scholarly journals 2747. Relative Vaccine Efficacy of High-Dose vs. Standard Dose Influenza Vaccines in Preventing Probable Influenza in a US Medicare Fee-for-Service Population

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S967-S967
Author(s):  
Misti Paudel ◽  
Salah Mahmud ◽  
Ami R Buikema ◽  
Stephanie Korrer ◽  
Van Voorhis Damon ◽  
...  

Abstract Background High dose (HD) influenza vaccine has been shown to be more efficacious than standard dose (SD) vaccine in multiple randomized trials. HD is currently the most commonly used vaccine in US seniors (≥65 years of age). In this study, we evaluated the real-world relative vaccine effectiveness (rVE) of HD vs SD over 3 influenza seasons. Methods This study includes a cohort of Medicare fee-for-service enrollees during influenza seasons 2011–2012 to 2013–2014 who received either HD or SD at a pharmacy or an outpatient clinic. HD recipients were matched 1:1 to SD recipients based on location, date of vaccination, age, and gender. Fine-Gray subdistribution hazard models with competing risk of death were used to adjust for residual confounding. The study outcome of probable influenza was defined as any inpatient stay with an influenza diagnosis on the claim, or an outpatient medical encounter with a rapid influenza test/culture followed by an antiviral prescription. Analyses were stratified based on vaccination location (clinic vs pharmacy) as it is expected that physicians carrying both vaccines may prioritize HD to frailer patients, while pharmacists may not exercise clinical judgment. Results Over the influenza seasons 2011–2012, 2012/–2013, and 2013–2014, 1.6–2.2 million seniors were immunized at a pharmacy; and 3.3–3.5 million at a clinic. After matching, there were 535,598; 1,017,552; and 1,548,164 in the pharmacy cohort, and 821,662; 1,151,080; and 1,559,488 in the clinic cohort, across study years. The rVE over 2011/12, 2012/13, and 2013/14 during peak influenza circulation was 21.8% (95% CI: −5.9%, 42.3%), 14.8% (9.3%,19.9%), and 16.9% (9.2%, 23.9%), respectively, in the pharmacy cohort; and 16.5% (−5.9%, 34.2%), 15.1% (10.9%, 19.1%), 10.0% (2.9%, 16.6%), respectively, in the clinic cohort. Conclusion HD was consistently associated with better protection against probable influenza events requiring outpatient or inpatient care. The slightly lower treatment effects observed in the outpatient clinic cohort could be a result of confounding by indication due to physicians triaging HD to frailer patients. Disclosures All authors: No reported disclosures.

Vaccine ◽  
2020 ◽  
Vol 38 (29) ◽  
pp. 4548-4556 ◽  
Author(s):  
Misti Paudel ◽  
Salah Mahmud ◽  
Ami Buikema ◽  
Stephanie Korrer ◽  
Damon Van Voorhis ◽  
...  

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 119-119
Author(s):  
Christopher Leigh Hallemeier ◽  
Jennifer Moughan ◽  
Michael G. Haddock ◽  
Arnold M. Herskovic ◽  
Bruce D. Minsky ◽  
...  

