Risk of cardiac valve regurgitation with dopamine agonist use in parkinsons disease and hyperprolactinaemia: A multi-country, nested case-control study

Drug Safety

Volumn 35, Issue 2, 2012, Pages 159-171

  Trifirò, Gianluca ^a,b,c   Mokhles, M Mostafa ^a   Dieleman, Jeanne P ^a   Soest, Eva M ^a   Verhamme, Katia ^a   Mazzaglia, Giampiero ^d   Herings, Ron ^e   Luise, Cynthia ^f   Ross, Douglas ^f   Brusselle, Guy ^g   Colao, Annamaria ^h   Haverkamp, Wilhelm ⁱ   chade, Rene ^a   Van Camp, Guy ^j   Zanettini, Renzo ^k   Sturkenboom, Miriam C ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b IRCCS CENTRO NEUROLESI BONINO PULEJO   (Italy)

^c UNIVERSITY OF MESSINA   (Italy)

^d Pharmacovigilance Network of Italian College of General Practitioners   (Italy)

^e PHARMO INSTITUTE FOR DRUG OUTCOMES RESEARCH   (Netherlands)

^f PFIZER INC   (United States)

^g GHENT UNIVERSITY   (Belgium)

^h UNIVERSITY OF NAPLES FEDERICO II   (Italy)

ⁱ CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^j UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^k PARKINSON INSTITUTE   (Italy)

more..

Author keywords

Dopamine receptor agonists; Heart disorders; Hyperprolactinaemia; Parkinsons disease; Valvular heart disorders

Indexed keywords

BROMOCRIPTINE; CABERGOLINE; DIHYDROERGOCRYPTINE; DOPAMINE RECEPTOR STIMULATING AGENT; LEVODOPA; LISURIDE; METERGOLINE; PERGOLIDE; PIRIBEDIL; PRAMIPEXOLE; QUINAGOLIDE; ROPINIROLE; ROTIGOTINE;

AGED; ARTICLE; CARDIOVASCULAR RISK; CASE CONTROL STUDY; COHORT ANALYSIS; CONTROLLED STUDY; DATA BASE; DISEASE ASSOCIATION; FEMALE; FOLLOW UP; HEART VALVE REGURGITATION; HUMAN; HYPERPROLACTINEMIA; MAJOR CLINICAL STUDY; MALE; MITRAL VALVE REGURGITATION; PARKINSON DISEASE; PARKINSONISM; PRIORITY JOURNAL; STENOSIS; TRICUSPID VALVE REGURGITATION;

EID: 84855834585     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11594940-000000000-00000     Document Type: Article

References (35)

