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Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial
Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by cha...
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| Published in: | Arthritis research & therapy 2013-08, Vol.15 (4), p.R88-R88, Article R88 |
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| creator | Clauw, Daniel J Mease, Philip J Palmer, Robert H Trugman, Joel M Wang, Yong |
| description | Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by characterizing changes in pain and other fibromyalgia symptoms after discontinuing long-term treatment. The mean length of milnacipran treatment at the time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months).
After completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ≥100 mg/day and reporting ≥50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to |
| doi_str_mv | 10.1186/ar4268 |
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After completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ≥100 mg/day and reporting ≥50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to <30% reduction from pre-milnacipran exposure or worsening of fibromyalgia requiring alternative treatment. Adverse events and vital signs were also monitored.
Time to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P < 0.001). Median time to LTR was 56 days with placebo and was not calculable for milnacipran, because less than half of the latter group of patients lost therapeutic response by study end. Additionally, 81% of patients continuing on milnacipran maintained clinically meaningful pain response (≥30% improvement from pre-milnacipran exposure), compared with 58% of patients switched to placebo (sensitivity analysis II; P < 0.001). The incidences of treatment-emergent adverse events were 58% and 47% for placebo and milnacipran, respectively. Mean decreases in blood pressure and heart rate were found in both groups, with greater decreases for patients switched to placebo.
Continuing efficacy of milnacipran was demonstrated by the loss of effect following withdrawal of treatment in patients who received an average of three years of milnacipran treatment.
ClinicalTrials.gov: NCT01014585.</description><identifier>ISSN: 1478-6354</identifier><identifier>EISSN: 1478-6362</identifier><identifier>EISSN: 1478-6354</identifier><identifier>DOI: 10.1186/ar4268</identifier><identifier>PMID: 23953493</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adrenergic Uptake Inhibitors - administration & dosage ; Adrenergic Uptake Inhibitors - adverse effects ; Analysis ; Care and treatment ; Chronic pain ; Clinical trials ; Complications and side effects ; Cyclopropanes - administration & dosage ; Cyclopropanes - adverse effects ; Double-Blind Method ; Female ; Fibromyalgia ; Fibromyalgia - drug therapy ; Humans ; Male ; Medical research ; Medicine, Experimental ; Middle Aged ; Pain Measurement ; Patient outcomes ; Pharmaceutical industry ; Placebo effect ; Time Factors ; Treatment Outcome</subject><ispartof>Arthritis research & therapy, 2013-08, Vol.15 (4), p.R88-R88, Article R88</ispartof><rights>COPYRIGHT 2013 BioMed Central Ltd.</rights><rights>Copyright © 2013 Clauw et al. licensee BioMed Central Ltd. 2013 Clauw et al. licensee BioMed Central Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c433t-ff81e5bce07c42a2289f1cddf73d15569b6c530f8a08a07a0853f23157c84d593</citedby><cites>FETCH-LOGICAL-c433t-ff81e5bce07c42a2289f1cddf73d15569b6c530f8a08a07a0853f23157c84d593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978750/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978750/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23953493$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Clauw, Daniel J</creatorcontrib><creatorcontrib>Mease, Philip J</creatorcontrib><creatorcontrib>Palmer, Robert H</creatorcontrib><creatorcontrib>Trugman, Joel M</creatorcontrib><creatorcontrib>Wang, Yong</creatorcontrib><title>Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial</title><title>Arthritis research & therapy</title><addtitle>Arthritis Res Ther</addtitle><description>Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by characterizing changes in pain and other fibromyalgia symptoms after discontinuing long-term treatment. The mean length of milnacipran treatment at the time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months).
After completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ≥100 mg/day and reporting ≥50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to <30% reduction from pre-milnacipran exposure or worsening of fibromyalgia requiring alternative treatment. Adverse events and vital signs were also monitored.
Time to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P < 0.001). Median time to LTR was 56 days with placebo and was not calculable for milnacipran, because less than half of the latter group of patients lost therapeutic response by study end. Additionally, 81% of patients continuing on milnacipran maintained clinically meaningful pain response (≥30% improvement from pre-milnacipran exposure), compared with 58% of patients switched to placebo (sensitivity analysis II; P < 0.001). The incidences of treatment-emergent adverse events were 58% and 47% for placebo and milnacipran, respectively. Mean decreases in blood pressure and heart rate were found in both groups, with greater decreases for patients switched to placebo.
Continuing efficacy of milnacipran was demonstrated by the loss of effect following withdrawal of treatment in patients who received an average of three years of milnacipran treatment.
