Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.
Identifieur interne : 000F51 ( PubMed/Corpus ); précédent : 000F50; suivant : 000F52Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.
Auteurs : Zoltan Szakacs ; Yves Dauvilliers ; Vladimir Mikhaylov ; Irina Poverennova ; Sergei Krylov ; Slavko Jankovic ; Karel Sonka ; Philippe Lehert ; Isabelle Lecomte ; Jeanne-Marie Lecomte ; Jean-Charles SchwartzSource :
- The Lancet. Neurology [ 1474-4465 ] ; 2017.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Cataplexy (drug therapy), Cataplexy (etiology), Databases, Bibliographic (statistics & numerical data), Double-Blind Method, Female, Follow-Up Studies, Histamine H3 Antagonists (therapeutic use), Humans, Male, Middle Aged, Narcolepsy (complications), Piperidines (therapeutic use), Retrospective Studies, Severity of Illness Index, Treatment Outcome, Young Adult.
- MESH :
- chemical , therapeutic use : Histamine H3 Antagonists, Piperidines.
- complications : Narcolepsy.
- drug therapy : Cataplexy.
- etiology : Cataplexy.
- statistics & numerical data : Databases, Bibliographic.
- Adolescent, Adult, Aged, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Young Adult.
Abstract
Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy.
DOI: 10.1016/S1474-4422(16)30333-7
PubMed: 28129985
Links to Exploration step
pubmed:28129985Le document en format XML
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Electronic address: jc.schwartz@bioprojet.com.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28129985</idno><idno type="pmid">28129985</idno><idno type="doi">10.1016/S1474-4422(16)30333-7</idno><idno type="wicri:Area/PubMed/Corpus">000F51</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000F51</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.</title><author><name sortKey="Szakacs, Zoltan" sort="Szakacs, Zoltan" uniqKey="Szakacs Z" first="Zoltan" last="Szakacs">Zoltan Szakacs</name><affiliation><nlm:affiliation>State Health Center, Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name><affiliation><nlm:affiliation>Reference National Center for Narcolepsy, Sleep Unit, Department of Neurology, Gui-de-Chauliac Hospital, University of Montpellier, Montpellier, INSERM U1061, France.</nlm:affiliation></affiliation></author><author><name sortKey="Mikhaylov, Vladimir" sort="Mikhaylov, Vladimir" uniqKey="Mikhaylov V" first="Vladimir" last="Mikhaylov">Vladimir Mikhaylov</name><affiliation><nlm:affiliation>VD Bekhterev Psycho-neurological Research Institute, Saint Petersburg, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Poverennova, Irina" sort="Poverennova, Irina" uniqKey="Poverennova I" first="Irina" last="Poverennova">Irina Poverennova</name><affiliation><nlm:affiliation>VD Seredavin Regional Clinical Hospital, Samara, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Krylov, Sergei" sort="Krylov, Sergei" uniqKey="Krylov S" first="Sergei" last="Krylov">Sergei Krylov</name><affiliation><nlm:affiliation>Clinical Psychiatric Hospital no 1, Simferopol, Crimea.</nlm:affiliation></affiliation></author><author><name sortKey="Jankovic, Slavko" sort="Jankovic, Slavko" uniqKey="Jankovic S" first="Slavko" last="Jankovic">Slavko Jankovic</name><affiliation><nlm:affiliation>Clinical Center of Serbia, Institute of Neurology, Belgrade, Serbia.</nlm:affiliation></affiliation></author><author><name sortKey="Sonka, Karel" sort="Sonka, Karel" uniqKey="Sonka K" first="Karel" last="Sonka">Karel Sonka</name><affiliation><nlm:affiliation>First Faculty of Medicine and General Teaching Hospital, Charles University, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Lehert, Philippe" sort="Lehert, Philippe" uniqKey="Lehert P" first="Philippe" last="Lehert">Philippe Lehert</name><affiliation><nlm:affiliation>Faculty of Economics, University of Louvain, Brussels, Belgium; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Lecomte, Isabelle" sort="Lecomte, Isabelle" uniqKey="Lecomte I" first="Isabelle" last="Lecomte">Isabelle Lecomte</name><affiliation><nlm:affiliation>Bioprojet Pharma, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Lecomte, Jeanne Marie" sort="Lecomte, Jeanne Marie" uniqKey="Lecomte J" first="Jeanne-Marie" last="Lecomte">Jeanne-Marie Lecomte</name><affiliation><nlm:affiliation>Bioprojet Pharma, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Schwartz, Jean Charles" sort="Schwartz, Jean Charles" uniqKey="Schwartz J" first="Jean-Charles" last="Schwartz">Jean-Charles Schwartz</name><affiliation><nlm:affiliation>Bioprojet Pharma, Paris, France. Electronic address: jc.schwartz@bioprojet.com.