European Journal of Clinical Pharmacology

, Volume 68, Issue 5, pp 857–865 | Cite as

Do Parkinson’s disease patients disclose their adverse events spontaneously?

  • Santiago Perez-Lloret
  • María Verónica Rey
  • Nelly Fabre
  • Fabienne Ory
  • Umberto Spampinato
  • Jean-Louis Montastruc
  • Olivier Rascol
Pharmacoepidemiology and Prescription

Abstract

Background

Underreporting of adverse drug reactions is common but has been rarely studied in Parkinson’s disease (PD).

Objective

To compare the prevalence of adverse events (AEs) in relation to antiparkinsonian drugs in PD patients using two different data collection methods: patient’s spontaneous reporting versus a predefined investigator-driven structured interview. Secondary objectives were to assess factors related to spontaneous reporting and to compare the rate of AE reporting in PD patients with that of a group of non-parkinsonian post-stroke patients.

Study design

Cross-sectional study.

Patients

Ambulatory, cognitively intact PD or post-stroke outpatients.

Interventions

None.

Outcome measures

Patients were first asked by means of an an open question to disclose any unpleasant effects in connection with their current medications that had occurred during the previous week. Afterwards, a predefined questionnaire listing the most common AEs known to be related to antiparkinsonian drugs was used to question the same patients in a systematic manner about the presence of any AE during the same week. Chronological and semiological criteria were used to classify the reported AEs as “unrelated” or “possibly/plausibly related” to the antiparkinsonian treatment.

Results

A total of 203 PD and 52 post-stroke patients of comparable age and sex were recruited. Eighty-five PD and five post-stroke patients reported spontaneously at least one AE (42 vs. 10%, p < 0.01), while 203 PD and 47 post-stroke patients reported at least one AE following the structured questionnaire (100 vs. 90%, p < 0.001). In PD patients, there were a total of 112 spontaneously reported AEs as compared with 1,574 according to the structured questionnaire (7%). Spontaneous disclosure of AEs was associated with experiencing >2 AEs [OR = 1.2 (1.1–3.2)], logistic regression). Seventy-four percent of PD patients had ≥1 AE possibly/plausibly related to antiparkinsonian drugs.

Conclusions

Results showed that only 7% of AEs were reported spontaneously by patients, thus underscoring the importance of systematically asking about AEs in PD patients.

Keywords

Parkinson’s disease Adverse drug reactions Pharmacological treatment Levodopa Dopamine agonists Underreporting Non-motor symptoms Motor fluctuations 

