- Email: [email protected]
Gastrointestinal safety of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients: GLORIA long-term registry interim results
Abstracts / Parkinsonism and Related Disorders 22 (2016) e16ee20
activities of daily living. More research, including anchor-based MID calculations, is encouraged to facilitate use of MID in interpreting PRO data in clinical trials. Reference: 1. Olanow CW, Kieburtz K, Odin P, et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol 2014;13:141e114. OP 2.50.20. GASTROINTESTINAL SAFETY OF LEVODOPA-CARBIDOPA INTESTINAL GEL IN ADVANCED PARKINSON'S DISEASE PATIENTS: GLORIA LONGTERM REGISTRY INTERIM RESULTS Dirk Domagk 1, Sanne Dam-Larsen 2, Angelo Antonini 3, Lars Bergmann 4, Ashley Yegin 4, Werner Poewe 5. 1 University of Münster, Münster, Germany; 2 KØge Hospital, KØge, Denmark; 3 Institute of Neurology, IRCCS, Venice, Italy; 4 AbbVie Inc., North Chicago, United States; 5 Medical University of Innsbruck, Innsbruck, Austria Objectives: To assess gastrointestinal (GI) safety of the levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) treatment system in advanced Parkinson’s disease patients from the GLORIA study. Methods: In this ongoing 24-month, observational study (N ¼ 374), patients underwent 2 weeks LCIG dose titration via nasojejunal tube, followed by infusion via PEG-J for 24 months. Months 1-6 (M1-6) safety data as of a January 2014 interim analysis was summarized from patients who had 1 infusion of LCIG (n ¼ 343). Gastrointestinal adverse drug reactions (ADRs) reported by the investigator were categorized post hoc by the authors as either procedure-related, device-related, or “other” type of GI reaction. Results: At interim, 266/343 patients (78%) completed 6 months of LCIG treatment post-PEG-J placement. M1-6 post-PEG-J placement, 70(20%) patients reported 1 ADR, mostly commonly device-related (11%) (Table 1). Incidence of the most frequently reported M1-6 ADRs and serious ADRs (Table 1) decreased dramatically after the first weeks. During M1-6, 4(1.2%) discontinued due to any ADR: 1 due to procedure-related ADR, 2 due to device-related ADR, and 1 due to “other” GI ADR. Seventeen deaths
occurred during the overall study period. Conclusions: Consistent with the GI-related safety profile in previous studies, most GI-related ADRs occurred within the first week of LCIG infusion post-PEG-J placement with a relatively low incidence afterward, supportive of the overall tolerability of LCIG. OP 2.50.22. COMPARISON OF THE ANTIPARKINSONIAN AND ANTIDYSKINETIC EFFECTS OF HEMANTANE AND AMANTADINE Elena Ivanova, Inga Kapitsa, Elena Valdman, Tatyana Voronina. Laboratory of Psychopharmacology, Zakusov Institute of Pharmacology, Moscow, Russian Federation Objectives: Antiparkinsonian drug hemantane is an uncompetitive, low affinity NMDA receptor open-channel blocker. Its closest analog is an antiparkinsonian and antidyskinetic drug amantadine. The aim of this study is to compare antiparkinsonian and antidyskinetic effects of hemantane and amantadine. Methods: Male outbred rats were given injections of 6-hydroxydopamine (6-OHDA) into the left medial forebrain bundle 12mg/4ml to induce
Ă
Table 1 Gastrointestinal Adverse Drug Reactions Over the First Six Months of LCIG Treatment Post-PEG-J Placement Weeks Number of Patients Out of 343a Any ADR Any Serious ADR ADRs occurring in 5 patients Any Procedure-related Postoperative wound infection Any Device-related Device related infection Device dislocation Device lead issue Any Other Type of GI Event Weight decreased Abdominal pain Serious ADRs occurring in 2 patients Any Procedure-related Pneumoperitoneum Postoperative wound infection Procedural complication Any Device-related Device dislocation Any Other Type of GI Event Abdominal pain
Months
1e2 43 17
3e4 6 3
2 7 3
3 11 4
4 14 2
5 5 1
6 5 0
1e6b 70 27
14 3 17 10 2 2 17 5 6
1 0 4 0 2 1 1 1 0
0 0 4 0 3 0 3 2 0
1 0 8 0 3 0 2 0 0
3 2 5 0 0 0 7 5 0
1 0 2 0 0 1 2 0 1
1 1 3 1 0 1 1 0 0
18 5 39 11 9 5 31 13 7
9 3 2 2 4 1 6 2
0 0 0 0 3 2 0 0
0 0 0 0 2 2 1 0
0 0 0 0 3 2 1 0
0 0 0 0 1 0 1 0
0 0 0 0 0 0 1 1
0 0 0 0 0 0 0 0
9 3 2 2 12 6 10 3
e19
a 266 patients (78%) completed at least 6 months of LCIG treatment post-PEG-J placement. b Incidence of initial event during months 1-6, therefore this column is not a sum of the other columns.
