Current Medical Research and Opinion最新文献

{"title":"Glucagon-like peptide 1 receptor agonists modestly reduced low-density lipoprotein cholesterol and total cholesterol levels independent of weight reduction: a meta-analysis and meta-regression of placebo controlled randomized controlled trials.","authors":"Frederick Berro Rivera, Marielle Nicole Cabusas Chin, Polyn Luz S Pine, Monica Marie Jadena Ruyeras, Danica Janine Cabahug Galang, Keshia Marice Gandionco, Benna Lynn Faye D Morales, Zackaree Michael V Climaco, Nathan Ross Baoy Bantayan, John Vincent Magalong, Gerard Francis Mangubat, Kenneth Ong","doi":"10.1080/03007995.2024.2442027","DOIUrl":"10.1080/03007995.2024.2442027","url":null,"abstract":"<p><strong>Background: </strong>The effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on lipid components are unclear. We aim to quantify the lipid lowering effects of GLP1-RAs.</p><p><strong>Methods: </strong>A comprehensive database search for placebo-controlled randomized controlled trials (RCTs) on GLP-1RA treatment was conducted until January 2023. Data extraction and quality assessment were performed, and outcomes were analyzed using a random-effects model to calculate weighted mean differences (MDs) in milligrams per deciliter (mg/dl) and 95% confidence intervals (CIs). The primary endpoint was the mean difference in low-density lipoprotein cholesterol (LDL-C). Secondary endpoints included total cholesterol (TC), triglycerides, high density lipoprotein-C (HLD-C), and very low-density lipoprotein-C (VLDL-C). Subgroup analyses and meta-regression accounted for covariates.</p><p><strong>Results: </strong>GLP-1RAs modestly reduced LDL-C (MD -2.93, 95% CI (-5.01, -0.85), <i>p</i> = 0.01), consistent across treatment durations: ≤12 weeks (MD: -5.39, 95% CI (-10.36, -0.42), <i>p</i> = 0.03) and >12 weeks (MD: -2.39, 95% CI (-4.70, -0.007), <i>p</i> = 0.04). GLP-1RA reduced TC by ∼7 mg/dl. There was no significant reduction in triglycerides (MD = -7.19, 95% CI (-15.01, 0.62), <i>p</i> = 0.07) or VLDL-C (MD = -3.99, 95%, CI (-8.73, 0.75), <i>p</i> = 0.10). GLP-1RA did not increase HDL-C (MD = -0.12, 95% CI (-0.73, 0.49), <i>p</i> = 0.69). Weight change did not influence LDL-C (tau2 = 28.38, I2 = 99.83, R2 = 0.0, <i>p</i> = 0.67) or TC (tau2 = 93.6, I2 = 99.86, R2 = 0.0, <i>p</i> = 0.92).</p><p><strong>Conclusion: </strong>GLP-1RA treatment modestly decreased LDL-C and TC but did not significantly affect triglycerides, VLDL-C, or HDL-C.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-13"},"PeriodicalIF":2.4,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sting operations in biomedical publishing violate truthfulness and undermine trust in research.","authors":"Jaime A Teixeira da Silva, Jens C Türp, Timothy Daly","doi":"10.1080/03007995.2024.2441340","DOIUrl":"10.1080/03007995.2024.2441340","url":null,"abstract":"<p><p>Biomedical research cannot function without the trust of peers and society. The truthfulness of claims made by knowledge-producing agents, such as authors of research, is a prerequisite for their trustworthiness, and violations of truthfulness are rightly seen as a threat to the existence and validity of such research. While most reflection on the lack of truthfulness has focused on fake research, little attention has been paid to how sting operations and hoaxes arguably pose an equally great risk to the ethical integrity of publishing. This paper posits that sting operations, like fake research, are examples of breaches of truthfulness. We also argue that for both fake research, as well as stings and hoaxes, the lack of respect for the ethical criterion of truthfulness makes those researchers who engage in them untrustworthy. Sting operations are akin to fighting fire with fire, further undermining trust in biomedical research. From a deontological perspective, we also argue that the reliance on anonymity in sting operations makes them just as bad, if not worse, than fake research. We advocate for critical scholarship as an alternative to hoaxes and sting operations to expose fake research, in order to promote truthfulness rather than violate it. Finally, we argue that journalists reporting on sting operations should insist less on their entertainment and sensationalist value, and focus more on their unethical nature.