Safety Profile of HTX-019 Administered as an Intravenous Push in Cancer Patients: A Retrospective Review

Abstract

Introduction

HTX-019 [CINVANTI^® (aprepitant injectable emulsion)] is a neurokinin 1 receptor antagonist (NK-1 RA) approved as a 30-min infusion for preventing acute and delayed chemotherapy-induced nausea and vomiting. HTX-019 has been generally well tolerated when administered as a 30-min infusion or 2-min injection [intravenous (IV) push] in healthy subjects. This real-world analysis assesses safety of HTX-019 via IV push in patients with cancer and addresses a recent IV bag shortage.

Methods

This retrospective review involved six sites in Alabama, USA. Analyzed patients were 18–94 years old with an Eastern Cooperative Oncology Group performance status ranging from 0 to 4. Seventy-six chemotherapy regimens were utilized (emetogenicity high, n = 35; moderate, n = 35; low, n = 6) and patients received HTX-019 130 mg only or switched from fosaprepitant 150 mg to HTX-019 130 mg within a three-drug antiemetic regimen with a 5-hydroxytryptamine type 3 RA and dexamethasone. HTX-019 was administered via IV push. Electronic medical records of patients receiving HTX-019 were queried for nursing and medical documentation associated with infusion-site adverse events (ISAEs). The detailed notes were also reviewed for any discontinuation of HTX-019 or substitution of HTX-019 with another NK-1 RA.

Results

The HTX-019 safety profile was analyzed on the basis of 2066 IV push administrations in 591 cancer patients (most common diagnoses: lung, n = 107; breast, n = 100; colon, n = 92). No clinically significant ISAEs or adverse events associated with HTX-019 were reported. Also, no patients discontinued HTX-019 treatment, and none switched from HTX-019 to another NK-1 RA.

Conclusion

This is the first study to demonstrate that HTX-019 can be safely administered via IV push in patients with cancer receiving emetogenic chemotherapy while negating the need for fluid bags, which are scarce.

Funding

Heron Therapeutics, Inc., San Diego, CA, USA.

Plain Language Summary

Plain language summary available for this article.

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Correction to: A Comparative Study of the Efficacy of Cognitive Behavioral Therapy and Zopiclone in Chronic Insomnia

The third author's name should read M. G. Poluektov.

http://bit.ly/2SnlBpz

Conservative treatment of type A aortic dissection following hybrid arch repair

Abstract

Objective

Type A aortic dissection (TAAD) following hybrid arch repair (HAR) is a lethal complication. Open surgical repair is the ideal treatment, but this can be difficult, as most candidates have complications and are unsuitable for the conventional open aortic repair. We herein report three cases of TAAD after HAR and assess the treatment options.

Methods

Of 261 aortic arch repair cases between April 2010 and March 2018, 38 underwent HAR using debranching of all the arch vessels followed by stent graft implantation landing proximally in zone 0 (type 1 HAR). Three cases suffered from TAAD, and their background characteristics and post-operative outcomes were studied retrospectively.

Results

The three TAAD cases were elderly with a high risk of mortality due to comorbidities. TAAD for Cases 1, 2, and 3 was detected on post-operative day (POD) 11, POD11, and during the procedure, respectively. Case 1 was complicated with both respiratory and renal failures, and Case 3 suffered from severe neurological impairment when TAAD was detected. No additional open aortic repair was performed in any cases. Case 3 died on POD5 due to aortic rupture. Cases 1 and 2 have survived for more than 50 months since their initial surgeries.

Conclusions

TAAD following HAR can be detected with post-operative imaging despite a lack of signs noted during the intra- and post-operative periods. Conservative therapy might, therefore, be an acceptable option for subacute-onset TAAD following HAR with stable hemodynamics, even though such patients do required a very careful follow-up.

http://bit.ly/2sUgtL3

High-flux thin film nanocomposite forward osmosis membrane incorporated with blue lemon polyoxometalate based open-framework

Abstract

In this study a novel type of polyoxometalate based open-frameworks (POM-OFs) by using blue lemon (BL) as POM and tetrabutylammonium bromide (TBAB) as organic cationic coordinating agent successfully synthesized (BL.TBA-OFs) and incorporated in polyamide active layer via interfacial polymerization (IP) to fabricate hydrophilic and high water permeable thin-film nanocomposite (TFN) membranes. The prepared POM-OFs and TFN membranes were fully characterized using physicochemical techniques and the effect of POM-OFs incorporation on TFN membranes performance was investigated using reverse osmosis (RO) and forward osmosis (FO) experiments with regard to the water permeability, salt rejection, and selectivity. The enhancement in hydrophilicity of TFN membranes was confirmed by contact angle measurements, which attributed to the presence of superhydrophilic BL.POM. Water flux of the TFN-BL.TBA-4 membrane (with 400 ppm BL.TBA-OFs incorporation) increased from 18.1 to 28.6 LMH in FO mode, and 23.1 to 36.3 LMH in PRO mode, in comparison with unmodified TFC membrane. Enhancement in separation performance of the modified TFN membranes was attributed to the incorporation of nanopores BL.POM, which create short water pathways. By using sodium alginate as a foulant model the novel modified membrane showed better anti-fouling propensity than the TFC one. This report opens up a new modification route in the achieving of high efficient TFN membranes for FO process.

