PMID- 22205275 OWN - NLM STAT- MEDLINE DCOM- 20120821 LR - 20211021 IS - 1432-1041 (Electronic) IS - 0031-6970 (Linking) VI - 68 IP - 5 DP - 2012 May TI - Do Parkinson's disease patients disclose their adverse events spontaneously? PG - 857-65 LID - 10.1007/s00228-011-1198-x [doi] AB - 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. FAU - Perez-Lloret, Santiago AU - Perez-Lloret S AD - Laboratoire de Pharmacologie Medicale et Clinique, INSERM U 1027 Equipe de PharmacoEpidemiologie, Faculte de Medecine, Universite de Toulouse, Toulouse, France. splloret@fleni.org.ar FAU - Rey, Maria Veronica AU - Rey MV FAU - Fabre, Nelly AU - Fabre N FAU - Ory, Fabienne AU - Ory F FAU - Spampinato, Umberto AU - Spampinato U FAU - Montastruc, Jean-Louis AU - Montastruc JL FAU - Rascol, Olivier AU - Rascol O LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20111229 PL - Germany TA - Eur J Clin Pharmacol JT - European journal of clinical pharmacology JID - 1256165 RN - 0 (Antiparkinson Agents) SB - IM MH - Aged MH - Antiparkinson Agents/*adverse effects/therapeutic use MH - Cross-Sectional Studies MH - *Disclosure MH - Drug Monitoring MH - Female MH - France MH - Hospitals, University MH - Humans MH - Interviews as Topic MH - Male MH - Outpatient Clinics, Hospital MH - Parkinson Disease/*drug therapy MH - Surveys and Questionnaires EDAT- 2011/12/30 06:00 MHDA- 2012/08/22 06:00 CRDT- 2011/12/30 06:00 PHST- 2011/09/14 00:00 [received] PHST- 2011/12/05 00:00 [accepted] PHST- 2011/12/30 06:00 [entrez] PHST- 2011/12/30 06:00 [pubmed] PHST- 2012/08/22 06:00 [medline] AID - 10.1007/s00228-011-1198-x [doi] PST - ppublish SO - Eur J Clin Pharmacol. 2012 May;68(5):857-65. doi: 10.1007/s00228-011-1198-x. Epub 2011 Dec 29.