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Neurology</title><idno type="eISSN">1474-4465</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Cataplexy (drug therapy)</term><term>Cataplexy (etiology)</term><term>Databases, Bibliographic (statistics & numerical data)</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Histamine H3 Antagonists (therapeutic use)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Narcolepsy (complications)</term><term>Piperidines (therapeutic use)</term><term>Retrospective Studies</term><term>Severity of Illness Index</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Histamine H3 Antagonists</term><term>Piperidines</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Narcolepsy</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Cataplexy</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Cataplexy</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Databases, Bibliographic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Retrospective Studies</term><term>Severity of Illness Index</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28129985</PMID><DateCreated><Year>2017</Year><Month>01</Month><Day>28</Day></DateCreated><DateCompleted><Year>2017</Year><Month>05</Month><Day>30</Day></DateCompleted><DateRevised><Year>2017</Year><Month>07</Month><Day>27</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4465</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>3</Issue><PubDate><Year>2017</Year><Month>03</Month></PubDate></JournalIssue><Title>The Lancet. Neurology</Title><ISOAbbreviation>Lancet Neurol</ISOAbbreviation></Journal><ArticleTitle>Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.</ArticleTitle><Pagination><MedlinePgn>200-207</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1474-4422(16)30333-7</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(16)30333-7</ELocationID><Abstract><AbstractText Label="BACKGROUND">Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy.</AbstractText><AbstractText Label="METHODS">For this randomised, double-blind, placebo-controlled trial we recruited patients with narcolepsy from 16 sleep centres in nine countries (Bulgaria, Czech Republic, Hungary, Macedonia, Poland, Russia, Serbia, Turkey, and Ukraine). Patients were eligible if they were aged 18 years or older, diagnosed with narcolepsy with cataplexy according to version two of the International Classification of Sleep Disorders criteria, experienced at least three cataplexies per week, and had excessive daytime sleepiness (defined as an Epworth Sleepiness Scale score ≥12). We used a computer-generated sequence via an interactive web response system to randomly assign patients to receive either pitolisant or placebo once per day (1:1 ratio). Randomisation was done in blocks of four. Participants and investigators were masked to treatment allocation. Treatment lasted for 7 weeks: 3 weeks of flexible dosing decided by investigators according to efficacy and tolerance (5 mg, 10 mg, or 20 mg oral pitolisant), followed by 4 weeks of stable dosing (5 mg, 10 mg, 20 mg, or 40 mg). The primary endpoint was the change in the average number of cataplexy attacks per week as recorded in patient diaries (weekly cataplexy rate [WCR]) between the 2 weeks of baseline and the 4 weeks of stable dosing period. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01800045.</AbstractText><AbstractText Label="FINDINGS">The trial was done between April 19, 2013, and Jan 28, 2015. We screened 117 patients, 106 of whom were randomly assigned to treatment (54 to pitolisant and 52 to placebo) and, after dropout, 54 patients from the pitolisant group and 51 from the placebo group were included in the intention-to-treat analysis. The WCR during the stable dosing period compared with baseline was decreased by 75% (WCRfinal=2·27; WCRbaseline=9·15; WCRfinal/baseline=0·25) in patients who received pitolisant and 38% (WCRfinal=4·52; WCRbaseline=7·31; WCRfinal/baseline=0·62) in patients who received placebo (rate ratio 0·512; 95% CI 0·43-0·60, p<0·0001). Treatment-related adverse events were significantly more common in the pitolisant group than in the placebo group (15 [28%] of 54 vs 6 [12%] of 51; p=0·048). There were no serious adverse events, but one case of severe nausea in the pitolisant group. The most frequent adverse events in the pitolisant group (headache, irritability, anxiety, and nausea) were mild or moderate except one case of severe nausea. No withdrawal syndrome was detected following pitolisant treatment; one case was detected in the placebo group.</AbstractText><AbstractText Label="INTERPRETATION">Pitolisant was well tolerated and efficacious in reducing cataplexy. If confirmed in long-term studies, pitolisant might constitute a useful first-line therapy for cataplexy in patients with narcolepsy, for whom there are currently few therapeutic options.</AbstractText><AbstractText Label="FUNDING">Bioprojet, France.