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Comparative Effectiveness and Safety of Ticagrelor versus Prasugrel in Patients with Acute Coronary Syndrome: A Retrospective Cohort Analysis 替格瑞洛与普拉格雷在急性冠脉综合征患者中的有效性和安全性比较:回顾性队列分析
Pub Date : 2019-09-01 DOI: 10.1002/phar.2311
G. Dawwas, E. Dietrich, D. Winchester, A. Winterstein, R. Segal, Haesuk Park
To compare the effectiveness and safety of ticagrelor versus prasugrel in preventing recurrent cardiovascular disease (CVD) and major bleeding events in patients with acute coronary syndrome (ACS).
比较替格瑞洛与普拉格雷预防急性冠脉综合征(ACS)患者复发性心血管疾病(CVD)和大出血事件的有效性和安全性。
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引用次数: 9
Bevacizumab Use and the Risk of Arterial and Venous Thromboembolism in Patients with High-Grade Gliomas: A Nested Case-Control Study. 高级别胶质瘤患者使用贝伐单抗与动脉和静脉血栓栓塞风险:一项嵌套病例对照研究。
Pub Date : 2019-09-01 Epub Date: 2019-08-06 DOI: 10.1002/phar.2310
Inyoung Lee, Sruthi Adimadhyam, Edith A Nutescu, Jifang Zhou, Alemseged A Asfaw, Karen I Sweiss, Pritesh R Patel, Gregory S Calip

Study objective: Bevacizumab is used in the treatment of recurrent glioblastoma, but evidence is limited on the incidence of thromboembolic complications regarding the use of this drug in real-world settings. We evaluated the risk of arterial thromboembolism (ATE) and venous thromboembolism (VTE) associated with the use of bevacizumab among adults diagnosed with high-grade gliomas in a commercially insured U.S.

Population:

Design: Nested case-control study.

Data source: Truven Health MarketScan Commercial and Medicare Supplemental health claims databases (2009-2015).

Patients: A total of 2157 patients with high-grade gliomas who underwent incident (first-time) craniotomy, radiation, and concurrent temozolomide treatment between 2009 and 2015 were identified. Overall, 25 cases of ATE and 99 cases of VTE were each identified in this cohort, and each case was matched to up to 10 controls (170 for ATE and 819 for VTE) based on sex, age, quarter year of index time, and follow-up duration by using incidence density sampling without replacement from the overall cohort. Controls were at risk for the outcome of interest (ATE or VTE) at the time of case occurrence and survived at least as long as their referent case.

Measurements and main results: Exposure to bevacizumab was determined during inpatient or outpatient encounters between the index date (date of the incident craniotomy) and the ATE or VTE event or corresponding matched control date. Multivariable conditional logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the risk of ATE and VTE separately. A higher proportion of patients with ATE received bevacizumab compared with controls (28% vs 17%; adjusted OR 1.51, 95% CI 0.54-4.24), but this excess in odds was not statistically significant. Similarly, bevacizumab was not significantly associated with VTE (13% vs 9%; adjusted OR 1.40, 95% CI 0.71-2.75).

Conclusion: We found no significant association between the use of bevacizumab and the occurrence of thromboembolic events in patients with high-grade gliomas, although our study was limited by the small number of ATE events. Because the potential for complications from arterial thrombosis cannot be completely ruled out, further research is needed to confirm the thromboembolic safety of bevacizumab in a larger sample of patients with high-grade gliomas.

