Current Therapeutic Research-clinical and Experimental最新文献

{"title":"Immunogenicity and Potential for Intraocular Inflammation of Intravitreal Anti-VEGF Drugs","authors":"Hyeong Min Kim MD, MSc ,&nbsp;Se Joon Woo MD, PhD","doi":"10.1016/j.curtheres.2024.100742","DOIUrl":"10.1016/j.curtheres.2024.100742","url":null,"abstract":"<div><h3>Background</h3><p>Concerns of intraocular inflammation associated with intravitreal administration of anti-VEGF drugs have been risen and the exact mechanism is not yet elucidated.</p></div><div><h3>Objective</h3><p>To explore the relationship between immunogenicity and intraocular inflammation in intravitreal anti-VEGF drugs.</p></div><div><h3>Methods</h3><p>This review examines the immunogenicity of individual intravitreal anti-VEGF drugs and their potential link to intraocular inflammation.</p></div><div><h3>Results</h3><p>We suggest that the main cause of intraocular inflammation is the presence of pre-existing and treatment-induced antidrug antibodies, along with considerations related to the molecular structure, which includes the drug's format and size.</p></div><div><h3>Conclusions</h3><p>Researchers and clinicians involved in the advancement of new anti-VEGF drugs should take into consideration the factors related to intraocular inflammation that have been discussed.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"100 ","pages":"Article 100742"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000122/pdfft?md5=726046823de302fc9e832324390aa5ae&pid=1-s2.0-S0011393X24000122-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140269179","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":"Herbal Self-medication Practice for Coronavirus Disease 2019 in Sudan: A Public Survey, 2021","authors":"Ahmad Izzoddeen MBBS, MSc, FETP ,&nbsp;Mustafa Magbol MBBS ,&nbsp;Safaa Fadlelmoula MBBS ,&nbsp;Sabir Ali MBBS, MD ,&nbsp;Wesam Yousif BSc ,&nbsp;Mawada Abouzeid BSc ,&nbsp;Alaa Hamed Dafaala BSc, MPH ,&nbsp;Magam Musa BSc ,&nbsp;Mohamed Hashim MBBS ,&nbsp;Elfatih Malik MBBS, MD, FPH-UK","doi":"10.1016/j.curtheres.2024.100761","DOIUrl":"10.1016/j.curtheres.2024.100761","url":null,"abstract":"<div><h3>Background</h3><div>The coronavirus disease 2019 (COVID-19) emerged in China in late 2019 with high rate of spread and transmission. As there was no recognized therapy many people worldwide used herbs in attempt to help their body overcome the disease.</div></div><div><h3>Objective</h3><div>This study aims to evaluate the use of herbs by patients with COVID-19 in Sudan and tries to identify a possible role in cure or lowering the severity of the illness.</div></div><div><h3>Methods</h3><div>A cross-sectional population-based online survey was done targeting those who experienced COVID-19 among Sudanese through an online internet-based questionnaire distributed on social media platforms (mainly Facebook and WhatsApp). Descriptive statistics used to summarize data and present it as frequency tables and graphs. Multivariate logistic regression was used to measure the association between independent variables (comorbidities and use of herbs) and the outcome variable reflecting the severity of the disease (hospitalization).</div></div><div><h3>Results</h3><div>A total of 204 responses received from COVID-19 former and active cases. Typical symptoms of the disease were identified: fever (68.1%), cough (52.7%), shortness of breathing (59.3%), sore throat (76.5%), and loss of smelling and/or taste (67.2%). All the respondents reported using traditional herbs or plants for cure with strong statement of their usefulness. Citrus plants such as lemon, orange, and grape fruits, were the commonest, used by 94%, followed by the local herbs, acacia (65%), ginger (56%), baobab fruit (46%), hibiscus (45%), black seed (45%), and cinnamon (17%). Other used plants included onion (29%) and garlic (24%). An adjusted analysis found that obesity was associated with higher hospital admission, while using herbs had no effect on hospital admission.