Therapeutics and Clinical Risk Management最新文献

{"title":"Economic Evaluation for Palbociclib Plus Fulvestrant vs Ribociclib Plus Fulvestrant and Abemaciclib Plus Fulvestrant in Endocrine-Resistant Advanced or Metastatic Breast Cancer in Italy.","authors":"Giorgio Lorenzo Colombo,&nbsp;Maria Chiara Valentino,&nbsp;Alessandra Fabi,&nbsp;Maria Vittoria Dieci,&nbsp;Mauro Caruggi,&nbsp;Giacomo Matteo Bruno,&nbsp;Gloria Lombardi,&nbsp;Sergio Di Matteo","doi":"10.2147/TCRM.S391769","DOIUrl":"https://doi.org/10.2147/TCRM.S391769","url":null,"abstract":"<p><strong>Background: </strong>To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestrant (FUL) vs ribociclib (RIB) plus FUL and abemaciclib (ABM) plus FUL in Italy. Cost-effectiveness analysis comparing the three cyclin-dependent 4/6 kinase inhibitors in combination with endocrine therapies for the management of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer in Italy was developed.</p><p><strong>Material and methods: </strong>To assess the cost-effectiveness of PAL plus FUL vs RIB plus FUL and ABM plus FUL, a cost-minimization has been carried out with a conservative scenario considering three CDK4/6 inhibitors with equal effectiveness in terms of overall survival (OS) (MAIC, Rugo et al 2021). Adverse events (AEs) associated with all therapies were obtained from clinical trials. Ad-hoc analysis was performed to estimate the cost-effectiveness considering the quality-of-life (QoL) data (Lloyd et al 2006).</p><p><strong>Results: </strong>Cost-minimization inputs were drugs, visits and exams, AE monitoring and best supportive care (BSC) before the progression state, active and BSC in the progression and terminal phase of the last two weeks of life. Given the comparability of PAL, RIB and ABM in terms of efficacy, this analysis demonstrated slight economic savings over a lifetime for PAL. Results showed saving per patient of €305 (lifetime) when PAL is compared with RIB; for PAL vs ABM a saving of €243 (lifetime) in a conservative scenario. Results of a budget impact analysis showed a potential savings of €319,563 for PAL vs RIB and €297,544 for PAL vs ABM. When QoL data were considered, results may favor PAL due to the lower impact of AE with savings and improvement in the QoL related to fewer AE.</p><p><strong>Conclusion: </strong>From the Italian perspective, a cost-saving profile associated with the use of PAL+FUL for the management of advanced/metastatic HR+/HER2- breast cancer compared to RIB+FUL and ABM+FUL emerged.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"301-312"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/58/33/tcrm-19-301.PMC10066701.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9248508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Safety of Oral Rehydration Solution Jelly for Water and Electrolyte Intake in Patients with Dysphagia.","authors":"Kazuharu Nakagawa,&nbsp;Kanako Yoshimi,&nbsp;Akira Yoshizawa,&nbsp;Kota Aritaki,&nbsp;Kohei Yamaguchi,&nbsp;Ayako Nakane,&nbsp;Haruka Tohara","doi":"10.2147/TCRM.S398281","DOIUrl":"https://doi.org/10.2147/TCRM.S398281","url":null,"abstract":"<p><strong>Purpose: </strong>Oral rehydration solutions (ORSs) are effective in replacing fluids and electrolytes and are widely used. OS-1 Jelly (Otsuka Pharmaceutical Factory, Tokushima, Japan) is a jelly drink corresponding to code 2-1 of the 2021 Japanese Dysphagia Diet. Although jelly drinks are less likely to be aspirated than liquids, their physical properties vary depending on the product. Therefore, the severity of dysphagia may affect intake status. This study aimed to investigate the association between the intake status of ORS jelly and swallowing function.</p><p><strong>Patients and methods: </strong>Thirty-six patients with dysphagia who required videoendoscopic swallowing evaluation at our university hospital were enrolled. Videoendoscopic swallowing evaluation was performed, and each participant swallowed 5 mL of OS-1 Jelly or thickened water modified to International Dysphagia Diet Standardization Initiative (IDDSI) level 2 three times. Statistical analysis was performed to determine the difference in the number of swallows, time until the swallowing reflex, position for inducing the swallowing reflex, presence of pharyngeal residue, penetration, or aspiration between ORS jelly and thickened water.