WARNING
Cardiac Valvulopathy and Fibrotic Complications
Cardiac Valvulopathy
The use of pergolide has been shown to increase the risk of cardiac valvular disease involving one or more valves. Some patients have required valve replacement, and deaths have been reported. Cases have been reported after exposures to pergolide ranging from several months to several years. The histopathology of explanted valves is similar to that of other drug-induced valvulopathies. Precise risk estimates of pergolide-induced cardiac valvular disease are not available.
Specific risk factors predisposing patients to developing cardiac valvular disease with pergolide have not been identified. Cardiac valvulopathy has been reported with all doses of pergolide; however, available data suggest that the risk may be greater with higher doses. Doses of pergolide above 5 mg/day are not recommended ( see DOSAGE & ADMINISTRATION ).
Pergolide is not recommended for use in patients with a history of cardiac valvulopathy.
Before initiating treatment with pergolide, all patients should undergo a cardiovascular evaluation, including an echocardiogram, to determine whether valvular disease is present and to provide a baseline for subsequent monitoring. Although the risk of disease progression in patients with asymptomatic valvular disease is unknown, pergolide ordinarily should not be initiated if valvulopathy is detected at screening.
All patients taking pergolide should undergo periodic echocardiograms to screen for the development of valvulopathy. Patients should also be monitored for signs and symptoms of valvulopathy, including dyspnea, edema, congestive heart failure and new cardiac murmurs. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation, including echocardiogram, has been performed. Pergolide should ordinarily be discontinued if a patient is diagnosed with cardiac valvular disease. In some cases, signs and/or symptoms of cardiac valvulopathy improved after discontinuation of pergolide.
Fibrotic Complications
Case reports have demonstrated that pergolide increases the risk of fibrotic complications including pulmonary, pleural, and/or retroperitoneal fibrosis, pericarditis, pleuritis, and pericardial and/or pleural effusions. Cases have been reported after exposures to pergolide ranging from about one to several years. Precise risk estimates of pergolide-induced fibrotic complications are not available.
Specific risk factors predisposing patients to developing fibrotic complications with pergolide have not been identified. Fibrotic complications have been reported with all therapeutic doses of pergolide.
Pergolide is not recommended for use in patients with a history of fibrotic conditions.
Patients should also be monitored for signs and symptoms of fibrotic complications, including dyspnea, persistent edema, cough, congestive heart failure, new cardiac rub, and/or signs of urinary tract obstruction. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation has been performed. Pergolide should ordinarily be discontinued if a patient is diagnosed with a specific fibrotic complication. In some cases, signs and/or symptoms of fibrotic complications improved after discontinuation of pergolide.
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PERMAX SUMMARY
PERMAX®
PERGOLIDE TABLETS, USP
Permax® (Pergolide Tablets, USP) is an ergot derivative dopamine receptor agonist at both D1 and D2 receptor sites.
Permax is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease.
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NEWS HIGHLIGHTS
Published Studies Related to Permax (Pergolide)
Dopamine and cognitive functioning in de novo subjects with Parkinson's disease: effects of pramipexole and pergolide on working memory. [2009.04]
Very few studies have investigated the relationship between dopaminergic therapy and working memory (WM) functioning in Parkinson's disease (PD) patients. The aim of the present study was to explore the effects of pharmacological treatment with pergolide (a D1+D2 receptor agonist) and pramipexole (a D2+D3 receptor agonist) on performance in visual-spatial, visual-object, and verbal WM tasks in PD patients...
Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study. [2006.03]
Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long-term studies, allowing "rescue" therapy with levodopa... The choice remains with the treating physician based on the different efficacy and adverse event profiles.
Nocturnal activity with nighttime pergolide in Parkinson disease: a controlled study using actigraphy. [2005.04.26]
Pergolide is a dopamine agonist that improves Parkinson disease but is associated with dose-dependent sleepiness... Side effects were more frequent in the pergolide group.
Trial of subtherapeutic pergolide in de novo Parkinson's disease. [2005.03]
The effect of pergolide 25 mug twice daily on levodopa initiation was assessed in a randomized, placebo-controlled, parallel group, double-blind multicenter trial in 106 untreated early Parkinson's disease patients. The primary endpoint of mean time until levodopa was 520 days (95% confidence interval [CI], 422-618 days) for pergolide versus 434 days (95% CI, 358-609 days) for placebo...
Pergolide effect on cognitive functions in early-mild Parkinson's disease. [2005.02]
In the present study, we evaluated the effect of pergolide, a mixed D1/D2 agonist, on cognitive function in mild Parkinson's disease (PD). After a two-week wash-out phase, twenty patients with a Hoehn and Yahr score </=2.5 entered a 16-week, cross-over study in which the order of administration of pergolide or 1-dopa was randomly assigned...
Clinical Trials Related to Permax (Pergolide)
Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide [Active, not recruiting]
The purpose of this study is to determine whether patients with Parkinson's disease and
treated with pergolide have a higher risk of heart valve disease compared to patients with
Parkinson's disease not treated with pergolide.
Effective Adjunctive Use of Pergolide for Cognitive Impairment and Negative Symptoms in Schizophrenia [Suspended]
Dopamine has been closely associated with prefrontal function. The hypothesis that a lower
dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed
in the patients of schizophrenia is of a heuristic value in guiding research in this area.
This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative
symptoms and cognitive impairments prevailing in most patients with schizophrenia. This
double-blind placebo controlled study will investigate the remedial effect of pergolide on
negative symptoms and cognitive impairments in schizophrenia.
Compassionate Use Study of Pergolide in Patients With Parkinson's Disease [Available]
This compassionate use study is designed to monitor safety in patients who have been doing
well on pergolide therapy, wish to continue treatment, and have not been able to tolerate
alternative treatments.
Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder [Recruiting]
Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1)
working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the
AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis
by drug administration of 0. 3 mg of oral pergolide interaction for performance on the
cognitive tasks, with the schizotypal personality disorder group demonstrating significantly
improved peformance compared to the other personality disorder group after pergolide
compared with placebo.
Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects
receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed
by pergolide for four weeks.
Pergolide Treatment for Substance Abusers - 4 [Completed]
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Page last updated: 2009-10-20
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