</div></div><div><h3>Conclusions</h3><div>All participants reported the use of herbs for cure beside other treatment. The most commonly used herbs were citrus fruits followed by acacia and ginger and other herbs. All participants stated that herbs were useful for their recovery, however our analysis revealed no significant effect on rate of hospitalization. We recommend further deeper, well-designed study to better assess the effect of herbs.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100761"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142661006","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":"Clinical Performance and Safety of Cerviron® Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study","authors":"Izabella Petre Ph.D, MD ,&nbsp;Daniela Oana Toader Ph.D, MD ,&nbsp;Ramona Petrita PharmD, MS ,&nbsp;Alexandru-Remus Pinta PharmD, MS ,&nbsp;Andreea-Anda Alexa Ph.D ,&nbsp;Romina Georgiana Bita Ph.D, MD","doi":"10.1016/j.curtheres.2024.100762","DOIUrl":"10.1016/j.curtheres.2024.100762","url":null,"abstract":"<div><h3>Background</h3><div>Cervical ectropion is frequently associated with vaginal symptoms requiring therapeutic intervention. However, no scientific consensus has been reached regarding the use of local re-epithelialization therapy to prevent severe bleeding, wound inflammation, and infection of cervical lesions.</div></div><div><h3>Objective</h3><div>The aim of our study was to investigate the aspect of the cervix by colposcopy after a 3-month treatment with an intravaginal medical device in the context of postoperative care of the symptomatic ectropion. The study analyzed additional clinical parameters, such as the evolution of primary and secondary inflammation and the degree of cervical epithelialization as secondary objectives.</div></div><div><h3>Methods</h3><div>Our pilot study included 27 participants with symptomatic cervical ectopy, with or without an associated human papillomavirus infection. The treatment protocol consisted of the monthly delivery of the medical device intravaginally, during day 1 to day 15, with a total study duration of 3 months.</div></div><div><h3>Results</h3><div>The medical device had a positive impact on cervical epithelialization, in terms of aspect of the cervix returning to normal for 100% of the participants. Between study visits, it was observed that primary inflammation was reduced by 85.19%, whereas vaginal ulceration, colpitis, and leukorrhea were improved by 70.37%, 81.48%, and by 66.67%, respectively.</div></div><div><h3>Conclusions</h3><div>The degree of cervical epithelialization reflects how well the cervix has healed after an injury or infection. The device showed clinical performance in complete re-epithelialization after surgical procedures. Moreover, our study findings suggest that supportive treatment with this intravaginal medical device can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100762"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11665293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881692","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":"Impact of Magnesium Supplementation on Blood Pressure: An Umbrella Meta-Analysis of Randomized Controlled Trials","authors":"Abdullah M Alharran ,&nbsp;Mooza M Alzayed ,&nbsp;Parsa Jamilian ,&nbsp;Kousalya Prabahar ,&nbsp;Aminah Hassan Kamal ,&nbsp;Muteb N Alotaibi ,&nbsp;Omar E Elshaer ,&nbsp;Mshal Alhatm ,&nbsp;Mohd Diya Masmoum ,&nbsp;Benjamin Hernández-Wolters ,&nbsp;Raghad Sindi ,&nbsp;Hamed Kord-Varkaneh ,&nbsp;Ahmed Abu-Zaid","doi":"10.1016/j.curtheres.2024.100755","DOIUrl":"10.1016/j.curtheres.2024.100755","url":null,"abstract":"<div><h3>Background and aim</h3><p>Conflicting results on the effect of magnesium supplementation on blood pressure have been published in previous meta-analyses; hence, we conducted this umbrella meta-analysis of RCTs to provide a more robust conclusion on its effects.</p></div><div><h3>Methods</h3><p>Four databases including PubMed, Scopus, EMBASE, and Web of Science were searched to find pertinent papers published on international scientific from inception up to July 15, 2024. We utilized STATA version 17.0 to carry out all statistical analyses (Stata Corporation, College Station, TX, US). The random effects model was used to calculate the overall effect size ES and CI.