Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials
Identifieur interne : 000674 ( Main/Exploration ); précédent : 000673; suivant : 000675Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials
Auteurs : Anthony E. Lang ; Ramon L. Rodriguez ; James T. Boyd ; Sylvain Chouinard ; Cindy Zadikoff ; Alberto J. Espay ; John T. Slevin ; Hubert H. Fernandez ; Mark F. Lew ; David A. Stein ; Per Odin ; Victor S. C. Fung ; Fabian Klostermann ; Alfonso Fasano ; Peter V. Draganov ; Nathan Schmulewitz ; Weining Z. Robieson ; Susan Eaton ; Krai Chatamra ; Janet A. Benesh ; Jordan DubowSource :
- Movement Disorders [ 0885-3185 ] ; 2015.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Carbidopa (administration & dosage), Carbidopa (adverse effects), Clinical Trials, Phase III as Topic (statistics & numerical data), Drug Combinations, Female, Gastric Bypass (adverse effects), Gels, Humans, Infusions, Parenteral (adverse effects), Levodopa (administration & dosage), Levodopa (adverse effects), Male, Middle Aged, Multicenter Studies as Topic (statistics & numerical data), Outcome Assessment (Health Care) (statistics & numerical data), Parkinson Disease (drug therapy), Prospective Studies.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , adverse effects : Antiparkinson Agents, Carbidopa, Levodopa.
- adverse effects : Gastric Bypass, Infusions, Parenteral.
- drug therapy : Parkinson Disease.
- statistics & numerical data : Clinical Trials, Phase III as Topic, Multicenter Studies as Topic, Outcome Assessment (Health Care).
- Aged, Drug Combinations, Female, Gels, Humans, Male, Middle Aged, Prospective Studies.
Abstract
Continuous administration of levodopa‐carbidopa intestinal gel (carbidopa‐levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.
Safety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device–associated (n = 395) from non‐procedure/device adverse events (n = 412).
At the data cutoff, median exposure to levodopa‐carbidopa intestinal gel was 911 days (range, 1‐1980 days) with 963 total patient‐years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non‐procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non‐procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment‐emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered “possibly related” to the treatment system.
In the largest collection of levodopa‐carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non‐procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients. © 2015 International Parkinson and Movement Disorder Society
Url:
DOI: 10.1002/mds.26485
PubMed: 26695437
PubMed Central: 5064722
Affiliations:
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Le document en format XML
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<term>Carbidopa (adverse effects)</term>
<term>Clinical Trials, Phase III as Topic (statistics & numerical data)</term>
<term>Drug Combinations</term>
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<term>Outcome Assessment (Health Care) (statistics & numerical data)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Prospective Studies</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Carbidopa</term>
<term>Levodopa</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Carbidopa</term>
<term>Levodopa</term>
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<term>Drug Combinations</term>
<term>Female</term>
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<front><div type="abstract" xml:lang="en"><title>ABSTRACT</title>
<sec id="mds26485-sec-0001"><title>Background</title>
<p>Continuous administration of levodopa‐carbidopa intestinal gel (carbidopa‐levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.</p>
</sec>
<sec id="mds26485-sec-0002"><title>Methods</title>
<p>Safety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device–associated (n = 395) from non‐procedure/device adverse events (n = 412).</p>
</sec>
<sec id="mds26485-sec-0003"><title>Results</title>
<p>At the data cutoff, median exposure to levodopa‐carbidopa intestinal gel was 911 days (range, 1‐1980 days) with 963 total patient‐years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non‐procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non‐procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment‐emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered “possibly related” to the treatment system.</p>
</sec>
<sec id="mds26485-sec-0004"><title>Conclusion</title>
<p>In the largest collection of levodopa‐carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non‐procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients. © 2015 International Parkinson and Movement Disorder Society</p>
</sec>
</div>
</front>
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<name sortKey="Chatamra, Krai" sort="Chatamra, Krai" uniqKey="Chatamra K" first="Krai" last="Chatamra">Krai Chatamra</name>
<name sortKey="Chouinard, Sylvain" sort="Chouinard, Sylvain" uniqKey="Chouinard S" first="Sylvain" last="Chouinard">Sylvain Chouinard</name>
<name sortKey="Draganov, Peter V" sort="Draganov, Peter V" uniqKey="Draganov P" first="Peter V." last="Draganov">Peter V. Draganov</name>
<name sortKey="Dubow, Jordan" sort="Dubow, Jordan" uniqKey="Dubow J" first="Jordan" last="Dubow">Jordan Dubow</name>
<name sortKey="Eaton, Susan" sort="Eaton, Susan" uniqKey="Eaton S" first="Susan" last="Eaton">Susan Eaton</name>
<name sortKey="Espay, Alberto J" sort="Espay, Alberto J" uniqKey="Espay A" first="Alberto J." last="Espay">Alberto J. Espay</name>
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<name sortKey="Fernandez, Hubert H" sort="Fernandez, Hubert H" uniqKey="Fernandez H" first="Hubert H." last="Fernandez">Hubert H. Fernandez</name>
<name sortKey="Fung, Victor S C" sort="Fung, Victor S C" uniqKey="Fung V" first="Victor S. C." last="Fung">Victor S. C. Fung</name>
<name sortKey="Klostermann, Fabian" sort="Klostermann, Fabian" uniqKey="Klostermann F" first="Fabian" last="Klostermann">Fabian Klostermann</name>
<name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name>
<name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
<name sortKey="Odin, Per" sort="Odin, Per" uniqKey="Odin P" first="Per" last="Odin">Per Odin</name>
<name sortKey="Robieson, Weining Z" sort="Robieson, Weining Z" uniqKey="Robieson W" first="Weining Z." last="Robieson">Weining Z. Robieson</name>
<name sortKey="Rodriguez, Ramon L" sort="Rodriguez, Ramon L" uniqKey="Rodriguez R" first="Ramon L." last="Rodriguez">Ramon L. Rodriguez</name>
<name sortKey="Schmulewitz, Nathan" sort="Schmulewitz, Nathan" uniqKey="Schmulewitz N" first="Nathan" last="Schmulewitz">Nathan Schmulewitz</name>
<name sortKey="Slevin, John T" sort="Slevin, John T" uniqKey="Slevin J" first="John T." last="Slevin">John T. Slevin</name>
<name sortKey="Stein, David A" sort="Stein, David A" uniqKey="Stein D" first="David A." last="Stein">David A. Stein</name>
<name sortKey="Zadikoff, Cindy" sort="Zadikoff, Cindy" uniqKey="Zadikoff C" first="Cindy" last="Zadikoff">Cindy Zadikoff</name>
</noCountry>
</tree>
</affiliations>
</record>
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