ClinicalTrials.gov: NCT01014585.</description><subject>Adrenergic Uptake Inhibitors - administration & dosage</subject><subject>Adrenergic Uptake Inhibitors - adverse effects</subject><subject>Analysis</subject><subject>Care and treatment</subject><subject>Chronic pain</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Cyclopropanes - administration & dosage</subject><subject>Cyclopropanes - adverse effects</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fibromyalgia</subject><subject>Fibromyalgia - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Middle Aged</subject><subject>Pain Measurement</subject><subject>Patient outcomes</subject><subject>Pharmaceutical industry</subject><subject>Placebo effect</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1478-6354</issn><issn>1478-6362</issn><issn>1478-6354</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNptkVtLHDEYhkNRumrbn1AGhN7NOjlNMr0QZKkHELzR65DNYfqVHJbMqGx_vZG1i0JJyBeS5335khehb7hbYiz7M10Y6eUndISZkG1Pe3Kw33O2QMfT9KfrCBkI-4wWhA6csoEeIbvKaYb0CGlsnPdgtNk22TcRQtIGNkWnxucQ8vMrEXIa29mV2MzF6Tm6NDdQAViXHLc6jKB_NrqpIpsj_HW2cqDDF3TodZjc17d6gh4uf92vrtvbu6ub1cVtaxilc-u9xI6vjeuEYUQTIgePjbVeUIs574d1bzjtvNRdnaKunHpCMRdGMssHeoLOd76bx3V01tT2ig5qUyDqslVZg_p4k-C3GvOTooOQgnfV4HRnMOrgFCSfK2YiTEZd1A8TkjIsKrX8D1WHdRFMTs5DPf8g-LETmJKnqTi_bwl36jU-tYuvgt_fP2CP_cuLvgCSjZac</recordid><startdate>20130816</startdate><enddate>20130816</enddate><creator>Clauw, Daniel J</creator><creator>Mease, Philip J</creator><creator>Palmer, Robert H</creator><creator>Trugman, Joel M</creator><creator>Wang, Yong</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20130816</creationdate><title>Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial</title><author>Clauw, Daniel J ; Mease, Philip J ; Palmer, Robert H ; Trugman, Joel M ; Wang, Yong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c433t-ff81e5bce07c42a2289f1cddf73d15569b6c530f8a08a07a0853f23157c84d593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adrenergic Uptake Inhibitors - administration & dosage</topic><topic>Adrenergic Uptake Inhibitors - adverse effects</topic><topic>Analysis</topic><topic>Care and treatment</topic><topic>Chronic pain</topic><topic>Clinical trials</topic><topic>Complications and side effects</topic><topic>Cyclopropanes - administration & dosage</topic><topic>Cyclopropanes - adverse effects</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fibromyalgia</topic><topic>Fibromyalgia - drug therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Middle Aged</topic><topic>Pain Measurement</topic><topic>Patient outcomes</topic><topic>Pharmaceutical industry</topic><topic>Placebo effect</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Clauw, Daniel J</creatorcontrib><creatorcontrib>Mease, Philip J</creatorcontrib><creatorcontrib>Palmer, Robert H</creatorcontrib><creatorcontrib>Trugman, Joel M</creatorcontrib><creatorcontrib>Wang, Yong</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Arthritis research & therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Clauw, Daniel J</au><au>Mease, Philip J</au><au>Palmer, Robert H</au><au>Trugman, Joel M</au><au>Wang, Yong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial</atitle><jtitle>Arthritis research & therapy</jtitle><addtitle>Arthritis Res Ther</addtitle><date>2013-08-16</date><risdate>2013</risdate><volume>15</volume><issue>4</issue><spage>R88</spage><epage>R88</epage><pages>R88-R88</pages><artnum>R88</artnum><issn>1478-6354</issn><eissn>1478-6362</eissn><eissn>1478-6354</eissn><abstract>Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by characterizing changes in pain and other fibromyalgia symptoms after discontinuing long-term treatment. The mean length of milnacipran treatment at the time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months).
After completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ≥100 mg/day and reporting ≥50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to <30% reduction from pre-milnacipran exposure or worsening of fibromyalgia requiring alternative treatment. Adverse events and vital signs were also monitored.
Time to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P < 0.001). Median time to LTR was 56 days with placebo and was not calculable for milnacipran, because less than half of the latter group of patients lost therapeutic response by study end. Additionally, 81% of patients continuing on milnacipran maintained clinically meaningful pain response (≥30% improvement from pre-milnacipran exposure), compared with 58% of patients switched to placebo (sensitivity analysis II; P < 0.001). The incidences of treatment-emergent adverse events were 58% and 47% for placebo and milnacipran, respectively. Mean decreases in blood pressure and heart rate were found in both groups, with greater decreases for patients switched to placebo.
Continuing efficacy of milnacipran was demonstrated by the loss of effect following withdrawal of treatment in patients who received an average of three years of milnacipran treatment.
ClinicalTrials.gov: NCT01014585.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>23953493</pmid><doi>10.1186/ar4268</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Adrenergic Uptake Inhibitors - administration & dosage Adrenergic Uptake Inhibitors - adverse effects Analysis Care and treatment Chronic pain Clinical trials Complications and side effects Cyclopropanes - administration & dosage Cyclopropanes - adverse effects Double-Blind Method Female Fibromyalgia Fibromyalgia - drug therapy Humans Male Medical research Medicine, Experimental Middle Aged Pain Measurement Patient outcomes Pharmaceutical industry Placebo effect Time Factors Treatment Outcome |
| title | Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial |
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