Efficacy and safety of pramipexole extended‐release in Parkinson's disease: a review based on meta‐analysis of randomized controlled trials

Shen, Ting; Ye, Rong; Zhang, B.

doi:10.1111/ene.13303

Cited by 20 publications

(20 citation statements)

References 23 publications

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“…Meanwhile, pramipexole caused muscle weakness, peripheral edema, and back pain. The study results were parallel with the results of a double-blinded study (11). Unlike PP cohort, in SG cohort, patients with dyskinesias were reported.…”

Section: Adverse Effects and Hospitalizationsupporting

confidence: 73%

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Pramipexole Versus Selegiline in Patients with Parkinson’s Disease: An Effectiveness and Safety (EAS) Analysis

Tao

Chen

Xiao

et al. 2019

Iran Red Crescent Med J

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Background: Levodopa treatment is the gold standard in Parkinson's disease but has the risk of dyskinesias. Selegiline delays the introduction of levodopa and pramipexole is used as a symptomatic treatment in Parkinson's disease. Objectives: This study aimed to compare the effectiveness of pramipexole with selegiline in Parkinson's disease patients. Methods: Data regarding motor and cognitive impairments and plasma phospholipids of 500 Chinese patients with confirmed Parkinson's disease from medical records of 1 January 2015 to 1 June 2016 were retrospectively evaluated. Patients received either pramipexole (PP cohort, n = 250) or selegiline (SG cohort, n = 250). Also, data regarding hospitalization, adverse effects, and expenditure were collected and analyzed from records of the follow-up period. Results: After 3-years of treatments, selegiline and pramipexole both improved motor and cognitive impairments and decreased plasma phospholipid levels (P < 0.05 for all). The intensity of improvement in motor and cognitive impairments and a decrease in the level of plasma phospholipids for pramipexole was higher than those of selegiline (P < 0.05 for all). Pramipexole caused muscle weakness (P = 0.015) and peripheral edema (P = 0.0004). While, selegiline caused cardiovascular disease (P = 0.008). Higher numbers of patients in the SG cohort were hospitalized during 3-years of treatment than those in PP cohort (11 vs. 1, P = 0.009). Selegiline treatment is more expensive than pramipexole (4,457 ± 345 ¥ vs. 3,649 ± 301 ¥/patient/year, P < 0.0001). Conclusions: Pramipexole treatment may have better improvement in motor and cognitive impairments than selegiline with neuroprotective action and manageable side effects (Level of Evidence: III).

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Section: Adverse Effects and Hospitalizationsupporting

confidence: 73%

“…After 3-years of treatment, in the same manner, motor and daily living tasks (UPDRS III scale) of the patients of PP cohort were also improved. The study results were parallel with the results of double-blind studies (11,12). Pramipexole may also delay the progression of disease in patients with confirmed Parkinson's disease.…”

Section: Expendituresupporting

confidence: 65%

Pramipexole Versus Selegiline in Patients with Parkinson’s Disease: An Effectiveness and Safety (EAS) Analysis

Tao

Chen

Xiao

et al. 2019

Iran Red Crescent Med J

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“…Nausea was the only side‐effect with a higher prevalence in pramipexole than placebo and SSRIs. Unexpectedly, studies on individuals treated with pramipexole for depression did not report some side‐effects commonly reported in studies on individuals treated with pramipexole for Parkinson's disease, such as lethargy, gambling, hypersexuality and compulsive shopping . In our opinion, this difference might be due to the different neurobiological dysfunctions underlying depression and Parkinson's disease or to the relatively small number of patients with depression treated with pramipexole, not sufficient to detect infrequent adverse events.…”

Section: Discussionmentioning

confidence: 61%

Pramipexole in the treatment of unipolar and bipolar depression. A systematic review and meta‐analysis