研究目的贝伐珠单抗用于治疗复发性胶质母细胞瘤,但在现实世界中使用这种药物的血栓栓塞并发症发生率方面证据有限。我们评估了在美国商业保险人群中确诊为高级别胶质瘤的成人中使用贝伐珠单抗引起动脉血栓栓塞(ATE)和静脉血栓栓塞(VTE)的风险:设计:嵌套病例对照研究:Truven Health MarketScan商业和医疗保险补充医疗索赔数据库(2009-2015年):2009年至2015年期间,共有2157名高级别胶质瘤患者接受了开颅手术、放射治疗和同期替莫唑胺治疗。总体而言,该队列中各发现了 25 例 ATE 和 99 例 VTE,并根据性别、年龄、指数时间的季度年和随访时间,采用不替换的发病率密度抽样法从整个队列中为每个病例配对了最多 10 个对照(ATE 170 例,VTE 819 例)。对照组在病例发生时面临相关结果(ATE或VTE)的风险,且存活时间至少与参照病例相同:贝伐珠单抗的暴露情况是在指数日期(事件性开颅手术日期)与ATE或VTE事件或相应的匹配对照日期之间的住院或门诊就诊期间确定的。采用多变量条件逻辑回归模型分别估算 ATE 和 VTE 风险的几率比 (OR) 和 95% 置信区间 (CI)。与对照组相比,接受贝伐珠单抗治疗的 ATE 患者比例更高(28% vs 17%;调整后 OR 1.51,95% CI 0.54-4.24),但这一超额几率在统计学上并不显著。同样,贝伐单抗与 VTE 的关系也不明显(13% vs 9%;调整 OR 1.40,95% CI 0.71-2.75):我们发现贝伐珠单抗的使用与高级别胶质瘤患者血栓栓塞事件的发生无明显关联,尽管我们的研究受到了ATE事件数量较少的限制。由于不能完全排除动脉血栓形成并发症的可能性,因此需要进一步研究,在更大样本的高级别胶质瘤患者中证实贝伐单抗的血栓栓塞安全性。
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引用次数: 0
Calcium Channel Blocker Use and the Risk for Prostate Cancer: A Population‐Based Nested Case‐Control Study 钙通道阻滞剂的使用和前列腺癌的风险:一项基于人群的嵌套病例对照研究
Pub Date : 2019-08-18 DOI: 10.1002/phar.2317
In Rotshild et al. some typographical errors were published in “Material and Methods” and “Discussion” sections. Material and Methods section Data Source The word “logistic” in the penultimate sentence should have been “logical”. The correct sentence is: . . . The CHS database system validates the diagnoses of chronic diseases and malignancies by logical checks, such as comparing diagnoses from various providers, and by direct authentication of the diagnoses of primary physicians. . . . Discussion section The word “no” should have been added between “have” and “reason” in the penultimate sentence. The correct sentence is: . . . However, we have no reason to assume the mortality rates would be differential between the exposure groups, as the study population is based on a homogeneous cohort of patients using antihypertensive drugs. We apologize for these errors. Reference 1. Rotshild V, Azoulay L, Feldhamer I, Perlman A, Muszkat M, Matok I. Calcium channel blocker use and the risk for prostate cancer: a population-based nested case-control study. Pharmacotherapy 2019;39(6):690–6. https://doi.org/10.1002/phar.2266
在rotschild等人的文章中,“材料和方法”和“讨论”部分出现了一些印刷错误。材料和方法部分数据来源倒数第二句中的“logistic”一词应该是“logical”。正确的句子是:……CHS数据库系统通过逻辑检查来验证慢性病和恶性肿瘤的诊断,例如比较来自不同提供者的诊断,以及通过对初级医生诊断的直接认证. . . .在倒数第二句的“have”和“reason”之间应该加上“no”。正确的句子是:……然而,我们没有理由假设不同暴露组之间的死亡率会有差异,因为研究人群是基于使用抗高血压药物的同质队列患者。我们为这些错误道歉。引用1。李建军,李建军,李建军,李建军。钙通道阻滞剂的使用与前列腺癌风险的关系:一项基于嵌套病例对照研究。药物治疗39 2019;(6):690 - 6。https://doi.org/10.1002/phar.2266
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引用次数: 0
Transitioning Hospitalized Patients with Opioid Use Disorder from Methadone to Buprenorphine without a Period of Opioid Abstinence Using a Microdosing Protocol 使用微剂量方案将阿片类药物使用障碍住院患者从美沙酮过渡到丁丙诺啡,无阿片类药物戒断期
Pub Date : 2019-08-15 DOI: 10.1002/phar.2313
Dale Terasaki, Christopher Smith, S. Calcaterra
Buprenorphine, a partial μ‐opioid agonist, is an effective treatment for opioid use disorder that conventionally requires symptoms of withdrawal before initiation to avoid precipitating withdrawal. Our institution implemented a microdosing approach to transition patients from full μ‐opioid agonists to buprenorphine without requiring patients to undergo a period of opioid abstinence. Little has been published about this strategy in the inpatient setting in the United States, and even less has been published dealing with the transition from methadone to buprenorphine. Our objective was to demonstrate that a microdosing protocol to transition patients from methadone to buprenorphine can be feasibly implemented in a U.S. hospital setting.
