MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03383nam a22004097a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
180730s20182018 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
|---|
| International Standard Serial Number |
1934-1482 |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1016/j.pmrj.2018.06.003 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
S1934-1482(18)30352-6 [pii] |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
|---|
| PMID |
29964212 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Dextromethorphan/Quinidine for Pseudobulbar Affect Following Stroke: Safety and Effectiveness in the PRISM II Trial. |
| 251 ## - Source |
|---|
| Source |
Pm & R. 2018 Jun 30 |
| 252 ## - Abbreviated Source |
|---|
| Abbreviated source |
PM R. 2018 Jun 30 |
| 253 ## - Journal Name |
|---|
| Journal name |
PM & R : the journal of injury, function, and rehabilitation |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Year |
2018 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Manufacturer |
FY2018 |
| 266 ## - Date added to catalog |
|---|
| Date added to catalog |
2018-07-30 |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
BACKGROUND: Dextromethorphan (DM) / quinidine (Q) was approved for pseudobulbar affect (PBA) treatment based on efficacy and safety trials in patients with PBA caused by amyotrophic lateral sclerosis or multiple sclerosis. The PRISM II trial evaluated DM/Q as PBA treatment in patients with stroke, dementia, or traumatic brain injury. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
CONCLUSIONS: DM/Q effectively treated PBA and was associated with global and functional improvement; adverse events were consistent with the known safety profile of DM/Q. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
Copyright (c) 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
DESIGN: Open-label trial evaluating twice-daily DM/Q over 90 days. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
MAIN OUTCOME MEASUREMENTS: Primary efficacy measure was changed from baseline to day 90 in Center for Neurologic Study-Lability Scale (CNS-LS) scores. Secondary outcomes included PBA episodes (estimated over 7 days), Clinical and Patient/Caregiver Global Impression of Change (CGI-C and PGI-C), Quality of Life-Visual Analog Scale (QOL-VAS), SIS, Patient Health Questionnaire (PHQ-9), and Mini-Mental State Examination (MMSE). |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
METHODS: PRISM II was an open-label, 12-week trial enrolling adults with PBA caused by dementia, stroke (reported here), or TBI. All study participants received DM/Q 20/10 mg twice daily. Study visits occurred at baseline and at days 30 and 90. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
OBJECTIVE: To report results from the stroke cohort of PRISM II, including the Stroke Impact Scale (SIS). |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
RESULTS: Compared with baseline, CNS-LS scores (SD) improved by -6.2 (6.1, P<.001) at day 30 and -7.6 (6.7, P<.001) at day 90. PBA episodes were reduced by 65% and 75% at day 30 and 90, respectively. Seventy-five percent of clinicians and 67% of patients/caregivers rated PBA as much or very much improved. All SIS items significantly improved from baseline (P<.05, all). Adverse events included diarrhea (4.4%), headache (3.5%), constipation (2.7%), and dizziness (2.7%); 5.3% had adverse events leading to study discontinuation. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
SETTING: 150 U.S. centers. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
STUDY PARTICIPANTS: Adults (n = 113) with a clinical diagnosis of PBA secondary to stroke; stable psychiatric medications were allowed. |
| 546 ## - LANGUAGE NOTE |
|---|
| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Institution |
MedStar National Rehabilitation Network |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Zorowitz, Richard D |
| 790 ## - Authors |
|---|
| All authors |
Alexander DN, Davis C, Formella AE, Ledon F, Siffert J, Zorowitz RD |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| DOI |
<a href="https://dx.doi.org/10.1016/j.pmrj.2018.06.003">https://dx.doi.org/10.1016/j.pmrj.2018.06.003</a> |
| Public note |
https://dx.doi.org/10.1016/j.pmrj.2018.06.003 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