</p><p><strong>Results: </strong>The time until the swallowing reflex was induced and the position of the swallowing reflex triggered were significantly earlier for ORS jelly (<i>p</i>=0.012, <i>p</i>=0.001). The incidence of pharyngeal residue was significantly lower with ORS jelly (<i>p</i>=0.002). The Penetration-Aspiration Scale score was similar for both samples (<i>p</i>=0.062), and no aspiration was observed in either sample.</p><p><strong>Conclusion: </strong>Patients with dysphagia who can swallow thickened water modified to IDDSI level 2 can consume ORS jelly. ORS jelly, which requires no thickening and can be easily and safely consumed, is effective for water and electrolyte intake in patients with dysphagia.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"219-227"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6b/fd/tcrm-19-219.PMC10010143.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9122063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Laparoscopic versus Open Inguinal Hernia Repair in Aging Patients: A Propensity Score Matching-Based Retrospective Study.","authors":"Zipeng Xu,&nbsp;Yong Zhao,&nbsp;Xu Fu,&nbsp;Weidong Hu,&nbsp;Chunlong Zhao,&nbsp;Chen Ge,&nbsp;Hui Ye,&nbsp;Chaobo Chen","doi":"10.2147/TCRM.S423307","DOIUrl":"https://doi.org/10.2147/TCRM.S423307","url":null,"abstract":"Objective Although laparoscopic repair has been widely carried out and promoted due to its minimally invasive advantages, open surgery is still popular compared to elderly patients. This study aims to compare the outcomes of laparoscopic (LIHR) vs open repair of inguinal hernias (OIHR) in elderly patients. Methods A retrospective analysis of the database was performed to identify elderly patients, from January 2021 through December 2022, who underwent surgery for an inguinal hernia. After a 1:1 propensity score matching (PSM) with a caliper of 0.1 was conducted to balance potential bias, binary logistic regressions were used for categorical and continuous outcomes. Results After PSM, 78 pairs of elderly patients were enrolled in this study, and there were no significant differences in baseline between LIHR and OIHR groups. Compared to OIHR, univariable and multivariable logistic regression analysis showed that LIHR was independently affected for reducing intraoperative hemorrhage (OR = 0.06, 95% CI: 0.02–0.18, P < 0.001) and shortening postoperative hospitalization time (OR = 0.29, 95% CI: 0.15–0.57, P < 0.001) in elderly patients. Furthermore, LIHR (OR = 0.28, 95% CI: 0.14–0.57, P < 0.001) and age (OR = 0.89, 95% CI: 0.82–0.96, P = 0.002) were independent affecting factors for relieving postoperative pain. Meanwhile, no obvious differences were detected in postoperative complications [LIHR 7.7% (6/78) vs OIHR 14.1% (11/78), P = 0.199]. Conclusion LIHR was closely associated with reducing intraoperative hemorrhage and shortening postoperative hospitalization time. Whilst LIHR and age were independently affecting factors for relieving postoperative pain.","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"657-666"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d3/4f/tcrm-19-657.PMC10422990.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10001011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality by Design: Development of Safe and Efficacious Full-Thickness Acellular Dermal Matrix Based on EuroGTPII Methodologies.","authors":"Patricia López-Chicón,&nbsp;Maria Luisa Pérez,&nbsp;Cristina Castells-Sala,&nbsp;Ana Rita Piteira,&nbsp;Oscar Fariñas,&nbsp;Jaime Tabera,&nbsp;Anna Vilarrodona","doi":"10.2147/TCRM.S410574","DOIUrl":"https://doi.org/10.2147/TCRM.S410574","url":null,"abstract":"<p><strong>Background: </strong>The activities of tissue establishments are constantly and rapidly evolving. The development of a new type of allograft, full-thickness acellular dermal matrix, with high mechanical properties to be used in tendon repair surgeries and abdominal wall reconstruction, has determined the need for quality by design process in order to assess evidence of quality, safety and efficacy. The EuroGTPII methodologies were specifically tailored to perform the risk assessment, identify and suggest tests in order to mitigate the potential risk consequences of a novel tissue preparation implementation.