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Tumor Necrosis Factor Inhibitor Therapy and the Risk for Depression Among Working-Age Adults with Rheumatoid Arthritis. 肿瘤坏死因子抑制剂治疗与工作年龄成人类风湿性关节炎患者抑郁风险。
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2019-02-01
Arijita Deb, Nilanjana Dwibedi, Traci LeMasters, Jo Ann Hornsby, Wenhui Wei, Usha Sambamoorthi

Background: Individuals with rheumatoid arthritis (RA) are at high risk for depression because of the overall burden of systemic inflammation. Although some evidence suggests that treatment with powerful anti-inflammatory drugs, such as tumor necrosis factor (TNF) inhibitors, may be effective in reducing the risk for depression in patients with RA, it is unclear whether such reduction in risk is dependent on the response to TNF inhibitor therapy.

Objective: To evaluate the association between the response to TNF inhibitor therapy and the risk for depression among working-age adults with RA.

Method: This retrospective, observational cohort study design was based on data derived from commercial claims data in the QuintilesIMS Real World Data Adjudicated Claims database between October 1, 2009, and September 30, 2015. A total of 4222 working-age adults (18-62 years) with RA who started treatment with TNF inhibitor therapy and were continuously enrolled during the 3 observation periods (ie, 1-year baseline, 1-year treatment, and 1-year follow-up periods) were included in the study. Treatment response to a TNF inhibitor was measured using prescription drug claims based on a published validated algorithm. Multivariable logistic regression was used to examine the association between treatment response to TNF inhibitor therapy and the risk for depression, after controlling for baseline demographic characteristics, clinical characteristics, and RA-related medication use. An inverse probability of treatment weighting technique was used to control for observable differences in TNF inhibitor responders' characteristics versus TNF inhibitor nonresponders.

Results: Overall, 359 (8.5%) patients with RA had depression during the follow-up period and 1679 (39.8%) patients responded to TNF inhibitor treatment during the 1-year treatment period. A significantly lower percentage of TNF inhibitor responders (7.1%, N = 119) had depression than TNF inhibitor nonresponders (9.4%, N = 239). After controlling for other risk factors, responders to TNF inhibitors were 20% less likely to have depression during the follow-up period (adjusted odds ratio, 0.80; 95% confidence interval, 0.64-0.98) than nonresponders to TNF inhibitor therapy.

Conclusion: The risk for depression was significantly reduced among patients with RA who responded to TNF inhibitor therapy compared with those who did not respond to such therapy. To determine whether the lower rate of depression observed with TNF inhibition is a direct effect of treatment with a TNF inhibitor, or whether it could be attributed to improvement in RA disease secondary to treatment, future studies need to also incorporate a control population of patients with RA who receive other antirheumatic regimens, such as disease-modifying antirheumatic drugs.

