Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson's disease

被引:11
作者
Valldeoriola, Francesc [1 ]
Jose Catalan, Maria [2 ]
Escamilla-Sevilla, Francisco [3 ]
Freire, Eric [4 ]
Olivares, Jesus [5 ]
Cubo, Esther [6 ]
Santos Garcia, Diego [7 ]
Calopa, Matilde [8 ]
Martinez-Martin, Pablo [9 ,10 ]
Carlos Parra, Juan [11 ]
Arroyo, Gloria [11 ]
Matias Arbelo, Jose [12 ]
机构
[1] Clin Hosp, Neurol Serv, Movement Disorders Unit, 170 Villarroel St, Barcelona 08036, Spain
[2] Clin San Carlos Hosp, Neurol Serv, Prof Martin Lagos St, Madrid 28040, Spain
[3] Virgen de las Nieves Univ Hosp, Biohlth Invest Inst, Movement Disorders Unit, Neurol Serv,Ibs, Granada, Spain
[4] Elche Univ Gen Hosp, Neurol Serv, 11 Camino Almazara St, Alicante 03203, Spain
[5] Torrecardenas Hosp Ctr, Neurol Serv, Hermandad de Donantes de Sangre St, Almeria 04009, Spain
[6] Burgos Univ Hosp, Neurol Serv, 3 Islas Baleares Av, Burgos 09006, Spain
[7] A Coruna Univ Hosp Ctr CHUAC, Dept Neurol, La Coruna, Spain
[8] Bellvitge Univ Hosp, Neurol Serv, Feixa Llarga St, Barcelona 08907, Spain
[9] Carlos III Inst Hlth, Natl Ctr Epidemiol, 5 Monforte de Lemos Av, Madrid 28029, Spain
[10] Carlos III Inst Hlth, Ctr Networked Biomed Res Neurodegenerat Dis CIBER, 5 Monforte de Lemos Av, Madrid 28029, Spain
[11] AbbVie Spain, SLU, 91 De Burgos Av, Madrid 28050, Spain
[12] Insular Gran Canaria Univ Hosp Maritima, Neurol Serv, Maritima Sur Av, Las Palmas Gran Canaria 35016, Spain
关键词
QUALITY-OF-LIFE; DEEP-BRAIN-STIMULATION; NONMOTOR SYMPTOMS; INTRAJEJUNAL LEVODOPA; INFUSION IMPROVES; DOUBLE-BLIND; IMPACT; DEPRESSION; MOTOR; VALIDATION;
D O I
10.1038/s41531-021-00246-y
中图分类号
Q189 [神经科学];
学科分类号
071006 ;
摘要
Levodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson's Disease (APD) patients QoL. Secondarily, the impact on motor symptoms and NMS, emotional well-being, treatment satisfaction, and caregiver QoL, stress, disease burden, anxiety, depression, and work impairment were also investigated. In this prospective, 6-month multicenter postmarketing observational study, LCIG was administered to 59 patients with APD. Endpoints were assessed using validated scales and questionnaires. LOG significantly improved patient QoL (PDQ-39 mean change +/- standard deviation from baseline, -12.8 +/- 14.6; P < 0.0001), motor symptoms (UPDRS-III in "On," -6.5 +/- 11.8; P = 0.0002), NMS (NMSS, -35.7 +/- 31.1; P < 0.0001), mood (Norris/Bond-Lader VAS, -6.6 +/- 21.1; P = 0.0297), fatigue (PFS-16, -0.6 +/- 1.0; P = 0.0003), depression (BDI-II, -5.1 +/- 9.4; P = 0.0002), anxiety (BAI, -6.2 +/- 9.6; P < 0.0001), and patient treatment satisfaction (SATMED-Q, 16.1 +/- 16.8; P < 0.0001). There were significant correlations between the change from baseline to 6 months between PDQ-39 and UPDRS-IV, NMSS, BA', BDI-II, AS, and PFS-16 scores, and Norris/Bond-Lader alertness/sedation factor. Caregiver anxiety also improved (Goldberg anxiety scale, -1.1 +/- 1.0; P = 0.0234), but the clinical relevance of this finding is questionable. The serious adverse events reported were similar to those previously described for LCIG. In patients with APD, LOG improves QoL, motor symptoms and NMS, emotional well-being, and satisfaction with the treatment. Improvement in patient QoL is associated with improvements in motor complications, NMS, anxiety, depression, apathy and fatigue. Improvements in patients' QoL does not correspond with improvements in caregivers' QoL or burden.
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页数:9
相关论文
共 79 条
[11]   USE OF ANALOG SCALES IN RATING SUBJECTIVE FEELINGS [J].
BOND, A ;
LADER, M .
BRITISH JOURNAL OF MEDICAL PSYCHOLOGY, 1974, 47 (SEP) :211-218
[12]   The Parkinson fatigue scale [J].
Brown, RG ;
Dittner, A ;
Findley, L ;
Wessely, SC .
