Comparison of frovatriptan plus dexketoprofen (25 mg or 37.5 mg) with          frovatriptan alone in the treatment of migraine attacks with or without aura: A randomized          study

Tullo, V.; Valguarnera, Fabio; Barbanti, Piero; Cortelli, Pietro; Sette, Giuliano; Allais, Gianni; d’Onofrio, Florindo; Curone, Marcella; Zava, Dario; Pezzola, D; Benedetto, Chiara; Frediani, Fabio; Bussone, Gennaro

doi:10.1177/0333102413515342

Cited by 26 publications

(31 citation statements)

References 30 publications

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“…This post hoc analysis of a previous randomized, doubleblind, dose comparison study [10] specifically evaluated the efficacy of frovatriptan plus dexketoprofen compared to frovatriptan alone, when administered within or after 1-h from headache onset. The combination was more effective than monotherapy on pain free at 2-h regardless of timing and dosing, confirming evidence from the main study [10] and from a previous post hoc analysis assessing the efficacy of the drug taken 30-min before or after pain onset [12].…”

Section: Discussionmentioning

confidence: 99%

“…As detailed in the main publication [10], the study enrolled 18-65 years old male and non-pregnant and non-breast feeding female subjects, suffering from migraine with or without aura [17] with at least one, but no more than six migraine attacks per month for 6 months prior to entering the study. In this post hoc analysis, we separately selected subjects who treated headache pain within 1-h of its earliest onset, or when headache pain was established (late use, [1-h).…”

Section: Study Population and Designmentioning

confidence: 99%

“…Each subject received the study medication and was instructed to self-administer the drug at home and complete the diary, for the first migraine attack occurring during the study period (i.e., within 1 month from randomization). Further details on the study protocol and methodology may be found in the original study publication [10].…”

Section: Study Population and Designmentioning

confidence: 99%

“…A randomized double-blind parallel group study evaluated the combination of frovatriptan and dexketoprofen (25 or 37.5 mg) over frovatriptan alone in the acute treatment of migraine. Both the combinations had an improved pain free activity at 2-h and ameliorated sustained pain free at 24-h compared to frovatriptan monotherapy [10]. The early use of triptan after headache onset is particularly recommended for patients with rapid pain onset and worsening, high frequency of recurrence and severe associated symptoms [11].…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2015

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Study Population and Designmentioning

confidence: 99%

Section: Study Population and Designmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

et al. 2015

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“…The elimination half-life of frovatriptan is fi ve times greater than that of other triptans, while the time to maximum concentration is similar to that of other triptans when given orally. 4 It has high affi nity to 5-HT 1B/1D receptors and moderate affi nity to 5-HT 7 receptors. It does not inhibit or induce cytochrome P450, associate to a low rate binding to plasma proteins, which in turn leads to a lower risk of drug interactions.…”

Section: Introductionmentioning

confidence: 99%

Effects of the Novel High-affinity 5-HT(1B/1D)-receptor Ligand Frovatriptan on the Rat Carotid Artery

et al. 2017

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Citation: Saracheva KE, Prissadova NA, Turiiski VI, Slavchev VI, Krastev AD, Getova DP. Effects of the novel high-affi nity 5-HT(1B/1D)-receptor ligand frovatriptan on the rat carotid artery.Folia Medica 2017;59(1): 31-36. doi: 10.1515/folmed-2017-0006 Background: In blood vessels 5-HT stimulates sympathetic nerves, the endothelium and vascular smooth muscle cells. Triptans are specifi c anti-migraine drugs and they activate the serotoninergic 5HT1b/d receptors causing vasoconstriction of the cerebral vessels. Aim: To evaluate the eff ect of frovatriptan on isolated rat carotid artery. Methods: Contractile activity of the preparations was registered isometrically. Krebs solution (pH = 7.4) was used for washing smooth muscle (SM) preparations aerated with 95% O 2 and 5% CO 2 at 37°C. The 60-minute adaptation of tone level of preparations was taken as a starting tone and the changes such as contraction or relaxation were calculated using it. Results: Frovatriptan (1×10 -6 mol/l -1×10 -5 mol/l) induced a contraction, but at higher concentrations it caused relaxation of the carotid artery. The L-norepinephrine contractile reaction was enhanced in the presence of frovatriptan. In the presence of 5-HT2 receptor antagonist, methysergide, frovatriptan increased the relaxation. In the presence of the specifi c α-1 receptor antagonist, prazosin, the frovatriptan-induced relaxation decreased. Conclusion:The observed contractile eff ect of frovatriptan is probably associated with the main eff ect of the drug -activation of the serotoninergic 5HT 1B /1D receptors causing vasoconstriction of the cerebral vessels and their anti-migraine eff ect. At higher concentrations, frovatriptan, most likely via some non-specifi c mechanism, could activate the following intracellular chain reaction: stimulation of α 1D could activate eNOS which may increase in the concentration of NO which results in the fi nal eff ect of relaxation. BACKGROUND

