0638 FUNCTION AND WORK PRODUCTIVITY MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA
Abstract Introduction: Excessive sleepiness in patients with obstructive sleep apnea (OSA) is associated with reductions in function and daily activities. JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. Effects of JZP-110 on function, work productivity,...
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| Veröffentlicht in: | Sleep (New York, N.Y.) N.Y.), 2017-04, Vol.40 (suppl_1), p.A236-A236 |
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| container_title | Sleep (New York, N.Y.) |
| container_volume | 40 |
| creator | Bogan, R Feldman, NT Stern, T Villa, KF Chen, D Carter, LP Wang, H Lu, Y Black, J Drake, C |
| description | Abstract
Introduction:
Excessive sleepiness in patients with obstructive sleep apnea (OSA) is associated with reductions in function and daily activities. JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. Effects of JZP-110 on function, work productivity, and activity impairment were evaluated in a phase 3 study in patients with OSA.
Methods:
Eligibility criteria included: OSA diagnosis according to International Classification of Sleep Disorders-3 criteria; past or present use of a primary OSA therapy; Epworth Sleepiness Scale score ≥10; mean sleep latency |
| doi_str_mv | 10.1093/sleepj/zsx050.637 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2503445373</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/sleepj/zsx050.637</oup_id><sourcerecordid>2503445373</sourcerecordid><originalsourceid>FETCH-LOGICAL-c1987-4fd31d92e1eaeab22d1cf5fb3e12d03c230b32715390202f2c05be441ef641983</originalsourceid><addsrcrecordid>eNqNkd2O0zAQhS0EEmXhAbizxG2965-kbS7dZELNunGUOFt2b6I2dSSqZVsSKgFPw7PwXkg4zT4AV9bMfGfOWAeh94xeMxqJm_7RudPh5lf_g4b0eibmL9CEhSElkR-_RBPKZowsGA1fozd9f6C-DiIxQX_pTCxwWmWxVSbDMkvwxhS3OC9MUvnenbL3eA2yrAoosfLEn9_5SpaAxRQXHjdr9QDJFOdaxrA0JDaZLYzWQy8x1VIDWWqV-WpdaatiyCwUU8w42QDc4tJWyT02KbYrwKVMwdsNR0CaqljGl9Gnh5wwRnFqigtmC5B27RcNQ_gcQ1mqO6_WALnKfDXcmUurPFLijbIrbJalLS7_eeawzDOQb9GrdvvYu3fP7xWq_AXximjz0dtr0rBoMSdBuxdsH3HH3NZtd5zvWdOG7U44xvdUNFzQneBzFoqIcspb3tBw54KAuXYW-A3iCn0Y956647ez67_Xh-O5e_KWNQ-pCIJQzIWn2Eg13bHvO9fWp-7L1233s2a0HlKux5TrMeXap-w101FzPJ_-A_8Hw_aZXw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2503445373</pqid></control><display><type>article</type><title>0638 FUNCTION AND WORK PRODUCTIVITY MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA</title><source>Oxford University Press</source><source>Alma/SFX Local Collection</source><source>EZB Electronic Journals Library</source><creator>Bogan, R ; Feldman, NT ; Stern, T ; Villa, KF ; Chen, D ; Carter, LP ; Wang, H ; Lu, Y ; Black, J ; Drake, C</creator><creatorcontrib>Bogan, R ; Feldman, NT ; Stern, T ; Villa, KF ; Chen, D ; Carter, LP ; Wang, H ; Lu, Y ; Black, J ; Drake, C</creatorcontrib><description>Abstract
Introduction:
Excessive sleepiness in patients with obstructive sleep apnea (OSA) is associated with reductions in function and daily activities. JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. Effects of JZP-110 on function, work productivity, and activity impairment were evaluated in a phase 3 study in patients with OSA.
Methods:
Eligibility criteria included: OSA diagnosis according to International Classification of Sleep Disorders-3 criteria; past or present use of a primary OSA therapy; Epworth Sleepiness Scale score ≥10; mean sleep latency <30 minutes on first 4 trials of a 5-trial, 40-minute Maintenance of Wakefulness Test; and usual nightly sleep time ≥6 hours. Patients were randomized (1:1:2:2:2) to JZP-110 37.5mg, 75mg, 150mg, or 300mg, or placebo for 12 weeks, stratified by adherent or non-adherent use of primary OSA therapy. The Functional Outcomes of Sleep questionnaire short version (FOSQ-10) evaluated functional status. Work productivity impairment among employed patients and overall activity impairment among all patients were assessed using the Work Productivity and Activity Impairment questionnaire for Specific Health Problems (WPAI:SHP); “OSA” was the specified health problem. Both measures were administered at baseline and weeks 1, 4, 8, and 12.