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Danke an alle Gutachter 2018

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Erfassung von tatsächlichem Schlafverhalten und Beschwerdesymptomatik mittels Selbstrating-Diagnostikfragebogen – eine Validierung anhand von Schlaftagebüchern

Zusammenfassung

Hintergrund

In der klinischen Routine werden retrospektive Selbstbewertungsfragebögen zu schlafassoziierten Symptomen als diagnostisches Instrument eingesetzt, ihre tatsächliche Validität ist bisher dennoch kaum untersucht. Auch ein aus dem Diagnostikfragebogen gebildeter Schlafqualitätsindex könnte dem Schlafmediziner einen schnellen Zugang zur weiteren spezifischen Anamnese ermöglichen.

Fragestellung

Es wurde überprüft, ob ein Diagnostikfragebogen, welcher eigens im Schlaflabor entwickelt wurde, sowie ein daraus abgeleiteter Schlafqualitätsindex valide Abbildungen von Schlafgewohnheiten und Beschwerdesymptomatik bei Patienten mit schlafbezogener Atmungsstörung (SBAS) darstellen.

Material und Methode

Von 326 Patienten mit Verdacht auf SBAS wurden ein zweiwöchiges Schlaftagebuch sowie ein Diagnostikfragebogen bearbeitet, welcher das Schlafverhalten der vorangegangenen vier Wochen erfasste. Mittels schrittweiser generalisierter linearer Regressionen wurde untersucht, ob die Angaben des Fragebogens korrespondierende Angaben des Tagebuchs vorhersagen. Ein aus dem Diagnostikfragebogen gebildeter Schlafqualitätsindex wurde ebenfalls als Prädiktor untersucht. Personenmerkmale (Geschlecht, Alter etc.) wurden adjustiert.

Ergebnisse

Die schlafbezogenen Fragebogenitems sagten die Tagebuchangaben signifikant vorher (p < 0,001). Der Schlafqualitätsindex (10,43 ± 6,16 Punkte) zeigte sich darüber hinaus als zusätzlicher Prädiktor für das Gefühl des Erholtseins, die Tagesschläfrigkeit und Konzentrationsfähigkeit (alle p < 0,05), nicht aber für die Einschlaflatenz (p > 0,05).

Schlussfolgerung

Ein laboreigener Diagnostikfragebogen ist eine valide Methode zur Erfassung von Schlafgewohnheiten und der Beschwerdesymptomatik bei Patienten mit schlafbezogener Atmungsstörung. Der Schlafqualitätsindex vermittelt Informationen über den subjektiven Tageszustand eines Patienten, was ihn als wertvolles Werkzeug des diagnostischen Prozesses auszeichnet.

http://bit.ly/2Sn4Bjf

Bilingual Children with Hearing Loss Learn Words Better with Bilingual Instruction

A new study conducted by a team from Vanderbilt University found that bilingual children with hearing loss learned new vocabulary better when taught using bilingual instruction. The researchers evaluated the effectiveness of bilingual and monolingual teaching practices to identify which method would work best with these children who face unique but under-investigated challenges in language learning.

The idea for the study was sparked when Ana Soares, a teacher of the deaf, and Andrea Vargas, a speech-language pathologist, from Mama Lere Hearing School at Vanderbilt noticed challenges that affected Spanish-speaking families when helping their children with hearing loss learn a language. 

"There are many different ideas on how to teach children learning more than one language, and this debate includes children with hearing loss who are bilingual," explained the study's lead author Jena C. McDaniel. "An ongoing difference in opinion is whether new vocabulary should be taught in the native language, the new language, or both. More importantly, some have argued that teaching in the native language harms the ability to learn words in the new language."

Surprised with the dearth of research into this important issue, the team set out to investigate for themselves. "We recognized the need for more evidence on how to meet the language needs of children with hearing loss who are bilingual, including the language used for intervention and instruction, and wanted to be a part of generating and disseminating that knowledge," McDaniel told The Hearing Journal. "Thus, we created a clinician-researcher team with the goal of optimizing intervention services and language outcomes for children with hearing loss who are bilingual." 

The study, which involved giving alternating bilingual or monolingual language instructions to three Spanish–English-speaking children with hearing loss, provided evidence that put to question a prevalent belief in language teaching.

"When we counted words said in both languages (i.e., conceptual vocabulary), bilingual children with hearing loss showed more effective word learning when they received instruction in Spanish and English compared with being taught in English alone. We did not find any evidence of an inhibitory effect of instruction in Spanish on the children's word learning in English," noted McDaniel. "That is, there was no harmful effect when children were taught in their native language."

"These findings do not support the widespread, but understudied, recommendation to teach bilingual children with hearing loss or other disabilities exclusively in English," she added. "Our data suggest that there is no benefit to decreasing these learning opportunities by recommending that these children be taught the new language exclusively (i.e., English only)."     

This study also helps the case of families who want to stay connected with their culture and native language. McDaniel noted, "We believe these findings are important because teaching children with hearing loss in their native language maximizes opportunities to learn new words from parents, siblings, and other community members who speak the child's native language."

Moving forward, the team hopes to replicate the study with participants with more diverse hearing loss profiles and language levels. "We would also like to focus on conceptual vocabulary as the primary dependent variable, vary the details of the bilingual intervention systematically to optimize its effectiveness, and target language skills other than vocabulary," shared McDaniel.

Published: 1/30/2019 11:09:00 AM

from #Audiology via ola Kala on Inoreader http://bit.ly/2HIwwpt