</p><p><strong>Methods: </strong>The new allograft and associated preparation processes were assessed using the EuroGTP methodologies and characterized to properly evaluate the novelty (Step 1), identify and quantify the potential risks and risk consequences (Step 2), and define the extent of pre-clinical and clinical assessments required to mitigate the risks identified in the assessment (Step 3).</p><p><strong>Results: </strong>Four risk consequences associated with the preparation process were identified: (i) implant failure related with tissue procurement and the reagents used during the decellularization protocol; (ii) unwanted immunogenicity related with the processing; (iii) disease transmission linked with the processing, reagents used, reduction in the reliability of microbiology testing and the storage conditions; and (iv) toxicity related to the reagents used and handling of the tissue during clinical application. The outcome of the risk assessment was a low level of risk. Nevertheless, it determined the need for a series of risk mitigation strategies proposed to reduce each individual risk and to provide additional evidence of the safety and efficacy of full-thickness acellular dermal matrix grafts.</p><p><strong>Conclusion: </strong>EuroGTPII methodologies allow us to identify the risks and ensure the correct definition of pre-clinical assessments required to address and mitigate the potential risk consequences, before proceeding with clinical use of the new allografts in patients.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"567-578"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d5/fb/tcrm-19-567.PMC10325720.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9813053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Accuracy Evaluation Trial of Mixed Reality-Guided Spinal Puncture Technology.","authors":"Jiajun Wu,&nbsp;Lei Gao,&nbsp;Qiao Shi,&nbsp;Chunhui Qin,&nbsp;Kai Xu,&nbsp;Zhaoshun Jiang,&nbsp;Xixue Zhang,&nbsp;Ming Li,&nbsp;Jianjian Qiu,&nbsp;Weidong Gu","doi":"10.2147/TCRM.S416918","DOIUrl":"https://doi.org/10.2147/TCRM.S416918","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the accuracy of mixed reality (MR)-guided visualization technology for spinal puncture (MRsp).</p><p><strong>Methods: </strong>MRsp involved the following three steps: 1. Lumbar spine computed tomography (CT) data were obtained to reconstruct virtual 3D images, which were imported into a HoloLens (2nd gen). 2. The patented MR system quickly recognized the spatial orientation and superimposed the virtual image over the real spine in the HoloLens. 3. The operator performed the spinal puncture with structural information provided by the virtual image. A posture fixation cushion was used to keep the subjects' lateral decubitus position consistent. 12 subjects were recruited to verify the setup error and the registration error. The setup error was calculated using the first two CT scans and measuring the displacement of two location markers. The projection points of the upper edge of the L3 spinous process (L3↑), the lower edge of the L3 spinous process (L3↓), and the lower edge of the L4 spinous process (L4↓) in the virtual image were positioned and marked on the skin as the registration markers. A third CT scan was performed to determine the registration error by measuring the displacement between the three registration markers and the corresponding real spinous process edges.</p><p><strong>Results: </strong>The setup errors in the position of the cranial location marker between CT scans along the left-right (LR), anterior-posterior (AP), and superior-inferior (SI) axes of the CT bed measured 0.09 ± 0.06 cm, 0.30 ± 0.28 cm, and 0.22 ± 0.12 cm, respectively, while those of the position of the caudal location marker measured 0.08 ± 0.06 cm, 0.29 ± 0.18 cm, and 0.18 ± 0.10 cm, respectively. The registration errors between the three registration markers and the subject's real L3↑, L3↓, and L4↓ were 0.11 ± 0.09 cm, 0.15 ± 0.13 cm, and 0.13 ± 0.10 cm, respectively, in the SI direction.