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-8"},"PeriodicalIF":2.4,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare resource utilization and related cost of non-HIV comorbidity management in people with HIV in a Spanish cohort from 2007-2016.","authors":"Yusnelkis Milanés-Guisado, Francisco Jódar-Sánchez, David J Sánchez-Pardo, Karin Neukam, Antonio Castro-Gómez, Luis Fernando López-Cortés","doi":"10.1080/03007995.2024.2438261","DOIUrl":"10.1080/03007995.2024.2438261","url":null,"abstract":"<p><strong>Objective: </strong>To estimate the cost and healthcare resource utilization (HRU) associated with the prevalence of comorbidities in people living with HIV (PLWH) in a Spanish cohort over ten years.</p><p><strong>Methods: </strong>A cohort study carried out at the HIV outpatient clinic of the University Hospital Virgen del Rocío based on data collected during 2007-2016. PLWH with at least one follow-up visit were included. Comorbidities were determined by examining diagnostic codes in the electronic medical records. Costs were estimated from hospitalizations, emergency and non-HIV visits, laboratory tests for conditions unrelated to HIV infection, HIV antiretroviral therapy, and other non-HIV diagnostic tests. A linear regression was performed with non-ART costs as the dependent variable and patient characteristics (sex, HIV transmission route, age, CD4, comorbidities, and infection duration) as independent variables.</p><p><strong>Results: </strong>The study included 2,798 PLWH; 83% were men with a mean age of 38.6 years. Overall, 52.5% of PLWH had at least one non-HIV comorbidity and 21.2% had ≥3 comorbidities. The most prevalent comorbidities were hepatitis C (25.3%) and hypertension (22.9%). The presence of comorbidities increased the total healthcare cost up to 80% in PLWH with ≥3 comorbidities compared with those without comorbidities (over a 10-year period (115,867.3€ vs 64,290.7€, <i>p</i> < .001). The number of comorbidities was linked to higher healthcare costs in PLWH in the adjusted model.</p><p><strong>Conclusion: </strong>Comorbidities raised the total healthcare costs for PLWH, with a greater impact on those with multiple comorbidities compared to those with few or none. Both clinical and economic decision-makers must consider and assess the cost of comorbidities when evaluating HIV treatment guidelines or recommendations.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-10"},"PeriodicalIF":2.4,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dupilumab improves sense of smell and clinical outcomes in patients with severe chronic rhinosinusitis with nasal polyps with anosmia.","authors":"Andrew P Lane, Joaquim Mullol, Claire Hopkins, Wytske J Fokkens, Stella E Lee, Jerome Msihid, Scott Nash, Harry Sacks, Kinga Borsos, Siddhesh Kamat, Paul J Rowe, Yamo Deniz, Juby A Jacob-Nara","doi":"10.1080/03007995.2024.2434083","DOIUrl":"10.1080/03007995.2024.2434083","url":null,"abstract":"<p><strong>Objective: </strong>Loss of sense of smell is a cardinal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP) and significantly impacts health-related quality-of-life. Dupilumab significantly improved smell outcomes (loss of smell [LoS] score; University of Pennsylvania Smell Identification Test [UPSIT]) versus placebo in the phase 3 SINUS-24/-52 studies (clinicaltrials.gov, NCT02898454/NCT02912468) in patients with severe CRSwNP. This post hoc analysis investigated the effect of dupilumab on olfaction using UPSIT smell impairment categories.</p><p><strong>Methods: </strong>Patients with baseline smell impairment (UPSIT ≤34/≤33 [women/men; score range 0-40] AND LoS score ≥1 [0-3] AND smell/taste item of the 22-item Sinonasal Outcome Test >0 [SNOT-22; 0-5]) treated with dupilumab 300 mg or placebo once every 2 weeks on background intranasal corticosteroids were analyzed.</p><p><strong>Results: </strong>Of 724 patients, 665 (91.9%) had smell impairment at baseline; most had anosmia (UPSIT 0-18) (dupilumab/placebo: 80.9%/79.8%). At week 24, the proportion of dupilumab-treated patients with anosmia decreased to 28.5%, while 14.9% achieved normosmia; most placebo-group patients (79.2%) remained anosmic and only 1.2% achieved normosmia (odds ratio = 17.3; 95% confidence interval = 5.1-59.0; <i>p</i> <.0001); results were similar at week 52. Improvements in Nasal Polyp Score, nasal congestion, and SNOT-22 total score were moderately correlated with improvements in UPSIT at weeks 24 and 52 (r = -.38 to -.50).</p><p><strong>Conclusion: </strong>Most patients with severe CRSwNP had anosmia at baseline. Dupilumab treatment significantly improved smell versus placebo, with 14.9% achieving normosmia by week 24. There was a trend for better clinical outcomes in patients with greater smell improvement.