Abstract
Previous studies indicated that addition of the antihistaminic chlorpheniramine to the usual combination of acetylsalicylic acid, acetaminophen, and caffeine further increases their synergism both in terms of anti-inflammatory and analgesic effect. The present non-interventional study tested the superiority of two Algopirin® tablets, containing a total of 250 mg acetylsalicylic acid (ASA), 150 mg acetaminophen (paracetamol, PAR), 30 mg caffeine (CAF) and 4 mg chlorpheniramine (CLF) vs. a combination containing 250 mg ASA, 250 mg PAR, and 65 mg CAF recognized as “safe and effective” by FDA in treating migraine. Patients evaluated their pain intensity on the Visual Analog Scale—VAS(PI) before and 30, 60, 120, 180, and 240 min after drug intake. Interpretation of the pain curves as “survival pain curves” was considered as a method for direct comparison of the pain curves. This interpretation permitted the application of the log rank test for comparison of pain hazards. The results of the applied parametric and non-parametric statistical tests indicated significant differences between the main endpoints: both Areas Under Pain Curves and time to decrease of the pain intensity to less than 50% of the initial value comparisons highlighted that Algopirin® was more efficient in spite of smaller doses of PAR and CAF. Comparison of “survival of pain” led to the same conclusion concerning the superiority of Algopririn. Consequently, the addition of CLF permitted decreasing of ASA, PAR, and CAF doses as well as their potential side effects, without a loss of analgesic effect.
Highlights
Migraine is a high prevalence primary headache form, associated with a high socio-economic burden
The study conformed with the Helsinki Declaration of 1964, as revised in 2013, and the protocol was approved by the “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania, Ethics Committee The study was conducted according to International Conference on Harmonization (ICH) Good Clinical Practices, to the Guidelines for Controlled Trials of Drugs in Migraine (Tfelt-Hansen et al, 2000) and to the Guidance on Clinical Investigation of Medicinal Products for the Treatment of Migraine (EMA., 2007)
In the Excedrin R cluster most of the pain curves are placed in the middle and lower region of the graph, whereas in the Algopirin R cluster the highest density of curves is in the lower part of the scale
Summary
Migraine is a high prevalence primary headache form, associated with a high socio-economic burden. About 41% use prescription medications, either alone or in combination with over-the-counter (OTC) drugs (Lipton and Silberstein, 2015). The OTC medication used for migraine treatment. Chlorpheniramine Analgesic Synergism with OTC Drugs includes single-ingredient formulations containing acetaminophen, acetylsalicylic acid or ibuprofen, as well as combinations containing no
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