Prednisone & Acetaminophen both for Flu Like Symptoms
Prednisone, Acetaminophen Equally Effective in Controlling Flulike Symptoms Associated With Interferon-Beta Therapy
Prednisone or acetaminophen may significantly control flulike symptoms (FLSs) in patients with relapsing multiple sclerosis (MS) who are treated with interferon (IFN) beta-1a, according to a study presented here at the 19th Meeting of the European Neurological Society (ENS).
Regine Buffels, MD, Biogen Idec, Inc., Zug, Switzerland, presented the results of the phase 4 multicenter, randomised, open-label study (AIMS) in which the efficacy of acetaminophen and prednisone were compared in the management of FLSs during 3 months of treatment with intramuscular (IM) IFN beta-1a in patients with relapsing MS.
"The participants received once-weekly injections of IM IFN beta-1a and were randomised to either acetaminophen 650 mg orally 1 hour before and 4, 8, and 12 hours after injection or prednisone 10 mg orally 1 hour before and 4 and 8 hours after injection," Dr. Buffels explained on June 22.
In both treatment groups, patients could switch to the other medication if their FLSs were not adequately controlled by their assigned treatment.
For 12 weeks, patients recorded the occurrence, intensity, and duration of FLSs within 48 hours of receiving each injection.
Of the 304 enrolled patients, 272 took at least 1 dose of study medication, and 254 (prednisone, n = 127; acetaminophen, n = 127) completed at least 4 evaluable visits.
"Compliance with treatment was high," Dr. Buffels said.
In the 272 patients who took at least 1 dose of study drug, compliance with IFN beta-1a was 98.8%. Mean compliance with acetaminophen was 97.2% before and 96.9% after the injection. Mean compliance with prednisone was 98.0% before and 95.2% after the injection.
"Both treatments provide good control of FLSs," Dr. Buffels summarized.
The mean frequency for combined FLSs was 40% per patient for both groups (P = .725). All FLSs were rated mild.
Also, in terms of change of frequency, duration, or intensity of FLSs over 12 weeks, the 2 groups showed no difference, although a significant decrease in frequency of all FLSs was seen over the study period (P < .001).
For the entire cohort, the percentage of patients reporting at least 1 FLS significantly decreased (P < .001). Intensity and duration of each FLS also decreased significantly from week 1 to week 12.
The trial was the first to demonstrate a significant and rapid decrease in FLSs over the first 12 weeks of therapy with INF beta-1a plus prednisone or acetaminophen.
Funding for this study was provided by Biogen Idec, Inc.
[Presentation title: A Phase 4 Study of Acetaminophen and Prednisone in the Management of Flu-Like Symptoms in Patients With Relapsing Multiple Sclerosis Receiving Intramuscular Interferon Beta-1a. Abstract P352]
By Judith Moser, MD
MILAN, Italy -- June 24, 2009 --
: Presented at ENS