Tundo

Filippis

Crescenzo

2019

Acta Psychiatr Scand

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Pramipexole in the treatment of unipolar and bipolar depression. A systematic review and meta-analysis Tundo A, de Filippis R, De Crescenzo F. Pramipexole in the treatment of unipolar and bipolar depression. A systematic review and metaanalysis Objective: Several depressed patients do not respond to traditional antidepressants. Our aim was to systematically review the effectiveness and safety of pramipexole in unipolar and bipolar depression. Methods: We conducted a systematic review of randomized clinical trials (RCTs) and observational studies on pramipexole for patients with major depressive episodes, following PRISMA guidelines. Our primary outcome measure was treatment response at endpoint. The study protocol was registered on PROSPERO: CRD42018108699. Results: We found five RCTs, three open-label trials and five observational studies, with 504 participants (57% women; mean age, 45.3 years; mean sample size, 39; median duration of treatment, 8 weeks; mean follow-up duration, 45 weeks; mean maximum dose, 1.62 mg). We found an overall short-term response rate of 52.2% and remission rate of 36.1%, and an overall long-term response rate of 62.1% and remission rate of 39.6%. In RCTs, patients treated with pramipexole had a superior response rate compared with placebo (RR: 1.77; 95% CI: 1.11-2.82) and similar to SSRIs (RR: 0.93; 95% CI: 0.44-1.95). Acceptability and tolerability were good, with nausea being the most frequent side-effect. Conclusion: Our study found some evidence for an effect of pramipexole for the treatment of major depressive episodes. Summations• Results from clinical trials found that pramipexole for major depressive episodes is superior to placebo and similar to SSRIs.• The use of pramipexole as antidepressant appears to be safe, with nausea being the most frequent side-effect.• Some side-effects commonly reported in studies on individuals with Parkinson's diseasesuch as lethargy, gambling, hypersexuality and compulsive shoppingare not reported for individuals treated with pramipexole for major depressive episodes. Limitations• Our systematic review includes only few studies.• The small sample size of the studies suggests that we are in an early phase of research and that a phase 3 trial is needed before drawing clinical conclusions.

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“…The IR formulation was first approved for use in the USA in 1997 [6], and then received European Medicines Agency approval in 1998 [7]. The ER formulation was subsequently developed and was shown to be associated with better adherence to the drug regimen, more constant blood level, and favorable clinical response and safety profiles in clinical trials [8][9][10][11]. Investigators from Italy studied Parkinson's disease patients from a single center in Rome and reported that the use of ER dopamine agonists, including transdermal rotigotine and ER formulations of oral ropinirole and pramipexole, was associated with lower daily levodopa doses and decreased frequency of adverse effects [12].…”

Section: Introductionmentioning

confidence: 99%

Changes in Pramipexole Utilization after Introduction of the Extended-Release Formulation: A Nationwide Study in Taiwan

Chan

Hsieh

et al. 2020

Drugs - Real World Outcomes

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Background Real-world impact of extended-release formulations of oral drugs should ideally be evaluated in populationbased health data. Objective To evaluate changes in utilization of the dopamine agonist pramipexole for Parkinson's disease after the introduction of extended-release (ER) pramipexole in Taiwan. Patients and Methods Source data were derived from National Health Insurance claims. Patients with a diagnosis of Parkinson's disease and pramipexole prescriptions were identified. Drug use patterns from 2009 through 2011 (only the immediaterelease [IR] formulation was available) and from 2012 through 2017 (both the IR and ER formulations were available) were assessed. Outcomes of interest were levodopa equivalent dose per day (LEDD) and 1-year adherence, as measured by the medication possession ratio (MPR). Results LEDDs associated with pramipexole ER prescriptions were more than twice as large as that associated with pramipexole IR, both in pramipexole used in monotherapy and that used in combination therapy. One-year MPRs for pramipexole ER initiators were all larger than 73% from 2012 through 2016 and 1-year MPRs for pramipexole IR initiators were less than 65% in 2010 and 2011. Conclusion Introduction of pramipexole ER to Taiwan resulted in higher LEDD in prescriptions with pramipexole. Patients with Parkinson's disease who were initiated on pramipexole ER had better adherence to the medication than those who were prescribed pramipexole IR.

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Efficacy and safety of pramipexole extended‐release in Parkinson's disease: a review based on meta‐analysis of randomized controlled trials

Abstract: Pramipexole ER is as safe and effective as pramipexole IR in the treatment of Parkinson's disease.

Cited by 20 publications

References 23 publications

Pramipexole Versus Selegiline in Patients with Parkinson’s Disease: An Effectiveness and Safety (EAS) Analysis

Pramipexole Versus Selegiline in Patients with Parkinson’s Disease: An Effectiveness and Safety (EAS) Analysis

Pramipexole in the treatment of unipolar and bipolar depression. A systematic review and meta‐analysis

Changes in Pramipexole Utilization after Introduction of the Extended-Release Formulation: A Nationwide Study in Taiwan

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