</p></div><div><h3>Findings</h3><p>Ten eligible review papers with 8610 participants studied the influence of magnesium on SBP and DBP. The pooling of their effect sizes resulted in a significant reduction of SBP (ES = -1.25 mmHg; 95% CI: -1.98, -0.51, <em>P</em> = 0.001) and DBP (ES = -1.40 mmHg; 95% CI: -2.04, -0.75, <em>P</em> = 0.000) by magnesium supplementation. In subgroup analysis, a significant reduction in SBP and DBP was observed in magnesium intervention with dosage ≥400 mg/day (ES for SBP = -6.38 mmHg; ES for DBP = -3.71mmHg), as well as in studies with a treatment duration of ≥12 weeks (ES for SBP = -0.42 mmHg; ES for DBP = -0.45 mmHg).</p></div><div><h3>Implications</h3><p>The findings of the present umbrella meta-analysis showed an overall decrease of SBP and DBP with magnesium supplementation, particularly at doses of ≥400 mg/day for ≥12 weeks.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100755"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000250/pdfft?md5=a8b8a2dc668f12e5bef20f98052ac230&pid=1-s2.0-S0011393X24000250-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142089037","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":"Evaluation of Analgesic Drug Therapy for Postoperative Pain Management in Cardiovascular Surgery","authors":"Yue Yue MBBS ,&nbsp;Hongyan Ji MBBS ,&nbsp;Shizhong Wang PhD ,&nbsp;Huawei Cheng MBBS ,&nbsp;Rongmei Wang MSc ,&nbsp;Haijun Qu MSc ,&nbsp;Jing Li MSc","doi":"10.1016/j.curtheres.2024.100744","DOIUrl":"10.1016/j.curtheres.2024.100744","url":null,"abstract":"<div><h3>Background</h3><p>Cardiovascular surgery is usually associated with higher degree of postoperative pain that influences a patient's physical recovery. Multiple clinical measures have been taken to avoid overuse of opioid agents for postoperative pain management, which led to the development of clinical pathways for analgesic drug treatment using a multimodal approach.</p></div><div><h3>Objective</h3><p>To evaluate the effectiveness and safety of a multimodal postoperative analgesic drug pathway (ADP) for pain management following cardiovascular surgery.</p></div><div><h3>Methods</h3><p>This retrospective, controlled, nonrandomized study evaluated a postoperative ADP in patients undergoing cardiovascular surgery in a tertiary general hospital in Qingdao, China. Effectiveness and safety outcomes were compared before and after the implementation of the ADP. Outcome indicators included postoperative pain scores, consumption of opioids in analgesic pumps, and incidence of adverse events.</p></div><div><h3>Results</h3><p>Patients who underwent cardiovascular surgery from September to November 2021 before the implementation of the ADP (n = 193) and from September to November 2022 after the implementation of the ADP (n = 218) were enrolled. Pain scores were reduced on day 1, 3, and 5 after surgery and the reduction was most significant in mild pain (<em>P</em> &lt; .001). Opioids in analgesic pumps consumption was also significantly reduced and there was decreased incidence of adverse events such as nausea and vomiting (<em>P</em> = .026), respiratory inhibition (<em>P</em> = .027), and dizziness and headache (<em>P</em> = .028) in cardiovascular surgery patients after implementation of the ADP.</p></div><div><h3>Conclusions</h3><p>Improved effectiveness and safety were observed following the implementation of the ADP. Multimodal analgesic ADP methodology can be effectively used for postoperative pain management in patients undergoing cardiovascular surgery.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"100 ","pages":"Article 100744"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000146/pdfft?md5=eafbb289bca97d2baca3da608d5ff777&pid=1-s2.0-S0011393X24000146-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140268742","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":"Clavulanic Acid-Mediated Increases in Anterior Cingulate Glutamate Levels are Associated With Decreased Cocaine Craving and Brain Network Functional Connectivity Changes","authors":"Joya Maser MS ,&nbsp;Mary F. Morrison MD ,&nbsp;Helene Philogene Khalid PhD ,&nbsp;Ronan Cunningham ,&nbsp;Daohai Yu PhD ,&nbsp;M. Ingre Walters MD ,&nbsp;Xiaoning Lu ,&nbsp;Nicolas R. Bolo PhD","doi":"10.1016/j.curtheres.2024.100751","DOIUrl":"10.1016/j.curtheres.2024.100751","url":null,"abstract":"<div><h3>Background</h3><p>There is an urgent need for pharmacological treatment for cocaine (COC) use disorder (CUD). Glutamatergic transmission in the prefrontal cortex is affected by addictive behaviors. Clavulanic acid (CLAV), a glutamate transporter GLT-1 (excitatory amino acid transporter) activator, is a clinical-stage medication that has potential for treating CUD.