Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials

Movement Disorders

Volumn 31, Issue 4, 2016, Pages 538-546

  Lang, Anthony E ^a   Rodriguez, Ramon L ^b   Boyd, James T ^c   Chouinard, Sylvain ^d   Zadikoff, Cindy ^e   Espay, Alberto J ^f   Slevin, John T ^g   Fernandez, Hubert H ^h   Lew, Mark F ⁱ   Stein, David A ^j   Odin, Per ^k   Fung, Victor S C ^l   Klostermann, Fabian ^m   Fasano, Alfonso ^a   Draganov, Peter V ^b   Schmulewitz, Nathan ^f   Robieson, Weining Z ⁿ   Eaton, Susan ⁿ   Chatamra, Krai ⁿ   Benesh, Janet A ⁿ   Dubow, Jordan ⁿ   more..

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^c UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

^d UNIVERSITÉ DE MONTRÉAL   (Canada)

^e NORTHWESTERN UNIVERSITY   (United States)

^f UNIVERSITY OF CINCINNATI ACADEMIC HEALTH CENTER   (United States)

^g UNIVERSITY OF KENTUCKY MEDICAL CENTER   (United States)

^h LERNER RESEARCH INSTITUTE   (United States)

ⁱ UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^j IQVIA   (United States)

^k LUND UNIVERSITY HOSPITAL   (Sweden)

^l UNIVERSITY OF SYDNEY   (Australia)

^m CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

ⁿ ABBVIE INC   (United States)

more..

Author keywords

Infusion; Levodopa carbidopa intestinal gel; Parkinson's disease; Percutaneous endoscopic gastrojejunostomy; Safety

Indexed keywords

CARBIDOPA PLUS LEVODOPA; ANTIPARKINSON AGENT; CARBIDOPA; CARBIDOPA, LEVODOPA DRUG COMBINATION; DRUG COMBINATION; GEL; LEVODOPA;

ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ABDOMINAL PAIN; ARTICLE; DEPRESSION; DEVICE SAFETY; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; FALLING; FEEDING APPARATUS; FLATULENCE; GEL; HUMAN; INCIDENCE; INSOMNIA; MEDICAL DEVICE COMPLICATION; MULTICENTER STUDY (TOPIC); NEURALGIA; PARKINSON DISEASE; PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WITH JEJUNAL EXTENSION; PERIPHERAL NEUROPATHY; PERITONITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMATOSIS INTESTINALIS; PNEUMONIA; PNEUMOPERITONEUM; PRIORITY JOURNAL; RISK ASSESSMENT; SIDE EFFECT; SMALL INTESTINE OBSTRUCTION; STOMACH TUBE; SUSPENSION; ADVERSE EFFECTS; AGED; DRUG COMBINATION; FEMALE; GASTRIC BYPASS SURGERY; MALE; MIDDLE AGED; OUTCOME ASSESSMENT; PARENTERAL DRUG ADMINISTRATION; PROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA;

AGED; ANTIPARKINSON AGENTS; CARBIDOPA; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG COMBINATIONS; FEMALE; GASTRIC BYPASS; GELS; HUMANS; INFUSIONS, PARENTERAL; LEVODOPA; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; OUTCOME ASSESSMENT (HEALTH CARE); PARKINSON DISEASE; PROSPECTIVE STUDIES;

EID: 84952342336     PISSN: 08853185     EISSN: 15318257     Source Type: Journal    
DOI: 10.1002/mds.26485     Document Type: Article

References (43)

1. Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord 2001;16(3):448-458.
2. Coelho M, Ferreira JJ. Late-stage Parkinson disease. Nat Rev Neurol 2012;8(8):435-442.
3. Contin M, Martinelli P. Pharmacokinetics of levodopa. J Neurol 2010;257(Suppl 2):S253-S261.
4. Nutt JG. Pharmacokinetics and pharmacodynamics of levodopa. Mov Disord 2008;23(Suppl 3):S580-S584.
5. Quinn NP. Classification of fluctuations in patients with Parkinson's disease. Neurology 1998;51(2 Suppl 2):S25-S29.
6. Terriff DL, Williams JV, Patten SB, Lavorato DH, Bulloch AG. Patterns of disability, care needs, and quality of life of people with Parkinson's disease in a general population sample. Parkinsonism Relat Disord 2012;18(7):828-832.
7. Nyholm D, Askmark H, Gomes-Trolin C, et al. Optimizing levodopa pharmacokinetics: intestinal infusion versus oral sustained-release tablets. Clin Neuropharmacol 2003;26(3):156-163.
8. Nyholm D, Odin P, Johansson A, et al. Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients. AAPS J 2013;15(2):316-323.
9. 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(2):141-149.
10. Fernandez HH, Standaert DG, Hauser RA, et al. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: Final 12-month, open-label results. Mov Disord 2015;30(4):500-509.
11. Slevin JT, Fernandez HH, Zadikoff C, et al. Long-Term Safety and Maintenance of Efficacy of Levodopa-Carbidopa Intestinal Gel: An Open-Label Extension of the Double-Blind Pivotal Study in Advanced Parkinson's Disease Patients. J Parkinsons Dis 2015;5(1):165-174.
12. Fernandez HH, Vanagunas A, Odin P, et al. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease open-label study: interim results. Parkinsonism Relat Disord 2013;19(3):339-345.
13. Organization MMaSS. Medical Dictionary for Regulatory Activities (MedDRA), Version 14.0 2011. Available at: https://meddramsso.com.
14. Guideline for Good Clinical Practice E6 (R1). USA: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 1996.
15. Activities MDfR. Standardised MedDRA Queries website. Available at: http://www.meddra.org/standardised-meddra-queries. Accessed May 2015.
16. Epstein M JDA, Hawes R, Schmulewitz N, et al. Gastrointestinal safety of the levodopa-carbidopa intestinal gel system in advanced Parkinson's patients. Mov Disord 2013;28(Suppl. 1):S144.
17. Antonini A, Yegin A, Preda C, et al. Global long-term study on motor and non-motor symptoms and safety of levodopa-carbidopa intestinal gel in routine care of advanced Parkinson's disease patients; 12-month interim outcomes. Parkinsonism Relat Disord 2015;21(3):231-235.
18. Rahnemai-Azar AA, Rahnemaiazar AA, Naghshizadian R, Kurtz A, Farkas DT. Percutaneous endoscopic gastrostomy: indications, technique, complications and management. World J Gastroenterol 2014;20(24):7739-7751.
19. Guttman M, Leger G, Cedarbaum JM, et al. 3-O-methyldopa administration does not alter fluorodopa transport into the brain. Ann Neurol 1992;31(6):638-643.
20. Johnell O, Melton LJ 3rd, Atkinson EJ, O'Fallon WM, Kurland LT. Fracture risk in patients with parkinsonism: a population-based study in Olmsted County, Minnesota. Age Ageing 1992;21(1):32-38.
21. Woodford H, Walker R. Emergency hospital admissions in idiopathic Parkinson's disease. Mov Disord 2005;20(9):1104-1108.
22. Pickering RM, Grimbergen YA, Rigney U, et al. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord 2007;22(13):1892-1900.
23. Lees A, Fahn S, Eggert KM, et al. Perampanel, an AMPA antagonist, found to have no benefit in reducing "off" time in Parkinson's disease. Mov Disord 2012;27(2):284-288.
24. Pahwa R, Lyons KE, Hauser RA, et al. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord 2014;20(2):142-148.
25. Pourcher E, Fernandez HH, Stacy M, Mori A, Ballerini R, Chaikin P. Istradefylline for Parkinson's disease patients experiencing motor fluctuations: results of the KW-6002-US-018 study. Parkinsonism Relat Disord 2012;18(2):178-184.
26. Stocchi F, Rascol O, Destee A, et al. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord 2013;28(13):1838-1846.
27. Garcia-Ruiz PJ, Martinez Castrillo JC, Alonso-Canovas A, et al. Impulse control disorder in patients with Parkinson's disease under dopamine agonist therapy: a multicentre study. J Neurol Neurosurg Psychiatry 2014;85(8):840-844.
28. Weintraub D, David AS, Evans AH, Grant JE, Stacy M. Clinical spectrum of impulse control disorders in Parkinson's disease. Mov Disord 2015;30(2):121-127.
29. Paus S, Brecht HM, Koster J, Seeger G, Klockgether T, Wullner U. Sleep attacks, daytime sleepiness, and dopamine agonists in Parkinson's disease. Mov Disord 2003;18(6):659-667.
30. Bulling MT, Wing LM, Burns RJ. Controlled release levodopa/carbidopa (Sinemet CR4) in Parkinson's disease--an open evaluation of efficacy and safety. Aust N Z J Med 1991;21(4):397-400.
31. Sinemet [package insert]. Kenilworth, NJ: Merck & Co; 2015.
32. Venu RP, Brown RD, Pastika BJ, Erikson LW Jr. The buried bumper syndrome: a simple management approach in two patients. Gastrointest Endosc 2002;56(4):582-584.
33. Blomberg J, Lagergren J, Martin L, Mattsson F, Lagergren P. Complications after percutaneous endoscopic gastrostomy in a prospective study. Scand J Gastroenterol 2012;47(6):737-742.
34. Kurien M, White S, Simpson G, Grant J, Sanders DS, McAlindon ME. Managing patients with gastrostomy tubes in the community: can a dedicated enteral feed dietetic service reduce hospital readmissions? Eur J Clin Nutr 2012;66(6):757-760.
35. Sheehan JJ, Hill AD, Fanning NP, et al. Percutaneous endoscopic gastrostomy: 5 years of clinical experience on 238 patients. Ir Med J 2003;96(9):265-267.
36. Itkin M, DeLegge MH, Fang JC, et al. Multidisciplinary practical guidelines for gastrointestinal access for enteral nutrition and decompression from the Society of Interventional Radiology and American Gastroenterological Association (AGA) Institute, with endorsement by Canadian Interventional Radiological Association (CIRA) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Gastroenterology 2011;141(2):742-765.
37. Zibetti M, Merola A, Artusi CA, et al. Levodopa/carbidopa intestinal gel infusion in advanced Parkinson's disease: a 7-year experience. Eur J Neurol 2014;21(2):312-318.
38. Devos D. Patient profile, indications, efficacy and safety of duodenal levodopa infusion in advanced Parkinson's disease. Mov Disord 2009;24(7):993-1000.
39. Nyholm D, Klangemo K, Johansson A. Levodopa/carbidopa intestinal gel infusion long-term therapy in advanced Parkinson's disease. Eur J Neurol 2012;19(8):1079-1085.
40. Di Rocco A, Molinari SP, Kollmeier B, Yahr MD. Parkinson's disease: progression and mortality in the L-DOPA era. Adv Neurol 1996;69:3-11.
41. Go AS, Mozaffarian D, Roger VL, et al. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013;127(1):143-152.
42. Kostic VS, Agosta F, Petrovic I, et al. Regional patterns of brain tissue loss associated with depression in Parkinson disease. Neurology 2010;75(10):857-863.
43. Nazem S, Siderowf AD, Duda JE, et al. Suicidal and death ideation in Parkinson's disease. Mov Disord 2008;23(11):1573-1579.