References

  1. 1.
    Poewe W (2006) The natural history of Parkinson’s disease. J Neurol 253(Suppl 7):VII2–VII6PubMedCrossRefGoogle Scholar
  2. 2.
    Fariello RG, Lieberman A (2006) Present and future approaches to Parkinson disease: from molecular insights to new therapeutic avenues. Neurology 67:S1–S4PubMedCrossRefGoogle Scholar
  3. 3.
    Goetz CG, Poewe W, Rascol O, Sampaio C (2005) Evidence-based medical review update: pharmacological and surgical treatments of Parkinson’s disease: 2001 to 2004. Mov Disord 20:523–539PubMedCrossRefGoogle Scholar
  4. 4.
    Brooks DJ (2004) Safety and tolerability of COMT inhibitors. Neurology 62:S39–S46PubMedGoogle Scholar
  5. 5.
    Perez-Lloret S, Rascol O (2010) Dopamine receptor agonists for the treatment of early or advanced Parkinson’s disease. CNS Drugs 24:941–968PubMedCrossRefGoogle Scholar
  6. 6.
    Rascol O (2005) Rasagiline in the pharmacotherapy of Parkinson’s disease—a review. Expert Opin Pharmacother 6:2061–2075PubMedCrossRefGoogle Scholar
  7. 7.
    Montastruc JL, Sommet A, Lacroix I, Olivier P, Durrieu G, Mase-Michel C, Lapeyre-Mestre M, Bagheri H (2006) Pharmacovigilance for evaluating adverse drug reactions: value, organization, and methods. Joint Bone Spine 73:629–632PubMedCrossRefGoogle Scholar
  8. 8.
    Hazell L, Shakir SA (2006) Under-reporting of adverse drug reactions: a systematic review. Drug Saf 29:385–396PubMedCrossRefGoogle Scholar
  9. 9.
    Carreno M, Gil-Nagel A, Sanchez JC, Elices E, Serratosa JM, Salas-Puig J, Villanueva V, Porcel J (2008) Strategies to detect adverse effects of antiepileptic drugs in clinical practice. Epilepsy Behav 13:178–183PubMedCrossRefGoogle Scholar
  10. 10.
    Hughes AJ, Daniel SE, Kilford L, Lees AJ (1992) Accuracy of clinical diagnosis of idiopathic Parkinson’s disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry 55:181–184PubMedCrossRefGoogle Scholar
  11. 11.
    Jankovic J, Tolosa E (2006) Parkinson’s disease and movement disorders, 5th edn. Lippincott Williams & Wilkins, LondonGoogle Scholar
  12. 12.
    Olanow CW, Stern MB, Sethi K (2009) The scientific and clinical basis for the treatment of Parkinson disease (2009). Neurology 72:S1–S136PubMedCrossRefGoogle Scholar
  13. 13.
    Sweetman SC (2009) Martindale: the complete drug reference. www.medicinescomplete.com/mc/martindale/current/. Accessed 1 June 2009
  14. 14.
    Fahn S, Elton RL, Members of the UPDRS committee (1987) Unified Parkinson’s disease rating scale. In: Fahn S, Mardsen CD, Goldstein M (eds) Recent developments in Parkinson’s disease, 2nd edn. McMillan, New York, pp 153–163Google Scholar
  15. 15.
    Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet 356:1255–1259PubMedCrossRefGoogle Scholar
  16. 16.
    Begaud B, Evreux JC, Jouglard J, Lagier G (1985) Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France. Therapie 40:111–118PubMedGoogle Scholar
  17. 17.
    Chaudhuri KR, Martinez-Martin P (2008) Quantitation of non-motor symptoms in Parkinson’s disease. Eur J Neurol 15(Suppl 2):2–7PubMedCrossRefGoogle Scholar
  18. 18.
    Jarernsiripornkul N, Kakaew W, Loalukkana W, Krska J (2009) Adverse drug reaction monitoring: comparing doctor and patient reporting for new drugs. Pharmacoepidemiol Drug Saf 18:240–245PubMedCrossRefGoogle Scholar
  19. 19.
    Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H (2004) Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology 62:23–27PubMedGoogle Scholar
  20. 20.
    Chaudhuri KR, Prieto-Jurcynska C, Naidu Y, Mitra T, Frades-Payo B, Tluk S, Ruessmann A, Odin P, Macphee G, Stocchi F, Ondo W, Sethi K, Schapira AH, Martinez Castrillo JC, Martinez-Martin P (2010) The nondeclaration of nonmotor symptoms of Parkinson’s disease to health care professionals: an international study using the nonmotor symptoms questionnaire. Mov Disord 25:697–701CrossRefGoogle Scholar
  21. 21.
    Giovannoni G, O’Sullivan JD, Turner K, Manson AJ, Lees AJ (2000) Hedonistic homeostatic dysregulation in patients with Parkinson’s disease on dopamine replacement therapies. J Neurol Neurosurg Psychiatry 68:423–428PubMedCrossRefGoogle Scholar
  22. 22.
    Frucht S, Rogers JD, Greene PE, Gordon MF, Fahn S (1999) Falling asleep at the wheel: motor vehicle mishaps in persons taking pramipexole and ropinirole. Neurology 52:1908–1910PubMedGoogle Scholar
  23. 23.
    Weintraub D, Koester J, Potenza MN, Siderowf AD, Stacy M, Voon V, Whetteckey J, Wunderlich GR, Lang AE (2010) Impulse control disorders in Parkinson disease: a cross-sectional study of 3090 patients. Arch Neurol 67:589–595PubMedCrossRefGoogle Scholar
  24. 24.
    Ferreira JJ, Desboeuf K, Galitzky M, Thalamas C, Brefel-Courbon C, Fabre N, Senard JM, Montastruc JL, Sampaio C, Rascol O (2006) Sleep disruption, daytime somnolence and ‘sleep attacks’ in Parkinson’s disease: a clinical survey in PD patients and age-matched healthy volunteers. Eur J Neurol 13:209–214PubMedCrossRefGoogle Scholar
  25. 25.
    Valko PO, Waldvogel D, Weller M, Bassetti CL, Held U, Baumann CR (2010) Fatigue and excessive daytime sleepiness in idiopathic Parkinson’s disease differently correlate with motor symptoms, depression and dopaminergic treatment. Eur J Neurol 17:1428–1436PubMedCrossRefGoogle Scholar
  26. 26.
    Johns MW (1991) A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 14:540–545PubMedGoogle Scholar
  27. 27.
    Grant JE, Levine L, Kim D, Potenza MN (2005) Impulse control disorders in adult psychiatric inpatients. Am J Psychiatry 162:2184–2188PubMedCrossRefGoogle Scholar
  28. 28.
    Mandal A, Chatterjee S, Das SK, Mishra A (2010) Drug safety monitoring in patients of movement disorders of a tertiary care hospital. Indian J Pharmacol 42:249–251PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Santiago Perez-Lloret
    • 1
    • 3
    • 7
    • 2
  • María Verónica Rey
    • 1
    • 3
    • 2
  • Nelly Fabre
    • 4
  • Fabienne Ory
    • 1
    • 2
  • Umberto Spampinato
    • 5
    • 6
  • Jean-Louis Montastruc
    • 1
    • 2
  • Olivier Rascol
    • 1
    • 3
    • 2
  1. 1.Laboratoire de Pharmacologie Médicale et Clinique, INSERM U 1027 Equipe de PharmacoEpidémiologie, Faculté de Médecine Université de ToulouseToulouseFrance
  2. 2.Service de Pharmacologie Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de PharmacoEpidémiologie et d’Informations sur le Médicament Centre Hospitalier UniversitaireToulouseFrance
  3. 3.INSERM Centre d’Investigation Clinique CIC 9203ToulouseFrance
  4. 4.Service de Neurologie et Explorations Fonctionnelles du Système NerveuxCHU RangueilToulouseFrance
  5. 5.Department of NeurologyUniversity Hospital BordeauxBordeauxFrance
  6. 6.INSERM U862, Neurocentre MagendieBordeauxFrance
  7. 7.Department of Clinical Pharmacology, Faculty of MedicineUniversity of ToulouseToulouseFrance

Personalised recommendations