</p></div><div><h3>Methods</h3><p>In a pilot study, nine participants with CUD received 500 mg CLAV with dose escalations to 750 mg and 1000 mg over 10 days. In 5 separate magnetic resonance imaging (MRI) sessions, brain anterior cingulate cortex (ACC) glutamate level and resting state network (RSN) functional connectivity (FC) were assessed using MR spectroscopy and functional MRI. Craving was assessed at the same time points, between baseline (before CLAV), 6 days, and 10 days of CLAV. Independent component analysis with dual regression was used to identify RSN FC changes from baseline to Days 6 and 10. Relationships among glutamate, craving, and resting state FC values were analyzed.</p></div><div><h3>Results</h3><p>Participants who achieved high ACC glutamate levels after CLAV treatment had robust decreases in COC craving (<em>r</em> = −0.90, <em>P</em> = 0.0009, <em>n</em> = 9). The salience network (SN) and executive control network (ECN) demonstrated an association between increased FC after CLAV treatment and low baseline ACC Glu levels (SN CLAV 750 mg, <em>r</em> = −0.82, <em>P</em> = 0.007) (ECN CLAV 1000 mg, <em>r</em> = −0.667, <em>P</em> = 0.050; <em>n</em> = 9).</p></div><div><h3>Conclusions</h3><p>Glutamate associated changes in craving and FC of the salience and executive control brain networks support CLAV as a potentially efficacious pharmacological treatment for CUD.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100751"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000213/pdfft?md5=4685750f478041c034c5aa42607f85c6&pid=1-s2.0-S0011393X24000213-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141391074","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":"Immunomodulatory Effects of Modified Colostrum, Whey, and Their Combination With Other Natural Products: Effects on Natural Killer Cells","authors":"Xuesheng Han MS ,&nbsp;David Vollmer MS ,&nbsp;Xuefei Yan MS ,&nbsp;Yahong Zhang MS ,&nbsp;Mingfa Zang MPVM ,&nbsp;Chenfei Zhang MS ,&nbsp;Catherine M. Sherwin MS ,&nbsp;Elena Y. Enioutina MS","doi":"10.1016/j.curtheres.2024.100750","DOIUrl":"10.1016/j.curtheres.2024.100750","url":null,"abstract":"<div><h3>Objectives</h3><p>Natural killer (NK) cells are important immune system effector cells providing innate defenses against intracellular infections, including viral infections, immune surveillance, and cancer immunoediting. The primary purpose of this study was to investigate whether modified ultra-filtrated colostrum (UC) and hydrolyzed whey (W) products or their combinations with other natural products with reported immunomodulatory properties will stimulate NK cell cytotoxic activity by activation of granzyme B and IFN-γ production.</p></div><div><h3>Methods</h3><p>The ability of study products to stimulate the cytotoxic activity of human-purified CD56⁺ NK cells and the production of granzyme B and IFN-γ by activated NK cells was evaluated in the cytotoxic assay.</p></div><div><h3>Results</h3><p>All study products significantly increased NK-cell cytotoxic activity at an E: T ratio of 20:1. Treatment of cells with UC had a maximal cytotoxic effect at the minimal dose of 10 µg/ml, which exceeded the cytotoxic activity of IL-2. In contrast, the addition of egg yolk (CE) or CE + botanical blend (CEB) to UC resulted in a dose-dependent cytotoxic response with a maximal response at 1000 µg/ml. The maximal activity of blend products was comparable to UC activity. W exerted minimal stimulatory activity on NK cells. The magnitude of granzyme B and IFN-γ production was closely associated with the cytotoxic activity of NK cells stimulated with the study products.