Third Interim Report of the Nationwide Collaborative Study on the Long-Term Effects of Bromocriptine in the Treatment of Parkinsonian Patients

Nakanishi, Takao; Kanazawa, Ichiro; Goto, Ikuo; Iwata, Makoto; Kowa, Hisayuki; Mannen, T; Mizuno, Yoshikuni; Nishitani, Hiroshi; Ogawa, Norio; Takahashi, Akira; Tashiro, Kunio; Tohgi, Hideo; Yanagisawa, Nobuo

doi:10.1159/000117167

Cited by 5 publications

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“…When therapy was initiated with a DA agonist, however, the percentage of patients who required supplementary levodopa gradually increased during the course of the study, while some patients remained on DA agonist monotherapy throughout the study without disturbance of daily activities [32]. Similar results were obtained in a Japanese open study using bromocriptine [22][23][24] (Fig. 2).…”

Section: Comparison Of the Therapeutic Usefulness Of Da Agonists And supporting

confidence: 74%

“…This low dose of bromocriptine may be the reason why many patients could not carry on their daily activities and needed levodopa supplementation within 3 years. Data shown were taken from references [22][23][24]. mended for patients with dementia, very elderly patients, and patients with complications, such as cerebrovascular disease, because of their poorer compliance with treatment and the higher possibility of adverse events.…”

Section: Comparison Of the Therapeutic Usefulness Of Da Agonists And mentioning

confidence: 99%

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Initial therapy for Parkinson's disease: levodopa vs. dopamine receptor agonists

Kondo

2002

Journal of Neurology

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Levodopa therapy is essential for patients in the advanced stages of Parkinson's disease. However, at early stages, DA agonist therapy has similar efficacy in the treatment of parkinsonism and a lower incidence of motor complications compared to levodopa therapy several years after the initiation of the therapy. The main factors causing motor complications have been speculated to be a severe reduction of dopaminergic nerve terminals because of disease progression, and a pulsatile stimulation of DA receptors using a drug with a short plasma half-life. DA agonists have longer plasma half-lifes than levodopa; therefore, they are expected to have a favorable effect on motor complications. Moreover, two clinical reports confirmed the potential neuroprotection by DA agonists. Although the patient's conditions should be considered in the selsction of a drug, DA agonist therapy is recommended as the initial therapy for Parkinson's disease.

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Section: Comparison Of the Therapeutic Usefulness Of Da Agonists And supporting

confidence: 74%

Section: Comparison Of the Therapeutic Usefulness Of Da Agonists And mentioning

confidence: 99%

Initial therapy for Parkinson's disease: levodopa vs. dopamine receptor agonists

Kondo

2002

Journal of Neurology

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“…Six other studies examined the same issue and reported no benefit of early bromocriptine treatment versus levodopa monotherapy. 30,[44][45][46][47][48] Three of the six studies were doubleblind but they also had metholodogic problems, including premature unblinding of patients and small numbers of patients enrolled. No double-blind study has ever demonstrated bromocriptine monotherapy or bromocriptine/levodopa combination therapy as being beneficial in preventing motor fluctuations or dyskinesia in patients with early PD.…”

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confidence: 99%

The initial treatment of Parkinson's disease should begin with levodopa

Weiner

1999

Mov. Disord.

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For over two decades controversy has surrounded the initial choice of therapeutic agent for patients with early symptomatic Parkinson's disease. Whether levodopa or dopamine receptor agonist monotherapy in these patients is more efficacious and/or results in fewer long‐term complications of dopaminergic therapy such as motor fluctuations, dyskinesias, or psychiatric disorders is unresolved. This article examines the evidence related to levodopa‐sparing strategies and levodopa‐induced toxicity in Parkinson's disease. At this time, there is little evidence to support levodopa‐sparing strategies or to suggest that levodopa is toxic and harmful to patients with Parkinson's disease.

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“…Seven Level-I trials corresponding to the predefined inclusion/exclusion criteria have been identified. 19,20,23,26,27,29 These studies have been described above (see section on Symptomatic Control of Parkinsonism: Monotherapy); therefore the outcomes regarding long-term motor complications will only be summarized below. …”

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DA agonists - Ergot derivaties: Bromocriptine

2002

Mov Disord.

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Bromocriptine is a tetracyclic ergoline compound derived from plant alkaloids. 6 It is the first DA agonist marketed for the treatment of PD. Bromocriptine is a D2-like receptor agonist and a partial D1-like receptor agonist (which means that it has some weak D1 antagonistic effects on normosensitive receptors). Like most ergot derivatives, bromocriptine has also 5-HT2 antagonist effects and mild adrenergic effects.Bromocriptine improves the symptoms of all available rodent and primate models of PD. Bromocriptine lowers prolactine plasma levels, induces nausea and lowers blood pressure. Some authors speculate that bromocriptine might have neuroprotective properties because it can act in vitro as a free radical scavenger, and it can reduce DA turnover in vivo and therefore, may minimize damage caused by oxidative stress. 7,8 PHARMACOKINETICSAfter oral administration, bromocriptine is not completely absorbed (in humans), and maximal plasma levels are reached after 70 to 100 minutes with high variations among individuals.9,10 The absolute oral bioavailability is less than 10 % since 90% of it undergoes first-pass hepatic metabolism. Bromocriptine plasma elimination half-life is about 6-8 hours. Ninety percent is bound to plasma proteins. Only a small amount is excreted unchanged in the urine (5%). The high level of metabolism that occurs increases the risk of drug interaction. Macrolides, acting as enzyme inhibitors and displacing bromocriptine from the binding protein, may lead to increased plasma bromocriptine concentrations and toxicity. REVIEW OF CLINICAL STUDIESThis paragraph is limited to clinical trials involving standard formulations of bromocriptine. A slow release formulation of bromocriptine has also been developed, but is excluded from this review because it has not been marketed in most countries. 11,12 PREVENTION OF DISEASE PROGRESSIONLevel-I Studies Olanow et al. (1995) 13 : Olanow and colleagues performed a randomized, parallel groups, double-blind, placebo-controlled study (also known as the SINDEPAR trial), which assessed the effect of selegiline and bromocriptine on the progression of PD. In this study, 101 untreated patients with PD (mean age = 66 years) were randomly assigned to one of the following four treatment groups (Deprenyl(r) plus Sinemet(r); placebo-Deprenyl(r) plus Sinemet(r); Deprenyl(r) plus bromocriptine; placebo-Deprenyl(r) plus bromocriptine). The final visit was performed at 14 months, 2 months after withdrawal of Deprenyl (or its placebo) and 7 days after withdrawal of Sinemet or bromocriptine. Deterioration of UPDRS total score between baseline and final visit was used as an index of PD progression. Deterioration in UPDRS score was not significantly different in patients randomized to treatment with Sinemet (1.7 ±1.6) or bromocriptine (4.5±1.2), suggesting that the disease probably progressed at the same rate in the L-dopa-and bromocriptine-treated patients. This result does not support a "neuroprotective" effect of bromocriptine. However, in the absence of placebo only-treated...

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Third Interim Report of the Nationwide Collaborative Study on the Long-Term Effects of Bromocriptine in the Treatment of Parkinsonian Patients

Cited by 5 publications

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Initial therapy for Parkinson's disease: levodopa vs. dopamine receptor agonists

Initial therapy for Parkinson's disease: levodopa vs. dopamine receptor agonists

The initial treatment of Parkinson's disease should begin with levodopa

DA agonists - Ergot derivaties: Bromocriptine

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