丁丙诺啡是一种部分μ阿片类药物激动剂,是阿片类药物使用障碍的有效治疗方法,通常需要在开始前出现戒断症状,以避免急性戒断。我们的机构实施了一种微剂量方法,将患者从全μ阿片激动剂过渡到丁丙诺啡,而不需要患者经历一段时间的阿片戒断。在美国,关于这种策略在住院患者中的应用的报道很少,关于从美沙酮到丁丙诺啡的过渡的报道就更少了。我们的目的是证明在美国的医院环境中,将患者从美沙酮过渡到丁丙诺啡的微剂量方案是可行的。
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引用次数: 54
Alternative Viewpoint of “Alteplase Therapy for Acute Ischemic Stroke in Pregnancy: Two Case Reports and a Systematic Review of the Literature” “阿替普酶治疗妊娠期急性缺血性脑卒中2例报告及文献系统复习”的另类观点
Pub Date : 2019-08-01 DOI: 10.1002/phar.2304
B. Gilbert, J. Dingman, Jacob A. Reeder, Amy L. Kiskaddon
We read with great enthusiasm the article by Ryman et al and wish to highlight a few key concepts not mentioned in their article. Although a large proportion of data for alteplase in acute ischemic stroke (AIS) remains controversial, we propose that the hemostatic variances seen during pregnancy make the women in this patient population ideal candidates for thrombolysis. Pregnancy is associated with a hypercoagulable state secondary to increased clotting factor production, decreased protein C and S activity, and decreased natural thrombolytic activity. It would be expected that clots formed during pregnancy would be fibrin rich, presenting an ideal therapeutic target for alteplase. This is in contrast to the typically more calcified composition of cardioembolic strokes, offering a theoretical explanation for the varied responses to alteplase seen in patients with this type of stroke. Also, although actual body weight has been the only dosing strategy evaluated for AIS during pregnancy in the literature thus far, lower dosing strategies were evaluated in select cohorts that have largely shown success. 5 Given the variances during pregnancy in volume of distribution, cardiac output, plasminogen activator inhibitor concentration, and hepatic clearance, it is reasonable to expect altered serum alteplase concentrations that may affect drug concentration and delivery to affected vessels. Therefore, optimal dosing strategies throughout each trimester should continue to be an area of active research. Given that the fatal bleed risk extends beyond just intracranial hemorrhages for pregnant patients, a question remains as to whether those at high risk for uterine hemorrhage or with mild stroke severity should bypass alteplase administration in favor of thrombectomy or antiplatelet therapies. Lastly, with increasing use of tenecteplase for ischemic stroke, it will be important to consider if alteplase alone or fibrinolytics as a class are safe and effective in pregnancy.
我们怀着极大的热情阅读了Ryman等人的文章,并希望强调他们文章中没有提到的几个关键概念。尽管阿替普酶在急性缺血性卒中(AIS)中的大部分数据仍存在争议,但我们认为妊娠期间的止血差异使该患者群体中的女性成为溶栓的理想候选者。妊娠与高凝状态有关,继发于凝血因子产生增加,蛋白C和S活性降低,天然溶栓活性降低。妊娠期间形成的血块可能富含纤维蛋白,是阿替普酶理想的治疗靶点。这与心脏栓塞性中风的典型钙化成分相反,为这类中风患者对阿替普酶的不同反应提供了理论解释。此外,尽管实际体重是迄今为止文献中唯一评估妊娠期AIS的剂量策略,但在选择的人群中评估了较低的剂量策略,这些策略在很大程度上显示了成功。考虑到妊娠期间分布容积、心输出量、纤溶酶原激活物抑制剂浓度和肝脏清除率的差异,我们有理由预期血清阿替普酶浓度的改变可能会影响药物浓度和影响血管的输送。因此,每个孕期的最佳给药策略应该继续是一个积极研究的领域。考虑到孕妇的致命出血风险不仅仅是颅内出血,一个问题仍然存在,即子宫出血高风险或轻度中风严重程度的患者是否应该绕过阿替普酶,而选择血栓切除术或抗血小板治疗。最后,随着替普酶在缺血性卒中中的应用越来越多,考虑阿替普酶单独使用或纤溶药物作为一类药物在妊娠期是否安全有效将是很重要的。
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引用次数: 1
Drs. Ryman et al. reply to Drs. Gilbert et al. and Drs. Guner et al. Ryman 博士等人回复 Gilbert 博士等人和 Guner 博士等人。
Pub Date : 2019-08-01 DOI: 10.1002/phar.2302
