Multicenter, placebo-controlled trial of cabergoline taken once daily in the treatment of Parkinson's disease

Hutton, J. Thomas; Koller, William C.; Ahlskog, J. Eric; Pahwa, Rajesh; Hurtig, H. I.; Stern, Matthew B.; Hiner, Bradley C.; Lieberman, Abraham; Pfeiffer, Ronald F.; Rodnitzky, Robert L.; Waters, Cheryl; Muenter, Manfred D.; Adler, Charles H.; Morris, Jerry L.

doi:10.1212/wnl.46.4.1062

Cited by 88 publications

(43 citation statements)

References 4 publications

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“…One is a placebo-controlled trial and the other is a bromocriptine-controlled. Hutton et al (1996) 4 : This was the only large (188 patients with suboptimally controlled PD and end-of-dose deterioration or motor complications, mean age 63 years), 6-month, randomized, parallel group, placebo-controlled study identified in the search. The primary efficacy endpoint was change in UPDRS Part II and III, and changes in daily dose of L-dopa were also assessed.…”

Section: Late Combinationmentioning

confidence: 99%

“…Therefore, only relevant data for control of motor complications will be reviewed here. Hutton et al (1996) 4 : This was 6-month, randomized, parallel, placebo-controlled study conducted in 188 patients with suboptimally controlled PD who had end-of-dose deterioration or other motor complications. Motor fluctuations were assessed as a secondary endpoint using item 39 of UPDRS Part IV (Complications of Therapy).…”

Section: Control Of Motor Complicationsmentioning

confidence: 99%

“…Based on one large level-I placebo-controlled study 4 conducted in L-dopa-treated patients with motor fluctuations, cabergoline is considered as EFFICACIOUS in improving control of parkinsonian motor symptoms in advanced L-dopa-treated patients with PD. There is INSUFFICIENT EVIDENCE to conclude on cabergoline efficacy as an early combination therapy with levodopa in PD patients without motor fluctuations.…”

Section: Adjunct Therapy In L-dopa-treated Patientsmentioning

confidence: 99%

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DA agonists - Ergot derivaties: Cabergoline

2002

Mov Disord.

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Cabergoline is an orally administered synthetic tetracyclic ergoline derivative that acts in vitro and in vivo as a selective D2 receptor agonist with no substantial affinity for D1 receptors. As with other ergotamine derivatives, it has also some affinity for nondopamine receptors (noradrenergic and serotonergic). Cabergoline improves the symptoms of the primate model of Parkinson's disease (PD) after MPTP intoxication. Cabergoline lowers prolactin secretion, and like all effective D2-agonists, induces nausea, vomiting and orthostatic hypotension in healthy volunteers. 1 PHARMACOKINETICSOne major characteristic of cabergoline is its long duration of effect with oral administration, probably because its elimination half-life is approximately 65 hours. For example, cabergoline is highly effective in suppressing prolactin levels with a duration of action up to 21 days after a single 1 mg oral dose. Such a pharmacokinetic profile allows a once-daily dosing treatment regimen. The cabergoline Tmax is observed at 2.5 hours, and it is metabolized into several metabolites excreted mainly by the fecal route. 1 REVIEW OF CLINICAL STUDIES PREVENTION OF DISEASE PROGRESSIONNo qualified studies were identified. SYMPTOMATIC CONTROL OF PARKINSONISM MONOTHERAPYTo date, there are no Level-I, placebo-controlled studies that have investigated the efficacy of cabergoline as monotherapy. Two clinical reports were identified, but correspond to the same L-dopacontrolled study that performed two different analyses: one planned interim analysis at 1 year 2 , and a final analysis at 3 to 5 years. 3 In this study, cabergoline was initiated as monotherapy, and L-dopa supplementation was added in patients if required (i.e. based on dose limiting adverse reactions and if they reached maximal dose of cabergoline). 2 : This is the only available study assessing the effects of cabergoline monotherapy (with secondary open Ldopa supplementation if needed) at one-year. It is a randomized, L-dopa-controlled (Level I), double-blind study conducted in 413 de novo patients with PD (mean age approximately 61 years). Cabergoline could be titrated up to 4 mg/d on a once a day regimen, and L-dopa up to 600 mg/d tid. Open label L-dopa supplementation was allowed during the course of the study. PD disability was evaluated using mean UPDRS (Unified Parkinson's Disease Rating Scale) scores and the CGI (Clinical Global Impression) scale. The proportion of patients experiencing a 30% decrease in parkinsonian disability and the proportion requiring the addition of L-dopa were also analysed. Thirty-seven (9%) patients withdrew from the study by 1 year. At this 1-year interim analysis, mean cabergoline daily dose was 2.8 mg/d and that of L-dopa was 468 mg/d. Thirty-eight percent of the patients received L-dopa supplementation in the cabergoline group (mean daily dose 305 mg/d). At baseline, UPDRS was 29.1 in the L-dopa and 27.5 in the cabergoline group. After 1-year of treatment, the decrease in scores was higher in the L-dopa (16.5) than in the cabergoline group (...

