PNL6 EXAMINATION OF THE COST-EFFECTIVENESS OF DOPAMINE AGONISTS FORTHETREATMENT OF RESTLESS LEGS SYNDROME

Background: Traditional treatment approaches for the management of restless legs syndrome (RLS) and Parkinson's disease (PD) include the use of medications that either directly or indirectly increase dopamine levels. In turn, a potential adverse event that could be expected is the development or exacerbation of psychiatric-related symptoms. Objective: To evaluate and describe the incidence of psychosis and associated behavioral features in patients taking ropinirole for RLS or PD. Methods: Patients were identified from a computerized database search of outpatients being treated with ropinirole for 1 of 2 medical conditions: PD or RLS. Data were collected in a retrospective manner from 95 patients who were tracked over the course of their therapy to determine whether psychosis or associated behavioral symptoms developed as a result and whether an intervention was needed to adjust ropinirole dosing or if additional medications had to be added to control features associated with psychosis. Results: A total of 284 patients being treated for RLS or PD were identified; of this group, 95 patients were identified as being treated for PD or RLS with ropinirole. Of the 95 patients being treated with ropinirole, 13 developed psychotic features that required therapeutic intervention with either the use of an antipsychotic or dose adjustment of ropinirole. PD patients included in this study were numerically more likely to develop psychotic features compared with RLS patients; however, the difference was not statistically significant (p = 0.122). The results do suggest that this risk is increased when ropinirole is used as part of a dual therapy approach with dopamine agonists in the treatment of either PD or RLS (p = 0.003). Discussion: Dopamine agonists have long been used as preferred treatment in the management of PD and RLS. When treating either PD or RLS in the psychiatric population, the concern arises that increased activity at dopamine receptors may induce or exacerbate psychiatric features. A potential clinical concern with the use of ropinirole is the potential for patients to develop psychiatric features, although there are few data available to demonstrate whether stimulation of targeted individual dopamine receptors is linked to the development or exacerbation of psychotic features. It is also undetermined whether concurrent antipsychotic treatment provides any protective benefit against psychosis, especially in patients already being treated for psychotic symptoms. Conclusions: Our findings suggest that ropinirole may play a role in inducing or exacerbating psychosis and its associated features, although a number of confounding variables prevent the determination of a clear association and suggest that further investigation is warranted in controlled clinical trials.

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SP439EXERCISE TRAINING AND DOPAMINE AGONISTS IN HEMODIALYSIS PATIENTS WITH RESTLESS LEGS SYNDROME. A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED STUDY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfv194.03 ◽

2015 ◽

Vol 30 (suppl_3) ◽

pp. iii523-iii524

Author(s):

Giorgos Sakkas ◽

Christoforos Giannaki ◽

Christina Karatzaferi ◽

Georgios M. Hadjigeorgiou ◽

Ioannis Stefanidis

Keyword(s):

Restless Legs Syndrome ◽

Dopamine Agonists ◽

Hemodialysis Patients ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Restless Legs

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Neurology: Effect of Non-Ergot Dopamine Agonists on Health-Related Quality of Life of Patients with Restless Legs Syndrome

Annals of Pharmacotherapy ◽

10.1345/aph.1l673 ◽

2009 ◽

Vol 43 (5) ◽

pp. 813-821 ◽

Cited By ~ 6

Author(s):

Ripple Talati ◽

Olivia J Phung ◽

Jeffrey Mather ◽

Craig I Coleman

Keyword(s):

Quality Of Life ◽

Restless Legs Syndrome ◽

Dopamine Agonists ◽

Meta Analysis ◽

Health Related Quality ◽

Restless Legs ◽

Hrqol Data ◽

Related Quality ◽

Health Related

Background Non-ergot dopamine agonists (NEDAs) have become the gold-standard agents for the treatment of restless legs syndrome (RLS). While the efficacy and safety of these drugs have been widely studied, their effect on patients' health-related quality of life (HRQoL) has not been fully elucidated. Objective To better define the usefulness of NEDAs by assessing their impact on HRQoL. Methods We performed a meta-analysis of randomized, double-blind, placebo-controlled trials evaluating the use of NEDAs in patients with RLS. A systematic literature search of MEDLINE, EMBASE, and Cochrane CENTRAL was performed from the earliest possible date through July 2008. Trials were included in the analysis if they evaluated NEDAs for the treatment of RLS and reported HRQoL using any RLS disease-specific HRQoL instrument. HRQoL data were pooled and evaluated using an inverse variance weighting approach as standardized mean differences (SMDs) and 95% confidence interval (CI). For trials reporting HRQoL data obtained using the Johns Hopkins RLS-QoL Questionnaire, adjusted mean difference data were pooled to calculate the weighted mean difference (WMD) and 95% CI. Results Seven trials (N = 1483) met all inclusion criteria. Patients with RLS taking NEDAs had significantly improved overall effect on HRQoL compared with those taking placebo (SMD 0.20; 95% CI 0.10 to 0.30; degree of inconsistency across studies [I2] = 0%). When analyzing trials using the Johns Hopkins RLS-QoL questionnaire, the results also showed improvement with NEDAs compared with placebo (WMD 4.72; 95% CI 2.96 to 6.47; I2 = 0%). Study conclusions were unchanged upon sensitivity analysis. The number of trials for each NEDA was small, limiting the usefulness of between-agent comparisons. Conclusions In patients with RLS, use of NEDAs showed improved HRQoL compared with placebo. Since pooled effect sizes observed in this meta-analysis appear to surpass accepted values for minimally important clinical differences, these improvements may be clinically relevant for the average studied patient. However, future studies evaluating long-term treatment of RLS with NEDAs are necessary, as are head-to-head comparative trials and economic assessments.

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