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Tolcapone was well tolerated and substantially increased on time and reduced off time in patients with fluctuating Parkinson disease. Additionally, levodopa requirements were significantly decreased.
There was no significant difference in motor, mood and quality-of-life scores in patients consuming below and above the 800 mg carbidopa/levodopa threshold, though a mild worsening in dyskinesia duration was noted without worsening in dyskinesia pain and disability. In PD patients who crossed the 800 mg threshold between two consecutive clinic visits, a significant improvement in depressive symptoms and quality-of-life measures was demonstrated, and in these patients there was no worsening of motor fluctuations or dyskinesia.
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The effect of a 2.5-fold increase in daily carbidopa intake on the bioavailability of levodopa was studied in six patients with Parkinson's disease on a low chronic regimen of carbidopa-levodopa (Sinemet) at the fixed ratio of 1:10. The extent of levodopa absorption, expressed as the area under the 11-h plasma levodopa concentration-time curve (AUC0-11 h), was not enhanced by the higher carbidopa dose. A significant increase in the AUC was found for the levodopa metabolite 3-O-methyldopa at the higher carbidopa intake. Clinical performances of individual patients were identical with both carbidopa-levodopa ratios. From these data, an adequate inhibition of peripheral decarboxylation and hence a good bioavailability of levodopa may be expected in patients taking low doses of carbidopa-levodopa, using currently available commercial preparations.
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Physicians modify drug schedules in response to their patients' clinical responses. Failure to relieve patients' symptoms or the emergence of drug-related side effects may reflect nonadherence to a prescribed drug schedule rather than incorrect therapeutic physician decisions. Using a medication questionnaire and a computerized medication event monitoring system (MEMS) to monitor medication use, nonadherence of drug use was examined in subjects with Parkinson's disease (PD). We report that prescription nonadherence in PD subjects was common and approximated that reported in other chronic diseases. During a 28-day observation period, only 4 of 39 subjects had complete schedule adherence, i.e., no missed, extra, or mistimed doses. Using a questionnaire, 24.3% of subjects acknowledged missing any doses but the computerized MEMS recorded that 51.3% of subjects missed at least one dose per week and 20.5% of subjects missed three or more doses per week. Mistiming of doses was admitted by 73% of subjects but 82.1% had recorded mistimed doses. Of multiple sociodemographic and disease-related items examined, only gender and level of education were statistically related to nonadherence.
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LCN PR tablets prolonged the in-vitro release of levodopa in HCl 0.1 m for more than 3 h. In-vivo plasma levodopa levels peaked at a later time point with LCN PR tablets as compared with that obtained with Sinemet 100/25 (2.7 vs 0.5 h). Nebicapone increased the maximum plasma concentration and area under the plasma concentration-time curve values for levodopa.
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The broad results of the treatment of patients with idiopathic Parkinson's disease who have received levodopa or its variants are reported. 50 patients, 24 males and 26 females, with a mean age of 66.5 years were treated with levodopa, in daily doses ranging from 0.25g to 6.0g or 'Sinemet' in daily doses of 300mg to 750mg. Periods of treatment ranged from 4 months to 8 years, with a mean of 4.02 years. The relationships of patients' age, onset of Parkinsonian symptoms and interval between initial treatment with levodopa and the current clinical state were studied. Patients were classified according to their clnical response into 3 categories: satisfactory response, progressive deterioration or intolerance of levodopa. The proportion of patients in each category was 66%, 22% and 12% respectively. The clinical results of treatment correlated with those of Webster Disability Testing Scale. Analysis showed that the majority of patients tolerated levodopa and showed an initially satisfactory response. Patients who responded well were considerably younger than those who failed to respond. Patients receiving the drug for a shorter period (less than 3 years) showed a better response. After 3 years' treatment, the response declined. Patients who had had Parkinson's disease for more than 4 years appeared to do less well than those with recently diagnosed disease, but many patients responded well even when treatment was initiated 10 years after the onset of symptoms. Patients discontinued levodopa treatment because of psychoses, nausea, dyskinesia or exacerbation of urinary incontinence. The commonest side effects were nausea (34%), postural hypotension (22%), psychoses (10%) and 'on-off' phenomena in 12% of patients.
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L-DOPA administration to 21--25-day-old rats with inherited stress-induced arterial hypertension (ISIAH rats)lowered arterial pressure both at rest and in emotional stress in adult rats. The effect seems to be due to enhancement of the brain catecholamine synthesis rather than the peripheral one in early ontogenesis. The long-term hypotensive effect of the L-DOPA was supposed to be caused in part by changes revealed in the brain catecholaminergic system.
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Entacapone increased the duration of action of carbidopa-levodopa and resulted in longer periods of symptomatic relief in a patient with restless legs syndrome. The only side effect was nausea.
