non-inFerioritY studY concerninG A new AnAlGesic FormulAtion versus An AcetYlsAlicYlic Acid, AcetAminoPHen And cAFFeine FiXed comBinAtion in PAtients witH HeAdAcHe

Headache, one of the most frequent conditions with negative impact on the patient quality of life, represents the reason for over-the-counter self-medication. The aim of this study was to determine the non-inferiority of one tablet of Algopirin, a new analgesic combination (patent RO120818/2006), versus one tablet of Excedrin (Novartis), fixed combination with acetylsalicylic acid, acetaminophen and caffeine for relieving headache. material and methods. There were included 46 patients diagnosed with headache, which treated two independent headache episodes with 1 tablet of Algopirin, respectively with 1 tablet of Excedrin, in a randomized order. There were recorded: date and time of headache, the time of drug administration, the pain severity using Visual Analogue Scale, before and 30, 60, 120, 180 and 240 min after drug intake, persistence of pain 2 h and 4 h after drug intake. results. Time to 50% pain relief in mean curves was 60 min for Algopirin and 45 min for Excedrin. Time to 80% pain relief was practically the same for both products (160 min). Comparisons of the two sets of the normalized mean pain intensity curves led to the conclusion that the equivalence hypothesis cannot be rejected. conclusions. The values of the differences and of the ratio between areas under curve of Algopirin and Excedrin suggest that administration of one tablet of Algopirin is equivalent to one tablet of Excedrin for the treatment of headache. It concerns a clinical point of view, the effect was installed somewhat more rapid in case of Excedrin but the extent was approximately similar. Since doses of active components in Algopirin tablets are half of the doses in Excedrin, Algopirin could be considered as an alternative at least in the case of patients with gastric and hepatic sensibility.