Results:
By final enrollment, which occurred in September 2016, preliminary baseline data from 427 (of 476 randomized) patients revealed 62.1% male, 74.9% white, and the mean±standard deviation age was 54.2 ± 10.6 years. Clinical Global Impression of Severity ratings were 41.5%, 33.3%, and 12.2% in patients moderately, markedly, or severely ill, respectively (2.8% were most extremely ill). All patients have completed participation in the study and data are being analyzed.
Conclusion:
Complete data on the effects of JZP-110 on the WPAI:SHP and FOSQ-10 functional measures and safety results will be reported at the time of presentation.
Support (If Any):
Jazz Pharmaceuticals.</description><identifier>ISSN: 0161-8105</identifier><identifier>EISSN: 1550-9109</identifier><identifier>DOI: 10.1093/sleepj/zsx050.637</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Double-blind studies ; Productivity ; Questionnaires ; Sleep apnea</subject><ispartof>Sleep (New York, N.Y.), 2017-04, Vol.40 (suppl_1), p.A236-A236</ispartof><rights>Sleep Research Society 2017. Published by Oxford University Press [on behalf of the Sleep Research Society]. All rights reserved. For permissions, please email: journals.permissions@oup.com 2017</rights><rights>Sleep Research Society 2017. Published by Oxford University Press [on behalf of the Sleep Research Society]. All rights reserved. For permissions, please email: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c1987-4fd31d92e1eaeab22d1cf5fb3e12d03c230b32715390202f2c05be441ef641983</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids></links><search><creatorcontrib>Bogan, R</creatorcontrib><creatorcontrib>Feldman, NT</creatorcontrib><creatorcontrib>Stern, T</creatorcontrib><creatorcontrib>Villa, KF</creatorcontrib><creatorcontrib>Chen, D</creatorcontrib><creatorcontrib>Carter, LP</creatorcontrib><creatorcontrib>Wang, H</creatorcontrib><creatorcontrib>Lu, Y</creatorcontrib><creatorcontrib>Black, J</creatorcontrib><creatorcontrib>Drake, C</creatorcontrib><title>0638 FUNCTION AND WORK PRODUCTIVITY MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA</title><title>Sleep (New York, N.Y.)</title><description>Abstract
Introduction:
Excessive sleepiness in patients with obstructive sleep apnea (OSA) is associated with reductions in function and daily activities. JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. Effects of JZP-110 on function, work productivity, and activity impairment were evaluated in a phase 3 study in patients with OSA.
Methods:
Eligibility criteria included: OSA diagnosis according to International Classification of Sleep Disorders-3 criteria; past or present use of a primary OSA therapy; Epworth Sleepiness Scale score ≥10; mean sleep latency <30 minutes on first 4 trials of a 5-trial, 40-minute Maintenance of Wakefulness Test; and usual nightly sleep time ≥6 hours. Patients were randomized (1:1:2:2:2) to JZP-110 37.5mg, 75mg, 150mg, or 300mg, or placebo for 12 weeks, stratified by adherent or non-adherent use of primary OSA therapy. The Functional Outcomes of Sleep questionnaire short version (FOSQ-10) evaluated functional status. Work productivity impairment among employed patients and overall activity impairment among all patients were assessed using the Work Productivity and Activity Impairment questionnaire for Specific Health Problems (WPAI:SHP); “OSA” was the specified health problem. Both measures were administered at baseline and weeks 1, 4, 8, and 12.
Results:
By final enrollment, which occurred in September 2016, preliminary baseline data from 427 (of 476 randomized) patients revealed 62.1% male, 74.9% white, and the mean±standard deviation age was 54.2 ± 10.6 years. Clinical Global Impression of Severity ratings were 41.5%, 33.3%, and 12.2% in patients moderately, markedly, or severely ill, respectively (2.8% were most extremely ill). All patients have completed participation in the study and data are being analyzed.
Conclusion:
Complete data on the effects of JZP-110 on the WPAI:SHP and FOSQ-10 functional measures and safety results will be reported at the time of presentation.
