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Acute Levodopa challenge for Diagnostic and Therapeutic purposes in elderly patients with Newly diagnosed Parkinsonian Syndrome
Poster Presentations
B. Pozuelo Moyano; J. Horvath; and F. Herrmann Hôpitaux Universitaires de Genève, Switzerland Background: Clinical response to acute levodopa challenge can predict the efficacy of this drug in the long-term treatment of Parkinson disease (PD). Furthermore, a good response supports the diagnosis of idiopathic PD. However, in elderly patients who usually suffer from many comorbidities, side effects of a single levodopa dose may limit the tolerance and usability of this test. Objective: 1. To assess the feasibility of acute levodopa challenge in elderly patients with newly diagnosed parkinsonian syndrome in a university hospital setting. 2. To assess the predictive value of acute levodopa test for the efficacy of chronic dopaminergic treatment. 3. To correlate the result of acute levodopa test with the dopamine transporter uptake ratio quantified by a DaTSCAN. Methods: Candidates for the study will be selected via neurological consultation, performed by a movement disorders specialist, among patients hospitalized in geriatric wards. Unstable cardiovascular or mental condition, severe infection or ongoing dopaminergic or dopamine receptor blocking treatment will constitute exclusion criteria. MDS-UPDRS 3 subscale (with video recording) will be performed for the assessment of parkinsonian motor signs before («time 1») and 1 hour after acute levodopa administration («time 2») as well on stable chronic levodopa therapy at 2 months («time 3»). The first acute levodopa dose will be calculated by the body weight and the chronic therapeutic dose will be titrated individually and progressively according to efficacy and tolerance to achieve the best clinical response. Cognitive state (Mini Mental State and Neecham Scale) and arterial blood pressure in lying and standing position (Schellong test) will be assessed at baseline and Neecham Scale and Schellong test at each evaluation time. Any other adverse effect will be searched and noted (nausea, dizziness, vomiting etc.) DaTSCAN will be performed during the hospital stay and striatal uptake of radioligand quantified. Statistical analyses will consist in computing Poisson 95% confidence intervals for the incidence of side effects predicting efficacy using logistic and linear regression models and the association with DaTSCAN with Pearson correlation coefficient.
Learning by doing in the student-run Pharmacovigilance Program T. Schutte1,2; J. Tichelaar1,2; M.O. Reumerman1; R. van Eekeren3,4; L. Rolfes3,4; M.C. Richir1,2; E. van Puijenbroek3,4; and M.A. van Agtmael1,2 1 VU University Medical Center, Amsterdam, the Netherlands; 2 RECIPE (Research & Expertise Center In Pharmacotherapy Education), Amsterdam, the Netherlands; 3The Netherlands Pharmacovigilance Centre Lareb (Lareb); and 4University of Groningen, Groningen, The Netherlands Background: Medication safety is an important topic in healthcare nowadays. Pharmacovigilance, the monitoring of drug safety after approval for marketing, depends mainly on the quality and quantity of reported adverse drug reactions (ADR). To increase pharmacovigilance awareness among medical students, we developed and evaluated a Student-run Pharmacovigilance program, together with pharmacovigilance centre Lareb. Method: A pilot study was performed in which teams of (1st-4th year) medical students assessed real ADR-reports from patients/ healthcare professionals reported to Lareb. After assessment on causality, students searched for a pharmacological explanation and wrote
August 2015
a feedback letter to the reporter and a summary for the pharmacovigilance-databases of the European Medicines Agency and WHO. This student-assessment was then verified by Lareb staff, who evaluated student-handling it in an e-questionnaire. Results: From May to December 2014, 89 different ADR-reports selected by Lareb staff were handled, with the top 3 reported ADRs being; palpitations, urinary retention and agitation. Thirty-five students and 3 Lareb staff members participated. Lareb staff rated the student assessments (very) useful (> 92%), scientifically substantiated (> 88%), complete (not lacking information) and without inaccuracies (both > 92%). Altogether the student-assessments were rated mean 8.3 (1–10; min-max). Compared to self-handling, Lareb staff indicated student-assessment cost less time in 33% assessments, neutral in 55%, and cost extra time in 11%. Conclusion: The Student-run pharmacovigilance program is a win-win venture. It offers students a valuable “pharmacovigilance experience”, creates awareness in future doctors with the potential to increase ADR-reporting, and didn’t cost Lareb staff extra time overall. The learner effects need to be investigated in future studies.
