Skip to main content

Advertisement

SpringerLink
Log in

Early (≤1-h) vs. late (>1-h) administration of frovatriptan plus dexketoprofen combination vs. frovatriptan monotherapy in the acute treatment of migraine attacks with or without aura: a post hoc analysis of a double-blind, randomized, parallel group study

  • BRIEF COMMUNICATION
  • Published:
Neurological Sciences Aims and scope Submit manuscript

An Erratum to this article was published on 24 December 2015

Abstract

The early use of triptan in combination with a nonsteroidal anti-inflammatory drug after headache onset may improve the efficacy of acute migraine treatment. In this retrospective analysis of a randomized, double-blind, parallel group study, we assessed the efficacy of early or late intake of frovatriptan 2.5 mg + dexketoprofen 25 or 37.5 mg (FroDex 25 and FroDex 37.5) vs. frovatriptan 2.5 mg alone (Frova) in the acute treatment of migraine attacks. In this double-blind, randomized parallel group study 314 subjects with acute migraine with or without aura were randomly assigned to Frova, FroDex 25, or FroDex 37.5. Pain free (PF) at 2-h (primary endpoint), PF at 4-h and pain relief (PR) at 2 and 4-h, speed of onset at 60, 90, 120 and 240-min, and sustained pain free (SPF) at 24-h were compared across study groups according to early (≤1-h; n = 220) or late (>1-h; n = 59) intake. PF rates at 2 and 4-h were significantly larger with FroDex 37.5 vs. Frova (early intake, n = 71 FroDex 37.5 and n = 75 Frova: 49 vs. 32 % and 68 vs. 52 %, p < 0.05; late intake, n = 20 Frodex 37.5, and n = 18 Frova: 55 vs. 17 %, p < 0.05 and 85 vs. 28 %, p < 0.01). Also with FroDex 25, in the early intake group (n = 74) PF episodes were significantly higher than Frova. PR at 2 and 4-h was significantly better under FroDex 37.5 than Frova (95 % vs. 50 %, p < 0.001, 100 % vs. 72 %, p < 0.05) in the late intake group (n = 21). SPF episodes at 24-h after early dosing were 25 % (Frova), 45 % (FroDex 25) and 41 % (FroDex 37.5, p < 0.05 combinations vs. monotherapy), whereas they were not significantly different with late intake. All treatments were equally well tolerated. FroDex was similarly effective regardless of intake timing from headache onset.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

References

  1. Sarchielli P, Granella F, Prudenzano MP, Pini LA, Guidetti V, Bono G, Pinessi L, Alessandri M, Antonaci F, Fanciullacci M, Ferrari A, Guazzelli M, Nappi G, Sances G, Sandrini G, Savi L, Tassorelli C, Zanchin G (2012) Italian guidelines for primary headaches: 2012 revised version. J Headache Pain 13(Suppl. 2):S31–S70

    Article  PubMed  Google Scholar 

  2. Allais G, Rolando S, De Lorenzo C, Benedetto C (2014) The efficacy and tolerability of frovatriptan and dexketoprofen for the treatment of acute migraine attacks. Expert Rev Neurother 14:867–877

    Article  PubMed  CAS  Google Scholar 

  3. Evers S, Afra J, Frese A, Goadsby PJ, Linde M, May A, Sandor PS, European Federation of Neurological Societies (2009) EFNS guideline on the drug treatment of migraine–revised report of an EFNS task force. Eur J Neur 16:968–981

    Article  CAS  Google Scholar 

  4. Balbisi EA (2004) Frovatriptan succinate, a 5-HT1B/1D receptor agonist for migraine. Int J Clin Pract 58:695–705

    Article  PubMed  CAS  Google Scholar 

  5. Kelman L (2008) Review of frovatriptan in the treatment of migraine. Neuropsychiatr Dis Treat 4:49–54

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  6. Cortelli P, Allais G, Tullo V, Benedetto C, Zava D, Omboni S, Bussone G (2011) Frovatriptan vs. other triptans in the acute treatment of migraine: pooled analysis of three double-blind, randomized, cross-over, multicenter, Italian studies. Neurol Sci 32(Suppl. 1):S95–S98

    Article  PubMed  Google Scholar 

  7. Barbanoj MJ, Antonijoan RM, Gich I (2001) Clinical pharmacokinetics of dexketoprofen. Clin Pharmacokinet 40:245–262

    Article  PubMed  CAS  Google Scholar 

  8. Ng-Mak DS, Hu XH, Chen YT, Ma L (2008) Acute migraine treatment with oral triptans and NSAIDs in a managed care population. Headache 48:1176–1185

    Article  PubMed  Google Scholar 

  9. Blumenfeld A, Gennings C, Cady R (2012) Pharmacological synergy: the next frontier on therapeutic advancement for migraine. Headache 52:636–647

    Article  PubMed  Google Scholar 

  10. Tullo V, Valguarnera F, Barbanti P, Cortelli P, Sette G, Allais G, d’Onofrio F, Curone M, Zava D, Pezzola D, Benedetto C, Frediani F, Bussone G (2014) Comparison of frovatriptan plus dexketoprofen (25 or 37.5 mg) with frovatriptan alone in the treatment of migraine attacks with or without aura: a randomized study. Cephalalgia 34:434–445

    Article  PubMed  Google Scholar 

  11. D’Amico D, Moschiano F, Bussone G (2006) Early treatment of migraine attacks with triptans: a strategy to enhance outcomes and patient satisfaction? Expert Rev Neurother 6:1087–1097

