The efficacy and tolerability of a fixed combination of acetylsalicylic acid,
paracetamol, and caffeine in patients with severe headache: a post-hoc subgroup
analysis from a multicentre, randomized, double-blind, single-dose,
placebo-controlled parallel group study.
Author(s): Diener HC, Peil H, Aicher B.
Affiliation(s): University Duisburg-Essen, Germany. hans.diener@uni-duisburg-essen.de
Publication date & source: 2011, Cephalalgia. , 31(14):1466-76
BACKGROUND: We investigated efficacy and tolerability of two tablets of the fixed
combination of 250 mg acetylsalicylic acid (ASA) + 200 mg paracetamol + 50 mg
caffeine (Thomapyrin) in comparison to two tablets of placebo in a post-hoc
analysis of a subgroup of patients with severe headache.
METHODS: Patients where included if they were used to treating their episodic
tension-type headache or migraine attacks with non-prescription analgesics and
reported a history of headache attacks characterized by at least severe pain and
greatly impaired usual daily activities and treated headaches with pain intensity
of at least 48 mm assessed on a 100-mm visual analogue scale and associated with
greatly impaired usual daily activities.
RESULTS: For the primary endpoint 'time to 50% pain relief' in this
intention-to-treat subset (n = 179 patients), the fixed combination of ASA,
paracetamol, and caffeine was statistically significantly superior to placebo (p
= 0.0008). The superior efficacy of the triple combination could also be shown
for all secondary endpoints such as time until reduction of pain intensity to 10
mm, weighted sum of pain intensity difference (%SPIDweighted), extent of
impairment of daily activities, and global assessment of efficacy. Both
treatments were well tolerated. The incidence of adverse events observed was low.
The results for this subgroup analysis are consistent with respect to all
endpoints and to the patients with non-severe headache and the overall patient
population. As with all post-hoc subgroup analyses, the findings are hypothesis
generating only and must be interpreted with caution.
DISCUSSION: The results of this subgroup analysis confirm that the fixed
combination of ASA (250 mg), paracetamol (200 mg), and caffeine (50 mg) is
effective and well tolerated in a broad spectrum from mild to severe migraine and
tension-type headache severity independently of the headache diagnosis.
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