Support (If Any):
Jazz Pharmaceuticals.</description><subject>Double-blind studies</subject><subject>Productivity</subject><subject>Questionnaires</subject><subject>Sleep apnea</subject><issn>0161-8105</issn><issn>1550-9109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNkd2O0zAQhS0EEmXhAbizxG2965-kbS7dZELNunGUOFt2b6I2dSSqZVsSKgFPw7PwXkg4zT4AV9bMfGfOWAeh94xeMxqJm_7RudPh5lf_g4b0eibmL9CEhSElkR-_RBPKZowsGA1fozd9f6C-DiIxQX_pTCxwWmWxVSbDMkvwxhS3OC9MUvnenbL3eA2yrAoosfLEn9_5SpaAxRQXHjdr9QDJFOdaxrA0JDaZLYzWQy8x1VIDWWqV-WpdaatiyCwUU8w42QDc4tJWyT02KbYrwKVMwdsNR0CaqljGl9Gnh5wwRnFqigtmC5B27RcNQ_gcQ1mqO6_WALnKfDXcmUurPFLijbIrbJalLS7_eeawzDOQb9GrdvvYu3fP7xWq_AXximjz0dtr0rBoMSdBuxdsH3HH3NZtd5zvWdOG7U44xvdUNFzQneBzFoqIcspb3tBw54KAuXYW-A3iCn0Y956647ez67_Xh-O5e_KWNQ-pCIJQzIWn2Eg13bHvO9fWp-7L1233s2a0HlKux5TrMeXap-w101FzPJ_-A_8Hw_aZXw</recordid><startdate>20170428</startdate><enddate>20170428</enddate><creator>Bogan, R</creator><creator>Feldman, NT</creator><creator>Stern, T</creator><creator>Villa, KF</creator><creator>Chen, D</creator><creator>Carter, LP</creator><creator>Wang, H</creator><creator>Lu, Y</creator><creator>Black, J</creator><creator>Drake, C</creator><general>Oxford University Press</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope></search><sort><creationdate>20170428</creationdate><title>0638 FUNCTION AND WORK PRODUCTIVITY MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA</title><author>Bogan, R ; Feldman, NT ; Stern, T ; Villa, KF ; Chen, D ; Carter, LP ; Wang, H ; Lu, Y ; Black, J ; Drake, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1987-4fd31d92e1eaeab22d1cf5fb3e12d03c230b32715390202f2c05be441ef641983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Double-blind studies</topic><topic>Productivity</topic><topic>Questionnaires</topic><topic>Sleep apnea</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bogan, R</creatorcontrib><creatorcontrib>Feldman, NT</creatorcontrib><creatorcontrib>Stern, T</creatorcontrib><creatorcontrib>Villa, KF</creatorcontrib><creatorcontrib>Chen, D</creatorcontrib><creatorcontrib>Carter, LP</creatorcontrib><creatorcontrib>Wang, H</creatorcontrib><creatorcontrib>Lu, Y</creatorcontrib><creatorcontrib>Black, J</creatorcontrib><creatorcontrib>Drake, C</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Psychology Database</collection><collection>ProQuest Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><jtitle>Sleep (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bogan, R</au><au>Feldman, NT</au><au>Stern, T</au><au>Villa, KF</au><au>Chen, D</au><au>Carter, LP</au><au>Wang, H</au><au>Lu, Y</au><au>Black, J</au><au>Drake, C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>0638 FUNCTION AND WORK PRODUCTIVITY MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA</atitle><jtitle>Sleep (New York, N.Y.)</jtitle><date>2017-04-28</date><risdate>2017</risdate><volume>40</volume><issue>suppl_1</issue><spage>A236</spage><epage>A236</epage><pages>A236-A236</pages><issn>0161-8105</issn><eissn>1550-9109</eissn><abstract>Abstract
Introduction:
Excessive sleepiness in patients with obstructive sleep apnea (OSA) is associated with reductions in function and daily activities. JZP-110 is a selective dopamine norepinephrine reuptake inhibitor with wake-promoting effects. Effects of JZP-110 on function, work productivity, and activity impairment were evaluated in a phase 3 study in patients with OSA.
Methods:
Eligibility criteria included: OSA diagnosis according to International Classification of Sleep Disorders-3 criteria; past or present use of a primary OSA therapy; Epworth Sleepiness Scale score ≥10; mean sleep latency <30 minutes on first 4 trials of a 5-trial, 40-minute Maintenance of Wakefulness Test; and usual nightly sleep time ≥6 hours. Patients were randomized (1:1:2:2:2) to JZP-110 37.5mg, 75mg, 150mg, or 300mg, or placebo for 12 weeks, stratified by adherent or non-adherent use of primary OSA therapy. The Functional Outcomes of Sleep questionnaire short version (FOSQ-10) evaluated functional status. Work productivity impairment among employed patients and overall activity impairment among all patients were assessed using the Work Productivity and Activity Impairment questionnaire for Specific Health Problems (WPAI:SHP); “OSA” was the specified health problem. Both measures were administered at baseline and weeks 1, 4, 8, and 12.
Results:
By final enrollment, which occurred in September 2016, preliminary baseline data from 427 (of 476 randomized) patients revealed 62.1% male, 74.9% white, and the mean±standard deviation age was 54.2 ± 10.6 years. Clinical Global Impression of Severity ratings were 41.5%, 33.3%, and 12.2% in patients moderately, markedly, or severely ill, respectively (2.8% were most extremely ill). All patients have completed participation in the study and data are being analyzed.
Conclusion:
Complete data on the effects of JZP-110 on the WPAI:SHP and FOSQ-10 functional measures and safety results will be reported at the time of presentation.
Support (If Any):
Jazz Pharmaceuticals.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/sleepj/zsx050.637</doi><oa>free_for_read</oa></addata></record> |
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| issn | 0161-8105 1550-9109 |
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| subjects | Double-blind studies Productivity Questionnaires Sleep apnea |
| title | 0638 FUNCTION AND WORK PRODUCTIVITY MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF JZP-110 FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA |
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