ESTREL-Fatigue-association of levodopa with post-stroke fatigue.
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Boos Lukas, Kaufmann Josefin E, Sauter Mirjam I, Lyrer Philippe, Zietz Annaelle, Trüssel Simon, Engelter Sophia V, Luft Andreas R, Polymeris Alexandros, Altersberger Valerian L, Wiesner Karin, Held Jeremia P O, Rottenberger Yannik, Schwarz Anne, Medlin Friedrich, Accolla Ettore A, Foucras Sandrine, Kägi Georg, De Marchis Gian Marco, Politz Svetlana, Greulich Matthias, Tarnutzer Alexander A, Sturzenegger Rolf, Katan Mira, Fischer Urs, Nedeltchev Krassen, Schär Janine, Deglon Katrien Van Den Keybus, Rapin Pierre-André, Salerno Alexander, Seiffge David, Auer Elias, Lippert Julian, Bonati Leo H, Schuster-Amft Corina, Gäumann Szabina, Chabwine Joelle N, Humm Andrea M, Möller Jens Carsten, Schweinfurther Raoul, Bujan Bartosz, Jedrysiak Piotr, Sandor Peter S, Gonzenbach Roman, Veit Mylius, Lutz Dietmar, Lienert Carmen, Peters Nils, Strambo Davide, Müri René M, Schädelin Sabine, Hemkens Lars G, Ford Gary A, Kuppuswamy Anna, Lerdal Anners, Simpson Dawn B, English Coralie, Blackwell Stewart, Gensicke Henrik, Traenka Christopher, Engelter Stefan T
Аннотация
PATIENTS AND METHODS: Enhancement of Stroke Rehabilitation with Levodopa (ESTREL)-Fatigue was an exploratory analysis of secondary outcome data obtained in the multicentre, randomised, placebo-controlled ESTREL trial. Participants with acute stroke received levodopa 100 mg/carbidopa 25 mg or placebo 3 times daily for 39 days to enhance motor recovery. Participants who (i) reported fatigue at 5 weeks and who (ii) took at least 80% of the study medication were included in ESTREL-Fatigue. No adjustments for confounding were made. The primary endpoint was the presence of PSF at 5 weeks, defined as a T-score of ≥ 55 on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short-form-4a. As secondary endpoints, T-score cutoffs of ≥ 60 (moderate fatigue) and ≥ 70 (severe fatigue) were used. Binary logistic regression was used to compare PSF at 5 weeks between treatment groups. Results are presented as odds ratios (ORs) with 95% CI.
RESULTS: A total of 456 of 505 (90.3%) participants were included (levodopa/placebo 235/221, median age 73 years, 41% female). Post-stroke fatigue at 5 weeks was present in 63/235 (26.8%) levodopa-treated participants and in 65/221 (29.4%) placebo-treated participants (OR: 0.88; 95% CI, 0.58-1.32; risk ratio 0.91; risk difference - 2.6%). For cutoffs of ≥ 60 and ≥ 70, ORs were 0.78 (95% CI, 0.43-1.41) and 0.8 (95% CI, 0.25-2.44), respectively. A sensitivity analysis as per intention-to-treat with all 610 randomised ESTREL participants also showed no significant difference in fatigue presence between levodopa and placebo groups (OR: 0.95; 95% CI, 0.65-1.39) and a sensitivity analysis using a mixed-effects logistic regression showed no evidence of centre-related clustering.
CONCLUSION: In ESTREL-Fatigue, levodopa, compared to placebo, was not associated with less PSF during in-hospital rehabilitation.