In search of the suspicious link: Smokeless Tobacco use and oral Mucositis in Head and Neck Cancer Patients S. Begum1; and S. Mukhopadhyay2 1 RG Kar Medical College, Kolkata, India; and 2Christian Medical College, Ludhiana, India Introduction: Smoking of tobacco is implicated as one of the major risk factors for development of oral mucositis (OM). Tobacco in other smokeless forms is a major form of addiction in many countries. However, the association of smokeless tobacco with oral mucositis has hardly studied. The present study aims at finding the association, if any, with different types of tobacco use with OM. Materials and Methods: In this cross-sectional study, head and neck cancer patients receiving radiation, chemotherapy or concurrent chemo-radiation who developed oral mucositis over a study period of three months were enrolled. History of different forms of tobacco use, alcohol, oral hygiene and other risk factors were noted along with other demographic variables and analyzed. Results: Out of total 20 enrolled patients of OM, data of 18 consenting patients were analyzed. Smokeless tobacco addiction in any form was found in 59% patients (n = 10) compared to 16.7% patients (n = 3) who had no history of tobacco addiction (P = 0.01). Similar numbers of smokers were detected to have OM. Poor dental hygiene was noted in 72% patients. Prevalence of Oral mucositis and different addictions 25
Number of patients
Acute Levodopa challenge for Diagnostic and Therapeutic purposes in elderly patients with Newly diagnosed Parkinsonian Syndrome
20
18
15 10
10
10 6
5
7
3
0 Total patient Smoker Smokeless t No tobacco Smoking + Alcohol Smokeless t Addiction types and total patients
Similar numbers of smokers were detected to have OM. Poor dental hygiene were noted in 72% patients. Conclusions: Smokeless tobacco, like its smoking counterpart, was found to being associated significantly with oral mucositis among the head neck cancer patients receiving radiation or chemotherapy.
e79
B. Pozuelo Moyano; J. Horvath; and F. Herrmann Hôpitaux Universitaires de Genève, Switzerland Background: Clinical response to acute levodopa challenge can predict the efficacy of this drug in the long-term treatment of Parkinson disease (PD). Furthermore, a good response supports the diagnosis of idiopathic PD. However, in elderly patients who usually suffer from many comorbidities, side effects of a single levodopa dose may limit the tolerance and usability of this test. Objective: 1. To assess the feasibility of acute levodopa challenge in elderly patients with newly diagnosed parkinsonian syndrome in a university hospital setting. 2. To assess the predictive value of acute levodopa test for the efficacy of chronic dopaminergic treatment. 3. To correlate the result of acute levodopa test with the dopamine transporter uptake ratio quantified by a DaTSCAN. Methods: Candidates for the study will be selected via neurological consultation, performed by a movement disorders specialist, among patients hospitalized in geriatric wards. Unstable cardiovascular or mental condition, severe infection or ongoing dopaminergic or dopamine receptor blocking treatment will constitute exclusion criteria. MDS-UPDRS 3 subscale (with video recording) will be performed for the assessment of parkinsonian motor signs before («time 1») and 1 hour after acute levodopa administration («time 2») as well on stable chronic levodopa therapy at 2 months («time 3»). The first acute levodopa dose will be calculated by the body weight and the chronic therapeutic dose will be titrated individually and progressively according to efficacy and tolerance to achieve the best clinical response. Cognitive state (Mini Mental State and Neecham Scale) and arterial blood pressure in lying and standing position (Schellong test) will be assessed at baseline and Neecham Scale and Schellong test at each evaluation time. Any other adverse effect will be searched and noted (nausea, dizziness, vomiting etc.) DaTSCAN will be performed during the hospital stay and striatal uptake of radioligand quantified. Statistical analyses will consist in computing Poisson 95% confidence intervals for the incidence of side effects predicting efficacy using logistic and linear regression models and the association with DaTSCAN with Pearson correlation coefficient.