</p></div><div><h3>Conclusions</h3><p>All study product<strong>s</strong> demonstrated stimulatory activity on NK cells, with UC having a maximal effect on NK cell cytotoxicity. The study products can be used as dietary supplements to support NK cell activity in healthy individuals.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100750"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000201/pdfft?md5=8cc99933b16afdb66465d88000328ed5&pid=1-s2.0-S0011393X24000201-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141407776","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":"Analysis of a Serious Adverse Reaction of Pulmonary Fibrosis Caused by Dronedarone","authors":"Yuyan Chen PM ,&nbsp;Zhendong Fu MM ,&nbsp;Xue Wen MM ,&nbsp;Mingxia Zhang PM ,&nbsp;Qiong Min PM ,&nbsp;Peng Wang PM ,&nbsp;Jin Zhang MB ,&nbsp;Jun Ren PM ,&nbsp;Wenbin Li PD ,&nbsp;Rong Wang PD","doi":"10.1016/j.curtheres.2024.100743","DOIUrl":"10.1016/j.curtheres.2024.100743","url":null,"abstract":"<div><h3>Objective</h3><p>This study aims to analyze a severe adverse reaction of pulmonary fibrosis induced by dronedarone hydrochloride tablets, and to provide a reference for clinical rational medication through drug precautions.</p></div><div><h3>Methods</h3><p>A case of pulmonary fibrosis induced by dronedarone hydrochloride tablets, along with related literature was retrospectively analyzed.</p></div><div><h3>Results</h3><p>Patients over 65 years old with a history of exposure to amiodarone may increase the incidence of pulmonary toxicity induced by dronedarone, and dronedarone should not be selected as a substitute treatment drug for patients with amiodarone-induced pulmonary toxicity.</p></div><div><h3>Conclusions</h3><p>It is recommended that clinicians monitor the diffusion capacity of carbon monoxide and lung ventilation function of patients before and after using dronedarone for treatment. For patients with a history of amiodarone exposure, intermittent monitoring of chest X-rays and lung function is necessary. If lung function decreases, dronedarone should be immediately discontinued.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"100 ","pages":"Article 100743"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000134/pdfft?md5=1f56ba5083d8a5b5645c5cf457bf46a5&pid=1-s2.0-S0011393X24000134-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140271964","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":"Cost-effectiveness of Evolocumab in Cardiovascular Disease: A Systematic Review","authors":"Nashmil Ghadimi ,&nbsp;Rajabali Daroudi ,&nbsp;Hosein Shabaninejad ,&nbsp;Mahshad Goharimehr ,&nbsp;Davoud Khodamorzideh ,&nbsp;Sara Kaveh","doi":"10.1016/j.curtheres.2024.100758","DOIUrl":"10.1016/j.curtheres.2024.100758","url":null,"abstract":"<div><h3>Background</h3><div>With the rising burden of cardiovascular disease (CVD) and the need for cost-effective interventions, evaluating the economic implications of Evolocumab becomes crucial.</div></div><div><h3>Objectives</h3><div>This study aimed to systematically review and evaluate the cost-effectiveness of Evolocumab in adults at risk of CVD.</div></div><div><h3>Methods</h3><div>We performed an extensive search in Cochrane Library, EMBASE, PubMed, ProQuest, and Web of Science. The reference lists of chosen literature reviews were also examined to find suitable cost-effectiveness analyses (CEAs) of Evolocumab in patients with CVD published until March 2023. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) was used to assess the reporting quality. Cost-related findings were adjusted to reflect 2023 purchase power parity (PPP) values in US dollars to enable cross-study comparisons.