A pilot evaluation of the tolerability, safety, and efficacy of tolcapone alone and in combination with oral selegiline in untreated Parkinson's disease patients. Tolcapone De Novo Study Group.
Identifieur interne : 005001 ( Ncbi/Merge ); précédent : 005000; suivant : 005002A pilot evaluation of the tolerability, safety, and efficacy of tolcapone alone and in combination with oral selegiline in untreated Parkinson's disease patients. Tolcapone De Novo Study Group.
Auteurs : R A Hauser [États-Unis] ; E. Molho ; H. Shale ; S. Pedder ; E E DorflingerSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 1998.
English descriptors
- KwdEn :
- Administration, Oral, Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Benzophenones (administration & dosage), Benzophenones (adverse effects), Catechol O-Methyltransferase Inhibitors, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Neurologic Examination (drug effects), Nitrophenols, Parkinson Disease (drug therapy), Pilot Projects, Selegiline (administration & dosage), Selegiline (adverse effects), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Benzophenones, Selegiline.
- chemical , adverse effects : Antiparkinson Agents, Benzophenones, Selegiline.
- drug effects : Neurologic Examination.
- drug therapy : Parkinson Disease.
- Administration, Oral, Aged, Catechol O-Methyltransferase Inhibitors, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Nitrophenols, Pilot Projects, Treatment Outcome.
Abstract
Tolcapone is a potent, reversible catechol-O-methyltransferase (COMT) inhibitor with both peripheral and central activity. It has been demonstrated to improve motor function and allow levodopa dose reductions in Parkinson's disease (PD) patients who are experiencing either a stable response or motor fluctuations while on levodopa/dopa decarboxylase inhibitor therapy. Because striatal dopamine is metabolized by COMT and monoamine oxidase (MAO), central COMT inhibition alone or in combination with MAO inhibition might provide symptomatic benefit for patients not receiving levodopa. We conducted a pilot study to evaluate the tolerability, safety, and efficacy of tolcapone alone and in combination with oral selegiline in early untreated PD patients. Patients were randomized to receive 200 mg tolcapone three times a day or placebo for the 8 weeks of the study. Open-label oral selegiline (5 mg in the morning and midday) was administered to all patients during the second 4 weeks of the study. There was no difference between treatment groups according to the investigator's assessment of tolerability at week 4. Ninety-five percent of tolcapone-treated patients and 98% of placebo-treated patients experienced excellent or good tolerability during the first 4 weeks (95% confidence interval [CI]: -10.3, 5.7; p = 0.57). A decrease in tolerability occurred in the tolcapone group during the second 4 weeks of the study following the addition of selegiline. The most commonly reported side effects were diarrhea (31% tolcapone, 7% placebo), nausea (21% tolcapone, 2% placebo), urine discoloration (12% tolcapone, 0% placebo), dizziness (12% tolcapone, 5% placebo), headaches (12% tolcapone, 10% placebo), and abdominal pain (10% tolcapone, 5% placebo). We did not identify symptomatic benefit associated with tolcapone alone or in combination with oral selegiline in this group of otherwise untreated PD patients.
DOI: 10.1002/mds.870130406
PubMed: 9686768
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Tolcapone De Novo Study Group.</title><author><name sortKey="Hauser, R A" sort="Hauser, R A" uniqKey="Hauser R" first="R A" last="Hauser">R A Hauser</name><affiliation wicri:level="4"><nlm:affiliation>University of South Florida, Tampa 33606, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Florida, Tampa 33606</wicri:regionArea><orgName type="university">Université de Floride du Sud</orgName><placeName><settlement type="city">Tampa</settlement><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Molho, E" sort="Molho, E" uniqKey="Molho E" first="E" last="Molho">E. Molho</name></author><author><name sortKey="Shale, H" sort="Shale, H" uniqKey="Shale H" first="H" last="Shale">H. Shale</name></author><author><name sortKey="Pedder, S" sort="Pedder, S" uniqKey="Pedder S" first="S" last="Pedder">S. Pedder</name></author><author><name sortKey="Dorflinger, E E" sort="Dorflinger, E E" uniqKey="Dorflinger E" first="E E" last="Dorflinger">E E Dorflinger</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="1998" type="published">1998</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (adverse effects)</term><term>Benzophenones (administration & dosage)</term><term>Benzophenones (adverse effects)</term><term>Catechol O-Methyltransferase Inhibitors</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neurologic Examination (drug effects)</term><term>Nitrophenols</term><term>Parkinson Disease (drug therapy)</term><term>Pilot Projects</term><term>Selegiline (administration & dosage)</term><term>Selegiline (adverse