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Guideline [Recommendations guide for the treatment of migraine in the clinical practice] 2007
Láinez JM, Castillo J, González VM, Otero M, Mateos V, Leira R, Pascual J, Anonymous00353. · Grupo de Estudio de Cefaleas de la Sociedad Española de Neurología. · Rev Clin Esp. · Pubmed #17475183 No free full text.
Abstract: Migraine is the most frequent neurological reason for consultation. The differences regarding health care system, type of professional seeing these patients and therapeutic armamentarium available in the different countries are important, which makes it very recommendable to have an action guide that reflects the local clinical practice. Following the year 2005 WHO recommendations in its "Global Campaign" against migraine, the coordinators of the Headache Study Groups of the Spanish Society of Neurology, the Spanish Society of Family and Community Medicine, the Spanish Society of Rural and General Medicine, the Spanish Society of General Medicine and the Global Campaign decided to jointly make this guide. To do so, they made a search in MEDLINE, using the terms "migraine", "migraine treatment" and "headache guidelines" and "migraine guidelines". The most relevant articles were analyzed, including the references that we considered to be of interest. Furthermore, we reviewed the most important textbooks on headache and migraine. In this paper, we detail the recommendations agreed on, according to the evidence grade, on symptomatic and preventive treatment of migraine.
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Review Marketed oral triptans in the acute treatment of migraine: a systematic review on efficacy and tolerability. 2007
Pascual J, Mateos V, Roig C, Sanchez-Del-Rio M, Jiménez D. · University Hospital--Neurology, Salamanca, Spain. · Headache. · Pubmed #17883520 No free full text.
Abstract: BACKGROUND: In the current literature, there is neither a reported systematic review comparing the efficacy of triptans at 30 minutes and 1 hour after the migraine treatment, nor data related to efficacy of new marketed triptans. OBJECTIVE: The main objective of this analysis was to compare the efficacy and tolerability of currently marketed oral, non-reencapsulated triptan formulations vs placebo in the treatment of moderate-to-severe migraine attacks. METHODS: A systematic review of double-blind, randomized clinical trials reporting data after a single migraine attack was conducted. Efficacy results are shown using relative risk ratios with 95% confidence intervals. A sensitivity analysis was also conducted. RESULTS: After reviewing 221 publications, 38 studies were included. All marketed triptans provided significant relief and/or absence of pain at 2 hours, and relief at 1 hour when compared with placebo. After 30 minutes, fast-dissolving sumatriptan 50 and 100 mg, sumatriptan 50 mg, and rizatriptan 10 mg showed significant relief when compared to placebo, whereas the fast-dissolving formulation of sumatriptan 100 mg was the only oral triptan that was superior to placebo in meeting the pain-free endpoint. On the other hand, fast-dissolving sumatriptan 50 and 100 mg and eletriptan 40 mg showed a lower rate of recurrence than placebo, whereas rizatriptan 10 mg was the only triptan with a recurrence rate greater than that of placebo. Adverse events associated with treatment with tablet formulations of sumatriptan and zolmitriptan were significantly more frequent than those of the placebo group. The inclusion of trials with reencapsulated triptans in the analysis introduced minor specific changes in these results. CONCLUSION: This analysis updates the comparative data available for the 7 currently marketed oral triptans and clearly demonstrates their efficacy when compared to placebo, even with stricter endpoints, such as efficacy at 30 minutes. No triptan exhibited better tolerability than placebo. Results are diverse, depending on the triptan, which probably is a reflection of heterogeneous pharmacokinetics.
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Clinical Conference Preventing disturbing migraine aura with lamotrigine: an open study. 2004
Pascual J, Caminero AB, Mateos V, Roig C, Leira R, García-Moncó C, Laínez MJ. · University Hospital M. de Valdecilla, Neurology, Santander, Cantabria, Spain. · Headache. · Pubmed #15546267 No free full text.
Abstract: BACKGROUND: Lamotrigine has been suggested as possibly effective for preventing migraine aura. OBJECTIVE: To describe our experience with a series of patients with disturbing migraine aura treated with lamotrigine. METHODS: The members of the Headache Group of the Spanish Society of Neurology were sent an ad hoc questionnaire to collect patients treated with lamotrigine due to disturbing migraine aura. The main outcome parameter ("response") was a >50% reduction in the mean frequency of migraine auras at 3 to 6 months of treatment. RESULTS: A total of 47 patients had been treated with lamotrigine due to severe migraine aura. Three could not complete the protocol as a result of developing skin rashes. Thirty (68%) patients responded. These were 21 females and 9 males whose ages ranged from 19 to 71 years. Eight suffered from migraine with "prolonged" aura, 8 typical aura with migraine headache (but had frequent episodes including speech symptoms), 6 basilar-type migraine, 6 typical aura without headache, and 2 hemiplegic migraine. Fifteen had been previously treated, without response, with other preventatives. The mean monthly frequency of migraine auras in these 30 patients changed from 4.2 (range: 1 to 15) to 0.7 (range: 0 to 6). Response was considered as excellent (>75% reduction) in 21 cases (70% of responders). Auras reappeared in 2 months in 9 out of 13 patients where lamotrigine was stopped, and ceased as soon as this drug was reintroduced. CONCLUSIONS: Lamotrigine should be considered in clinical practice for the preventive treatment of selected patients with disturbing migraine auras. Lamotrigine seems worthy of a controlled trial as prophylaxis of migraine aura.
