MARC details
| 000 -LEADER |
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| fixed length control field |
03768nam a22003497a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
230411s20232023 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0022-3565 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1124/jpet.122.001404 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
jpet.122.001404 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
36868827 |
| 245 ## - TITLE STATEMENT |
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| Title |
Comparison of safety and biological efficacy of anakinra (Kineret R) dispensed in polycarbonate plastic versus borosilicate glass syringes: a patient-level analysis of VCUART2 and VCUART3 clinical trials. |
| 251 ## - Source |
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| Source |
Journal of Pharmacology & Experimental Therapeutics. 2023 Mar 03 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
J Pharmacol Exp Ther. 2023 Mar 03 |
| 253 ## - Journal Name |
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| Journal name |
The Journal of pharmacology and experimental therapeutics |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2023 Mar 03 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Medline status |
Publisher |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2023-04-11 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: 1997 - present (after 1 year), Available in print through MWHC library: 1999 - March 2003 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
Anakinra is a recombinant human interleukin-1 (IL-1) receptor antagonist approved for the treatment of inflammatory diseases. Kineret R is available as a solution prepared in a borosilicate glass syringe. For implementing a placebo-controlled double-blind randomized clinical trial, anakinra is commonly transferred into plastic syringes. However, there is limited data on anakinra's stability in polycarbonate syringes. We described the results of our previous studies on the use of anakinra in glass (VCUART3) versus plastic syringes (VCUART2) compared to placebo. These studies were conducted in patients with ST-elevation myocardial infarction (STEMI), and we assessed the anti-inflammatory effects of anakinra versus placebo, by comparing the area-under-the-curve for high-sensitive cardiac reactive protein (AUC-CRP) levels during the first 14 days of STEMI, its clinical effects on heart failure (HF) hospitalization, cardiovascular death, or new diagnosis of HF as well as adverse events profile between groups. The levels of AUC-CRP were 75 (50-255 mg.day/L) for anakinra in plastic syringes vs 255 (116-592 mg.day/L) in placebo and 60 (24-139 mg.day/L), 86 (43-123 mg.day /L) for anakinra once and twice daily in glass syringes, respectively compared to placebo 214 (131-394 mg.day/L). The rate of adverse events was also comparable between groups. There were no differences in the rate of HF hospitalization or cardiovascular death in patients who received anakinra in plastic or glass syringes. Fewer cases of new-onset heart failure occurred in patients receiving anakinra in plastic or glass syringes compared to placebo. Anakinra stored in plastic (polycarbonate) syringes provides comparable biological and clinical effect to glass (borosilicate) syringes. Significance Statement Anakinra (Kineret R) 100 mg administered subcutaneously in patients with STEMI for a duration of up to 14 days appears to have comparable safety and biological efficacy signals when delivered in prefilled glass or transferred into plastic polycarbonate syringes. This may have important implications for the feasibility of designing clinical trials in STEMI and other clinical conditions. Copyright © 2023 American Society for Pharmacology and Experimental Therapeutics. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Lipinski, Michael |
| Institution Code |
MHVI |
| 790 ## - Authors |
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| All authors |
Talasaz A, Sculthorpe R, Pak M, Lipinski M, Roberts C, Markley R, Trankle C, Canada JM, Wohlford GF, Golino M, Dixon DL, Van Tassell B, Abbate A |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1124/jpet.122.001404">https://dx.doi.org/10.1124/jpet.122.001404</a> |
| Public note |
https://dx.doi.org/10.1124/jpet.122.001404 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