Learning by doing in the student-run Pharmacovigilance Program T. Schutte1,2; J. Tichelaar1,2; M.O. Reumerman1; R. van Eekeren3,4; L. Rolfes3,4; M.C. Richir1,2; E. van Puijenbroek3,4; and M.A. van Agtmael1,2 1 VU University Medical Center, Amsterdam, the Netherlands; 2 RECIPE (Research & Expertise Center In Pharmacotherapy Education), Amsterdam, the Netherlands; 3The Netherlands Pharmacovigilance Centre Lareb (Lareb); and 4University of Groningen, Groningen, The Netherlands Background: Medication safety is an important topic in healthcare nowadays. Pharmacovigilance, the monitoring of drug safety after approval for marketing, depends mainly on the quality and quantity of reported adverse drug reactions (ADR). To increase pharmacovigilance awareness among medical students, we developed and evaluated a Student-run Pharmacovigilance program, together with pharmacovigilance centre Lareb. Method: A pilot study was performed in which teams of (1st-4th year) medical students assessed real ADR-reports from patients/ healthcare professionals reported to Lareb. After assessment on causality, students searched for a pharmacological explanation and wrote
August 2015
a feedback letter to the reporter and a summary for the pharmacovigilance-databases of the European Medicines Agency and WHO. This student-assessment was then verified by Lareb staff, who evaluated student-handling it in an e-questionnaire. Results: From May to December 2014, 89 different ADR-reports selected by Lareb staff were handled, with the top 3 reported ADRs being; palpitations, urinary retention and agitation. Thirty-five students and 3 Lareb staff members participated. Lareb staff rated the student assessments (very) useful (> 92%), scientifically substantiated (> 88%), complete (not lacking information) and without inaccuracies (both > 92%). Altogether the student-assessments were rated mean 8.3 (1–10; min-max). Compared to self-handling, Lareb staff indicated student-assessment cost less time in 33% assessments, neutral in 55%, and cost extra time in 11%. Conclusion: The Student-run pharmacovigilance program is a win-win venture. It offers students a valuable “pharmacovigilance experience”, creates awareness in future doctors with the potential to increase ADR-reporting, and didn’t cost Lareb staff extra time overall. The learner effects need to be investigated in future studies.
In search of the suspicious link: Smokeless Tobacco use and oral Mucositis in Head and Neck Cancer Patients S. Begum1; and S. Mukhopadhyay2 1 RG Kar Medical College, Kolkata, India; and 2Christian Medical College, Ludhiana, India Introduction: Smoking of tobacco is implicated as one of the major risk factors for development of oral mucositis (OM). Tobacco in other smokeless forms is a major form of addiction in many countries. However, the association of smokeless tobacco with oral mucositis has hardly studied. The present study aims at finding the association, if any, with different types of tobacco use with OM. Materials and Methods: In this cross-sectional study, head and neck cancer patients receiving radiation, chemotherapy or concurrent chemo-radiation who developed oral mucositis over a study period of three months were enrolled. History of different forms of tobacco use, alcohol, oral hygiene and other risk factors were noted along with other demographic variables and analyzed. Results: Out of total 20 enrolled patients of OM, data of 18 consenting patients were analyzed. Smokeless tobacco addiction in any form was found in 59% patients (n = 10) compared to 16.7% patients (n = 3) who had no history of tobacco addiction (P = 0.01). Similar numbers of smokers were detected to have OM. Poor dental hygiene was noted in 72% patients. Prevalence of Oral mucositis and different addictions 25
Number of patients
Acute Levodopa challenge for Diagnostic and Therapeutic purposes in elderly patients with Newly diagnosed Parkinsonian Syndrome
20
18
15 10
10
10 6
5
7
3
0 Total patient Smoker Smokeless t No tobacco Smoking + Alcohol Smokeless t Addiction types and total patients
Similar numbers of smokers were detected to have OM. Poor dental hygiene were noted in 72% patients. Conclusions: Smokeless tobacco, like its smoking counterpart, was found to being associated significantly with oral mucositis among the head neck cancer patients receiving radiation or chemotherapy.
e79