Klayton M Ryman, Wilson D Pace, Shawn Smith, Gabriel V Fontaine
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引用次数: 0
Critique of “Alteplase Therapy for Acute Ischemic Stroke in Pregnancy: Two Case Reports and a Systematic Review of the Literature” 《阿替普酶治疗妊娠期急性缺血性脑卒中:2例报告及文献系统综述》评论
Pub Date : 2019-08-01 DOI: 10.1002/phar.2303
A. Guner, M. Kalçık, M. Özkan
We recently read with great interest the article by Ryman et al entitled “Alteplase Therapy for Acute Ischemic Stroke in Pregnancy: Two Case Reports and a Systematic Review of the Literature.” We would like to congratulate the authors for achieving a successful outcome in such a high-risk patient for acute ischemic stroke (AIS) during pregnancy, and we want to share our experience in pregnant women with prosthetic valve thrombosis (PVT) who underwent AIS during thrombolytic therapy (TT). A prosthetic heart valve is highly thrombogenic and increases the risk of thrombosis up to 10% (especially a mechanical prosthetic valve) with the procoagulant condition of pregnancy. We previously reported that a low-dose slow infusion of tissue-type plasminogen activator (tPA [alteplase]) with repeated doses as needed is an effective therapy with an excellent thrombolytic success rate for the treatment of PVT in pregnant women and that TT should be considered firstline therapy in pregnant patients with PVT. The most feared complication is the risk of cerebral embolism that can be up to 5–6% for left-sided PVT. The first 6 hours after cerebral thromboembolism are crucial, and early diagnosis and exclusion of hemorrhage by multidetector computed tomography is very important. Although the recommended dose of alteplase according to the stroke guideline is 0.9 mg/kg (maximum dose 90 mg) for 60 minutes for AIS according to current guidelines, with 10% of the dose given as a bolus for 1 minute, we used lower doses for safety concerns. Our success reported in our case reports may have been due to the early diagnosis and fresh nature of the thrombus. 4 Faster TT regimens may induce new thromboembolisms in patients with concomitant PVT. In conclusion, low-dose and slow-infusion TT is effective and safe in AIS during PVT treatment.
我们最近怀着极大的兴趣阅读了Ryman等人的文章,题为“阿替普酶治疗妊娠期急性缺血性中风:两例病例报告和文献系统综述”。我们祝贺作者在妊娠期如此高风险的急性缺血性卒中(AIS)患者中取得了成功的结果,并希望分享我们在溶栓治疗(TT)期间接受AIS的人工瓣膜血栓形成(PVT)孕妇中的经验。人工心脏瓣膜是高度致血栓性的,在妊娠的促凝状态下,血栓形成的风险可增加10%(尤其是机械人工瓣膜)。我们之前报道过,低剂量缓慢输注组织型纤溶酶原激活剂(tPA[阿替普酶]),根据需要重复剂量,是一种有效的治疗妊娠期PVT的方法,具有良好的溶栓成功率,对于妊娠期PVT患者,TT应被视为第线治疗。最可怕的并发症是脑栓塞的风险,左侧PVT可高达5-6%。多探头计算机断层扫描对出血的早期诊断和排除非常重要。尽管根据卒中指南,AIS的推荐剂量为0.9 mg/kg(最大剂量90mg),根据目前的指南,服用60分钟的阿替普酶,其中10%的剂量为1分钟,但出于安全考虑,我们使用了较低的剂量。在我们的病例报告中,我们的成功报告可能是由于早期诊断和血栓的新鲜性质。4更快的TT方案可能导致合并PVT患者发生新的血栓栓塞。综上所述,在AIS患者PVT治疗期间,低剂量和慢速输注TT是有效和安全的。
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引用次数: 0
2018 ACCP Updates in Therapeutics 2018 ACCP治疗学更新
Pub Date : 2018-06-01 DOI: 10.1002/phar.2122
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引用次数: 0
ACCP Updates in Therapeutics® 2018 May 23–24, 2018 UT Clinical Pharmacy Forum 2018年5月23-24日,UT临床药学论坛
Pub Date : 2018-01-01 DOI: 10.1002/phar.2101
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引用次数: 0
ACCP Virtual Poster Symposium ACCP虚拟海报研讨会
Pub Date : 2017-10-01 DOI: 10.1002/phar.1964
Pouran Manzouri
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引用次数: 0
期刊
Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy
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