Levodopa and the Progression of Parkinson's Disease
This randomized trial examined the effect of levodopa on the progression of Parkinson's disease. After 40 weeks of treatment followed by another 2 weeks for washout, the clinical severity of Parkinson's disease was greater in patients receiving placebo than in those treated with levodopa....
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| Published in | The New England journal of medicine Vol. 351; no. 24; pp. 2498 - 2508 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston, MA
Massachusetts Medical Society
09.12.2004
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0028-4793 1533-4406 1533-4406 |
| DOI | 10.1056/NEJMoa033447 |
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| Abstract | This randomized trial examined the effect of levodopa on the progression of Parkinson's disease. After 40 weeks of treatment followed by another 2 weeks for washout, the clinical severity of Parkinson's disease was greater in patients receiving placebo than in those treated with levodopa. However, neuroimaging data suggested a greater loss of dopamine nerve terminals in the patients treated with levodopa.
In this randomized trial the clinical data indicate that levodopa reduces symptoms without accelerating clinical progression of Parkinson's disease. However, the neuroimaging data are not concordant.
Parkinson's disease is a progressively disabling neurodegenerative disorder that is manifested clinically by bradykinesia, tremor, rigidity, flexed posture, postural instability, and freezing of gait. It is characterized pathologically by the loss of pigmented dopaminergic neurons in the substantia nigra. The course of the clinical decline parallels that of the progressive degeneration of the remaining dopaminergic neurons.
1
The use of levodopa as dopamine-replacement therapy is highly effective in ameliorating the symptoms of the disease and remains the standard drug with which other therapies are compared.
2
,
3
Because levodopa and dopamine can generate reactive oxygen species and induce the degeneration of cultured . . . |
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| AbstractList | Background Despite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten neurodegeneration. This study assessed the effect of levodopa on the rate of progression of Parkinson's disease. Methods In this randomized, double-blind, placebo-controlled trial, we evaluated 361 patients with early Parkinson's disease who were assigned to receive carbidopa-levodopa at a daily dose of 37.5 and 150 mg, 75 and 300 mg, or 150 and 600 mg, respectively, or a matching placebo for a period of 40 weeks, and then to undergo withdrawal of treatment for 2 weeks. The primary outcome was a change in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) between baseline and 42 weeks. Neuroimaging studies of 142 subjects were performed at baseline and at week 40 to assess striatal dopamine-transporter density with the use of iodine-123-labeled 2-β-carboxymethoxy-3-β-(4-iodophenyl)tropane ([123 I]β-CIT) uptake. Results The severity of parkinsonism increased more in the placebo group than in all the groups receiving levodopa: the mean difference between the total score on the UPDRS at baseline and at 42 weeks was 7.8 units in the placebo group, 1.9 units in the group receiving levodopa at a dose of 150 mg daily, 1.9 in those receiving 300 mg daily, and -1.4 in those receiving 600 mg daily (P<0.001). In contrast, in a substudy of 116 patients the mean percent decline in the [123 I]β-CIT uptake was significantly greater with levodopa than placebo (-6 percent among those receiving levodopa at 150 mg daily, -4 percent in those receiving it at 300 mg daily, and -7.2 percent among those receiving it at 600 mg daily, as compared with -1.4 percent among those receiving placebo; 19 patients with no dopaminergic deficits on the baseline scans were excluded from the analysis) (P=0.036). The subjects receiving the highest dose of levodopa had significantly more dyskinesia, hypertonia, infection, headache, and nausea than those receiving placebo. Conclusions The clinical data suggest that levodopa either slows the progression of Parkinson's disease or has a prolonged effect on the symptoms of the disease. In contrast, the neuroimaging data suggest either that levodopa accelerates the loss of nigrostriatal dopamine nerve terminals or that its pharmacologic effects modify the dopamine transporter. The potential long-term effects of levodopa on Parkinson's disease remain uncertain. This randomized trial examined the effect of levodopa on the progression of