背景:类风湿性关节炎(RA)患者由于全身炎症的总体负担,患抑郁症的风险很高。尽管一些证据表明,使用强效抗炎药(如肿瘤坏死因子(TNF)抑制剂)治疗可能有效降低RA患者患抑郁症的风险,但尚不清楚这种风险的降低是否取决于对TNF抑制剂治疗的反应。目的:评估RA工作年龄成年人对TNF抑制剂治疗的反应与抑郁风险之间的关系。方法:本回顾性观察性队列研究设计基于2009年10月1日至2015年9月30日期间QuintilesIMS真实世界数据裁决索赔数据库中商业索赔数据。共有4222名RA工作年龄成年人(18-62岁)开始接受TNF抑制剂治疗,并在3个观察期(即1年基线期、1年治疗期和1年随访期)内连续入选。使用基于已发表的验证算法的处方药声明来测量对TNF抑制剂的治疗反应。在控制了基线人口统计学特征、临床特征和RA相关药物使用后,使用多变量逻辑回归来检查TNF抑制剂治疗的治疗反应与抑郁症风险之间的关系。使用反概率治疗加权技术来控制TNF抑制剂应答者与TNF抑制剂无应答者特征的可观察差异。结果:总体而言,359名(8.5%)RA患者在随访期间出现抑郁症,1679名(39.8%)患者在1年治疗期间对TNF抑制剂治疗有反应。TNF抑制剂应答者(7.1%,N=119)患有抑郁症的比例显著低于TNF抑制剂无应答者(9.4%,N=239)。在控制了其他风险因素后,对TNF抑制剂有反应的患者在随访期间患抑郁症的可能性比对TNF抑制剂治疗无反应的患者低20%(调整比值比,0.80;95%置信区间,0.64-0.98)。结论:与对TNF抑制剂治疗无效的RA患者相比,对TNF抑制剂有反应的RA患者患抑郁症的风险显著降低。为了确定用TNF抑制剂观察到的较低抑郁率是否是用TNF抑制剂治疗的直接影响,或者它是否可以归因于治疗后RA疾病的改善,未来的研究还需要纳入接受其他抗风湿治疗方案(如疾病改性抗风湿药物)的RA患者的对照人群。
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引用次数: 0
Comparing the Medicaid Prospective Drug Utilization Review Program Cost-Savings Methods Used by State Agencies in 2015 and 2016. 比较2015年和2016年国家机构使用的医疗补助前瞻性药物利用审查项目成本节约方法。
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2019-02-01
Sergio I Prada, Johan S Loaiza

Background: The Medicaid Drug Utilization Review (DUR) program is a 2-phase process conducted by Medicaid state agencies. The first phase is a prospective DUR process and involves electronically monitoring prescription drug claims to identify prescription-related problems, such as therapeutic duplication, contraindications, incorrect dosage, or duration of treatment. The second phase is a retrospective DUR involving ongoing, periodic examinations of claims data to identify patterns of fraud, abuse, underutilization, drug-drug interaction, and medically unnecessary care, and implement corrective actions when needed. The Centers for Medicare & Medicaid Services requires each state to measure the prescription drug cost-savings generated from its DUR programs annually, but it provides no methodology for doing so. An earlier article compared the methodologies used by states to measure cost-savings in their retrospective DUR program in fiscal years 2014 and 2015.

Objective: To describe and synthesize the methodologies used by states to measure cost-savings using their Medicaid prospective DUR program in federal fiscal years 2015 and 2016.

Methods: For each state, we downloaded from Medicaid's website the cost-savings methodologies included in the Medicaid DUR 2015 and 2016 reports. We then reviewed and synthesized the reports. Methods described by the states were classified into a unique group based on the methodology used, except for Arkansas and Connecticut, which were classified in more than 1 category for the same period.

Results: Currently, 3 different methodologies are being used by states. In 2015 and 2016, the most common methodology used (by 18 states) was the calculation of total claim rejections and subtracting claim resubmissions at the amount actually paid. The comparisons of DUR program cost-savings among states are unreliable, because the states lack a common methodology in the way they measure their performance.

Conclusions: Considering the lack of methodologic consistency among states in measuring the savings in the Medicaid DUR program shown in this analysis, the federal government must lead an effort to define a unique methodology to measure cost-savings in its entire DUR program. This will help to improve the measure of savings among states and understand how this program is performing in that matter.