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Long-term follow-up of eight patients who underwent stereotactic grafting of adrenal medullary tissue into unilateral or bilateral caudate nuclei is presented. We demonstrate that this procedure can be performed with minimal risk. Our results show little benefit when the group as a whole is analyzed. A subgroup of four patients was identified who responded to the procedure, as evidenced by a reduction in motor scores, reduction in medication requirements, and greater "on" time. Three of these patients continue to accrue benefit after 2 years. No characterization of a responder profile was evident. We conclude that a modest benefit is derived from this procedure that may persist for as long as 2 years. Future clinical studies to evaluate grafting procedures are encouraged.
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We report a case of possible SS in an elderly patient receiving linezolid in combination with carbidopa-levodopa (CL).
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The animal model of Parkinson's disease was successfully established in all 4 monkeys, showing typical parkinsonian syndromes of bradykinesia, rigidity and hypokinesia. Changes in high nervous activities such as apathetic and less aggressive behaviors were also observed. Their scores of Parkinson disease scale exceeded 20. The parkinsonian syndromes were relieved after the administration of sinemet. The 18FDG-PET-CT scans showed significant glucose reduction after the MPTP injection within and outside of the basal ganglion area.
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Mood swings accompanying the motor fluctuations of patients with Parkinson's disease on chronic levodopa treatment frequently occur, but are poorly recognized. Occasionally, their functional impact may be greater than that caused by the motor disability itself. In this study we have assessed the nature of, and relationship between, mood and motor fluctuations in nine Parkinsonian patients with 'on-off' motor swings. The results of an additional questionnaire survey confirm that 'on-off' mood swings occur in approximately two thirds of patients with Parkinson's disease experiencing motor fluctuations on dopaminergic treatment. Aetiological and therapeutic implications are discussed.
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Two hundred fifteen referred outpatients with Parkinson disease who showed predictable end-of-dose motor fluctuations that were not controlled by a stable levodopa-carbidopa (Sinemet) regimen of at least 4 weeks' duration.
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The COMT 158val allele was associated with an increased startle potentiation by unpleasant stimuli as compared with neutral stimuli irrespective of L-dopa or placebo intervention. COMT 158met/met genotype carriers, while displaying no difference in startle magnitude in response to unpleasant or neutral pictures in the placebo condition, showed startle potentiation by unpleasant pictures under L-dopa administration only.
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Several large, open-label studies have presented data that are in line with the randomized controlled trial on L-dopa-carbidopa intestinal gel infusion, which shows that a continuous drug delivery can improve motor fluctuations and dyskinesia in patients with advanced Parkinson's disease. Furthermore, new extended-release formulations of L-dopa aim to stabilize plasma concentrations and thus reduce the degree of motor complications - despite a reduced number of daily doses. Transdermal rotigotine has been shown to be effective for specific subgroups of patients, although the general effect on nonmotor symptoms is still unclear. New products for L-dopa infusion are also at different stages of development, but the routes of administration are widely different: intrajejunal, subcutaneous, and oral.
Carbidopa/levodopa enteral suspension (CLES; Duopa) is a suspension or gel formulation of carbidopa/levodopa that is approved by the USA Food and Drug Administration for the treatment of advanced Parkinson's disease patients with motor fluctuations. CLES is delivered at a constant rate continuously throughout the day into the jejunum through an infusion pump via a PEG-J tube implanted surgically. The efficacy of CLES was established in the USA based on a randomized, double-blind, double-dummy, active controlled, parallel group and 12-week study, in which mean daily OFF time was reduced by 4.0 h, compared to 1.9 h with oral immediate release carbidopa/levodopa. The CLES hardware consists of a cassette containing the drug, a pump to deliver the drug and tubing to connect the PEG-J to the pump. It is critical to understand the appropriate conversion of the carbidopa/levodopa daily dosages to the CLES dosage and how to program the pump and titrate CLES to achieve the most effective dose. We describe one methodology for patient selection, outpatient titration and pump programming.
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Nineteen patients with Itsenko-Cushing's disease aged 13 to 18 were examined during an active stage of the disease and during a remission after proton exposure of the hypophysis. Nine normal subjects were controls. Adenohypophyseal tropic hormones and hydrocortisone were radioimmunoassayed before and after administration of nakom, a dopaminergic agent. ACTH, hydrocortisone, TTH, parlodel secretion were found decreased and LH increased in patients with Itsenko-Cushing's disease, and no STH increase characteristic of normal subjects was observed. During remission after proton therapy adenohypophyseal tropic hormones and hydrocortisone secretion normalized in response to nakom. Recovery of STH secretion was observed, but not in all patients, this being confirmed by the absence of a normal somatotropin response in nakom test in 26.32% of patients.
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Dopamine is an important neurotransmitter in the regulation of the sleep-wake cycle, and parkinsonian patients suffer from prominent sleep abnormalities. Hence, the question arises whether the disrupted sleep pattern in Parkinson's disease (PD) is responsive to dopaminergic treatment.
