Systematic evaluation of levodopa-carbidopa intestinal gel patient-responder characteristics

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Standaert, David GUniversity of Alabama (author)

Systematic evaluation of levodopa-carbidopa intestinal gel patient-responder characteristics

Article/chapterEnglish2018

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2018-01-24
Springer Science and Business Media LLC,2018

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LIBRIS-ID:oai:lup.lub.lu.se:43007ff1-fc8c-4300-8f19-1ef98a3db21b
https://lup.lub.lu.se/record/43007ff1-fc8c-4300-8f19-1ef98a3db21bURI
https://doi.org/10.1038/s41531-017-0040-2DOI

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Language:English
Summary in:English

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SwePubSwePub

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Subject category:art swepub-publicationtype
Subject category:ref swepub-contenttype

Notes

Levodopa-carbidopa intestinal gel (LCIG, carbidopa-levodopa enteral suspension in the United States) is a treatment option for advanced Parkinson's disease (PD) patients with motor fluctuations. The objective of this investigation was to identify the baseline characteristics predictive of treatment response, measured by improvement in motor symptom severity, in advanced PD patients treated with LCIG during a 54-week, open-label phase 3 study. Patients with ≥1 h improvement from baseline in "Off" time were categorized as "Responders"; whereas those with <1 h improvement, any worsening, or no post-baseline assessment were "Non-Responders". A subgroup of Responders with ≥3 h improvement in "Off" time was also examined; this subgroup was identified as "Robust Responders". Baseline demographics and disease characteristics were analyzed and their predictive relationship to change from baseline in normalized "Off" time was assessed. Out of the 324 patients included in the analysis, 272 (84.0%) were categorized as Responders and 52 (16.0%) were Non-Responders. A majority of patients (65.7%) had ≥3 h improvement in "Off" time. In general, baseline characteristics were similar between Non-responders, Responders, and the subgroup of Robust Responders. A conditional tree-structured regression analysis identified baseline "Off" time as the only factor that had significant effect on Responder and Robust Responder status. The safety profile of LCIG was similar between patient groups. Overall, this analysis showed that 84% of LCIG-treated advanced PD patients had ≥1 h improvement in "Off" time and the number-needed-to-treat to observe one patient responder was 1.19 patients. Notably, Responders and Robust Responders to LCIG were observed across the range of baseline demographics and clinical characteristics examined.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Neurologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Neurology hsv//eng

Added entries (persons, corporate bodies, meetings, titles ...)

Boyd, James TUniversity of Vermont (author)
Odin, PerLund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Restorative Parkinson Unit,Forskargrupper vid Lunds universitet,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University Research Groups(Swepub:lu)med-poi (author)
Robieson, Weining ZAbbVie Inc. (author)
Zamudio, JorgeAbbVie Inc. (author)
Chatamra, KraiAbbVie Inc. (author)
University of AlabamaUniversity of Vermont (creator_code:org_t)

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In:npj Parkinson's Disease: Springer Science and Business Media LLC4, s. 1-62373-8057

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