NEWS HIGHLIGHTS
Published Studies Related to Dostinex (Cabergoline)
Dopamine agonist cabergoline reduces hemoconcentration and ascites in hyperstimulated women undergoing assisted reproduction. [2007.08]
CONTEXT: Ovarian hyperstimulation syndrome (OHSS) results from increased vascular permeability (VP) caused by ovarian hypersecretion of vascular endothelial growth factor (VEGF), which activates its receptor-2. In animals, the dopamine receptor 2 agonist cabergoline (Cb2) inactivates VEGF receptor-2 and prevents increased VP. OBJECTIVE: Our objective was to test whether Cb2 reduces VP and prevents OHSS in humans... CONCLUSIONS: Given that Cb2 is a well-established and safe medication, this study provides proof of concept for the use of dopamine agonists in the prevention of OHSS in women undergoing assisted reproduction.
Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: Results from a multi-center, randomized, active controlled trial. [2007.04.15]
We report the first large-scale double-blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks...
Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: Results from a multi-center, randomized, active controlled trial. [2007.02.01]
We report the first large-scale double-blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks...
Salvage of sildenafil failures with cabergoline: a randomized, double-blind, placebo-controlled study. [2006.11]
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...
Efficacy of cabergoline in restless legs syndrome: a placebo-controlled study with polysomnography (CATOR). [2006.09.26]
OBJECTIVE: To assess the efficacy and safety of the dopamine agonist cabergoline in the treatment of patients with idiopathic restless legs syndrome (CATOR study)... CONCLUSION: Single-evening cabergoline is an efficacious and well-tolerated short-term therapy for sensorimotor symptoms of restless legs syndrome and associated sleep disturbances.
Clinical Trials Related to Dostinex (Cabergoline)
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions [Completed]
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions [Completed]
Cardiac Valve Complications in Prolactinomas Treated With Cabergoline [Completed]
Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and
Parkinson's disease (2). There is evidence supporting a causal relationship between the
occurrence of drug-induced "restrictive" valvular heart disease and treatment with pergolide
(3): in several cases, the valvulopathy improved when pergolide was discontinued (4).
Valvular heart damage has also been reported with the ergot-derived dopamine agonists
bromocriptine and cabergoline (5,6).
Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are
associated with an increased risk of new cardiac valve regurgitation in patients treated for
Parkinson's disease.
The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those
observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in
the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity.
These abnormalities also closely resemble carcinoid-related valvulopathies (9).
Cardiac valve disease has never been reported in patients with prolactinomas who require
treatment with dopamine-agonists even life-long (1). At variance with patients with
Parkinson's disease, patients with prolactinomas are younger and are treated with an average
dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and
median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most
patients with microprolactinomas start dopamine-agonist treatment in early adulthood),
treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine
agonists for such a long period of treatment is currently unknown.
To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we
wish to perform an echocardiography screening in a large representative sample of patients
with prolactinoma who were treated with cabergoline for at least 12 months and in a group of
control subjects recruited prospectively. We wish to evaluate the severity of regurgitation
for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared
with treatment duration and cumulative cabergoline dose.
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease [Completed]
This study investigates whether there is a change in 123iodine-2ß-
carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with
levodopa compared to either dopamine agonist or placebo.
Cabergoline Reduces OHSS [Completed]
The present study was designed to provide clinical confirmation of Cb2’s value as a new
approach in the prevention of increased vascular permeability and hemoconcentration, both
signs of OHSS in humans, and in order to explore its mechanism of action. To this end, a
prospective, randomized, placebo-controlled study was designed in which Cb2 was employed in
women at risk of OHSS after gonadotropin administration for ART. Simultaneously, ovarian
perfusion was assessed in these patients using MR pharmacokinetic modeling.
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