Ă
activities of daily living. More research, including anchor-based MID calculations, is encouraged to facilitate use of MID in interpreting PRO data in clinical trials. Reference: 1. Olanow CW, Kieburtz K, Odin P, et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol 2014;13:141e114. OP 2.50.20. GASTROINTESTINAL SAFETY OF LEVODOPA-CARBIDOPA INTESTINAL GEL IN ADVANCED PARKINSON'S DISEASE PATIENTS: GLORIA LONGTERM REGISTRY INTERIM RESULTS Dirk Domagk 1, Sanne Dam-Larsen 2, Angelo Antonini 3, Lars Bergmann 4, Ashley Yegin 4, Werner Poewe 5. 1 University of Münster, Münster, Germany; 2 KØge Hospital, KØge, Denmark; 3 Institute of Neurology, IRCCS, Venice, Italy; 4 AbbVie Inc., North Chicago, United States; 5 Medical University of Innsbruck, Innsbruck, Austria Objectives: To assess gastrointestinal (GI) safety of the levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) treatment system in advanced Parkinson’s disease patients from the GLORIA study. Methods: In this ongoing 24-month, observational study (N ¼ 374), patients underwent 2 weeks LCIG dose titration via nasojejunal tube, followed by infusion via PEG-J for 24 months. Months 1-6 (M1-6) safety data as of a January 2014 interim analysis was summarized from patients who had 1 infusion of LCIG (n ¼ 343). Gastrointestinal adverse drug reactions (ADRs) reported by the investigator were categorized post hoc by the authors as either procedure-related, device-related, or “other” type of GI reaction. Results: At interim, 266/343 patients (78%) completed 6 months of LCIG treatment post-PEG-J placement. M1-6 post-PEG-J placement, 70(20%) patients reported 1 ADR, mostly commonly device-related (11%) (Table 1). Incidence of the most frequently reported M1-6 ADRs and serious ADRs (Table 1) decreased dramatically after the first weeks. During M1-6, 4(1.2%) discontinued due to any ADR: 1 due to procedure-related ADR, 2 due to device-related ADR, and 1 due to “other” GI ADR. Seventeen deaths
occurred during the overall study period. Conclusions: Consistent with the GI-related safety profile in previous studies, most GI-related ADRs occurred within the first week of LCIG infusion post-PEG-J placement with a relatively low incidence afterward, supportive of the overall tolerability of LCIG. OP 2.50.22. COMPARISON OF THE ANTIPARKINSONIAN AND ANTIDYSKINETIC EFFECTS OF HEMANTANE AND AMANTADINE Elena Ivanova, Inga Kapitsa, Elena Valdman, Tatyana Voronina. Laboratory of Psychopharmacology, Zakusov Institute of Pharmacology, Moscow, Russian Federation Objectives: Antiparkinsonian drug hemantane is an uncompetitive, low affinity NMDA receptor open-channel blocker. Its closest analog is an antiparkinsonian and antidyskinetic drug amantadine. The aim of this study is to compare antiparkinsonian and antidyskinetic effects of hemantane and amantadine. Methods: Male outbred rats were given injections of 6-hydroxydopamine (6-OHDA) into the left medial forebrain bundle 12mg/4ml to induce
Ă
Table 1 Gastrointestinal Adverse Drug Reactions Over the First Six Months of LCIG Treatment Post-PEG-J Placement Weeks Number of Patients Out of 343a Any ADR Any Serious ADR ADRs occurring in 5 patients Any Procedure-related Postoperative wound infection Any Device-related Device related infection Device dislocation Device lead issue Any Other Type of GI Event Weight decreased Abdominal pain Serious ADRs occurring in 2 patients Any Procedure-related Pneumoperitoneum Postoperative wound infection Procedural complication Any Device-related Device dislocation Any Other Type of GI Event Abdominal pain
Months
1e2 43 17
3e4 6 3
2 7 3
3 11 4
4 14 2
5 5 1
6 5 0
1e6b 70 27
14 3 17 10 2 2 17 5 6
1 0 4 0 2 1 1 1 0
0 0 4 0 3 0 3 2 0
1 0 8 0 3 0 2 0 0
3 2 5 0 0 0 7 5 0
1 0 2 0 0 1 2 0 1
1 1 3 1 0 1 1 0 0
18 5 39 11 9 5 31 13 7
9 3 2 2 4 1 6 2
0 0 0 0 3 2 0 0
0 0 0 0 2 2 1 0
0 0 0 0 3 2 1 0
0 0 0 0 1 0 1 0
0 0 0 0 0 0 1 1
0 0 0 0 0 0 0 0
9 3 2 2 12 6 10 3
e19
a 266 patients (78%) completed at least 6 months of LCIG treatment post-PEG-J placement. b Incidence of initial event during months 1-6, therefore this column is not a sum of the other columns.
Ă