</p><p><strong>Conclusion: </strong>This MR-guided visualization technology for spinal puncture can accurately and quickly superimpose the reconstructed 3D CT images over a real human spine.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"599-609"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/08/83/tcrm-19-599.PMC10361284.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9861992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of Liver Venous Deprivation Following Transarterial Chemoembolization Before Major Hepatectomy for Hepatocellular Carcinoma.","authors":"Than-Van Sy,&nbsp;Le Thanh Dung,&nbsp;Bui-Van Giang,&nbsp;Nguyen Quang Nghia,&nbsp;Ninh Viet Khai,&nbsp;Cao Manh Thau,&nbsp;Pham Gia Anh,&nbsp;Trinh Hong Son,&nbsp;Nguyen Minh Duc","doi":"10.2147/TCRM.S411080","DOIUrl":"https://doi.org/10.2147/TCRM.S411080","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate the safety and efficacy of liver venous deprivation (LVD) following transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).</p><p><strong>Methods: </strong>Between January 2021 and December 2022, HCC patients indicated for hepatectomy with initial insufficient future liver remnant (FLR) underwent LVD after TACE to induce preoperative liver hypertrophy.</p><p><strong>Results: </strong>Twenty-seven HCC patients with a median age of 55 years underwent LVD. No TACE or LVD procedure-associated complications occurred, except for 1 case presenting with grade A liver failure after LVD (then recovered after 7 days). The FLR volume was 29.3% (interquartile range [IQR] = 7.5) and 48.9% (IQR = 8.6) of the total liver volume before and after LVD, respectively (p < 0.001). The degree of hypertrophy and FLR hypertrophy rate were 14.8% (IQR = 8.4) and 55.2% (IQR = 36.7), respectively. All 27 patients demonstrated sufficient FLR after LVD (24 patients at three weeks post-LVD, one at six weeks, and two at ten weeks), but only 21 patients accepted surgery. Postoperative histopathology showed 16 patients with cirrhosis and five with mild fibrosis (F1, F2). One patient presented with severe intraoperative bleeding due to damage of left hepatic vein and developed grade C liver failure, then died on day 32 postoperation.</p><p><strong>Conclusion: </strong>LVD following TACE seems to be a safe, effective, and feasible method of inducing significant FLR regeneration in HCC, even in well-selected cirrhotic livers. Comparative studies with a large patient population and multicenter data are needed for further evaluation.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"425-433"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d6/33/tcrm-19-425.PMC10202697.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9896923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Status and Future Directions of Therapeutics and Prognosis of Cardiac Amyloidosis.","authors":"Wenbing Zhang,&nbsp;Jian Ding,&nbsp;Wenhai Wang,&nbsp;Duo Wang,&nbsp;Yinping Pan,&nbsp;Dexin Xu","doi":"10.2147/TCRM.S414821","DOIUrl":"https://doi.org/10.2147/TCRM.S414821","url":null,"abstract":"<p><p>Accumulation of aberrant proteins in the heart causes cardiac amyloidosis, an uncommon and complicated illness. It can be classified into two main types: light chain (AL) and transthyretin (ATTR). The diagnosis of cardiac amyloidosis is challenging due to its non-specific clinical presentation and lack of definitive diagnostic tests. Diagnostic accuracy has increased with the advent of modern imaging methods, including cardiac magnetic resonance imaging (MRI) and positron emission tomography (PET) scans. Depending on the severity of cardiac amyloidosis, a number of treatments may be attempted and specified according to the subtype of amyloidosis and the presence of complications. However, there are still significant challenges in treating this condition due to its complexity and lack of effective treatments. The prognosis for patients with cardiac amyloidosis is poor. Despite recent advances in diagnosis and treatment, there is still a need for more effective treatments to improve outcomes for patients with this condition. Therefore, we aim to review the current and future therapeutics reported in the literature and among ongoing clinical trials recruiting patients with CA.