PARKINSONISM & RELATED DISORDERS, 2005, 11 (01) :49-55
[13]   Long-term levodopa/carbidopa intestinal gel in advanced Parkinson's disease [J].
Caceres-Redondo, Maria T. ;
Carrillo, Fatima ;
Lama, Maria J. ;
Huertas-Fernandez, Ismael ;
Vargas-Gonzalez, Laura ;
Carballo, Manuel ;
Mir, Pablo .
JOURNAL OF NEUROLOGY, 2014, 261 (03) :561-569
[14]   Intraduodenal levodopa-carbidopa intestinal gel infusion improves both motor performance and quality of life in advanced Parkinson's disease [J].
Chang, Florence C. F. ;
Kwan, Vu ;
van der Poorten, David ;
Mahant, Neil ;
Wolfe, Nigel ;
Ha, Ainhi D. ;
Griffith, Jane M. ;
Tsui, David ;
Kim, Samuel D. ;
Fung, Victor S. C. .
JOURNAL OF CLINICAL NEUROSCIENCE, 2016, 25 :41-45
[15]   Impact of the motor complications of Parkinson's disease on the quality of life [J].
Chapuis, S ;
Ouchchane, L ;
Metz, O ;
Gerbaud, L ;
Durif, F .
MOVEMENT DISORDERS, 2005, 20 (02) :224-230
[16]   Assessment of Duodopa® effects on quality of life of patients with advanced Parkinson's disease and their caregivers [J].
Ciurleo, Rosella ;
Corallo, Francesco ;
Bonanno, Lilla ;
Lo Buono, Viviana ;
Di Lorenzo, Giuseppe ;
Versaci, Roberta ;
Allone, Cettina ;
Palmeri, Rosanna ;
Bramanti, Placido ;
Marino, Silvia .
JOURNAL OF NEUROLOGY, 2018, 265 (09) :2005-2014
[17]   Deep brain stimulation for patients with Parkinson's disease: Effect on caregiver burden [J].
Crespo-Burillo, J. A. ;
Rivero-Celada, D. ;
Saenz-de Cabezon, A. ;
Casado-Pellejero, J. ;
Alberdi-Vinas, J. ;
Alarcia-Alejos, R. .
NEUROLOGIA, 2018, 33 (03) :154-159
[18]   Subthalamic Stimulation Improves Quality of Life of Patients Aged 61 Years or Older With Short Duration of Parkinson's Disease [J].
Dafsari, Haidar Salimi ;
Reker, Paul ;
Silverdale, Monty ;
Reddy, Prashanth ;
Pilleri, Manuela ;
Martinez-Martin, Pablo ;
Rizos, Alexandra ;
Perrier, Estelle ;
Weiss, Luisa ;
Ashkan, Keyoumars ;
Samuel, Michael ;
Evans, Julian ;
Visser-Vandewalle, Veerle ;
Antonini, Angelo ;
Ray-Chaudhuri, Kallol ;
Timmermann, Lars .
NEUROMODULATION, 2018, 21 (06) :532-540
[19]   Long-term safety and effectiveness of levodopa-carbidopa intestinal gel infusion [J].
De Fabregues, Oriol ;
Dot, Joan ;
Abu-Suboh, Monder ;
Hernandez-Vara, Jorge ;
Ferre, Alex ;
Romero, Odile ;
Ibarria, Marta ;
Luis Seoane, Jose ;
Raguer, Nuria ;
Puiggros, Carolina ;
Rosa Gomez, Maria ;
Quintana, Manuel ;
Ramon Armengol, Josep ;
Alvarez-Sabin, Jose .
BRAIN AND BEHAVIOR, 2017, 7 (08)
[20]   A randomized trial of deep-brain stimulation for Parkinson's disease [J].
Deuschl, Guenther ;
Schade-Brittinger, Carmen ;
Krack, Paul ;
Volkmann, Jens ;
Schaefer, Helmut ;
Boetzel, Kai ;
Daniels, Christine ;
Deutschlaender, Angela ;
Dillmann, Ulrich ;
Eisner, Wilhelm ;
Gruber, Doreen ;
Hamel, Wolfgang ;
Herzog, Jan ;
Hilker, Ruediger ;
Klebe, Stephan ;
Kloss, Manja ;
Koy, Jan ;
Krause, Martin ;
Kupsch, Andreas ;
Lorenz, Delia ;
Lorenzl, Stefan ;
Mehdorn, H. Maximilian ;
Moringlane, Jean Richard ;
Oertel, Wolfgang ;
Pinsker, Marcus O. ;
Reichmann, Heinz ;
Reuss, Alexander ;
Schneider, Gerd-Helge ;
Schnitzler, Alfons ;
Steude, Ulrich ;
Sturm, Volker ;
Timmermann, Lars ;
Tronnier, Volker ;
Trottenberg, Thomas ;
Wojtecki, Lars ;
Wolf, Elisabeth ;
Poewe, Werner ;
Voges, Juergen .
NEW ENGLAND JOURNAL OF MEDICINE, 2006, 355 (09) :896-908