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Szakacs</LastName><ForeName>Zoltan</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>State Health Center, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dauvilliers</LastName><ForeName>Yves</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Reference National Center for Narcolepsy, Sleep Unit, Department of Neurology, Gui-de-Chauliac Hospital, University of Montpellier, Montpellier, INSERM U1061, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mikhaylov</LastName><ForeName>Vladimir</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>VD Bekhterev Psycho-neurological Research Institute, Saint Petersburg, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poverennova</LastName><ForeName>Irina</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>VD Seredavin Regional Clinical Hospital, Samara, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Krylov</LastName><ForeName>Sergei</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Clinical Psychiatric Hospital no 1, Simferopol, Crimea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Slavko</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Clinical Center of Serbia, Institute of Neurology, Belgrade, Serbia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sonka</LastName><ForeName>Karel</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>First Faculty of Medicine and General Teaching Hospital, Charles University, Prague, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lehert</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Faculty of Economics, University of Louvain, Brussels, Belgium; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lecomte</LastName><ForeName>Isabelle</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Bioprojet Pharma, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lecomte</LastName><ForeName>Jeanne-Marie</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Bioprojet Pharma, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwartz</LastName><ForeName>Jean-Charles</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Bioprojet Pharma, Paris, France. Electronic address: jc.schwartz@bioprojet.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>HARMONY-CTP study group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>01</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Neurol</MedlineTA><NlmUniqueID>101139309</NlmUniqueID><ISSNLinking>1474-4422</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D054828">Histamine H3 Antagonists</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010880">Piperidines</NameOfSubstance></Chemical><Chemical><RegistryNumber>4BC83L4PIY</RegistryNumber><NameOfSubstance UI="C516975">1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002385" MajorTopicYN="N">Cataplexy</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000209" MajorTopicYN="Y">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016206" MajorTopicYN="N">Databases, Bibliographic</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D054828" MajorTopicYN="N">Histamine H3 Antagonists</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009290" MajorTopicYN="N">Narcolepsy</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="Y">complications</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010880" MajorTopicYN="N">Piperidines</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="Y">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Poluektov</LastName><ForeName>Mikhail</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yakupov</LastName><ForeName>Eduard</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kalinkin</LastName><ForeName>Alexander</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Aksu</LastName><ForeName>Murat</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yilmaz</LastName><ForeName>Hikmet</ForeName><Initials>H</Initials></Investigator><Investigator ValidYN="Y"><LastName>Benbir</LastName><ForeName>Gülcin</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Wolynczyk-Gmaj</LastName><ForeName>Dorota</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Jernajczyk</LastName><ForeName>Wojchiech</ForeName><Initials>W</Initials></Investigator><Investigator ValidYN="Y"><LastName>Staykov</LastName><ForeName>Ivan</ForeName><Initials>I</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tavarari</LastName><ForeName>Arben N</ForeName><Initials>AN</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>06</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>10</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>11</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>1</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>5</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>1</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28129985</ArticleId><ArticleId IdType="pii">S1474-4422(16)30333-7</ArticleId><ArticleId 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