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"581-597"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f9/e9/tcrm-19-581.PMC10348342.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9816666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PTH Predicts the in-Hospital MACE After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction.","authors":"Zu-Fei Wu,&nbsp;Wen-Tao Su,&nbsp;Shi Chen,&nbsp;Bai-Da Xu,&nbsp;Gang-Jun Zong,&nbsp;Cun-Ming Fang,&nbsp;Zheng Huang,&nbsp;Xue-Jun Hu,&nbsp;Gang-Yong Wu,&nbsp;Xiao-Lin Ma","doi":"10.2147/TCRM.S420335","DOIUrl":"https://doi.org/10.2147/TCRM.S420335","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the correlation between serum parathyroid hormone (PTH) levels and in-hospital major adverse cardiovascular events (MACE) in patients with acute ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI), and establish a risk prediction model based on parameters such as PTH for in-hospital MACE.</p><p><strong>Methods: </strong>This observational retrospective study consecutively enrolled 340 patients who underwent primary PCI for STEMI between January 2016 and December 2020, divided into a MACE group (n=92) and a control group (n=248). The least absolute shrinkage and selection operator (LASSO) and logistic regression analyses were used to determine the risk factors for MACE after primary PCI. The rms package in R-studio statistical software was used to construct a nomogram, to detect the line chart C-index, and to draw a calibration curve. The decision curve analysis (DCA) method was used to evaluate the clinical application value and net benefit.</p><p><strong>Results: </strong>Correlation analysis revealed that PTH level positively correlated with the occurrence of in-hospital MACE. Receiver operating characteristic curve analyses revealed that PTH had a good predictive value for in-hospital MACE. Multivariate logistic regression analysis indicated that Killip class II-IV, and FBG were independently associated with in-hospital MACE after primary PCI. A nomogram model was constructed using the above parameters. The model C-index was 0.894 and the calibration curve indicated that the model was well calibrated. The DCA curve suggested that the nomogram model was better than TIMI score model in terms of net clinical benefit.</p><p><strong>Conclusion: </strong>Serum PTH levels in patients with STEMI are associated with in-hospital MACE after primary PCI, and the nomogram risk prediction model based on PTH demonstrated good predictive ability with obvious clinical practical value.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"699-712"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/24/e0/tcrm-19-699.PMC10460584.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10467189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medications and Food Interfering with the Bioavailability of Levothyroxine: A Systematic Review.","authors":"Hanqing Liu,&nbsp;Man Lu,&nbsp;Jiawei Hu,&nbsp;Guangzhao Fu,&nbsp;Qinyu Feng,&nbsp;Shengrong Sun,&nbsp;Chuang Chen","doi":"10.2147/TCRM.S414460","DOIUrl":"https://doi.org/10.2147/TCRM.S414460","url":null,"abstract":"<p><strong>Purpose: </strong>Levothyroxine is a common prescribed drug. Many medications and food, however, can interfere with its bioavailability. The aim of this review was to summarize the medications, food and beverages that interact with levothyroxine and to assess their effects, mechanisms and treatments.</p><p><strong>Methods: </strong>A systematic review on interfering substances that interact with levothyroxine was performed. Web of Science, Embase, PubMed, the Cochrane library, grey literature from other sources and the lists of references were searched for human studies comparing the levothyroxine efficacy with and without interfering substances. The patient characteristics, drug classes, effects and mechanism were extracted. The NHLBI study quality assessment tools and the JBI critical appraisal checklist were used to assess the quality of included studies.