Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice - Results of a Multicenter, Non-Interventional Study (MOVE 2) in Patients with Multiple Sclerosis Spasticity
Background: Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximol...
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| Veröffentlicht in: | European neurology 2014-01, Vol.71 (5-6), p.271-279 |
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| creator | Flachenecker, Peter Henze, Thomas Zettl, Uwe K. |
| description | Background: Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. Methods: This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. Results: Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. Conclusion: Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice. |
| doi_str_mv | 10.1159/000357427 |
| format | Article |
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The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. Methods: This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. Results: Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. Conclusion: Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice.</description><identifier>ISSN: 0014-3022</identifier><identifier>EISSN: 1421-9913</identifier><identifier>DOI: 10.1159/000357427</identifier><identifier>PMID: 24525548</identifier><identifier>CODEN: EUNEAP</identifier><language>eng</language><publisher>Basel, Switzerland: S. Karger AG</publisher><subject>Adult ; Aged ; Cannabidiol - adverse effects ; Cannabidiol - therapeutic use ; Dronabinol - adverse effects ; Dronabinol - therapeutic use ; Drug Combinations ; Female ; Follow-Up Studies ; Germany ; Humans ; Male ; Middle Aged ; Multiple Sclerosis - drug therapy ; Multiple Sclerosis - physiopathology ; Muscle Spasticity - drug therapy ; Muscle Spasticity - physiopathology ; Neuromuscular Agents - adverse effects ; Neuromuscular Agents - therapeutic use ; Original Paper ; Plant Extracts - adverse effects ; Plant Extracts - therapeutic use ; Prospective Studies ; Severity of Illness Index ; Sleep - drug effects ; Surveys and Questionnaires ; Treatment Outcome ; Young Adult</subject><ispartof>European neurology, 2014-01, Vol.71 (5-6), p.271-279</ispartof><rights>2014 S. Karger AG, Basel</rights><rights>2014 S. Karger AG, Basel.</rights><rights>Copyright (c) 2014 S. Karger AG, Basel</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c395t-5d0e24adc2baf250a135f46bb831bd6b2431189c45df64adb11ee467e4b77e383</citedby><cites>FETCH-LOGICAL-c395t-5d0e24adc2baf250a135f46bb831bd6b2431189c45df64adb11ee467e4b77e383</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,2423,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24525548$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Flachenecker, Peter</creatorcontrib><creatorcontrib>Henze, Thomas</creatorcontrib><creatorcontrib>Zettl, Uwe K.</creatorcontrib><title>Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice - Results of a Multicenter, Non-Interventional Study (MOVE 2) in Patients with Multiple Sclerosis Spasticity</title><title>European neurology</title><addtitle>Eur Neurol</addtitle><description>Background: Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. Methods: This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. Results: Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. Conclusion: Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice.</description><subject>Adult</subject><subject>Aged</subject><subject>Cannabidiol - adverse effects</subject><subject>Cannabidiol - therapeutic use</subject><subject>Dronabinol - adverse effects</subject><subject>Dronabinol - therapeutic use</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Germany</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multiple Sclerosis - drug therapy</subject><subject>Multiple Sclerosis - physiopathology</subject><subject>Muscle Spasticity - drug therapy</subject><subject>Muscle Spasticity - physiopathology</subject><subject>Neuromuscular Agents - adverse effects</subject><subject>Neuromuscular Agents - therapeutic use</subject><subject>Original Paper</subject><subject>Plant Extracts - adverse effects</subject><subject>Plant Extracts - therapeutic use</subject><subject>Prospective Studies</subject><subject>Severity of Illness Index</subject><subject>Sleep - drug