背景:医疗补助药物使用审查(DUR)项目是由医疗补助州机构进行的两个阶段的过程。第一阶段是前瞻性DUR流程,涉及电子监测处方药索赔,以识别处方相关问题,如治疗重复、禁忌症、不正确的剂量或治疗持续时间。第二阶段是回顾性药品索赔审查,涉及对索赔数据进行持续的定期检查,以确定欺诈、滥用、利用不足、药物-药物相互作用和医疗上不必要的护理模式,并在需要时采取纠正行动。医疗保险和医疗补助服务中心要求每个州每年衡量其DUR项目所节省的处方药成本,但它没有提供这样做的方法。之前的一篇文章比较了各州在2014财年和2015财年回顾性DUR计划中用于衡量成本节约的方法。目的:描述和综合各州在2015年和2016年联邦财政年度使用其医疗补助预期DUR计划来衡量成本节约的方法。方法:对于每个州,我们从医疗补助网站下载了2015年和2016年医疗补助DUR报告中包含的成本节约方法。然后,我们审查并综合了这些报告。各州所描述的方法根据所使用的方法被划分为一个独特的组,除了阿肯色州和康涅狄格州,它们在同一时期被划分为多个类别。结果:目前,各州正在使用3种不同的方法。在2015年和2016年,(18个州)最常用的方法是计算被拒绝的索赔总额,然后减去实际支付的索赔重新提交的金额。各州之间对DUR项目成本节约的比较是不可靠的,因为各州在衡量其绩效的方式上缺乏共同的方法。结论:考虑到本分析中各州在衡量医疗补助DUR项目节约方面缺乏方法一致性,联邦政府必须努力定义一种独特的方法来衡量其整个DUR项目的成本节约。这将有助于改善各州之间的节约措施,并了解该计划在这方面的表现。
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引用次数: 0
A Shift in Party Majority, a Shift in Priority? What the Pharmaceutical Industry Can Expect. 政党多数的转变,优先事项的转变?制药行业可以期待什么?
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2019-02-01
Gary Branning, Randy Ross, Kathryn Hayes
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引用次数: 0
Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective. 从医院角度看奥马达环素对美国社区获得性细菌性肺炎患者治疗的预算影响
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2019-02-01
Kenneth LaPensee, Rohit Mistry, Thomas Lodise

Background: Community-acquired bacterial pneumonia (CABP) is an acute, lower respiratory bacterial infection. Despite advances in medical care, CABP remains associated with considerable morbidity, mortality, and healthcare costs; early empiric treatment is recommended by the Infectious Diseases Society of America and by the American Thoracic Society. Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adult patients with CABP.

Objective: To estimate the budget impact of introducing omadacycline as a treatment option among patients with suspected or documented CABP from a US hospital perspective.

Methods: A budget impact model was developed in Microsoft Excel® 2010. Population, clinical, and cost inputs were based on the available literature, clinical trial data, and real-world evidence databases. Emergency departments and observation units were assumed to be hospital-owned as part of the analyses. Sensitivity analyses assessed the impact of key parameters on the model results, and scenario analyses were explored to analyze the budget impact of reducing length of hospital stay and avoiding hospitalization.

Results: The introduction of omadacycline as a treatment resulted in a total budget increase of $20,643 over 3 years. This increase was mainly attributed to treatment acquisition costs. In a scenario where the length of hospital stay was reduced by 1 day (under the assumption that an antibiotic with IV and oral formulations can facilitate earlier discharge from inpatient care), the 3-year total budget decreased to $2384; reducing the hospital stay by 2 days resulted in 3-year cost-savings of $15,875. Shifting inpatient care to the outpatient setting with omadacycline resulted in 3-year cumulative cost-savings of $112,843.

Conclusion: This is the first omadacycline budget impact model developed for adult patients with suspected or documented CABP. The model projected a modest budget increase with the introduction of omadacycline, mainly due to treatment acquisition costs.