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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

et al. 2014

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Early triptan use after headache onset may help improve the efficacy of acute migraine treatment. This may be particularly the case when triptan therapy is combined with a nonsteroidal anti-inflammatory drug (NSAID). The objective of this is to assess whether the combination of frovatriptan 2.5 mg + dexketoprofen 25 or 37.5 mg (FroDex25 and FroDex37.5) is superior to frovatriptan 2.5 mg alone (Frova) in the acute treatment of migraine attacks in patients who took the drug within 30 min from the onset of pain (early use) or after (late use). A total of 314 subjects with a history of migraine with or without aura were randomized into a double-blind, multicenter, parallel group, pilot study to Frova, FroDex25 or FroDex37.5 and were required to treat at least one migraine attack. In the present post hoc analysis, traditional migraine endpoints were compared across study drugs for subgroups of the 279 patients of the full analysis set according to early (n = 172) or late (n = 107) drug use. The proportion of patients pain free at 2 h in the early drug use subgroup was 33 % with Frova, 50 % with FroDex25 and 51 % with FroDex37.5 mg (p = NS combinations vs. monotherapy), while in the late drug use subgroup was 22, 51 and 50 % (p < 0.05 FroDex25 and FroDex37.5 vs. Frova), respectively. Pain-free episodes at 4 h were 54 % for early and 34 % for late use of Frova, 71 and 57 % with FroDex25 and 74 and 68 % with FroDex37.5 (p < 0.05 for early and p < 0.01 for late use vs. Frova). The proportion of sustained pain free at 24 h was 26 % under Frova, 43 % under FroDex25 mg and 40 % under FroDex37.5 mg (p = NS FroDex25 or 37.5 vs. Frova) in the early drug intake subgroup, while it was 19 % under Frova, 43 % under FroDex25 mg and 45 % under FroDex37.5 mg (p < 0.05 FroDex25 and FroDex37.5 vs. Frova) in the late drug intake subgroup. Risk of relapse at 48 h was similar (p = NS) among study drug groups (Frova: 25 %, FroDex25: 21 %, and FroDex37.5: 37 %) for the early as well as for the late drug use subgroup (14, 42 and 32 %). FroDex was found to be more effective than Frova taken either early or late. The intrinsic pharmacokinetic properties of the two single drug components made FroDex combination particularly effective within the 2–48-h window from the onset of the acute migraine attack. The efficacy does not seem to be influenced by the time of drug use relative to the onset of headache.

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Comparison of frovatriptan plus dexketoprofen (25 mg or 37.5 mg) with frovatriptan alone in the treatment of migraine attacks with or without aura: A randomized study

Abstract: FroDex improved initial efficacy at two hours compared to Frova whilst maintaining efficacy at 48 hours in this study. Tolerability profiles were comparable. Intrinsic pharmacokinetic properties of the two single drugs contribute to this improved efficacy profile.

Cited by 26 publications

References 30 publications

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

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

Effects of the Novel High-affinity 5-HT(1B/1D)-receptor Ligand Frovatriptan on the Rat Carotid Artery

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

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