</p><p><strong>Results: </strong>A total of 107 articles with 128 studies were included. Drugs interactions were revealed in calcium and iron supplements, proton pump inhibitors, bile acid sequestrants, phosphate binders, sex hormones, anticonvulsants and other drugs. Some food and beverage could also induce malabsorption. Proposed mechanisms included direct complexing, alkalization, alteration of serum thyroxine-binding globulin levels and acceleration of levothyroxine catabolism via deiodination. Dose adjustment, administration separation and discontinuation of interfering substances can eliminate the interactions. Liquid solutions and soft-gel capsules could eliminate the malabsorption due to chelation and alkalization. The qualities of most included studies were moderate.</p><p><strong>Conclusion: </strong>Lots of medications and food can impair the bioavailability of levothyroxine. Clinicians, patients and pharmaceutical companies should be aware of the possible interactions. Further well-designed studies are needed to provide more solid evidence on treatment and mechanisms.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"503-523"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/69/7a/tcrm-19-503.PMC10295503.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9735945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nomograms Based on Non-High-Density Lipoprotein to Predict Outcomes in Patients with Prior Coronary Artery Bypass Grafting with Acute Coronary Syndrome: A Single-Center Retrospective Study.","authors":"Chuang Li,&nbsp;Kuizheng He,&nbsp;Yixing Yang,&nbsp;Kuibao Li,&nbsp;Mulei Chen,&nbsp;Lefeng Wang,&nbsp;Xiaorong Xu,&nbsp;Weiming Li","doi":"10.2147/TCRM.S389694","DOIUrl":"https://doi.org/10.2147/TCRM.S389694","url":null,"abstract":"<p><strong>Introduction: </strong>Non-high-density-lipoprotein cholesterol (non-HDL-C) is a secondary therapeutic target in cardiovascular diseases and is used for residual risk assessment in patients with coronary artery syndrome (ACS). This study was designed to determine the association between non-HDL-C in patients with prior coronary artery bypass graft (CABG) with ACS and clinical outcomes.</p><p><strong>Methods: </strong>We retrospectively analyzed 468 patients with prior CABG with ACS and categorized them into two groups based on the median non-HDL-C level. The primary endpoints were major adverse cardiovascular events (MACEs), including cardiovascular death and recurrent myocardial infarction. Kaplan-Meier curves, Cox proportional-hazard regressions, and restricted cubic splines were used to determine the association between non-HDL-C and MACEs. The discrimination and reclassification of the nomogram based on non-HDL-C were assessed using time-dependent receiver operating characteristic (ROC) curves and net reclassification improvement (NRI).</p><p><strong>Results: </strong>During the average follow-up time of 744.5 days, non-HDL-C was independently associated with the occurrence of MACEs (hazard ratio [HR] = 5.01, 95% confidence interval [CI] = 1.65-15.24; <i>p</i> = 0.005) after adjusting for other lipid parameters. The spline curves indicated a linear relationship between non-HDL-C and MACEs (p-nonlinear: 0.863). The time-dependent areas under the ROC curves of prior-CABG-ACS nomograms containing non-HDL regarding MACEs in two consecutive years were 91.7 (95% CI: 85.5-97.9) and 91.5 (95% CI: 87.3-95.7), respectively. The NRI analysis indicated that the prior-CABG-ACS model improved the reclassification ability for 1- and 2-year MACEs (22.4% and 7%, <i>p</i> < 0.05, respectively).</p><p><strong>Discussion: </strong>Non-HDL is independently associated with the risk of MACEs in patients with prior CABG with ACS. The prior-CABG-ACS nomogram based on non-HDL-C and five convenient variables generates valid and stable predictions of MACE occurrence.</p>","PeriodicalId":48769,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"19 ","pages":"15-26"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/4d/tcrm-19-15.PMC9830084.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10581886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}