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Nervenheilkunde 2005; 24(07): 626-639
DOI: 10.1055/s-0038-1629992
Originaler Artikel
Schattauer GmbH

Dreierkombination (Thomapyrin®) ist wirksamer bei Kopfschmerzen als Monosubstanzen und Zweierkombination

Ergebnisse einer randomisierten, doppelblinden, Plazebo-kontrollierten, klinischen Multizenterstudie im ParallelgruppendesignTriple combination (Thomapyrin®) is more efficient for the treatment of headache than mono substances and dual combination
H. C. Diener
1   Neurologische Klinik, Universitätsklinikum Essen
,
V. Pfaffenrath
2   Neurologische Praxis, München
,
L. Pageler
1   Neurologische Klinik, Universitätsklinikum Essen
,
H. Peil
3   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
,
B. Aicher
3   Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
› Author Affiliations
Further Information

Publication History

Publication Date:
25 January 2018 (online)

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Zusammenfassung

Die Wirksamkeit, Sicherheit und Verträglichkeit einer Einzelgabe von zwei Tabletten der fixen Dreierkombination mit 250 mg Azetylsalizylsäure (ASS) plus 200 mg Paracetamol plus 50 mg Koffein (Thomapyrin®) gegenüber zwei Tabletten mit 500 mg ASS, oder zwei Tabletten mit 500 mg Paracetamol, oder zwei Tabletten mit 50 mg Koffein beziehungsweise Plazebo wurde in einer klinischen Studie an 1 743 Patienten geprüft, die ihre episodischen Kopfschmerzen vom Spannungstyp oder ihre Migräne mit und ohne Aura üblicherweise erfolgreich mit verschreibungsfreien Analgetika behandeln. Die Dreierkombination war im a priori definierten primären Endpunkt “Zeit bis zu 50% Schmerzreduktion” sowohl der Zweierkombination aus ASS plus Paracetamol (p = 0,0181), als auch den Monoanalgetika ASS (p = 0,0398) und Paracetamol (p = 0,0016), sowie auch der Monotherapie mit Koffein (p < 0,0001) und Plazebo (p < 0,0001) überlegen. Alle Behandlungen außer der Koffein-Monotherapie waren der Plazebobehandlung überlegen (p < 0,0001). Die überlegene Wirksamkeit der Dreierkombination gilt auch für alle sekundären Endpunkte wie beispielsweise der “Verringerung der Kopfschmerzen auf 10 mm VAS (visual analog scale = visuelle Analogskala zur Schmerzmessung), dem gewichteten % SPID (sum of pain intensity difference = aufsummierte Schmerzintensitätsdifferenz gegenüber dem Ausgangsschmerz in Prozent), dem Ausmaß der Beeinträchtigung der alltäglichen Aktivitäten und der globalen Beurteilung der Wirksamkeit durch die Patienten. Alle Behandlungen waren gut verträglich, die Inzidenz von unerwünschten Begleiterscheinungen war gering.

Summary

We investigated efficacy, safety, and tolerability of two tablets of the fixed combination of 250 mg acetylsalicylic acid (ASA) plus 200 mg paracetamol plus 50 mg caffeine (Thomapyrin ®) in comparison to two tablets of 250 mg ASA plus 200 mg paracetamol, two tablets of 500 mg ASA, two tablets of 500 mg paracetamol, two tablets of 50 mg caffeine, and placebo in patients who are used to treat their episodic tension-type headache or migraine attacks with non-prescription analgesics. For the primary endpoint “time to 50% pain relief“ in the ITT data set (n = 1 743 patients), the fixed combination of acetylsalicylic acid, paracetamol and caffeine was statistically significantly superior to the combination without caffeine (p = 0,0181), the mono substances ASA (p = 0,0398), paracetamol (p = 0,0016), caffeine (p < 0,0001) and placebo (p < 0,0001). All active treatments except caffeine differed significantly (p < 0,0001) from placebo. The superior efficacy of the triple combination could also be shown for all secondary endpoints like time until reduction of pain intensity to 10 mm, weighted Sum of Pain Intensity Difference (% SPID weighted), extent of impairment of daily activities, global assessment of efficacy. All treatments were well tolerated. The incidence of adverse events observed was low.

Schlüsselwörter

Kopfschmerz - Migräne - episodische Kopfschmerzen vom Spannungstyp - Kombinationsanalgetika - Azetylsalizylsäure - Paracetamol - Koffein

Key words

Headache - combination analgesics - acetylsalicylic acid - paracetamol - caffeine
 

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