119 Background: Radiotherapy (RT) interruptions have a negative impact on outcomes in many epithelial malignancies treated with definitive RT. The purpose of this study was to analyze the impact of RT duration on outcomes in patients (pts) with esophageal cancer treated with definitive chemoradiotherapy (CRT). Methods: Pts treated with definitive CRT on RTOG trials 8501 and 9405 were included. Separate analyses were performed in pts receiving standard dose (SD-CRT; 50 Gy + 5FU + cisplatin) and high dose (HD-CRT; 64.8 Gy + 5FU + cisplatin) CRT. Local (LF) and regional (RF) failure were estimated by the cumulative incidence method. Disease-free (DFS) and overall (OS) survival were estimated by the Kaplan-Meier method. Univariate (UVA) and multivariate (MVA) Cox proportional hazards models were utilized to examine for correlation between RT duration (< vs. ≥ median) with LF, RF, DFS and OS. Results: In the SD-CRT cohort (n=235), 96 pts (41%) had ≥ 1 RT interruption for a median of 3 (IQR 1-6) days. The median RT duration was 39 (IQR 37-43) days. In UVA and MVA, RT duration was not associated with LF, RF, DFS, or OS. Estimated outcome rates are in the table. In the HD-CRT cohort (n=107), 64 pts (60%) had ≥ 1 RT interruption for a median of 3.5 (IQR 2-7.5) days. The median RT duration was 52 (IQR 50-57) days. In UVA, RT duration ≥ 52 days was associated with a 33% reduction in risk of DFS failure (HR=0.66, 95% CI [0.44-0.98], p=0.039) and a 29% reduction in risk of death (HR=0.71, 95% CI [0.48-1.06], p=0.09). When excluding the 25 pts with RT dose < 64.8 Gy, RT duration was not associated with DFS or OS. Conclusions: In pts with esophageal cancer receiving definitive SD-CRT, an association between RT duration and outcomes was not observed. In pts receiving HD-CRT, longer RT duration was associated with improved DFS, which may have been due to a significant number of deaths at RT dose < 64.8 Gy. Supported by NCI U10 grants CA21661, CA180868, CA180822, CA37422. Clinical trial information: NCT00002631. [Table: see text]


Author(s):  
Mahila Monajati ◽  
Shahram Ala ◽  
Masoud Aliyali ◽  
Roya Ghasemian ◽  
Fatemeh Heidari ◽  
...  

Background: Meropenem standard doses are based on the minimum inhibitory concentration of sensitive pathogens and the pharmacokinetic parameter of not critically ill patients. We compared the efficacy of high versus standard dose of meropenem in ventilator-associated pneumonia (VAP). Methods: 24 out of 34 eligible patients were randomized to receive meropenem 3 g q8h (high dose group, 11 patients) or 2 g q8h (standard dose group, 13 patients) as a 3h infusion. Primary outcome was considered as clinical success that was defined as stable hemodynamic, improved sequential organ failure assessment (SOFA) score, stable or improved PaO2/FiO2 after 7 days. A sputum culture was taken before intervention. Results: Clinical success rate was not significantly different between the high and standard dose group (54.5% vs. 38.5%, P= 0.431). There was a significant difference in reduction of clinical pulmonary infection score (CPIS) compared to high dose with standard group (P=0.038). SOFA score declined significantly in high dose group through the study (P=0.006). A shorter duration of VAP treatment was recorded in high dose group (P=0.061). We did not observe any significant adverse event related to meropenem. Acinetobacter spp. (34.8%), Klebsiella spp. (32.6%) and, Pseudomonas aeruginosa (19.5%) isolated more frequently from sputum cultures. Conclusion: Treatment with high dose of meropenem seems to be safe. However, it did not provide significantly higher clinical success rate in comparison with the standard dose, but could be considered as an appropriate empirical treatment in patients with severe infection due to reducing in SOFA and CPIS.


2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Mouzarllem B. Reis ◽  
Fernanda L. Rodrigues ◽  
Natalia Lautherbach ◽  
Alexandre Kanashiro ◽  
Carlos A. Sorgi ◽  
...  

Abstract Scorpion envenomation is a leading cause of morbidity and mortality among accidents caused by venomous animals. Major clinical manifestations that precede death after scorpion envenomation include heart failure and pulmonary edema. Here, we demonstrate that cardiac dysfunction and fatal outcomes caused by lethal scorpion envenomation in mice are mediated by a neuro-immune interaction linking IL-1 receptor signaling, prostaglandin E2, and acetylcholine release. IL-1R deficiency, the treatment with a high dose of dexamethasone or blockage of parasympathetic signaling using atropine or vagotomy, abolished heart failure and mortality of envenomed mice. Therefore, we propose the use of dexamethasone administration very early after envenomation, even before antiserum, to inhibit the production of inflammatory mediators and acetylcholine release, and to reduce the risk of death.