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-7"},"PeriodicalIF":2.4,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of lebrikizumab combined with topical corticosteroids in Japanese patients with moderate-to-severe atopic dermatitis: a phase 3, double-blind, placebo-controlled, randomized clinical trial (ADhere-J).","authors":"Norito Katoh, Akio Tanaka, Hidetoshi Takahashi, Ryosuke Shimizu, Yoko Kataoka, Hitoe Torisu-Itakura, Yoji Morisaki, Ken Igawa","doi":"10.1080/03007995.2024.2436982","DOIUrl":"10.1080/03007995.2024.2436982","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate efficacy and safety of lebrikizumab combined with topical corticosteroids (TCS) in Japanese patients with moderate-to-severe atopic dermatitis (AD).</p><p><strong>Methods: </strong>Phase 3, randomized, double-blind, placebo-controlled study (ADhere-J; NCT04760314) conducted at 37 centers in Japan (March 2021-February 2023), comprising 16-week induction (reported herein) and 52-week maintenance periods. Overall, 286 patients aged ≥12 years and ≥40 kg were randomized (interactive web response system) to subcutaneous placebo, lebrikizumab 250 mg every 4 weeks (Q4W), or lebrikizumab 250 mg every 2 weeks (Q2W) with TCS (82, 81, and 123 patients, respectively). Coprimary endpoints were proportions of patients achieving (1) Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with ≥2-point improvement from baseline, and (2) ≥75% improvement from baseline in Eczema Area and Severity Index (EASI 75) at week 16.</p><p><strong>Results: </strong>At week 16, compared with placebo, a significantly greater proportion of the lebrikizumab Q4W and Q2W groups achieved IGA (0,1) (6.1% vs. 29.1% and 33.4%, respectively; both <i>p</i> < 0.001) and EASI 75 (13.4% vs. 47.2% and 51.2%, respectively; both <i>p</i> < 0.001). Serious adverse events (AEs) occurred in 2.4%, 0%, and 0.8% of placebo, lebrikizumab Q4W and Q2W groups, respectively. Common treatment-emergent AEs, including pyrexia (placebo: 15.9%; lebrikizumab Q4W/Q2W: 18.5%/20.3%), conjunctivitis allergic (placebo: 4.9%; lebrikizumab Q4W/Q2W: 12.3%/17.1%), and conjunctivitis (placebo: 2.4%; lebrikizumab Q4W/Q2W: 6.2%/9.8%), were more frequent with lebrikizumab; most were mild or moderate.</p><p><strong>Conclusion: </strong>Consistent with global data, lebrikizumab demonstrated clinical improvements with a positive benefit-risk profile in Japanese adults and adolescents with moderate-to-severe AD through 16 weeks.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-12"},"PeriodicalIF":2.4,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction.","authors":"","doi":"10.1080/03007995.2024.2441012","DOIUrl":"https://doi.org/10.1080/03007995.2024.2441012","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1"},"PeriodicalIF":2.4,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Changes in serum uric acid, glutathione, and amyloid-β1-42 levels in Parkinson's disease patients and their association with disease progression and cognitive decline.","authors":"Qianqian He, Zhaoting Zhang, Bing Fu, Jiechun Chen, Jianhua Liu","doi":"10.1080/03007995.2024.2422002","DOIUrl":"10.1080/03007995.2024.2422002","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to evaluate the diagnostic significance of serum uric acid (UA), glutathione (GSH), and amyloid-β1-42 (Aβ1-42) levels in relation to disease progression and cognitive impairment in patients with Parkinson's disease (PD).</p><p><strong>Methods: </strong>A total of 209 PD patients with disease duration ranging from 4.0 to 6.8 years were enrolled. Based on the Hoehn-Yahr staging system, patients were classified into Early (<i>n</i> = 67), Medium-term (<i>n</i> = 70), and Advanced (<i>n</i> = 72) stages. Cognitive function was assessed using the Mini-Mental State Examination (MMSE), dividing the cohort into CD (cognitive dysfunction, <i>n</i> = 94) and NO-CD (no cognitive dysfunction, <i>n</i> = 115) groups. Serum UA, GSH, and Aβ1-42 levels were analyzed for correlations with clinical data. Independent risk factors and diagnostic value were determined through multivariable logistic regression models and receiver operating characteristic curve analysis.