THE IMPACT OF PLECANATIDE ON QUALITY OF LIFE FOR PATIENTS WITH CHRONIC IDIOPATHIC CONSTIPATION (CIC): RESULTS FROM TWO PHASE 3 CLINICAL STUDIES
OBJECTIVES: To investigate whether plecanatide, a uroguanylin analog, improved health-related quality of life (HRQoL) in 2 clinical trials of patients with chronic idiopathic constipation (CIC). METHODS: Patients meeting modified Rome III CIC criteria were randomized to placebo, plecanatide 3mg or 6...
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| Veröffentlicht in: | Value in health 2017-05, Vol.20 (5), p.A186 |
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| creator | Rao, SS Hixson, MA Mikhelashvili, T |
| description | OBJECTIVES: To investigate whether plecanatide, a uroguanylin analog, improved health-related quality of life (HRQoL) in 2 clinical trials of patients with chronic idiopathic constipation (CIC). METHODS: Patients meeting modified Rome III CIC criteria were randomized to placebo, plecanatide 3mg or 6mg daily for 12 weeks. The primary endpoint was the proportion of durable overall CSBM responders (≥3 CSBMs plus increase of ≥1 CSBM over baseline in the same week) for ≥9 of 12 treatment weeks, including ≥3 of the last 4 weeks. HRQpL assessments included: Patient Assessment of Constipation-Symptoms (PAC-SYM), PAC-Quality of life (PAC-QOL), and Treatment Satisfaction. Results are versus placebo. RESULTS: Patients (N=2683) had similar baseline characteristics. Pooled efficacy showed significantly greater overall durable CSBM responders with plecanatide 3mg (n=184,20.5%) and 6mg (n=176,19.8%) vs placebo (n=103,11.5%; P |
| doi_str_mv | 10.1016/j.jval.2017.05.005 |
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METHODS: Patients meeting modified Rome III CIC criteria were randomized to placebo, plecanatide 3mg or 6mg daily for 12 weeks. The primary endpoint was the proportion of durable overall CSBM responders (≥3 CSBMs plus increase of ≥1 CSBM over baseline in the same week) for ≥9 of 12 treatment weeks, including ≥3 of the last 4 weeks. HRQpL assessments included: Patient Assessment of Constipation-Symptoms (PAC-SYM), PAC-Quality of life (PAC-QOL), and Treatment Satisfaction. Results are versus placebo. RESULTS: Patients (N=2683) had similar baseline characteristics. Pooled efficacy showed significantly greater overall durable CSBM responders with plecanatide 3mg (n=184,20.5%) and 6mg (n=176,19.8%) vs placebo (n=103,11.5%; P<.001 both doses). Significant increases in CSBMs were seen during Week 1 and were maintained through Week 12. Plecanatide 3mg and 6mg significantly improved PAC-SYM at Weeks 4, 8 and 12 in both studies, with a mean change differences at Week 12 of -0.22 (P<.001) and -0.23 (P<.001) [Study 1] and -0.18 (P=.002) and -0.15 (P=.009) [Study 2]. A similar improvement in PAC-QOL was noted for both doses at Weeks 4, 8 and 12 in both studies; the mean change differences at Week 12 for plecanatide 3mg and 6mg were -0.25 (P < .001) and -0.28 (P < .001) [Study 1] and -0.20 (P<.001) and -0.19 (P=.001) [Study 2]. Plecanatide yielded significantly (P≤.001) higher mean treatment satisfaction scores at each assessment point and increased over time. CONCLUSIONS: Plecanatide 3mg and 6mg significantly improved bowel symptoms and HRQoL at all time points and increased the proportion of durable overall]]></description><identifier>ISSN: 1098-3015</identifier><identifier>EISSN: 1524-4733</identifier><identifier>DOI: 10.1016/j.jval.2017.05.005</identifier><language>eng</language><publisher>Lawrenceville: Elsevier Science Ltd</publisher><subject>Chronic constipation ; Clinical research ; Clinical trials ; Constipation ; Dosage ; Efficacy ; Health status ; Idiopathic ; Intestine ; Patients ; Quality of