背景:社区获得性细菌性肺炎(CABP)是一种急性下呼吸道细菌感染。尽管医疗保健取得了进步,但CABP仍然与相当高的发病率、死亡率和医疗费用有关;美国传染病学会和美国胸科学会推荐早期经验性治疗。Omadacycline是一种口服和静脉注射(IV)每日一次的氨甲基环素抗生素,在美国被批准用于治疗成人CABP患者。目的:从美国医院的角度估计引入奥马达环素作为疑似或记录的CABP患者的治疗选择的预算影响。方法:在Microsoft Excel®2010中建立预算影响模型。人口、临床和成本输入基于现有文献、临床试验数据和真实世界证据数据库。作为分析的一部分,假定急诊科和观察科为医院所有。敏感性分析评估了关键参数对模型结果的影响,情景分析探讨了减少住院时间和避免住院对预算的影响。结果:引进奥马达环素作为治疗导致3年内总预算增加20,643美元。这一增加主要归因于获得治疗的费用。在住院时间缩短1天的情况下(假设静脉注射和口服配方的抗生素可以促进住院治疗的早期出院),3年总预算减少到2384美元;住院时间减少2天,3年费用节省15 875美元。将住院病人的护理转移到门诊使用奥马达环素,3年累计节省成本112,843美元。结论:这是第一个为疑似或有记录的CABP的成人患者开发的奥马达环素预算影响模型。该模型预测,随着奥马达环素的引入,预算将适度增加,主要是由于获得治疗的费用。
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引用次数: 0
A Proposed Intervention to Decrease Resident-Performed Cataract Surgery Cancellation in a Tertiary Eye Care Center. 减少三级眼科护理中心住院医师白内障手术取消的建议干预。
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2018-12-01
Eileen L Mayro, Laura T Pizzi, Lisa A Hark, Ann P Murchison, Douglas Wisner, Anish Koka, Benjamin E Leiby, Nooreen Dabbish, Adedoyin Okulate, Alexa Dessy, Caitlin Green, Robert Bailey

Background: Cataracts are the leading cause of preventable blindness globally. As a result, competence in cataract surgery is an important component of ophthalmology residency training. Residency programs must optimize the number of cataract surgery cases to train proficient physicians. However, the rate of cataract surgery cancellations is high, and some are canceled because of preventable causes.

Objective: To evaluate the effect of mandatory on-site preadmission testing, including having a physical examination, on resident-performed cataract surgery cancellation rates.

Methods: For this study, patients scheduled for cataract surgery at the Wills Eye Hospital resident cataract clinic between January 2015 and November 2015 were enrolled and randomized into 2 groups: usual care or intervention. The patients randomized to the usual care group were instructed to complete preadmission testing and to have a physical examination with their primary care physician. The patients randomized to the intervention group were escorted to a Wills Eye Hospital-affiliated cardiologist to complete preadmission testing and to have a physical examination. Patients in both groups received a reminder call before the cataract surgery.

Results: A total of 441 patients were included in the study-240 patients in the usual care group and 201 patients in the intervention group. The overall cataract surgery cancellation rate was 14.5%; the rate was 12.4% in the intervention group and 16.3% in the usual care group (P = .28). The patients receiving the intervention were more likely to have preadmission testing and a physical examination than the patients in the usual care arm (P <.001).

Conclusions: Facilitating the completion of preadmission testing for patients decreased the rates of resident-performed cataract surgery cancellation at a Wills Eye Hospital resident clinic and has the potential to improve patient outcomes and prevent blindness.