</p><p><strong>Results: </strong>Serum UA and GSH levels progressively declined with advancing disease stage, while Aβ1-42 increased. Compared to the NO-CD group, the CD group showed lower serum UA and GSH levels, and higher Aβ1-42 levels. Serum UA and GSH were inversely correlated with disease duration, levodopa equivalent daily dose, and Unified Parkinson's Disease Rating Scale scores, while Aβ1-42 showed positive correlations. UA (<i>p</i> = 0.006), GSH (<i>p</i> < 0.001), and Aβ1-42 (<i>p</i> = 0.040) were independent predictors of disease stage. Similarly, UA (<i>p</i> = 0.003), GSH (<i>p</i> < 0.001), and Aβ1-42 (<i>p</i> < 0.001) were independent predictors of cognitive dysfunction. The combined assessment of these markers demonstrated a higher area under the curve (AUC) than individual markers for disease and cognitive decline identification.</p><p><strong>Conclusions: </strong>Serum UA, GSH, and Aβ1-42 are independent predictors of disease progression and cognitive decline in PD patients. Their combined use offers enhanced diagnostic accuracy for disease staging and cognitive impairment in PD.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-9"},"PeriodicalIF":2.4,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Tango to Modern Collaboration and Patient-Centric Value Generation in Health Care - a real-world guide from practitioners for practitioners.","authors":"Lisa Hefti, Hanna Boëthius, Detlef Loppow, Nakisa Serry, Rocio Martin, Katrin Rupalla, Dietmar Krämer, Isabelle Juchler, Caitlin Masters, Verena Voelter","doi":"10.1080/03007995.2024.2433245","DOIUrl":"10.1080/03007995.2024.2433245","url":null,"abstract":"<p><strong>Background: </strong>Value-Based Health Care (VBHC) represents a pivotal shift from volume-based to outcome-driven quality metrics centered on patient-valued outcomes. This approach requires collaboration across all participants in the health care value chain; providers, payers, pharma, policymakers and patients (collectively known as the 5Ps). Despite substantial theoretical endorsement of VBHC's potential for improving health outcomes and system efficiency, empirical evidence detailing its practical implementation remains limited. This field study evaluates the real-word implementation of VBHC within a health care organization.</p><p><strong>Methods: </strong>In 2022, a health care collaboration Think Tank initiated this investigation during a breakout session, gathering insights from 12 leading international organizations to construct an empirical VBHC transformation reference guide. Real-world data was collected through structured interviews over a 1-year period, covering the 5 P value chain in various healthcare settings. The VBHC initiatives were analyzed through four stages: initiation, data acquisition, collaborative frameworks, and results evaluation.</p><p><strong>Results: </strong>The 12 interviews identified five key enablers for successful VBHC implementation: 1. Organizational Purpose: defining core motivators for change; 2. People: identifying pivotal roles and leadership to endorse change; 3. Resources: securing personnel and financial support; 4. Data Infrastructure: developing interoperable IT systems for effective data sharing and collection; 5. Execution: prioritizing sustained implementation processes.</p><p><strong>Conclusion: </strong>The findings highlight that VBHC implementation and adoption is complex and requires incremental advancements, dedicated leadership, and resilient strategic framework spanning over multiple years. A comprehensive understanding of patient populations, risk stratification, and appropriate outcome metrics are essential to measure and deliver the VBHC transformation. Executive endorsement and transition funding during the transformation process are paramount to support this systemic shift. Collaboration among all 5 P stakeholders is essential for success. This field study underscores the importance of continuous learning and adaptation, providing a practical guide to enhance health care quality and efficiency that serves all stakeholders.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-11"},"PeriodicalIF":2.4,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142715513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling the chasm of economic burden from metastatic prostate cancer through a nationwide retrospective cohort study.","authors":"Hyunha Kang, Nayoung Kwak, Eunjung Choo, Sung-Hee Oh, Jiwon Sophie Lee, Chang Wook Jeong, Hankil Lee","doi":"10.1080/03007995.2024.2425059","DOIUrl":"10.1080/03007995.2024.2425059","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the clinical and economic consequences of the progression to castration-resistant status for patients with metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC) in South Korea.