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Effectiveness of a piroxicam fast dissolving formulation sublingually administered in the symptomatic treatment of migraine without aura.

Abstract

In this study we evaluated the efficacy of a new preparation (Fast Dissolving Dosage Form--FDDF) of piroxicam (40 mg in a single sublingual dose) in the acute treatment of migraine. The study plan was of single blind type versus placebo and involved 40 patients with migraine without aura (according to the IHS Classification criteria) who had to take Piroxicam FDDF (or placebo) within 2 hours from the beginning of a migraine attack. Pain intensity and associated symptoms were evaluated in the basal condition and then monitored at serial intervals for 24 hours. In the group of patients treated with the active drug (n = 20), a significant reduction of pain intensity (Visual Analogue Scale) was observed after only 15 minutes (P = 0.0034). After an hour, headache has disappeared in 15 patients, become mild in 4 and remained unchanged in only one subject. Associated symptoms also quickly disappeared after Piroxicam FDDF administration and headache recurred in only two patients within the 24 hour period. Sublingual administration of Piroxicam FDDF was well tolerated: no systemic side-effects were reported and only two subjects complained about mouth dysesthesias which were described as mild and short-lasting. In conclusion, Piroxicam FDDF has been shown in this preliminary study to have striking efficacy in the acute treatment of migraine. The treatment is characterized by quick onset, long duration and good tolerability.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Dept. of Neurology, C. Mondino Foundation, University of Pavia, Italy.

    , , ,

    Source

    Headache 33:6 1993 Jun pg 296-300

    MeSH

    Administration, Sublingual
    Adolescent
    Adult
    Female
    Humans
    Male
    Middle Aged
    Migraine Disorders
    Piroxicam
    Single-Blind Method
    Time Factors

    Pub Type(s)

    Clinical Trial
    Controlled Clinical Trial
    Journal Article

    Language

    eng

    PubMed ID

    8349471

    Citation

    Nappi, G, et al. "Effectiveness of a Piroxicam Fast Dissolving Formulation Sublingually Administered in the Symptomatic Treatment of Migraine Without Aura." Headache, vol. 33, no. 6, 1993, pp. 296-300.
    Nappi G, Micieli G, Tassorelli C, et al. Effectiveness of a piroxicam fast dissolving formulation sublingually administered in the symptomatic treatment of migraine without aura. Headache. 1993;33(6):296-300.
    Nappi, G., Micieli, G., Tassorelli, C., Viotti, E., & Altavilla, T. (1993). Effectiveness of a piroxicam fast dissolving formulation sublingually administered in the symptomatic treatment of migraine without aura. Headache, 33(6), pp. 296-300.
    Nappi G, et al. Effectiveness of a Piroxicam Fast Dissolving Formulation Sublingually Administered in the Symptomatic Treatment of Migraine Without Aura. Headache. 1993;33(6):296-300. PubMed PMID: 8349471.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effectiveness of a piroxicam fast dissolving formulation sublingually administered in the symptomatic treatment of migraine without aura. AU - Nappi,G, AU - Micieli,G, AU - Tassorelli,C, AU - Viotti,E, AU - Altavilla,T, PY - 1993/6/1/pubmed PY - 1993/6/1/medline PY - 1993/6/1/entrez SP - 296 EP - 300 JF - Headache JO - Headache VL - 33 IS - 6 N2 - In this study we evaluated the efficacy of a new preparation (Fast Dissolving Dosage Form--FDDF) of piroxicam (40 mg in a single sublingual dose) in the acute treatment of migraine. The study plan was of single blind type versus placebo and involved 40 patients with migraine without aura (according to the IHS Classification criteria) who had to take Piroxicam FDDF (or placebo) within 2 hours from the beginning of a migraine attack. Pain intensity and associated symptoms were evaluated in the basal condition and then monitored at serial intervals for 24 hours. In the group of patients treated with the active drug (n = 20), a significant reduction of pain intensity (Visual Analogue Scale) was observed after only 15 minutes (P = 0.0034). After an hour, headache has disappeared in 15 patients, become mild in 4 and remained unchanged in only one subject. Associated symptoms also quickly disappeared after Piroxicam FDDF administration and headache recurred in only two patients within the 24 hour period. Sublingual administration of Piroxicam FDDF was well tolerated: no systemic side-effects were reported and only two subjects complained about mouth dysesthesias which were described as mild and short-lasting. In conclusion, Piroxicam FDDF has been shown in this preliminary study to have striking efficacy in the acute treatment of migraine. The treatment is characterized by quick onset, long duration and good tolerability. SN - 0017-8748 UR - https://www.unboundmedicine.com/medline/citation/8349471/full_citation L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0017-8748&date=1993&volume=33&issue=6&spage=296 DB - PRIME DP - Unbound Medicine ER -