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Dexketoprofen trometamol in the acute treatment of migraine attack: a phase II, randomized, double-blind, crossover, placebo-controlled, dose optimization study.
Mainardi, F, Maggioni, F, Pezzola, D, Zava, D, Zanchin, G
The journal of pain. 2014;(4):388-94
Abstract
UNLABELLED Migraine is a disabling disease that can significantly affect a person's quality of life. This study assessed the efficacy and tolerability of the 2 doses of dexketoprofen trometamol (DKP) compared to placebo for migraine treatment. Ninety-three patients with at least 1 migraine attack per month in the preceding 6 months were enrolled and randomized to 25 mg DKP, 50 mg DKP, and placebo in a randomized, double-blind, single-center, crossover, placebo-controlled study. Primary endpoint was pain-free episodes 2 hours after drug intake. The presence of accompanying symptoms and adverse effects was also recorded. Seventy-six patients (mean age 40.5 ± 10.9 and 61% female) completed the study. At baseline, mean number of attacks/month was 3.7 ± 1.3, with a mean duration of 15.4 ± 13.5 hours. Prevalence of pain-free episodes after drug intake was significantly reduced by 50 mg DKP vs placebo (33.8 vs 14.7%, P = .0065) whereas the dose of DKP 25 mg was better than placebo but did not reach statistical significance (23 vs 14.7%, P = .1182). Both 25 mg DKP (56.8 vs 25.3%, P = .0002) and 50 mg DKP improved headache relief compared to placebo. Furthermore, both doses of DKP increased the absence of functional disability (25 mg DKP, 39.7 vs 24%, P = .045; and 50 mg DKP, 45.9 vs 24%, P < .0004). Both doses of DKP were effective and well tolerated for acute migraine treatment. PERSPECTIVE This article demonstrates the efficacy and tolerability of DKP in the treatment of migraine without and with aura attacks. Its rapid absorption rate with higher maximum plasma concentrations and shorter time to maximum values suggest that this drug is a good option for acute migraine treatment.
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Effect of vitamin D therapy in addition to amitriptyline on migraine attacks in pediatric patients.
Cayir, A, Turan, MI, Tan, H
Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas. 2014;(4):349-54
Abstract
The purpose of this study was to investigate the effect of supplementary vitamin D therapy in addition to amitriptyline on the frequency of migraine attacks in pediatric migraine patients. Fifty-three children 8-16 years of age and diagnosed with migraine following the International Headache Society 2005 definition, which includes childhood criteria, were enrolled. Patients were classified into four groups on the basis of their 25-hydroxyvitamin D [25(OH)D] levels. Group 1 had normal 25(OH)D levels and received amitriptyline therapy alone; group 2 had normal 25(OH)D levels and received vitamin D supplementation (400 IU/day) plus amitriptyline; group 3 had mildly deficient 25(OH)D levels and received amitriptyline plus vitamin D (800 IU/day); and group 4 had severely deficient 25(OH)D levels and was given amitriptyline plus vitamin D (5000 IU/day). All groups were monitored for 6 months, and the number of migraine attacks before and during treatment was determined. Calcium, phosphorus alkaline phosphatase, parathormone, and 25(OH)D levels were also determined before and during treatment. Results were compared between the groups. Data obtained from the groups were analyzed using one-way analysis of variance. The number of pretreatment attacks in groups 1 to 4 was 7 ± 0.12, 6.8 ± 0.2, 7.3 ± 0.4, and 7.2 ± 0.3 for 6 months, respectively (all P > 0.05). The number of attacks during treatment was 3 ± 0.25, 1.76 ± 0.37 (P < 0.05), 2.14 ± 0.29 (P < 0.05), and 1.15 ± 0.15 (P < 0.05), respectively. No statistically significant differences in calcium, phosphorus, alkaline phosphatase, or parathormone levels were observed (P > 0.05). Vitamin D given in addition to anti-migraine treatment reduced the number of migraine attacks.
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[A comparative study of the effectiveness of topiramate and flunarizine in independent series of chronic migraine patients without medication abuse].