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Clinical Conference Topiramate for patients with refractory migraine: an observational, multicenter study in Spain. free! 2003
Pascual J, Sánchez del Rio M, Mateos V, Láinez JM, Hernández-Gallego J, Leira R, Jiménez MD. · University Hospital Marqués de Valdecilla (UC), Santander. · Neurologia. · Pubmed #14505244 links to free full text
Abstract: INTRODUCTION: The efficacy of current preventive migraine treatments is limited. In addition, tolerability problems are not infrequent. OBJECTIVES: To check our experience with topiramate in the treatment of patients with refractory migraine. PATIENTS AND METHODS: We offered treatment with topiramate to patients with the diagnosis of International Headache Society (IHS) migraine who had not responded to or tolerated beta-blockers, amitriptyline, flunarizine and/or valproate. This series is made up of 115 patients (88 women), between 16 and 81 years. Most of them (n=79) fulfilled the Silberstein et al. criteria for transformed migraine. The parameters analyzed were "response" (reduction in migraine frequency>50%), excellent response (>75%) and tolerability. RESULTS: After 3 months, the maintenance doses of topiramate ranged from 25 to 400 mg, though most patients took 100 mg. Twenty-four (21%) patients withdrew due to adverse events, mostly cognitive difficulties, that had already occurred with doses as low as 25-50 mg, while 26 (23%) found topiramate ineffective. The remaining 65 (56%) patients responded, 34 with excellent response. Sixteen patients (10 obese) lost weight (3-13 kg). CONCLUSIONS: Topiramate seems to be a good therapeutic option for about half of the patients with refractory migraine. In these patients response is usually excellent. Intolerance due to adverse events appears in one-fifth of the cases early and at low doses.
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Clinical Conference [Satisfaction and recovery of normal activity with rizatriptan 10 mg. Results from the open, prospective, observational 4M study] free! 2002
Mateos V, Roig C, López Rodríguez I, López-Gil A. · Servicio de Neurología II,Hospital General de Asturias, Oviedo, Spain. · Neurologia. · Pubmed #12487957 links to free full text
Abstract: BACKGROUND: To evaluate the impact of the treatment with rizatriptan 10 mg (Maxalt) on the return to normal activity and satisfaction with treatment in the general population with migraine. PATIENTS AND METHOD: We conducted an open, prospective study in patients with migraine (International Headache Society [IHS] criteria) who were followed for up to 3 migraine attacks. We measured the degree of functional disability at 0 and 2 hours after treatment, and satisfaction at 24 hours. Other domains of satisfaction were evaluated after three migraine attacks. The relationship between baseline pain severity, satisfaction after 24 hours and functional disability was analyzed. RESULTS: 2,469 patients were enrolled who experienced 6,323 migraine attacks. A return to normal activity was achieved two hours after treatment in 67% of all attacks treated with rizatriptan 10 mg. The percentage of attacks causing severe functional disability decreased from 39% before therapy to 3.6% two hours after treatment. In more than 90% of moderate or severe attacks, a normal or slightly impaired functional capacity was restored two hours after treatment. In 76.3% of the attacks the patients were fully or very satisfied 24 hours after treatment with rizatriptan 10 mg. After treating three migraine attacks, the proportion of patients fully or very satisfied with rizatriptan was over 79% for all the domains explored. CONCLUSIONS: The patients were highly satisfied after 24 hours and following three migraine attacks treated with rizatriptan 10 mg. In more than two-thirds of the attacks treated with rizatriptan 10 mg, the patients returned to normal activity two hours after treatment.
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Clinical Conference Crossover comparison of efficacy and preference for rizatriptan 10 mg versus ergotamine/caffeine in migraine. 2003
Christie S, Göbel H, Mateos V, Allen C, Vrijens F, Shivaprakash M, Anonymous00006. · Ottawa Headache Centre, Ottawa, Canada. · Eur Neurol. · Pubmed #12464714 No free full text.
