Comparison of Sinemet CR4 and standard Sinemet: Double blind and long‐term open trial in parkinsonian patients with fluctuations
Identifieur interne : 006465 ( Main/Exploration ); précédent : 006464; suivant : 006466Comparison of Sinemet CR4 and standard Sinemet: Double blind and long‐term open trial in parkinsonian patients with fluctuations
Auteurs : Jankovic [États-Unis] ; Kenneth Schwartz [États-Unis] ; Chris Vander Linden [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 1989.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (pharmacology), Carbidopa, Carbidopa (administration & dosage), Carbidopa (pharmacology), Delayed-Action Preparations, Double-Blind Method, Drug Combinations (administration & dosage), Drug Combinations (pharmacology), Humans, Levodopa, Levodopa (administration & dosage), Levodopa (pharmacology), Middle Aged, Movement (drug effects), Parkinson Disease (drug therapy), Parkinson Disease (physiopathology), Parkinson's disease, Randomized Controlled Trials as Topic, Sinemet CR4, Standard Sinemet.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Carbidopa, Drug Combinations, Levodopa.
- chemical , pharmacology : Antiparkinson Agents, Carbidopa, Drug Combinations, Levodopa.
- drug effects : Movement.
- drug therapy : Parkinson Disease.
- physiopathology : Parkinson Disease.
- Aged, Delayed-Action Preparations, Double-Blind Method, Humans, Middle Aged, Randomized Controlled Trials as Topic.
Abstract
“Wearing‐off” effect, the most common form of levodopa‐induced fluctuations, seems to be related to the short plasma half‐life of the drug. More sustained plasma levodopa levels may be achieved with a new controlledrelease formulation of carbidopa/levodopa, Sinemet CR4. We studied 20 patients, 12 men and 8 women, with Parkinson's disease complicated by “wearing‐off” phenomenon. Mean age was 61.1 ± 8.1 years, duration of symptoms 8.3 ± 2.4 years, and the Hoehn‐Yahr stage 3.0 ± 0.9. In a 12‐week double‐blind study, the average number of tablets administered per day decreased from 5.7 ± 1.2 to 3.8 ± 0.7 when Sinemet CR4 (50/200) was substituted for the standard Sinemet (25/100) (p < 0.001). However, this was at the expense of reducing the “on” time (without dyskinesia) from 9.3 ± 4.6 to 7.5 ± 4.3 (p < 0.05), although the total “on” time did not significantly change. In a long‐term follow‐up of 18 patients, the “on” time with dyskinesia and morning dystonia significantly increased (p < 0.05). There was no significant change in the total daily dosage of levodopa, but the daily number of doses and tablets significantly decreased (p < 0.001). Despite increased dyskinesia, most patients preferred taking fewer tablets and have elected to continue taking Sinemet CR4 instead of standard Sinemet. Sinemet CR4 seems to offer a new and effective strategy for the management of levodopa‐related fluctuations.
Url:
DOI: 10.1002/mds.870040403
Affiliations:
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Le document en format XML
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<term>Carbidopa (administration & dosage)</term>
<term>Carbidopa (pharmacology)</term>
<term>Delayed-Action Preparations</term>
<term>Double-Blind Method</term>
<term>Drug Combinations (administration & dosage)</term>
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<term>Humans</term>
<term>Levodopa</term>
<term>Levodopa (administration & dosage)</term>
<term>Levodopa (pharmacology)</term>
<term>Middle Aged</term>
<term>Movement (drug effects)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson Disease (physiopathology)</term>
<term>Parkinson's disease</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Sinemet CR4</term>
<term>Standard Sinemet</term>
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<term>Carbidopa</term>
<term>Drug Combinations</term>
<term>Levodopa</term>
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<term>Carbidopa</term>
<term>Drug Combinations</term>
<term>Levodopa</term>
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<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Movement</term>
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<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Delayed-Action Preparations</term>
<term>Double-Blind Method</term>
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<term>Middle Aged</term>
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<front><div type="abstract" xml:lang="en">“Wearing‐off” effect, the most common form of levodopa‐induced fluctuations, seems to be related to the short plasma half‐life of the drug. More sustained plasma levodopa levels may be achieved with a new controlledrelease formulation of carbidopa/levodopa, Sinemet CR4. We studied 20 patients, 12 men and 8 women, with Parkinson's disease complicated by “wearing‐off” phenomenon. Mean age was 61.1 ± 8.1 years, duration of symptoms 8.3 ± 2.4 years, and the Hoehn‐Yahr stage 3.0 ± 0.9. In a 12‐week double‐blind study, the average number of tablets administered per day decreased from 5.7 ± 1.2 to 3.8 ± 0.7 when Sinemet CR4 (50/200) was substituted for the standard Sinemet (25/100) (p < 0.001). However, this was at the expense of reducing the “on” time (without dyskinesia) from 9.3 ± 4.6 to 7.5 ± 4.3 (p < 0.05), although the total “on” time did not significantly change. In a long‐term follow‐up of 18 patients, the “on” time with dyskinesia and morning dystonia significantly increased (p < 0.05). There was no significant change in the total daily dosage of levodopa, but the daily number of doses and tablets significantly decreased (p < 0.001). Despite increased dyskinesia, most patients preferred taking fewer tablets and have elected to continue taking Sinemet CR4 instead of standard Sinemet. Sinemet CR4 seems to offer a new and effective strategy for the management of levodopa‐related fluctuations.</div>
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