Gracia-Naya, M, Ríos, C, García-Gomara, MJ, Sánchez-Valiente, S, Mauri-Llerda, JÁ, Santos-Lasaosa, S, Artal-Roy, J, Latorre-Jiménez, AM
Revista de neurologia. 2013;(8):347-53
Abstract
INTRODUCTION Topiramate and onabotulinumtoxin A have proven to be effective in chronic migraine with or without medication abuse according to recent criteria of the International Headache Society's Headache Classification. AIMS To show that flunarizine is as effective as topiramate in cases of chronic migraine without medication abuse. PATIENTS AND METHODS We conducted a prospective, non-randomised, comparative study of two groups of patients paired by age and sex, with chronic migraine without abuse, who had been treated preventively for the first time with topiramate or flunarizine. RESULTS Forty patients treated with flunarizine were assigned a patient of their same sex and age who was being treated with topiramate. The mean rate of reduction in intense migraines in the topiramate group was 59% and in the flunarizine group, 58.5% (p = 0.9444); the responder rate at four months of treatment did not show any significant differences either, the figures being 75% for topiramate and 70% for flunarizine (p = 0.6236). The mean reduction of other headaches in the topiramate group was 57% and in the flunarizine group, 64% (p = 0.4261); the responder rate at four months of treatment was similar in the two groups: 76%. The percentage of dropouts from treatment was higher with topiramate (19.5%) than with flunarizine (10%) (p = 0.3493). No serious side effects occurred in either of the groups. In all, 78.9% of the patients who took topiramate said they were satisfied with the drug versus 75% of those in the flunarizine group (p = 0.7903). CONCLUSIONS Flunarizine proved to be as effective as topiramate in the treatment of chronic migraine without medication abuse.
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Gingkolide B as migraine preventive treatment in young age: results at 1-year follow-up.
Usai, S, Grazzi, L, Bussone, G
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2011;(Suppl 1):S197-9
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Abstract
Primary headaches, migraine and tension-type headaches are some of the most frequent conditions in young age. Even before pharmacological treatment, it is mainly useful in these patients to adopt an appropriate lifestyle, with regular sleep, meals, computer and TV, sport, and avoiding triggers. Any specific and effective pharmacological treatment for migraine and tension-type headache is never lacking in side effects. Gingkolide B, an herbal constituent extract from Ginko biloba tree leaves, is a natural anti platelet activating factor (PAF). PAF is a potent pro inflammatory and nociceptive agent released during the inflammation process. Therefore, Gingkolide B can be considered a promising non pharmacological tool for treatment of migraine with and without aura. In an earlier clinical report, we described our initial attempts to assess the clinical utility of Gingkolide B in a small group of young migraine patients. A small sample of 30 young patients suffering from migraine without aura entered the open-label prospective trial. Migraine without aura was diagnosed according to International Headache Society (IHS) criteria. The treatment was well tolerated and the compliance was good. Despite the uncontrolled open-label design of this study and the small sample of patients, these data show that Gingkolide B seems to be effective as preventive treatment in reducing migraine attack frequency and in attenuating the use of symptomatic medication in our small series of children with primary headache.
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Naproxen sodium decreases migraine recurrence when administered with sumatriptan.
Krymchantowski, AV
Arquivos de neuro-psiquiatria. 2000;(2B):428-30
Abstract
Forty to 78% of the patients using sumatriptan for the acute treatment of migraine may present recurrence at least occasionally. The concomitant use of a NSAID (nonsteroidal anti-inflammatory drug) has been recommended to decrease the recurrence rate. Sixty seven patients that treated successfully 8 migraine attacks with 100 mg of sumatritpan PO and presented recurrence in at least 5 attacks were studied prospectively. The patients received 100 mg of sumatriptan and 550 mg of naproxen sodium PO to treat 4 consecutive moderate or severe migraine attacks. The recurrence rate, once at least 62.5% (5 out of 8 attacks), decreased to 14.2% (38 out of 268 attacks) with the combination of compounds (p<0.0001). We then studied two groups of 13 patients made randomicaly from the 67 initially evaluated, that were given sumatriptan 100 mg plus naproxen sodium 550 mg or placebo, in a double-blind design, to treat 3 other consecutive migraine attacks. Each group of patients treated 39 attacks. The recurrence among the patients taking sumatriptan plus placebo was 59% (23 out of 39 attacks) and the recurrence presented by the group taking sumatriptan plus naproxen was 25.5% (10 out of 39 attacks) (p<0.0003). We concluded that the combination of sumatriptan plus naproxen sodium decreases significantly migraine recurrence presented by patients taking sumatriptan alone.