effects</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0014-3022</issn><issn>1421-9913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkc1u1DAUhS0EotPCgj1ClrqZSg31bxIvSzrQSu1MxRS2keM44OLEwU5K56VY8Ag8GR5SZoFYsPL1Pd89_jkAvMDoNcZcnCCEKM8YyR6BGWYEJ0Jg-hjMEMIsoYiQPbAfwm3ccpHlT8EeYZxwzvIZ-LGUlbk3rbMBzm_Oi5PizRlcedeOygVp4br3cnMM13Iwd_r-5_cjaDpYWNMZFdVrL9VglIYJfK_DaIcAXQMlvIplbHeD9sdw6brkYlvexYZx3dZ1GOsNnF-tPi4g-W15HQ-IcoDfzPB5mu-thmtltXfBhHgRGaKnGTbPwJNG2qCfP6wH4MPbxU1xnlyu3l0Up5eJooIPCa-RJkzWilSyIRxJTHnD0qrKKa7qtCKMYpwLxXjdpJGrMNaapZlmVZZpmtMDMJ98e---jjoMZWuC0tbKTrsxlJhTlmOR5_-DEpFzSgmJ6OFf6K0bffyULcUYFQylIlJHE6Xi64PXTdl700q_KTEqt5mXu8wj--rBcaxaXe_IPyFH4OUEfJH-k_Y7YDd_-E95sVxMRNnXDf0FOwq7Zw</recordid><startdate>20140101</startdate><enddate>20140101</enddate><creator>Flachenecker, Peter</creator><creator>Henze, Thomas</creator><creator>Zettl, Uwe K.</creator><general>S. 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Henze, Thomas ; Zettl, Uwe K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c395t-5d0e24adc2baf250a135f46bb831bd6b2431189c45df64adb11ee467e4b77e383</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Cannabidiol - adverse effects</topic><topic>Cannabidiol - therapeutic use</topic><topic>Dronabinol - adverse effects</topic><topic>Dronabinol - therapeutic use</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Germany</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multiple Sclerosis - drug therapy</topic><topic>Multiple Sclerosis - physiopathology</topic><topic>Muscle Spasticity - drug therapy</topic><topic>Muscle Spasticity - physiopathology</topic><topic>Neuromuscular Agents - adverse effects</topic><topic>Neuromuscular Agents - therapeutic use</topic><topic>Original Paper</topic><topic>Plant Extracts - adverse effects</topic><topic>Plant Extracts - therapeutic use</topic><topic>Prospective Studies</topic><topic>Severity of Illness Index</topic><topic>Sleep - drug effects</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Flachenecker, Peter</creatorcontrib><creatorcontrib>Henze, Thomas</creatorcontrib><creatorcontrib>Zettl, Uwe K.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database (ProQuest)</collection><collection>ProQuest Science Journals</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 One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>European neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Flachenecker, Peter</au><au>Henze, Thomas</au><au>Zettl, Uwe K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice - Results of a Multicenter, Non-Interventional Study (MOVE 2) in Patients with Multiple Sclerosis Spasticity</atitle><jtitle>European neurology</jtitle><addtitle>Eur Neurol</addtitle><date>2014-01-01</date><risdate>2014</risdate><volume>71</volume><issue>5-6</issue><spage>271</spage><epage>279</epage><pages>271-279</pages><issn>0014-3022</issn><eissn>1421-9913</eissn><coden>EUNEAP</coden><abstract>Background: Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. Methods: This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. Results: Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. Conclusion: Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice.</abstract><cop>Basel, Switzerland</cop><pub>S. Karger AG</pub><pmid>24525548</pmid><doi>10.1159/000357427</doi><tpages>9</tpages></addata></record> |
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| ispartof | European neurology, 2014-01, Vol.71 (5-6), p.271-279 |
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| language | eng |
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| source | Karger电子期刊和电子书数据库; MEDLINE |
| subjects | Adult Aged Cannabidiol - adverse effects Cannabidiol - therapeutic use Dronabinol - adverse effects Dronabinol - therapeutic use Drug Combinations Female Follow-Up Studies Germany Humans Male Middle Aged Multiple Sclerosis - drug therapy Multiple Sclerosis - physiopathology Muscle Spasticity - drug therapy Muscle Spasticity - physiopathology Neuromuscular Agents - adverse effects Neuromuscular Agents - therapeutic use Original Paper Plant Extracts - adverse effects Plant Extracts - therapeutic use Prospective Studies Severity of Illness Index Sleep - drug effects Surveys and Questionnaires Treatment Outcome Young Adult |
| title | Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice - Results of a Multicenter, Non-Interventional Study (MOVE 2) in Patients with Multiple Sclerosis Spasticity |
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