Parkinson's disease. After 40 weeks of treatment followed by another 2 weeks for washout, the clinical severity of Parkinson's disease was greater in patients receiving placebo than in those treated with levodopa. However, neuroimaging data suggested a greater loss of dopamine nerve terminals in the patients treated with levodopa. In this randomized trial the clinical data indicate that levodopa reduces symptoms without accelerating clinical progression of Parkinson's disease. However, the neuroimaging data are not concordant. Parkinson's disease is a progressively disabling neurodegenerative disorder that is manifested clinically by bradykinesia, tremor, rigidity, flexed posture, postural instability, and freezing of gait. It is characterized pathologically by the loss of pigmented dopaminergic neurons in the substantia nigra. The course of the clinical decline parallels that of the progressive degeneration of the remaining dopaminergic neurons. 1 The use of levodopa as dopamine-replacement therapy is highly effective in ameliorating the symptoms of the disease and remains the standard drug with which other therapies are compared. 2 , 3 Because levodopa and dopamine can generate reactive oxygen species and induce the degeneration of cultured . . . Despite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten neurodegeneration. This study assessed the effect of levodopa on the rate of progression of Parkinson's disease.BACKGROUNDDespite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten neurodegeneration. This study assessed the effect of levodopa on the rate of progression of Parkinson's disease.In this randomized, double-blind, placebo-controlled trial, we evaluated 361 patients with early Parkinson's disease who were assigned to receive carbidopa-levodopa at a daily dose of 37.5 and 150 mg, 75 and 300 mg, or 150 and 600 mg, respectively, or a matching placebo for a period of 40 weeks, and then to undergo withdrawal of treatment for 2 weeks. The primary outcome was a change in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) between baseline and 42 weeks. Neuroimaging studies of 142 subjects were performed at baseline and at week 40 to assess striatal dopamine-transporter density with the use of iodine-123-labeled 2-beta-carboxymethoxy-3-beta-(4-iodophenyl)tropane ([123I]beta-CIT) uptake.METHODSIn this randomized, double-blind, placebo-controlled trial, we evaluated 361 patients with early Parkinson's disease who were assigned to receive carbidopa-levodopa at a daily dose of 37.5 and 150 mg, 75 and 300 mg, or 150 and 600 mg, respectively, or a matching placebo for a period of 40 weeks, and then to undergo withdrawal of treatment for 2 weeks. The primary outcome was a change in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) between baseline and 42 weeks. Neuroimaging studies of 142 subjects were performed at baseline and at week 40 to assess striatal dopamine-transporter density with the use of iodine-123-labeled 2-beta-carboxymethoxy-3-beta-(4-iodophenyl)tropane ([123I]beta-CIT) uptake.The severity of parkinsonism increased more in the placebo group than in all the groups receiving levodopa: the mean difference between the total score on the UPDRS at baseline and at 42 weeks was 7.8 units in the placebo group, 1.9 units in the group receiving levodopa at a dose of 150 mg daily, 1.9 in those receiving 300 mg daily, and -1.4 in those receiving 600 mg daily (P<0.001). In contrast, in a substudy of 116 patients the mean percent decline in the [123I]beta-CIT uptake was significantly greater with levodopa than placebo (-6 percent among those receiving levodopa at 150 mg daily, -4 percent in those receiving it at 300 mg daily, and -7.2 percent among those receiving it at 600 mg daily, as compared with -1.4 percent among those receiving placebo; 19 patients with no dopaminergic deficits on the baseline scans were excluded from the analysis) (P=0.036). The subjects receiving the highest dose of levodopa had significantly more dyskinesia, hypertonia, infection, headache, and nausea than those receiving placebo.RESULTSThe severity of parkinsonism increased more in the placebo group than in all the groups receiving levodopa: the mean difference between the total score on the UPDRS at baseline and at 42 weeks was 7.8 units in the placebo group, 1.9 units in the group receiving levodopa at a dose of 150 mg daily, 1.9 in those receiving 300 mg daily, and -1.4 in those receiving 600 mg daily (P<0.001). In contrast, in a substudy of 116 patients the mean percent decline in the [123I]beta-CIT uptake was significantly greater with levodopa than placebo (-6 