Abstract: Rizatriptan is a selective 5-HT(1B/1D) receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine. This randomized double- blind crossover outpatient study assessed the preference for 1 rizatriptan 10 mg tablet to 2 ergotamine 1 mg/caffeine 100 mg tablets in 439 patients treating a single migraine attack with each therapy. Of patients expressing a preference (89.1%), more than twice as many preferred rizatriptan to ergotamine/caffeine (69.9 vs. 30.1%, p < or = 0.001). Faster relief of headache was the most important reason for preference, cited by 67.3% of patients preferring rizatriptan and 54.2% of patients who preferred ergotamine/caffeine. The co-primary endpoint of being pain free at 2 h was also in favor of rizatriptan. Forty-nine percent of patients were pain free 2 h after rizatriptan, compared with 24.3% treated with ergotamine/caffeine (p < or = 0.001), rizatriptan being superior within 1 h of treatment. Headache relief at 2 h was 75.9% for rizatriptan and 47.3% for ergotamine/caffeine (p < or = 0.001), with rizatriptan being superior to ergotamine/caffeine within 30 min of dosing. Almost 36% of patients taking rizatriptan were pain free at 2 h and had no recurrence or need for additional medication within 24 h, compared to 20% of patients on ergotamine/caffeine (p < or = 0.001). Rizatriptan was also superior to ergotamine/caffeine in the proportions of patients with no nausea, vomiting, phonophobia or photophobia and for patients with normal function 2 h after drug intake (p < or = 0.001). More patients were (completely, very or somewhat) satisfied 2 h after treatment with rizatriptan (69.8%) than at 2 h after treatment with ergotamine/caffeine (38.6%, p < or = 0.001). Recurrence rates were 31.4% with rizatriptan and 15.3% with ergotamine/caffeine. Both active treatments were well tolerated. The most common adverse events (incidence > or = 5% in one group) after rizatriptan and ergotamine/caffeine, respectively, were dizziness (6.7 and 5.3%), nausea (4.2 and 8.5%) and somnolence (5.5 and 2.3%).
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Article Almotriptan and zolmitriptan in the acute treatment of migraine. 2007
Goadsby PJ, Massiou H, Pascual J, Diener HC, Dahlöf CG, Mateos V, Dowson AJ, Raets I, Cunha L, Färkkilä M, Manzoni GC. · Headache Group, Institute of Neurology, Queen Square, London, UK. · Acta Neurol Scand. · Pubmed #17156263 No free full text.
Abstract: OBJECTIVE: To compare almotriptan and zolmitriptan in the treatment of acute migraine. METHODS: This multicentre, double-blind trial randomized adult migraineurs to almotriptan 12.5 mg (n = 532) or zolmitriptan 2.5 mg (n = 530) for the treatment of a single migraine attack. The primary end point was sustained pain free plus no adverse events (SNAE); other end points included pain relief and pain free at several time points, sustained pain free, headache recurrence, use of rescue medication, functional impairment, time lost because of migraine, treatment acceptability, and overall treatment satisfaction. RESULTS: No significant difference was seen in SNAE (almotriptan 29.2% vs zolmitriptan 31.8%) or the other efficacy end points measured. The incidence of triptan-associated AEs and triptan-associated central nervous system AEs was significantly lower for patients receiving almotriptan compared to zolmitriptan. CONCLUSIONS: Almotriptan and zolmitriptan were associated with similar efficacy and overall tolerability in the treatment of acute migraine. Almotriptan was associated with a significantly lower rate of triptan-associated AEs.
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Article [Therapeutic strategies used by neurologists and primary care physicians in the symptomatic treatment of migraine. Findings from Strategia-I and Strategia-II opinion studies] free! 2006
Mateos V, Galván J, Heras J. · Servicio de Neurología, Hospital Central de Asturias, 33006 Oviedo, España. · Rev Neurol. · Pubmed #17072805 links to free full text
Abstract: INTRODUCTION: Few studies have been carried out on the subject of stratification of medical care for migraines, and even fewer have been conducted with the aim of determining the attitudes adopted by physicians towards their patients when dealing with this issue. Strategia-I and II studies were designed for this purpose. SUBJECTS AND METHODS: The sample consisted of 162 neurologists and 3,168 Primary Care physicians (PCP). Participants in the studies filled out an opinion survey that was produced ad hoc and included the different possible strategies, namely a) Stepped care between attacks (the patient takes medication during several attacks and, if it is not effective, it is replaced by another in successive attacks); b) Stepped care within attacks (the patient treats his or her seizures with medication and, if it does not work, another is used as rescue medication); and c) Stratified care (the physician classifies the patient according to the degree of disability produced by the migraine and recommends the most appropriate drug at the start). RESULTS: Most participants in the study (90.7% of neurologists, 85.2% of PCP) reported using a single strategy. Stratified care was found to be the preferred choice by both collectives (67.6% of neurologists, 43.8% of PCP; p < 0.0001). Only 16% of the respondents admitted using some disability scale. Nonsteroidal antiinflammatory drugs are the medication chosen if disability is mild-moderate, while triptans are preferred if it is moderate-severe (92.9% of neurologists, 78.8% of PCP; p < 0.001). CONCLUSIONS: The strategy based on stratified care is the most widely used in visits to Neurology and Primary Care in Spain, although there are significant differences between the two collectives. Triptans are perceived as being the ideal medication in situations involving moderate-severe disability.