背景:白内障是全球可预防性失明的主要原因。因此,白内障手术能力是眼科住院医师培训的重要组成部分。住院医师项目必须优化白内障手术病例的数量,以培养熟练的医生。然而,白内障手术的取消率很高,其中一些是由于可预防的原因而取消的。目的:评价强制性入院前检查(包括体格检查)对住院医师白内障手术取消率的影响。方法:本研究选取2015年1月至2015年11月在威尔斯眼科医院白内障住院门诊行白内障手术的患者,随机分为常规护理组和干预组。随机分配到常规护理组的患者被指示完成入院前测试,并与他们的初级保健医生进行体检。随机分配到干预组的患者被护送到威尔斯眼科医院附属的心脏病专家那里完成入院前测试并进行身体检查。两组患者在白内障手术前都会接到提醒电话。结果:共纳入441例患者,常规护理组240例,干预组201例。白内障手术总取消率为14.5%;干预组为12.4%,常规护理组为16.3% (P = 0.28)。与常规护理组相比,接受干预的患者更有可能进行入院前检查和体格检查(P结论:促进患者完成入院前检查,降低了威尔斯眼科医院住院医师诊所取消住院医师白内障手术的比率,并有可能改善患者的预后和预防失明。
{"title":"A Proposed Intervention to Decrease Resident-Performed Cataract Surgery Cancellation in a Tertiary Eye Care Center.","authors":"Eileen L Mayro,&nbsp;Laura T Pizzi,&nbsp;Lisa A Hark,&nbsp;Ann P Murchison,&nbsp;Douglas Wisner,&nbsp;Anish Koka,&nbsp;Benjamin E Leiby,&nbsp;Nooreen Dabbish,&nbsp;Adedoyin Okulate,&nbsp;Alexa Dessy,&nbsp;Caitlin Green,&nbsp;Robert Bailey","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Cataracts are the leading cause of preventable blindness globally. As a result, competence in cataract surgery is an important component of ophthalmology residency training. Residency programs must optimize the number of cataract surgery cases to train proficient physicians. However, the rate of cataract surgery cancellations is high, and some are canceled because of preventable causes.</p><p><strong>Objective: </strong>To evaluate the effect of mandatory on-site preadmission testing, including having a physical examination, on resident-performed cataract surgery cancellation rates.</p><p><strong>Methods: </strong>For this study, patients scheduled for cataract surgery at the Wills Eye Hospital resident cataract clinic between January 2015 and November 2015 were enrolled and randomized into 2 groups: usual care or intervention. The patients randomized to the usual care group were instructed to complete preadmission testing and to have a physical examination with their primary care physician. The patients randomized to the intervention group were escorted to a Wills Eye Hospital-affiliated cardiologist to complete preadmission testing and to have a physical examination. Patients in both groups received a reminder call before the cataract surgery.</p><p><strong>Results: </strong>A total of 441 patients were included in the study-240 patients in the usual care group and 201 patients in the intervention group. The overall cataract surgery cancellation rate was 14.5%; the rate was 12.4% in the intervention group and 16.3% in the usual care group (<i>P</i> = .28). The patients receiving the intervention were more likely to have preadmission testing and a physical examination than the patients in the usual care arm (<i>P</i> <.001).</p><p><strong>Conclusions: </strong>Facilitating the completion of preadmission testing for patients decreased the rates of resident-performed cataract surgery cancellation at a Wills Eye Hospital resident clinic and has the potential to improve patient outcomes and prevent blindness.</p>","PeriodicalId":48595,"journal":{"name":"American Health and Drug Benefits","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322594/pdf/ahdb-11-480.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36952662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improved Quality of Life in Adults with Acute Bacterial Skin and Skin Structure Infections with Omadacycline or Linezolid Therapy. 奥马达环素或利奈唑胺治疗改善急性细菌性皮肤和皮肤结构感染的成人生活质量。
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2018-12-01
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引用次数: 0
Pharmacist-Led Drug Therapy Problem Management in an Interprofessional Geriatric Care Continuum: A Subset of the PIVOTS Group. 药剂师主导的老年病跨专业护理中的药物治疗问题管理:PIVOTS 小组的一个子小组。
IF 1.4 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2018-12-01
Ashley M Campbell, Kim C Coley, Jason M Corbo, Teresa M DeLellis, Matthew Joseph, Carolyn T Thorpe, Melissa S McGivney, Patricia Klatt, Lora Cox-Vance, Vincent Balestrino, Heather Sakely

Background: Drug therapy problems, which are adverse events involving medications that can ultimately interfere with a patient's therapeutic goals, occur frequently in older adults. If not identified, resolved, and prevented through clinical decision-making, drug therapy problems may negatively affect patient health outcomes.

Objective: To quantify the impact of pharmacist interventions on the care of older adults by identifying the most common drug therapy problems, the medications most often involved in these problems, and the actions taken by pharmacists to resolve these problems.