percent among those receiving levodopa at 150 mg daily, -4 percent in those receiving it at 300 mg daily, and -7.2 percent among those receiving it at 600 mg daily, as compared with -1.4 percent among those receiving placebo; 19 patients with no dopaminergic deficits on the baseline scans were excluded from the analysis) (P=0.036). The subjects receiving the highest dose of levodopa had significantly more dyskinesia, hypertonia, infection, headache, and nausea than those receiving placebo.The clinical data suggest that levodopa either slows the progression of Parkinson's disease or has a prolonged effect on the symptoms of the disease. In contrast, the neuroimaging data suggest either that levodopa accelerates the loss of nigrostriatal dopamine nerve terminals or that its pharmacologic effects modify the dopamine transporter. The potential long-term effects of levodopa on Parkinson's disease remain uncertain.CONCLUSIONSThe clinical data suggest that levodopa either slows the progression of Parkinson's disease or has a prolonged effect on the symptoms of the disease. In contrast, the neuroimaging data suggest either that levodopa accelerates the loss of nigrostriatal dopamine nerve terminals or that its pharmacologic effects modify the dopamine transporter. The potential long-term effects of levodopa on Parkinson's disease remain uncertain. Despite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten neurodegeneration. This study assessed the effect of levodopa on the rate of progression of Parkinson's disease. In this randomized, double-blind, placebo-controlled trial, we evaluated 361 patients with early Parkinson's disease who were assigned to receive carbidopa-levodopa at a daily dose of 37.5 and 150 mg, 75 and 300 mg, or 150 and 600 mg, respectively, or a matching placebo for a period of 40 weeks, and then to undergo withdrawal of treatment for 2 weeks. The primary outcome was a change in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) between baseline and 42 weeks. Neuroimaging studies of 142 subjects were performed at baseline and at week 40 to assess striatal dopamine-transporter density with the use of iodine-123-labeled 2- beta -carboxymethoxy-3- beta -(4-iodophenyl)tropane ([ super(123)I] beta -CIT) uptake. The severity of parkinsonism increased more in the placebo group than in all the groups receiving levodopa: the mean difference between the total score on the UPDRS at baseline and at 42 weeks was 7.8 units in the placebo group, 1.9 units in the group receiving levodopa at a dose of 150 mg daily, 1.9 in those receiving 300 mg daily, and -1.4 in those receiving 600 mg daily (P<0.001). In contrast, in a substudy of 116 patients the mean percent decline in the [ super(123)I] beta -CIT uptake was significantly greater with levodopa than placebo (-6 percent among those receiving levodopa at 150 mg daily,-4 percent in those receiving it at 300 mg daily, and -7.2 percent among those receiving it at 600 mg daily, as compared with -1.4 percent among those receiving placebo; 19 patients with no dopaminergic deficits on the baseline scans were excluded from the analysis) (P=0.036). The subjects receiving the highest dose of levodopa had significantly more dyskinesia, hypertonia, infection, headache, and nausea than those receiving placebo. The clinical data suggest that levodopa either slows the progression of Parkinson's disease or has a prolonged effect on the symptoms of the disease. In contrast, the neuroimaging data suggest either that levodopa accelerates the loss of nigrostriatal dopamine nerve terminals or that its pharmacologic effects modify the dopamine transporter. The potential long-term effects of levodopa on Parkinson's disease remain uncertain. Despite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten neurodegeneration. This study assessed the effect of levodopa on the rate of progression of Parkinson's disease. In this randomized, double-blind, placebo-controlled trial, we evaluated 361 patients with early Parkinson's disease who were assigned to receive carbidopa-levodopa at a daily dose of 37.5 and 150 mg, 75 and 300 mg, or 150 and 600 mg, respectively, or a matching placebo for a period of 40 weeks, and then to undergo withdrawal of treatment for 2 weeks. The primary outcome was a change in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) between baseline and 42 weeks. Neuroimaging studies of 142 subjects were performed at baseline and at week 40 to assess striatal dopamine-transporter density with the use of iodine-123-labeled 2-beta-carboxymethoxy-3-beta-(4-iodophenyl)tropane ([123I]beta-CIT) uptake. The severity of