    Article  PubMed  Google Scholar 

  12. Allais G, Tullo V, Cortelli P, Barbanti P, Valguarnera F, Sette G, D’Onofrio F, Curone M, Zava D, Pezzola D, Reggiardo G, Omboni S, Frediani F, Bussone G, Benedetto C (2014) Efficacy of early vs. late use of frovatriptan combined with dexketoprofen vs. frovatriptan alone in the acute treatment of migraine attacks with or without aura. Neurol Sci 35(Suppl. 1):107–113

    Article  PubMed  PubMed Central  Google Scholar 

  13. Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE (2009) Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache 49:687–696

    Article  PubMed  Google Scholar 

  14. Scholpp J, Schellenberg R, Moeckesch B, Banik N (2004) Early treatment of a migraine attack while pain is still mild increases the efficacy of sumatriptan. Cephalalgia 24:925–933

    Article  PubMed  CAS  Google Scholar 

  15. Landy S, Hoagland R, Hoagland NA (2012) Sumatriptan-naproxen migraine efficacy in allodynic patients: early intervention. Headache 52:133–139

    Article  PubMed  Google Scholar 

  16. Gendolla A (2008) Early treatment in migraine: how strong is the current evidence? Cephalalgia 28(Suppl. 2):28–35

    Article  PubMed  Google Scholar 

  17. Headache Classification Subcommittee of the International Headache Society (2004) The International Classification of Headache Disorders: 2nd edition. Cephalalgia 24(Suppl. 1):9–160

    Google Scholar 

  18. Silberstein SD (2000) Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 55:754–762

    Article  PubMed  CAS  Google Scholar 

  19. Worthington I, Pringsheim T, Gawel MJ, Gladstone J, Cooper P, Dilli E, Aube M, Leroux E, Becker WJ (2013) Canadian Headache Society Acute Migraine Treatment Guideline Development Group. Canadian Headache Society Guideline: acute drug therapy for migraine headache. Can J Neurol Sci 40(Suppl. 3):S1–S80

    Article  PubMed  Google Scholar 

  20. Lainez M (2004) Clinical benefits of early triptan therapy for migraine. Cephalalgia 24(Suppl. 2):24–30

    Article  PubMed  Google Scholar 

  21. Ferrari MD (2005) Should we advise patients to treat migraine attacks early: methodologic issues. Eur Neurol 53(Suppl. 1):17–21

    Article  PubMed  Google Scholar 

  22. Krymchantowski AV, Jevoux Cda C (2007) The experience of combining agents, specially triptans and non steroidal anti-inflammatory drugs, for the acute treatment of migraine—a review. Recent Pat CNS Drug Discov 2:141–144

    Article  PubMed  CAS  Google Scholar 

  23. Krymchantowski AV (2006) The use of combination therapies in the acute management of migraine. Neuropsychiatr Dis Treat 2:293–297

    Article  PubMed  CAS  PubMed Central  Google Scholar 

Download references

Acknowledgments

The present study was supported by Istituto Lusofarmaco d’Italia S.p.A.

Conflict of interest

All authors have occasionally served as scientific consultants for manufacturers of frovatriptan.

Author information

Authors and Affiliations

  1. Department of Surgical Sciences, Women’s Headache Center, University of Turin, Via Ventimiglia 3, 10126, Turin, Italy

    Gianni Allais & Chiara Benedetto

  2. Headache Center, Casa di Cura Igea, Milan, Italy

    Gennaro Bussone & Vincenzo Tullo

  3. Neurological Clinic, Department of Neurological Science, University of Bologna, Bologna, Italy

    Pietro Cortelli

  4. Sestri Ponente Hospital, Genoa, Italy

    Fabio Valguarnera

  5. Unit for Treatment and Research of Headache and Pain, IRCCS San Raffaele Pisana, Rome, Italy

    Piero Barbanti

  6. Sant’Andrea Hospital, Rome, Italy

    Giuliano Sette

  7. A.O. S.Carlo Borromeo, Milan, Italy

    Fabio Frediani & Giacomo D’Arrigo

  8. Neurologic Unit, San Giuseppe Moscati Hospital, Avellino, Italy

    Florindo d’Onofrio

  9. Headache Unit, Department of Neurology, San Raffaele Hospital, University Vita-Salute, Milan, Italy

    Giancarlo Comi & Bruno Colombo

  10. Department of Clinical Neuroscience, National Neurological Institute Carlo Besta, Milan, Italy

    Marcella Curone

  11. Clinical Research Unit, Italian Institute of Telemedicine, Varese, Italy

    Stefano Omboni

Authors
  1. Gianni Allais
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gennaro Bussone
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Vincenzo Tullo
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Pietro Cortelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Fabio Valguarnera
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Piero Barbanti
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Giuliano Sette
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Fabio Frediani
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Giacomo D’Arrigo
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Florindo d’Onofrio
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Giancarlo Comi
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Marcella Curone
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Bruno Colombo
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Stefano Omboni
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Chiara Benedetto
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Gianni Allais.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Allais, G., Bussone, G., Tullo, V. et al. Early (≤1-h) vs. late (>1-h) administration of frovatriptan plus dexketoprofen combination vs. frovatriptan monotherapy in the acute treatment of migraine attacks with or without aura: a post hoc analysis of a double-blind, randomized, parallel group study. Neurol Sci 36 (Suppl 1), 161–167 (2015). https://doi.org/10.1007/s10072-015-2165-6

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10072-015-2165-6

Keywords

Search

Navigation