Methods: This retrospective chart review included individuals seen by a geriatric pharmacist in one geriatric practice, where 4 pharmacists provide continuous, comprehensive medication management across 2 outpatient geriatric clinics, skilled-nursing facilities, and assisted-living facilities. The individuals were seen between August 2014 and November 2015. For all patient care encounters during this time frame, pharmacists used the Assurance System to document each drug therapy problem, the medications involved, the patient's care setting (ie, outpatient clinic, assisted-living facility, skilled-nursing facility), the actions taken to resolve any drug therapy problems, and the estimated 90-day impact on the patient and the healthcare system.

Results: A total of 3100 drug therapy problems were identified during 3309 patient-pharmacist encounters for 452 patients (mean age, 81.4 years), 48.7% of whom were seen in the skilled-nursing facility. The most common drug therapy problem was dose too low, followed by dose too high, and warfarin was the most common drug associated with drug therapy problems. Pharmacists provided 4921 interventions, often more than 1 intervention per drug therapy problem, for 275 different medications. Laboratory monitoring and dose change were the most common interventions, with an estimated annual financial savings between $268,690 and $270,591.

Conclusion: Older patients are a vulnerable patient population who often receive unsafe medication regimens, which can result in adverse drug reactions and other critical problems. When integrated into interprofessional geriatric care teams, pharmacists' interventions provide an invaluable qualitative and monetary resource to the medication-based management of patients with well-recognized, high-risk geriatric syndromes as they transition to and through various levels of care.

背景:药物治疗问题是涉及药物的不良事件,最终会影响患者的治疗目标,在老年人中经常出现。如果不通过临床决策来识别、解决和预防,药物治疗问题可能会对患者的健康结果产生负面影响:通过确定最常见的药物治疗问题、这些问题最常涉及的药物以及药剂师为解决这些问题所采取的措施,量化药剂师干预对老年人护理的影响:该诊所有 4 名药剂师在 2 个老年病门诊、专业护理机构和生活辅助机构提供持续、全面的药物管理服务。患者就诊时间为 2014 年 8 月至 2015 年 11 月。对于在此期间接触的所有患者,药剂师使用 "保证系统 "记录了每个药物治疗问题、涉及的药物、患者的护理环境(即门诊诊所、生活辅助设施、专业护理设施)、为解决任何药物治疗问题所采取的措施,以及对患者和医疗保健系统的 90 天估计影响:在 452 名患者(平均年龄 81.4 岁)与药剂师的 3309 次接触中,共发现了 3100 个药物治疗问题,其中 48.7% 的患者在专业护理机构就诊。最常见的药物治疗问题是剂量过低,其次是剂量过高,华法林是与药物治疗问题相关的最常见药物。药剂师针对 275 种不同的药物提供了 4921 次干预,通常每个药物治疗问题的干预次数都在 1 次以上。实验室监测和改变剂量是最常见的干预措施,估计每年可节省 268690 美元至 270591 美元:老年患者是一个易受伤害的群体,他们经常接受不安全的药物治疗,这可能会导致药物不良反应和其他严重问题。如果将药剂师纳入跨专业老年病护理团队,那么药剂师的干预措施将为患有公认的高风险老年病综合征的患者提供宝贵的质量和金钱资源,帮助他们在过渡到不同护理级别的过程中进行以药物为基础的管理。
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引用次数: 0
Omadacycline for Acute Bacterial Skin and Skin Structure Infections: Integrated Analysis of Randomized Clinical Trials. 奥马达环素治疗急性细菌性皮肤和皮肤结构感染:随机临床试验的综合分析。
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2018-12-01
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引用次数: 0
Potential Cost-Savings with Once-Daily Aminomethylcycline Antibiotic versus Vancomycin in Hospitalized Patients with Acute Bacterial Skin and Skin Structure Infections. 急性细菌性皮肤和皮肤结构感染住院患者每日一次氨基甲基环素抗生素与万古霉素的潜在成本节约
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2018-12-01
Ken LaPensee, Thomas Lodise

Background: Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that was recently approved by the US Food and Drug Administration for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). In 2 phase 3 clinical trials, IV-to-oral switch and oral-only administration of omadacycline achieved the primary end points of noninferiority compared with linezolid in treating patients with ABSSSI.