parkinsonism increased more in the placebo group than in all the groups receiving levodopa: the mean difference between the total score on the UPDRS at baseline and at 42 weeks was 7.8 units in the placebo group, 1.9 units in the group receiving levodopa at a dose of 150 mg daily, 1.9 in those receiving 300 mg daily, and -1.4 in those receiving 600 mg daily (P<0.001). In contrast, in a substudy of 116 patients the mean percent decline in the [123I]beta-CIT uptake was significantly greater with levodopa than placebo (-6 percent among those receiving levodopa at 150 mg daily, -4 percent in those receiving it at 300 mg daily, and -7.2 percent among those receiving it at 600 mg daily, as compared with -1.4 percent among those receiving placebo; 19 patients with no dopaminergic deficits on the baseline scans were excluded from the analysis) (P=0.036). The subjects receiving the highest dose of levodopa had significantly more dyskinesia, hypertonia, infection, headache, and nausea than those receiving placebo. The clinical data suggest that levodopa either slows the progression of Parkinson's disease or has a prolonged effect on the symptoms of the disease. In contrast, the neuroimaging data suggest either that levodopa accelerates the loss of nigrostriatal dopamine nerve terminals or that its pharmacologic effects modify the dopamine transporter. The potential long-term effects of levodopa on Parkinson's disease remain uncertain. |
| Author | Kieburtz, Karl Rudolph, Alice Olanow, C Warren Oakes, David Fahn, Stanley Shoulson, Ira Lang, Anthony Tanner, Caroline Marek, Kenneth |
| Author_xml | – sequence: 1 givenname: Stanley surname: Fahn fullname: Fahn, Stanley email: fahn@neuro.columbia.edu organization: Columbia University, New York, USA. fahn@neuro.columbia.edu – sequence: 2 givenname: David surname: Oakes fullname: Oakes, David – sequence: 3 givenname: Ira surname: Shoulson fullname: Shoulson, Ira – sequence: 4 givenname: Karl surname: Kieburtz fullname: Kieburtz, Karl – sequence: 5 givenname: Alice surname: Rudolph fullname: Rudolph, Alice – sequence: 6 givenname: Anthony surname: Lang fullname: Lang, Anthony – sequence: 7 givenname: C Warren surname: Olanow fullname: Olanow, C Warren – sequence: 8 givenname: Caroline surname: Tanner fullname: Tanner, Caroline – sequence: 9 givenname: Kenneth surname: Marek fullname: Marek, Kenneth |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16328187$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/15590952$$D View this record in MEDLINE/PubMed |
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| References | r020 r021 r022 r001 r017 Muenter MD (r023) 1971; 46 Desagher S (r031) 1996; 16 Fahn S (r005) 1996; 47 r019 r035 r014 r015 r016 r010 Hoehn MM (r013) 1967; 17 r032 r011 Marek K (r018) 2001; 57 Guttman M (r024) 2001; 56 r033 r012 r034 Agid Y (r008) 1998; 50 r030 r006 r028 r007 r029 r009 r003 r025 (r002) 1993; 43 r004 r026 r027 15590960 - N Engl J Med. 2004 Dec 9;351(24):2547-9 15800240 - N Engl J Med. 2005 Mar 31;352(13):1386; author reply 1386 |
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| Snippet | This randomized trial examined the effect of levodopa on the progression of Parkinson's disease. After 40 weeks of treatment followed by another 2 weeks for... Despite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten neurodegeneration.... Background Despite the known benefit of levodopa in reducing the symptoms of Parkinson's disease, concern has been expressed that its use might hasten... |
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| SubjectTerms | Aged Antiparkinson Agents - administration & dosage Antiparkinson Agents - therapeutic use Biological and medical sciences Carbidopa - administration & dosage Carbidopa - therapeutic use Clinical trials Corpus Striatum - diagnostic imaging Corpus Striatum - metabolism Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases Disease Progression Dopamine Dopamine Plasma Membrane Transport Proteins Double-Blind Method Drug Combinations Drug dosages Female General aspects Humans Levodopa - administration & dosage Levodopa - therapeutic use Male Medical sciences Membrane Glycoproteins - metabolism Membrane Transport Proteins - metabolism Middle Aged Nerve Tissue Proteins - metabolism Neurology Oxidative stress Parkinson Disease - diagnostic imaging Parkinson Disease - drug therapy Parkinson Disease - metabolism Parkinson's disease Tomography, Emission-Computed, Single-Photon |
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| Title | Levodopa and the Progression of Parkinson's Disease |
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