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted using National Health Insurance claims data from 2013 to 2021. Patients defined as newly diagnosed with mHSPC had an index date of first claim for metastatic PC between 2015 and 2016 and no exposure to CRPC medicines during the washout period. All-cause monthly medical and end-of-life costs were described for mHSPC and mCRPC. Descriptive statistics were used to analyze medical costs, and generalized estimating equations were used to evaluate the correlation between medical costs and significant variables, including disease progression, death, and clinical characteristics.</p><p><strong>Results: </strong>Of the 3,739 patients with mHSPC included (mean 72.9 years), 779 progressed to mCRPC. The overall study population underwent a median 60.48-month follow-up period. The average monthly medical cost depending on CRPC progression was 1.5 times higher in the mCRPC than in the mHSPC group ($1,734.2 vs. $1,185.4). Monthly medical costs for those who progressed to mCRPC were 2.4 times higher one year after progression than one year before. In all groups, the average total medical costs gradually increased near mortality. Disease progression and death had a significant correlation with medical costs, by 1.7 times and 2.46 times, respectively.</p><p><strong>Conclusion: </strong>This study highlights the economic and health benefits of preventing progression to castration resistance in patients with mHSPC based on real-world data.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"2155-2162"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tapentadol: navigating the complexities of abuse, patient safety & regulatory measures.","authors":"Jaishree Suresh, Shatrunajay Shukla, Kalaiselvan Vivekanandan, Rajeev Singh Raghuvanshi","doi":"10.1080/03007995.2024.2427881","DOIUrl":"10.1080/03007995.2024.2427881","url":null,"abstract":"<p><strong>Aim: </strong>To evaluate tapentadol abuse cases by analyzing real-world data and identifying under-reporting countries from Southeast Asian Region (SEAR) to enhance vigilance.</p><p><strong>Method: </strong>A retrospective, observational study from 2013 to March 2024 using VigiBase was conducted.</p><p><strong>Result: </strong>Tapentadol-related abuse falls within the System Organ Class (SOC) categories of psychiatric disorder, nervous system disorder and injury, poisoning, and procedural complications. These are further categorized into Preferred Terms (PT) such as anxiety, delirium, Central Nervous System toxicity, depressive disorder, drug abuse, dependence/withdrawal syndrome, and overdose using the Medical Dictionary for Regulatory Activities (MedDRA) system. Among the 11 countries in the SEAR, India is the only country to report cases of tapentadol-related abuse, no Individual Case Safety Reports (ICSRs) related to tapentadol abuse have been submitted from other SEAR nations. Out of 127 ICSRs concerning tapentadol-related adverse events reported in India, 20 cases involved abuse. Focusing on the ICSRs submitted in India, the reported adverse reactions included anger(<i>n</i> = 1,10%), anxiety (<i>n</i> = 2, 10%), delirium (<i>n</i> = 1, 5%), drug abuse (<i>n</i> = 4, 20%), drug dependence/withdrawal syndrome (<i>n</i> = 7, 35%), intentional overdose (<i>n</i> = 2, 10%), depressive disorder (<i>n</i> = 1, 5%), euphoric mood (<i>n</i> = 1, 5%), and product misuse (<i>n</i> = 1, 5%) indicating a concerning pattern of substance abuse.</p><p><strong>Conclusion: </strong>Stringent regulatory actions are needed to curb this practice in India, such as rescheduling tapentadol from Schedule H (Prescription drugs) to Schedule X(Narcotic drugs) in India could offer more regulatory oversight and measures to reduce risks related to abuse, addiction, and dependence while enhancing patient safety in pain management practices. Additionally, tapentadol should be closely monitored in other SEAR countries due to its potential for dependence. This study also emphasizes the importance of encouraging SEAR countries to report more Adverse Drug Reactions (ADRs), which would facilitate the implementation of more rigorous regulatory measures.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"2201-2207"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}