</div></div><div><h3>Results</h3><div>This systematic review comprised 16 studies, published between 2016 and 2023, mostly from the USA and China. Compliance with the CHEERS checklist was high in sections like abstracts, backgrounds, and objectives. However, areas like perspective (71.4%), time horizon (57.1%), and engagement with patients (14.3%) showed lower reporting rates. All studies evaluated the cost-effectiveness of Evolocumab in combination with other lipid-lowering treatments (LLTs). Notably, all studies employed model-based economic evaluations using a Markov cohort state-transition model, with a majority adopting a lifetime horizon. Most studies (10 cases) simultaneously reported both the Incremental Cost-Effectiveness Ratio (ICER) per Quality Adjusted Life Years (QALY) and the ICER per Life-Years Saved (LYS). Four studies exclusively reported ICER/QALY, and 2 studies solely focused on ICER/LYS. The ICER/ QALY exhibited a wide range (3,342.57 to 2,687,920.13 USD), with one study presenting as an outlier. Sensitivity analyses revealed factors influencing cost-effectiveness outcomes, including Low-Density Lipoprotein Cholesterol (LDL-C) levels, Evolocumab costs, and disease type, while several studies reported accepted thresholds for cost-effectiveness analysis.</div></div><div><h3>Conclusions</h3><div>Our systematic review concludes that Evolocumab could be a cost-effective treatment, particularly for high-risk patient groups, but this varies by disease category, risk level, and evaluation methods. Future studies should investigate the economic impact's certainty and uncertainty, and consider different countries' income levels. LDL-C levels, medication costs, and CVD types are important factors affecting cost-effectiveness analysis.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100758"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142445506","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":"US Real-World Effectiveness Study of Nirmatrelvir/Ritonavir in Preventing Hospitalization of High-Risk COVID-19 Patients","authors":"Mark R. Cullen MD ,&nbsp;Xiaofeng Zhou PhD ,&nbsp;Scott P. Kelly PhD ,&nbsp;Caihua Liang MD, PhD ,&nbsp;Ling Li MS ,&nbsp;Rongjun Shen MS ,&nbsp;Heidi K. Leister-Tebbe BSN ,&nbsp;Steven G. Terra PharmD ,&nbsp;Michael Gaffney PhD ,&nbsp;Leo Russo PhD","doi":"10.1016/j.curtheres.2024.100757","DOIUrl":"10.1016/j.curtheres.2024.100757","url":null,"abstract":"<div><h3>Purpose</h3><div>We describe nirmatrelvir/ritonavir (NMV/r) effectiveness in preventing hospitalization among COVID-19 patients at high risk of severe disease.</div></div><div><h3>Methods</h3><div>An ongoing US population-based observational cohort study with retrospective and prospective collection of national electronic healthcare data collected from the US Optum® deidentified COVID-19 Electronic Health Record dataset during December 22, 2021−July 20, 2022. Participants were ≥12 years old; had a positive SARS-CoV-2 test, COVID-19 diagnosis, or NMV/r prescription; and were at high risk of severe COVID-19 based on demographic/clinical characteristics. Potential confounders between groups were balanced using propensity score matching. Immortal time bias was addressed. Hospitalization rates within 30 days from COVID-19 diagnosis were evaluated. Sensitivity analyses included 15-day hospitalization, chart review to investigate incidental hospitalization effects, and exclusion of patients identified as having COVID-19 based on NMV/r prescription alone. Outcomes were also evaluated by race, age, and COVID-19 vaccine status.</div></div><div><h3>Findings</h3><div>Overall, 12,440 and 234,123 patients were included in the NMV/r and non-NMV/r groups, respectively. After propensity score matching, baseline characteristics were well balanced across groups (NMV/r, <em>n</em> = 12,439; non-NMV/r, <em>n</em> = 36,490). Incidence of hospitalization (95% CI) within 30 days was 0.90% (0.74%−1.08%) for the NMV/r group and 5.91% (5.67%−6.16%) for the non-NMV/r group, with relative risk (95% CI) of 0.15 (0.13−0.18; 85% risk reduction). NMV/r was comparably effective in Black patients (relative risk, 0.19 [0.10−0.34]; 81% risk reduction). Sensitivity analyses supported the main outcomes.</div></div><div><h3>Implications</h3><div>Real-world NMV/r effectiveness against hospitalization during Omicron predominance among COVID-19 patients at high risk of severe disease supports demonstrated clinical trial efficacy. Black patients underutilized NMV/r despite high effectiveness.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"101 ","pages":"Article 100757"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142701847","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}