2021 ◽  
pp. 106002802110072
Author(s):  
Casey A. Dubrawka ◽  
Kevin D. Betthauser ◽  
Hannah E. Pope ◽  
Gabrielle A. Gibson

Background No clear association between standard vasopressin doses and body mass index exists, despite potential pharmacokinetic and pharmacodynamic variability among patients with septic shock. It is unknown if higher doses may alter hemodynamic response. Objective The purpose of this study was to evaluate the effect of vasopressin dose on hemodynamic response in obese patients with septic shock. Methods A single-center, retrospective cohort study was conducted in adult, obese patients with septic shock receiving catecholamine vasopressors and vasopressin. Patients were analyzed according to vasopressin dose received: standard dose (≤0.04 U/min) and high dose (>0.04 U/min). The primary outcome was percentage change in norepinephrine equivalent (NEQ) dose. Results A total of 182 patients were included in the analysis, with 136 in the standard-dose vasopressin group and 46 in the high-dose vasopressin group. There was no difference in percentage change in NEQ dose at 6 hours after standard- or high-dose vasopressin attainment (−28.6% vs −19.1%; P = 0.166). A greater increase in mean arterial pressure (MAP) at 6 hours was observed with receipt of high-dose vasopressin (23.3% vs 15.3%; P = 0.023). Duration of shock and length of stay were significantly longer in patients who received high-dose vasopressin, with no difference in in-hospital mortality. Conclusion and Relevance This represents the first analysis comparing standard and higher doses of vasopressin in obese patients with septic shock. Receipt of high-dose vasopressin was not associated with a difference in catecholamine requirement or improved outcomes. Further studies are warranted to provide guidance on the use of high-dose vasopressin in septic shock.


2021 ◽  
Vol 35 ◽  
pp. 205873842110303
Author(s):  
Wenwen Gao ◽  
Xiang Zhang ◽  
Yanhui Yin ◽  
Shuwen Yu ◽  
Lu Wang

The evidence on whether high-dose new generation proton pump inhibitors (PPIs) including rabeprazole and esomeprazole achieve a higher eradication rate of Helicobacter pylori has not been assessed. The primary comparison was eradication and adverse events (AEs) rate of standard (esomeprazole 20 mg bid, rabeprazole 10 mg bid) versus high-dose (esomeprazole 40 mg bid, rabeprazole 20 mg bid) PPIs. Sub-analyses were performed to evaluate the eradication rate between Asians and Caucasians, clarithromycin-resistance (CAM-R) strains, and clarithromycin-sensitivity (CAM-S) strains of different dose PPIs. We conducted a literature search for randomized controlled trials comparing high-with standard-dose esomeprazole and rabeprazole for H. pylori eradication and AEs. A total of 12 trials with 2237 patients were included. The eradication rate of high-dose PPIs was not significantly superior to standard-dose PPIs regimens: 85.3% versus 84.2%, OR 1.09 (0.86–1.37), P = 0.47. The high dose induced more AEs than those of the standard dose, but didn’t reach statistical significance (OR 1.25, 95% CI: 0.99–1.56, P = 0.06). Subgroup analysis showed that the difference in eradication rate of PPIs between high- and standard-dose groups were not statistically significant both in Asians (OR 0.99, 95% CI 0.75–1.32, P = 0.97) and Caucasians (OR 1.27, 95% CI 0.84–1.92, P = 0.26). Furthermore, there were similar eradication rates in CAM-S (OR 1.2; 95% CI 0.58–2.5; P = 0.63) and CAM-R strains (OR 1.08; 95% CI 0.45–2.56; P = 0.87) between the standard-and high-dose groups. High and standard dosages of new generation of the PPIs showed similar H. pylori eradication rates and AEs as well as between Asian versus Caucasian populations, with or without clarithromycin-resistance. However, further studies are needed to confirm.


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