Objective: To estimate the potential cost-savings with bioequivalent IV-to-oral antibiotics, such as omadacycline, compared with the standard of care with IV vancomycin by avoiding hospitalizations and reducing hospital stays in patients presenting from the emergency department for ABSSSI treatment.

Methods: We used hospital avoidance models to examine the potential cost-savings of managing patients with ABSSSI and no or limited comorbidities and without life-threatening conditions by using omadacycline in the outpatient setting compared with the current standard of care. Early hospital discharge models were used to evaluate the hospital stay reduction that would be required to be achieved with omadacycline treatment relative to IV vancomycin to confer cost-savings compared with standard of care among patients with ABSSSI and ≥2 comorbidities but no life-threatening conditions.

Results: In the hospital stay avoidance models, cost-savings may be realized by using therapeutically bioequivalent IV-to-oral antibiotics, such as omadacycline, compared with inpatient treatment with IV vancomycin. Based on a sensitivity analysis, further savings could be possible with outpatient administration of omadacycline, even if 20% of omadacycline outpatients were subsequently admitted and incurred the full inpatient cost, with no reimbursement penalties. Of more than 300 patients, only 1 was admitted to the hospital after a full course of omadacycline in the oral-only clinical trial. In the early hospital discharge models, the maximum cost-minimizing daily expense of omadacycline varied from $173 to $936, depending on the presence of active comorbidities or systemic symptoms, hospital stay reduction, and model perspective.

Conclusion: These results suggest that the targeted use of antibiotics with bioequivalent IV-to-oral formulations, such as omadacycline, for select patients with ABSSSI may lead to cost-savings compared with inpatient IV vancomycin treatment by shifting care to the outpatient setting or by facilitating earlier hospital discharge among hospitalized patients.

背景:Omadacycline是一种口服和静脉注射(IV)每日一次的氨基甲基环素抗生素,最近被美国食品和药物管理局批准用于治疗急性细菌性皮肤和皮肤结构感染(ABSSSI)患者。在2项3期临床试验中,与利奈唑胺相比,iv -口服切换和口服给药奥马达环素在治疗ABSSSI患者方面达到了非劣效性的主要终点。目的:通过避免住院和减少在急诊科就诊的ABSSSI患者的住院时间,与静脉万古霉素的标准护理相比,估计使用生物等效静脉注射到口服抗生素(如奥马达环素)的潜在成本节约。方法:我们使用医院回避模型来研究与目前的护理标准相比,在门诊使用奥马达环素管理无或有限合并症和无危及生命的ABSSSI患者的潜在成本节约。早期出院模型用于评估与静脉万古霉素治疗相比,奥马达环素治疗所需的住院时间减少,与标准治疗相比,具有ABSSSI和≥2个合并症但没有危及生命的疾病的患者节省成本。结果:在避免住院模型中,与住院患者使用静脉万古霉素相比,使用治疗生物等效的静脉口服抗生素(如奥马达环素)可实现成本节约。根据敏感性分析,即使20%的门诊患者随后入院并承担全部住院费用,且没有报销处罚,门诊使用奥马达环素可能会进一步节省费用。在300多名患者中,只有1名患者在口服奥马达环素的整个疗程后入院。在早期出院模型中,奥马达环素每日最大成本-最小化费用从173美元到936美元不等,这取决于是否存在活动性合共病或全身性症状、住院时间减少和模型观点。结论:这些结果表明,对于选择性ABSSSI患者,通过将护理转移到门诊或促进住院患者早期出院,有针对性地使用生物等效IV-to-oral配方的抗生素,如奥马达环素,可能会比住院患者静脉万古霉素治疗节省成本。
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引用次数: 0
Shut Off the Faucet and Stop Mopping the Floor. 关掉水龙头,停止拖地。
IF 1.4 4区 医学 Q1 Medicine Pub Date : 2018-12-01
David B Nash
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引用次数: 0
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American Health and Drug Benefits
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