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Article [Spanish contribution to the clinical development of eletriptan: an analysis of controlled studies] free! 2004
Pascual J, Leira R, Lainez JM, Liaño H, Díez-Tejedor E, Navarro A, Jiménez D, Ezpeleta D, Mateos V, Madrigal M, Palacios G, Anonymous00284. · Servicio de Neurología, Hospital Universitario Marqués de Valdecilla, Santander. · Neurologia. · Pubmed #15470580 links to free full text
Abstract: INTRODUCTION: Eletriptan is a recently marketed second-generation triptan with a potent agonist activity on 5-HT1B/ 1D receptors. Our aim has been to analyze the specific results from the Spanish participation in phase IIIa and IIIb clinical trials vs placebo and compare them with the results obtained in the global clinical development of eletriptan. PATIENTS AND METHODS: Analysis of the results obtained in 40 centers in Spain (358 patients) vs global sample 4,677 patients) for the first migraine attack in 6 controlled clinical trials with eletriptan 40 mg, eletriptan 80 mg and placebo. This ad hoc analysis was carried out for those treatment groups with more than 50 patients, which reduced the final number of patients from Spain to 250. RESULTS: The proportion of patients with relief at 2 hours (main endpoint) in the Spanish sample was 22 %, 59 % and 67 % for placebo, eletriptan 40 mg and eletriptan 80 mg, respectively. These values were significantly higher (p < 0.05) than those of placebo and similar to those from the total sample. The proportion of pain free patients at 2 hours in the Spanish sample was 10 %, 36 % and 41 % for placebo, eletriptan 40 mg and eletriptan 80 mg, respectively. These values were significantly better than those for placebo (p < 0.05) and about 15 %-20 % higher than those from the total sample. Recurrence rate in the Spanish sample was 50 %, 16 % and 25 % for placebo, eletriptan 40 and eletriptan 80 mg, respectively, and did not differ from that of the total sample. Sustained relief for the two eletriptan doses was 46 % for both eletriptan 40 and eletriptan 80, this being significant (p < 0.05) over placebo (11 %) for the Spanish sample and similar to that of the global sample. The results for other efficacy parameters, such as need of rescue medication, functional response at 2 hours, complete response for pain-freeness and acceptability followed a similar pattern. Eletriptan was, in general, well-tolerated. Adverse events were slight-moderate in intensity, transient and were not different, either in profile or proportion, from those from the global sample. CONCLUSIONS: These results confirm eletriptan 40 mg and 80 mg as an excellent option for the symptomatic treatment of migraine in our setting.
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Article [Almotriptan in the treatment of migraine attacks in clinical practice: results of the TEA 2000 observational study] free! 2003
Pascual J, Láinez JM, Leira R, Titus F, Mateos V, Galván J, Anonymous00116. · Servicio de Neurología, Hospital Universitario Marqués de Valdecilla, Santander, España. · Neurologia. · Pubmed #12590376 links to free full text
Abstract: BACKGROUND: Almotriptan, the most recent drug of the triptan family, has shown good efficacy and tolerability profile in clinical trials. OBJECTIVE: To assess almotriptan's tolerability and effectiveness in the setting of routine clinical practice. PATIENTS AND METHODS: 1,643 patients diagnosed of migraine according to IHS criteria were recruited by 317 neurologists in the TEA 2000 study. Patients were instructed to report data on migraine attacks in a diary for a three months follow-up period. Data from 4,253 migraine attacks were obtained. RESULTS: The incidence of adverse events was 0.02 per migraine attack (3,9 % of patients). Subjective clinical improvement after 30 minutes (33.2 y 37.1 %), pain improvement after 2 hours (65.5 % and 70.2 %), pain free response after 2 hours (26.6 % and 29.2 %), recurrence between 2 and 24 hours (21.2 % and 17 %) and a complete response by 24 hours (18.6 % and 22.9 %) were found. These results were obtained in both "intention to treat" and "per protocol" analyses, being even much better when only low pain intensity attacks were considered. CONCLUSIONS: The TEA 2000 study results demonstrate good effectiveness and excellent tolerability profile of almotriptan 12.5 mg in the daily clinical neurological practice. The results of this study confirm those obtained in clinical trials carried out before almotriptan was introduced into the market and that it is a good therapeutic choice for the symptomatic treatment for migraine attacks.
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