effects)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzophenones</term><term>Selegiline</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzophenones</term><term>Selegiline</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Neurologic Examination</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Aged</term><term>Catechol O-Methyltransferase Inhibitors</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Nitrophenols</term><term>Pilot Projects</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Tolcapone is a potent, reversible catechol-O-methyltransferase (COMT) inhibitor with both peripheral and central activity. It has been demonstrated to improve motor function and allow levodopa dose reductions in Parkinson's disease (PD) patients who are experiencing either a stable response or motor fluctuations while on levodopa/dopa decarboxylase inhibitor therapy. Because striatal dopamine is metabolized by COMT and monoamine oxidase (MAO), central COMT inhibition alone or in combination with MAO inhibition might provide symptomatic benefit for patients not receiving levodopa. We conducted a pilot study to evaluate the tolerability, safety, and efficacy of tolcapone alone and in combination with oral selegiline in early untreated PD patients. Patients were randomized to receive 200 mg tolcapone three times a day or placebo for the 8 weeks of the study. Open-label oral selegiline (5 mg in the morning and midday) was administered to all patients during the second 4 weeks of the study. There was no difference between treatment groups according to the investigator's assessment of tolerability at week 4. Ninety-five percent of tolcapone-treated patients and 98% of placebo-treated patients experienced excellent or good tolerability during the first 4 weeks (95% confidence interval [CI]: -10.3, 5.7; p = 0.57). A decrease in tolerability occurred in the tolcapone group during the second 4 weeks of the study following the addition of selegiline. The most commonly reported side effects were diarrhea (31% tolcapone, 7% placebo), nausea (21% tolcapone, 2% placebo), urine discoloration (12% tolcapone, 0% placebo), dizziness (12% tolcapone, 5% placebo), headaches (12% tolcapone, 10% placebo), and abdominal pain (10% tolcapone, 5% placebo). We did not identify symptomatic benefit associated with tolcapone alone or in combination with oral selegiline in this group of otherwise untreated PD patients.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">9686768</PMID><DateCreated><Year>1998</Year><Month>10</Month><Day>28</Day></DateCreated><DateCompleted><Year>1998</Year><Month>10</Month><Day>28</Day></DateCompleted><DateRevised><Year>2014</Year><Month>11</Month><Day>20</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>13</Volume><Issue>4</Issue><PubDate><Year>1998</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. 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We conducted a pilot study to evaluate the tolerability, safety, and efficacy of tolcapone alone and in combination with oral selegiline in early untreated PD patients. Patients were randomized to receive 200 mg tolcapone three times a day or placebo for the 8 weeks of the study. Open-label oral selegiline (5 mg in the morning and midday) was administered to all patients during the second 4 weeks of the study. There was no difference between treatment groups according to the investigator's assessment of tolerability at week 4. Ninety-five percent of tolcapone-treated patients and 98% of placebo-treated patients experienced excellent or good tolerability during the first 4 weeks (95% confidence interval [CI]: -10.3, 5.7; p = 0.57). A decrease in tolerability occurred in the tolcapone group during the second 4 weeks of the study following the addition of selegiline. The most commonly reported side effects were diarrhea (31% tolcapone, 7% placebo), nausea (21% tolcapone, 2% placebo), urine discoloration (12% tolcapone, 0% placebo), dizziness (12% tolcapone, 5% placebo), headaches (12% tolcapone, 10% placebo), and abdominal pain (10% tolcapone, 5% placebo). 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PubStatus="pubmed"><Year>1998</Year><Month>8</Month><Day>1</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1998</Year><Month>8</Month><Day>1</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1998</Year><Month>8</Month><Day>1</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">9686768</ArticleId><ArticleId IdType="doi">10.1002/mds.870130406</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><noCountry><name sortKey="Dorflinger, E E" sort="Dorflinger, E E" uniqKey="Dorflinger E" first="E E" last="Dorflinger">E E Dorflinger</name><name sortKey="Molho, E" sort="Molho, E" uniqKey="Molho E" first="E" last="Molho">E. Molho</name><name sortKey="Pedder, S" sort="Pedder, S" uniqKey="Pedder S" first="S" last="Pedder">S. Pedder</name><name sortKey="Shale, H" sort="Shale, H" uniqKey="Shale H" first="H" last="Shale">H. Shale</name></noCountry><country name="États-Unis"><region name="Floride"><name sortKey="Hauser, R A" sort="Hauser, R A" uniqKey="Hauser R" first="R A" last="Hauser">R A Hauser</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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