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Section: Late Combinationmentioning

confidence: 99%

Section: Control Of Motor Complicationsmentioning

confidence: 99%

Section: Adjunct Therapy In L-dopa-treated Patientsmentioning

confidence: 99%

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DA agonists - Ergot derivaties: Cabergoline

2002

Mov Disord.

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“…2 The efficacy of cabergoline has been evaluated in many clinical trials. [3][4][5] The synthesis of cabergoline, an N-acylurea and a potent prolactin inhibitor, has been reported by Ashford et al in 2002, 6 and in the same year, its effectiveness in treating acromegaly has also been announced. 7 Furthermore, some acylureas have found application in agriculture because they hamper the growth and reproduction of the fall armyworm and house fly.…”

Section: Introductionmentioning

confidence: 98%

Microwave-mediated and customery synthesis of N-benzoyl- or N-substituted benzoyl-N,N'-dialkylureas from arylcarboxylic acids and N,N'-disubstituted carbodiimides under solvent-free conditions

Filho

Oliveira

Srivastava

2007

J. Braz. Chem. Soc.

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bons rendimentos em condições livre de solvente. Primeiramente, a reação entre um ácido carboxílico e uma carbodiimida dissubstituída foi feita empregando radiação de microondas, e depois a mesma reação foi realizada sob aquecimento convencional. Os rendimentos são comparáveis em ambos os casos.An easy, efficient and quick synthesis of N-benzoyl-(and N-substituted benzoyl)-N,N′-dialkylureas, in good yields, under solvent-free conditions is described. First, the reaction between a carboxylic acid and a disubstituted carbodiimide was carried out employing microwave radiation, and later on the same reaction was performed separately under dry heating without any radiation. The yields are comparable in both cases.

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“…37 Although there are no published reports on the use of cabergoline as an ED pharmacotherapy, several reports show that cabergoline is able to ameliorate disorders associated with DA deficiency and hence is an appropriate candidate for this trial. [38][39][40][41][42] To our knowledge this the first study to assess the efficacy of cabergoline in nonresponders to sildenafil.…”

Section: Introductionmentioning

confidence: 99%

Salvage of sildenafil failures with cabergoline: a randomized, double-blind, placebo-controlled study

Safarinejad¹

2006

Int J Impot Res

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To evaluate the safety and efficacy of cabergoline in men with erectile dysfunction (ED) who did not respond to sildenafil. Four hundred two sildenafil nonresponders aged from 21 to 59 years were included in the study. Patients were randomly divided into group 1, those who received 0.5-1 mg cabergoline weekly for 6 months and group 2, who received placebo for the same period. They underwent preliminary assessment, including medical and sexual history, self-administered International Index of Erectile Function (IIEF) and intravaginal ejaculatory latency time (IVELT) evaluation. Standard biochemistry and hematological laboratory tests, and measurement of serum testosterone and prolactin levels were also carried out. When indicated, other tests were used to establish the diagnosis of vasculogenic and neurogenic ED, including penile color duplex Doppler ultrasonography, pudendal nerve conduction test and impaired sensory-evoked potentials studies. The efficacy of two treatments was assessed every 2 weeks during treatment, at the end of the study, using responses to IIEF, IVELT evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. The trial was completed by 370 (92%) men. Positive clinical results were seen in 31.2% of patients in the cabergoline group compared with 7.1% of patients in the placebo group (P ¼ 0.04). The mean weekly intercourse episodes increased from pretreatment values of 1.4 and 1.2 to 2.2 and 1.4, for cabergoline and placebo, respectively (P ¼ 0.04). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 15 and 10 at 6-month treatment in groups 1 and 2, respectively (P ¼ 0.04). The IVELT after cabergoline and placebo gradually increased from 98 and 101 s to approximately 242 and 116 s, respectively (P ¼ 0.001). More drug-related adverse effects occurred in cabergoline group and 12 (5.9%) had to discontinue treatment (P ¼ 0.001). Cabergoline is moderately effective salvage therapy for sildenafil nonresponse. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in ED.

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Multicenter, placebo-controlled trial of cabergoline taken once daily in the treatment of Parkinson's disease

Cited by 88 publications

References 4 publications

DA agonists - Ergot derivaties: Cabergoline

DA agonists - Ergot derivaties: Cabergoline

Microwave-mediated and customery synthesis of N-benzoyl- or N-substituted benzoyl-N,N'-dialkylureas from arylcarboxylic acids and N,N'-disubstituted carbodiimides under solvent-free conditions

Salvage of sildenafil failures with cabergoline: a randomized, double-blind, placebo-controlled study

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