1. Kvernmo T, Hartter S, Burger E. A review of the receptorbinding and pharmacokinetic properties of dopamine agonists. Clin Ther 2006; 28: 1065-78 (Pubitemid 44374749)
2. Goetz CG, PoeweW, Rascol O, et al. Evidence-based medical review update: pharmacological and surgical treatments of Parkinson's disease: 2001 to 2004. Mov Disord 2005; 20: 523-39 (Pubitemid 40862249)
3. Horvath J, Fross RD, Kleiner-Fisman G, et al. Severe multivalvular heart disease: a new complication of the ergot derivative dopamine agonists. Mov Disord 2004; 19: 656-62 (Pubitemid 39173018)
4. Pritchett AM, Morrison JF, Edwards WD, et al. Valvular heart disease in patients taking pergolide. Mayo Clin Proc 2002; 77: 1280-6 (Pubitemid 35403801)
5. Van Camp G, Flamez A, Cosyns B, et al. Heart valvular disease in patients with Parkinson's disease treated with high-dose pergolide. Neurology 2003; 61: 859-61 (Pubitemid 37174494)
6. Pinero A, Marcos-Alberca P, Fortes J. Cabergoline-related severe restrictive mitral regurgitation. N Engl J Med 2005; 353: 1976-7 (Pubitemid 41565968)
7. Bhattacharyya S, Schapira AH, Mikhailidis DP, et al. Druginduced fibrotic valvular heart disease. Lancet 2009; 374: 577-85
8. Tan LC, Ng KK, Au WL, et al. Bromocriptine use and the risk of valvular heart disease. Mov Disord 2009; 24: 344-9
9. Zanettini R, Antonini A, Gatto G, et al. Valvular heart disease and the use of dopamine agonists for Parkinson's disease. N Engl J Med 2007; 356: 39-46 (Pubitemid 46041752)
10. Simonis G, Fuhrmann JT, Strasser RH. Meta-analysis of heart valve abnormalities in Parkinson's disease patients treated with dopamine agonists. Mov Disord 2007; 22: 1936-42 (Pubitemid 350134208)
11. Schade R, Andersohn F, Suissa S, et al. Dopamine agonists and the risk of cardiac-valve regurgitation. N Engl J Med 2007; 356: 29-38 (Pubitemid 46041751)
12. Food and Drug Administration. Withdrawal of Parkinson's treatment: pergolide. April 17, 2007 [online]. Available from URL: http://www.fda.gov/ ForConsumers/Consumer Updates/ucm048819.htm [Accessed 2011 Feb 15]
13. European Medicines Agency. Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets of cabergoline presented by the EMA [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Refer rals-document/Ergot- derived-dopamine-agonists-31/WC 500011459.pdf [Accessed 2011 Feb 15]
14. Klibanski A. Clinical practice: prolactinomas. N Engl J Med 2010; 362: 1219-26
15. Colao A, Galderisi M, Di Sarno A, et al. Increased prevalence of tricuspid regurgitation in patients with prolactinomas chronically treated with cabergoline. J Clin Endocrinol Metab 2008; 93: 3777-84
16. Bogazzi F, Buralli S, Manetti L, et al. Treatment with low doses of cabergoline is not associated with increased prevalence of cardiac valve regurgitation in patients with hyperprolactinaemia. Int J Clin Pract 2008; 62: 1864-9
17. Vallette S, Serri K, Rivera J, et al. Long-term cabergoline therapy is not associated with valvular heart disease in patients with prolactinomas. Pituitary 2009; 12: 153-7
18. Herring N, Szmigielski C, Becher H, et al. Valvular heart disease and the use of cabergoline for the treatment of prolactinoma. Clin Endocrinol (Oxf) 2009; 70: 104-8
19. Nachtigall LB, Valassi E, Lo J, et al. Gender effects on cardiac valvular function in hyperprolactinaemic patients receiving cabergoline: a retrospective study. Clin Endocrinol (Oxf) 2010; 72: 53-8
20. Kars M, Delgado V, Holman ER, et al. Aortic valve calcification and mild tricuspid regurgitation but no clinical heart disease after 8 years of dopamine agonist therapy for prolactinoma. J Clin Endocrinol Metab 2008; 93: 3348-56
21. Wakil A, Rigby AS, Clark AL, et al. Low dose cabergoline for hyperprolactinaemia is not associated with clinically significant valvular heart disease. Eur J Endocrinol 2008; 159:R11-4
22. Lancellotti P, Livadariu E, Markov M, et al. Cabergoline and the risk of valvular lesions in endocrine disease. Eur J Endocrinol 2008; 159: 1-5 (Pubitemid 351969123)
23. Devin JK, Lakhani VT, Byrd 3rd BF, et al. Prevalence of valvular heart disease in a cohort of patients taking cabergoline for management of hyperprolactinemia. Endocr Pract 2008; 14: 672-7
24. Lafeber M, Stades A, Valk G, et al. Absence of major fibrotic adverse events in hyperprolactinemic patients treated with cabergoline. Eur J Endocrinol 2010; 162: 667-75
25. Tan T, Cabrita IZ, Hensman D, et al. Assessment of cardiac valve dysfunction in patients receiving cabergoline treatment for hyperprolactinaemia. Clin Endocrinol (Oxf) 2010; 73: 369-74
26. Lewis JD, Schinnar R, Bilker WB, et al. Validation studies of the health improvement network (THIN) database for pharmacoepidemiology research. Pharmacoepidemiol Drug Saf 2007; 16: 393-401 (Pubitemid 46656860)
27. Cricelli C, Mazzaglia G, Samani F, et al. Prevalence estimates for chronic diseases in Italy: exploring the differences between self-report and primary care databases. J Public Health Med 2003; 25: 254-7 (Pubitemid 37237080)
28. van der Lei J, Duisterhout JS, Westerhof HP, et al. The introduction of computer-based patient records in The Netherlands. Ann Intern Med 1993; 119: 1036-41 (Pubitemid 23334661)
29. Richardson DB. An incidence density sampling program for nested case-control analyses. Occup Environ Med 2004; 61: e59
30. Committee on Safety of Medicines. Pergolide (Celance) and cardiac valvulopathy. Current problems in pharmacovigilance bulletin. Vol. 29. London: Medicines and Healthcare Products Regulatory Agency, 2003: 7
31. Vallette S, Serri K, Serri O. Cabergoline therapy for prolactinomas: is valvular heart disease a real safety concern? Expert Rev Cardiovasc Ther 2010; 8: 49-54
32. Yamamoto M, Uesugi T, Nakayama T. Dopamine agonists and cardiac valvulopathy in Parkinson disease: a casecontrol study. Neurology 2006; 67: 1225-9 (Pubitemid 44563832)
33. Peralta C, Wolf E, Alber H, et al. Valvular heart disease in Parkinson's disease vs. controls: an echocardiographic study. Mov Disord 2006; 21: 1109-13 (Pubitemid 44348515)
34. Zanettini R, Antonini A, Gatto G, et al. Regression of cardiac valvulopathy related to ergot-derived dopamine agonists. Cardiovasc Ther. Epub 2010 Jun 11
35. Van Camp G, Flamez A, Cosyns B, et al. Treatment of Parkinson's disease with pergolide and relation to restrictive valvular heart disease. Lancet 2004; 363: 1179-83 (Pubitemid 38481842)