Risk of adverse cardiovascular reactions in Parkinson?s disease patients treated with pramipexole: a systematic

JAMES CRISPO; SANTIAGO PÉREZ LLORET

Congreso; 18th International Congress of Parkinson's Disease and Movement Disorders; 2014

Objective: The objective of this study was to systematically review the literature to evaluate the risk of adversecardiovascular reactions (such as heart failure (HF), valvular heart disease, and blood pressure disorders) inParkinson?s disease (PD) patients treated with the non-ergot dopamine agonist pramipexole.The objective of this study was to systematically review the literature to evaluate the risk of adversecardiovascular reactions (such as heart failure (HF), valvular heart disease, and blood pressure disorders) inParkinson?s disease (PD) patients treated with the non-ergot dopamine agonist pramipexole.Background: Withdrawal of pergolide from Canadian and US markets following findings that ergot dopamine agonistsare associated with an increased risk of cardiac valvulopathy has increased interest in clinical and epidemiologicalresearch on the cardiac safety of non-ergot dopamine agonists. A recent pooled analysis of randomized control trials bythe US Food and Drug Administration (FDA) found a non-significant increase in heart failure associated withpramipexole. This led to the release of a safety announcement by the FDA in September 2012 regarding the use ofpramipexole and the risk of heart failure. To the best of our knowledge, current reviews addressing the cardiac safetyof pramipexole are outdated, underpowered, and/or not completed in a systematic manner.Withdrawal of pergolide from Canadian and US markets following findings that ergot dopamine agonistsare associated with an increased risk of cardiac valvulopathy has increased interest in clinical and epidemiologicalresearch on the cardiac safety of non-ergot dopamine agonists. A recent pooled analysis of randomized control trials bythe US Food and Drug Administration (FDA) found a non-significant increase in heart failure associated withpramipexole. This led to the release of a safety announcement by the FDA in September 2012 regarding the use ofpramipexole and the risk of heart failure. To the best of our knowledge, current reviews addressing the cardiac safetyof pramipexole are outdated, underpowered, and/or not completed in a systematic manner.Methods: A systematic review of the association between pramipexole treatment and adverse cardiovascular reactionswas completed. A comprehensive search of all anti-Parkinson drugs in eight electronic databases (Medline, Embase,PsycINFO, CINAHL, PubMed, the Cochrane Database of Systematic Reviews, DARE, and CENTRAL) was performed,followed by three levels of screening by two independent reviewers and a descriptive analysis of included studies.Included studies were restricted to quantitative studies with >10 PD patients that were published in either English orFrench and involved human subjects.A systematic review of the association between pramipexole treatment and adverse cardiovascular reactionswas completed. A comprehensive search of all anti-Parkinson drugs in eight electronic databases (Medline, Embase,PsycINFO, CINAHL, PubMed, the Cochrane Database of Systematic Reviews, DARE, and CENTRAL) was performed,followed by three levels of screening by two independent reviewers and a descriptive analysis of included studies.Included studies were restricted to quantitative studies with >10 PD patients that were published in either English orFrench and involved human subjects.Results: Our search of the databases returned 3,732 articles. After removing duplicates 2,800 articles remained forscreening, data extraction, and quality appraisal. Preliminary analyses suggest that pramipexole may be associatedwith adverse cardiovascular reactions, specifically HF and orthostatic hypotension. An in-depth interpretation of ourfindings will be presented and discussed.Our search of the databases returned 3,732 articles. After removing duplicates 2,800 articles remained forscreening, data extraction, and quality appraisal. Preliminary analyses suggest that pramipexole may be associatedwith adverse cardiovascular reactions, specifically HF and orthostatic hypotension. An in-depth interpretation of ourfindings will be presented and discussed.Conclusions: This is the first study of its kind to systematically investigate the cardiac safety of pramipexole in PDpatients following the release of the FDA safety announcement. Our findings highlight gaps in the existing literature onpramipexole and adverse cardiovascular reactions.This is the first study of its kind to systematically investigate the cardiac safety of pramipexole in PDpatients following the release of the FDA safety announcement. Our findings highlight gaps in the existing literature onpramipexole and adverse cardiovascular reactions.