life ; Symptoms ; Uroguanylin</subject><ispartof>Value in health, 2017-05, Vol.20 (5), p.A186</ispartof><rights>Copyright Elsevier Science Ltd. May 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906,30980</link.rule.ids></links><search><creatorcontrib>Rao, SS</creatorcontrib><creatorcontrib>Hixson, MA</creatorcontrib><creatorcontrib>Mikhelashvili, T</creatorcontrib><title>THE IMPACT OF PLECANATIDE ON QUALITY OF LIFE FOR PATIENTS WITH CHRONIC IDIOPATHIC CONSTIPATION (CIC): RESULTS FROM TWO PHASE 3 CLINICAL STUDIES</title><title>Value in health</title><description><![CDATA[OBJECTIVES: To investigate whether plecanatide, a uroguanylin analog, improved health-related quality of life (HRQoL) in 2 clinical trials of patients with chronic idiopathic constipation (CIC). METHODS: Patients meeting modified Rome III CIC criteria were randomized to placebo, plecanatide 3mg or 6mg daily for 12 weeks. The primary endpoint was the proportion of durable overall CSBM responders (≥3 CSBMs plus increase of ≥1 CSBM over baseline in the same week) for ≥9 of 12 treatment weeks, including ≥3 of the last 4 weeks. HRQpL assessments included: Patient Assessment of Constipation-Symptoms (PAC-SYM), PAC-Quality of life (PAC-QOL), and Treatment Satisfaction. Results are versus placebo. RESULTS: Patients (N=2683) had similar baseline characteristics. Pooled efficacy showed significantly greater overall durable CSBM responders with plecanatide 3mg (n=184,20.5%) and 6mg (n=176,19.8%) vs placebo (n=103,11.5%; P<.001 both doses). Significant increases in CSBMs were seen during Week 1 and were maintained through Week 12. Plecanatide 3mg and 6mg significantly improved PAC-SYM at Weeks 4, 8 and 12 in both studies, with a mean change differences at Week 12 of -0.22 (P<.001) and -0.23 (P<.001) [Study 1] and -0.18 (P=.002) and -0.15 (P=.009) [Study 2]. A similar improvement in PAC-QOL was noted for both doses at Weeks 4, 8 and 12 in both studies; the mean change differences at Week 12 for plecanatide 3mg and 6mg were -0.25 (P < .001) and -0.28 (P < .001) [Study 1] and -0.20 (P<.001) and -0.19 (P=.001) [Study 2]. Plecanatide yielded significantly (P≤.001) higher mean treatment satisfaction scores at each assessment point and increased over time. CONCLUSIONS: Plecanatide 3mg and 6mg significantly improved bowel symptoms and HRQoL at all time points and increased the proportion of durable overall]]></description><subject>Chronic constipation</subject><subject>Clinical research</subject><subject>Clinical trials</subject><subject>Constipation</subject><subject>Dosage</subject><subject>Efficacy</subject><subject>Health status</subject><subject>Idiopathic</subject><subject>Intestine</subject><subject>Patients</subject><subject>Quality of life</subject><subject>Symptoms</subject><subject>Uroguanylin</subject><issn>1098-3015</issn><issn>1524-4733</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>7QJ</sourceid><recordid>eNqNjE1OwzAUhC0EEuXnAqyexAYWCc9x41J2luPIT3LjEDuqWFVdlEVUUWgo1-iVcSUOwGpG-r4Zxu445hy5fBry4We9zQvksxzLHLE8YxNeFtNsOhPiPHWcP2cCeXnJrsZxQEQpinLCjtEaoEWrdARfQ-uMVo2KVBnwDbz2ylF8OxFHtYHad9AmapoYYEnRgradb0gDVeQTsalq34RIJy09PGjSjy_QmdC7tKk7v4C49NBaFQwI0I7SXDkIsa_IhBt28b7ejpvbv7xm97WJ2maf-93XYTN-r4bdYf-R0KrA-UxKKbgU_7N-AU3dTww</recordid><startdate>20170501</startdate><enddate>20170501</enddate><creator>Rao, SS</creator><creator>Hixson, MA</creator><creator>Mikhelashvili, T</creator><general>Elsevier Science Ltd</general><scope>7QJ</scope></search><sort><creationdate>20170501</creationdate><title>THE IMPACT OF PLECANATIDE ON QUALITY OF LIFE FOR PATIENTS WITH CHRONIC IDIOPATHIC CONSTIPATION (CIC): RESULTS FROM TWO PHASE 3 CLINICAL STUDIES</title><author>Rao, SS ; Hixson, MA ; Mikhelashvili, T</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-proquest_journals_20976663163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Chronic constipation</topic><topic>Clinical research</topic><topic>Clinical trials</topic><topic>Constipation</topic><topic>Dosage</topic><topic>Efficacy</topic><topic>Health status</topic><topic>Idiopathic</topic><topic>Intestine</topic><topic>Patients</topic><topic>Quality of life</topic><topic>Symptoms</topic><topic>Uroguanylin</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rao, SS</creatorcontrib><creatorcontrib>Hixson, MA</creatorcontrib><creatorcontrib>Mikhelashvili, T</creatorcontrib><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><jtitle>Value in health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rao, SS</au><au>Hixson, MA</au><au>Mikhelashvili, T</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>THE IMPACT OF PLECANATIDE ON QUALITY OF LIFE FOR PATIENTS WITH CHRONIC IDIOPATHIC CONSTIPATION (CIC): RESULTS FROM TWO PHASE 3 CLINICAL STUDIES</atitle><jtitle>Value in health</jtitle><date>2017-05-01</date><risdate>2017</risdate><volume>20</volume><issue>5</issue><spage>A186</spage><pages>A186-</pages><issn>1098-3015</issn><eissn>1524-4733</eissn><abstract><![CDATA[OBJECTIVES: To investigate whether plecanatide, a uroguanylin analog, improved health-related quality of life (HRQoL) in 2 clinical trials of patients with chronic idiopathic constipation (CIC). METHODS: Patients meeting modified Rome III CIC criteria were randomized to placebo, plecanatide 3mg or 6mg daily for 12 weeks. The primary endpoint was the proportion of durable overall CSBM responders (≥3 CSBMs plus increase of ≥1 CSBM over baseline in the same week) for ≥9 of 12 treatment weeks, including ≥3 of the last 4 weeks. HRQpL assessments included: Patient Assessment of Constipation-Symptoms (PAC-SYM), PAC-Quality of life (PAC-QOL), and Treatment Satisfaction. Results are versus placebo. RESULTS: Patients (N=2683) had similar baseline characteristics. Pooled efficacy showed significantly greater overall durable CSBM responders with plecanatide 3mg (n=184,20.5%) and 6mg (n=176,19.8%) vs placebo (n=103,11.5%; P<.001 both doses). Significant increases in CSBMs were seen during Week 1 and were maintained through Week 12. Plecanatide 3mg and 6mg significantly improved PAC-SYM at Weeks 4, 8 and 12 in both studies, with a mean change differences at Week 12 of -0.22 (P<.001) and -0.23 (P<.001) [Study 1] and -0.18 (P=.002) and -0.15 (P=.009) [Study 2]. A similar improvement in PAC-QOL was noted for both doses at Weeks 4, 8 and 12 in both studies; the mean change differences at Week 12 for plecanatide 3mg and 6mg were -0.25 (P < .001) and -0.28 (P < .001) [Study 1] and -0.20 (P<.001) and -0.19 (P=.001) [Study 2]. Plecanatide yielded significantly (P≤.001) higher mean treatment satisfaction scores at each assessment point and increased over time. CONCLUSIONS: Plecanatide 3mg and 6mg significantly improved bowel symptoms and HRQoL at all time points and increased the proportion of durable overall]]></abstract><cop>Lawrenceville</cop><pub>Elsevier Science Ltd</pub><doi>10.1016/j.jval.2017.05.005</doi></addata></record> |
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| source | Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Applied Social Sciences Index & Abstracts (ASSIA) |
| subjects | Chronic constipation Clinical research Clinical trials Constipation Dosage Efficacy Health status Idiopathic Intestine Patients Quality of life Symptoms Uroguanylin |
| title | THE IMPACT OF PLECANATIDE ON QUALITY OF LIFE FOR PATIENTS WITH CHRONIC IDIOPATHIC CONSTIPATION (CIC): RESULTS FROM TWO PHASE 3 CLINICAL STUDIES |
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