years or older had UR. Among the underlying diseases, 8.22% (930/11,316 cases) and 0.43% (3723/876,388 cases) of patients with BPH and without BPH had UR, respectively. Further, 1.99% (337/16,959 cases) and 0.50% (4316/870,745 cases) of patients with depression and without depression had UR, respectively. Overall, 38 psychotropic drugs met the criteria for signal detection. In logistic regression, a total of 783,083 patients of discernible age and sex were included. The selected variables were sex, age, BPH, depression, and 23 drugs, including quetiapine [adjusted reporting odds ratio (ROR) 95% confidence interval (CI): 1.46-2.81], chlorpromazine (adjusted ROR 95%CI: 1.29-3.13), etizolam (adjusted ROR 95%CI: 1.47-3.09), maprotiline (adjusted ROR 95%CI: 1.99-8.34), mirtazapine (adjusted ROR 95%CI: 1.37-2.88), and duloxetine (adjusted ROR 95%CI: 2.15-4.21).</p><p><strong>Conclusions: </strong>Many psychotropic drugs induce UR, which may be owing to their pharmacological effects. Appropriate monitoring is needed, especially in patients with other risk factors for UR.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"691-700"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616809","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":"Prognostic Factors in Japanese EGFR Mutation-Positive Non-Small-Cell Lung Cancer: A Real-World Single-Center Retrospective Cohort Study.","authors":"Kenta Takashima, Hiroki Wakabayashi, Yu Murakami, Atsuhito Saiki, Yasuo Matsuzawa","doi":"10.1007/s40801-024-00449-8","DOIUrl":"10.1007/s40801-024-00449-8","url":null,"abstract":"<p><strong>Background: </strong>The prognosis of patients with epidermal growth factor receptor (EGFR) mutation-positive lung cancer has improved significantly since the advent of EGFR tyrosine kinase inhibitors (EGFR-TKIs). We aimed to investigate the relationship between patient characteristics, EGFR genotype, therapeutic agents, and the prognosis of the patients with EGFR mutation-positive lung cancer.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed 198 Japanese patients with unresectable EGFR mutation-positive lung cancer who were treated with EGFR-TKIs at Toho University Sakura Medical Center from April 2006 to December 2021. Factors associated with overall survival (OS) were analyzed using Cox proportional hazards analysis.</p><p><strong>Results: </strong>Patients who received osimertinib had a significantly longer OS than did those not receiving it (median OS, 36.2 versus 20.7 months; p < 0.001).There were significant differences in OS between patients with EGFR mutation who received osimertinib as first-line treatment, T790M-positive patients who received osimertinib as second- or later-line treatment, and those who did not receive it (median OS, 28.2 versus 40.2 versus 20.7 months; p = 0.003). However, in T790M-negative patients, no significant difference in OS was noted between those who did and did not receive osimertinib as post-treatment (median OS, 28.0 versus 40.0 months; p = 0.619). Multivariate Cox proportional hazards analysis showed that osimertinib treatment was associated with longer OS (hazard ratio, 0.480; 95% confidence interval, 0.326-0.707; p < 0.001).</p><p><strong>Conclusion: </strong>The patients who were T790M-positive in the first-line treatment with first or second-generation EGFR-TKIs and were given osimertinib as the second or later line treatment had a better prognosis than the patients who were T790M-negative in the first-line treatment with first or second-generation EGFR-TKIs and could not receive osimertinib.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"603-615"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142092481","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":"Evaluating the Effectiveness of Prophylactic Strategies for Hemophilia A Management: A Real-World, Longitudinal Observational Study.","authors":"Shyh-Shin Chiou, Ching-Yeh Lin, Te-Fu Weng, Jiaan-Der Wang, Sheng-Chieh Chou, Ching-Tien Peng, Pei-Chin Lin, Yu-Mei Liao, Leanne Lai, Ming-Ching Shen","doi":"10.1007/s40801-024-00452-z","DOIUrl":"10.1007/s40801-024-00452-z","url":null,"abstract":"<p><strong>Background: </strong>Hemophilia A (HA) treatment strategies aim to manage bleeding episodes and improve patients' quality of life. This study investigates the effectiveness of a preventative approach using intermediate-dose prophylaxis with standard half-life FVIII products in reducing bleeding rates and enhancing the quality of life for patients with severe HA.</p><p><strong>Methods: </strong>A 4-year prospective longitudinal study followed 35 patients with severe HA (without FVIII inhibitors) who transitioned from a reactive treatment approach to intermediate-dose prophylaxis in Taiwan from 2014 until 2018. The study tracked annual bleeding rates (ABR) and annual joint bleeding rates (AjBR) alongside associated costs and patient-reported quality-of-life measures.</p><p><strong>Results: </strong>Prophylaxis significantly reduced both ABR and AjBR compared with the previous treatment. After one year, ABR and AjBR decreased by 76.9% and 72.5%, respectively, with further reductions to 91.0% and 90.8% after 4 years (p < 0.001). While the average annual cost of factor VIII concentrate increased by 41.0% in the first year, the incremental cost-effectiveness ratio demonstrated ongoing benefits from ABR avoidance over the 4 years. Additionally, patients reported significant improvements in quality-of-life measures following the switch to prophylaxis (p = 0.036).</p><p><strong>Conclusion: </strong>Intermediate-dose prophylaxis effectively reduced bleeding rates and improved quality of life in patients with severe HA. Despite initial cost increases, the intervention became cost effective over time. This study provides valuable data for healthcare policymakers, highlighting the long-term benefits of prophylaxis as a preventative approach for managing bleeding and improving overall well-being in patients with severe HA.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"711-723"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675276","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":"Correction to: Omeprazole and Risk of Hypertension: Analysis of Existing Literature and the WHO Global Pharmacovigilance Database.","authors":"Merhawi Bahta, Natnael Russom, Amon Solomon Ghebrenegus, Yohana Tecleab Okubamichael, Mulugeta Russom","doi":"10.1007/s40801-024-00448-9","DOIUrl":"10.1007/s40801-024-00448-9","url":null,"abstract":"","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"745"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046458","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}