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All PD patients treated with LCIG at our centre over a 7-year period were analysed to determine the duration of treatment, retention rate, reasons for discontinuation, LCIG efficacy in motor complications, modifications of concomitant therapy and adverse events.
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LCIG has demonstrated efficacy in reducing levodopa-associated motor complications in patients with advanced PD, and improving UPDRS and HRQOL scores. Because it involves PEG and its associated risks, LCIG is recommended for patients in whom motor fluctuations and dyskinesias are inadequately treated with traditional peroral medication. For these patients, LCIG can be a valuable alternative to deep brain stimulation (DBS), especially when DBS is contraindicated. These conclusions are limited by the modest number and size of completed randomized, controlled trials of LCIG.
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The current studies sought to evaluate the safety, tolerability and efficacy of L-dopa as a treatment for cocaine dependence.
Guidelines for clinical transplantation studies for Parkinson's disease emphasize that transplants should be considered as an adjunct to systemic L-DOPA, yet few preclinical studies have specifically assessed the potential of transplants as an adjunct to the clinical gold standard treatment. The objectives of the present study were to determine if encapsulated PC12 cells implanted in rats with severe unilateral dopamine depletions: (i) have a direct therapeutic effect on measures of parkinsonian symptoms; and/or (ii) increase the therapeutic window of oral sinemet in this model. Rats with severe unilateral dopamine depletions received striatal implants of encapsulated PC12 cells producing dopamine and L-DOPA. These rats were tested on a battery of behavioral measures of parkinsonian symptoms, at a range of doses of oral sinemet (0, 12, 24, and 36 mg/kg). Stereotypies/dyskinesias were also quantified after high doses of oral sinemet (36 and 50 mg/kg). The results confirm that parkinsonian symptoms can be quantified in rats with severe dopamine depletions, and the validity and clinical relevance of these measures are supported by the fact that the clinical gold standard treatment, oral sinemet, attenuates these parkinsonian symptoms. Somatic delivery of dopamine and L-DOPA, directly to the dopamine-depleted striatum, also attenuates parkinsonian symptoms. In fact, the magnitude of the therapeutic effect produced by continuous, site-specific, somatic delivery of dopamine and L-DOPA was larger than the effect produced by acute, systemic, oral sinemet. The beneficial effects of oral sinemet and striatal implants of catecholamine-producing devices were additive, but there were no adverse effects related to striatal catecholamine-producing devices, and these devices did not increase the adverse effects related to oral sinemet. Therefore, striatal implants of catecholamine-producing devices have direct therapeutic effects which are fairly robust, and they widen the therapeutic window of oral sinemet.
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The paper reports plasma levels of levodopa (LD), its main metabolites [dopamine, dihydroxyphenylacetic acid, homovanillic acid, 3-O-methyldopa (3-O-MD)] and carbidopa in 14 parkinsonian patients first treated with Sinemet and thereafter with Sinemet-CR4. A good relationship was observed between LD plasma levels and pharmacological effects. While the LD area under the curve increased after Sinemet-CR4, the same was not observed with metabolites, except with 3-O-MD. The experiments in volunteer subjects confirmed the increase in 3-O-MD in plasma after Sinemet-CR4. Higher levels were observed also in the CSF with a reduction of LD concentrations. This seems to corroborate the hypothesis of an interference with LD passage through the blood-brain barrier in humans.
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A major problem in the long-term treatment of Parkinson's disease with chronic, intermittent levodopa therapy is fluctuations in motor response. Both peripheral and central pharmacokinetic properties of levodopa are important in determining the duration of response. The "wearing-off" phenomenon or "end-of-dose" deterioration is related directly to the level of plasma levodopa. Therefore, a principal strategy for the treatment of motor fluctuations has been the attempt to prolong levodopa plasma levels with the use of long-acting, controlled-release levodopa preparations. This paper reviews the available data on the two compounds that are commercially available: benserazide-levodopa hydrodynamically balanced system (Madopar HBS) and controlled-release carbidopa-levodopa (Sinemet CR).
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These two studies demonstrate the safety and tolerability of L-dopa pharmacotherapy in cocaine-dependent patients. No evidence for greater efficacy of L-dopa compared to placebo was observed. The possibility of enhancing treatment effects by combining L-dopa with other behavioral or pharmacological interventions is discussed.
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Parkinson's disease affects thousands of Americans, men and women equally and apparently with little regard to race. Its diagnosis depends largely on repeated clinical observations of representative signs, such as resting tremor, rigidity, bradykinesia, and gait disturbances. Patients progress through stages: Early disease involves only one limb or side and confers minimal disability, but advanced disease restricts patients to full care. Treatment is chosen on the basis of disease stage and patient response. Combination carbidopa-levodopa (Sinemet) is appropriate for any significant degree of disability, and other antiparkinsonian drugs and anticholinergic agents may be used as adjuncts. Electroconvulsive therapy, use of selegiline hydrochloride (Eldepryl), and surgery are still undergoing investigation but may hold promise.