Migraine Disorders: Pascual J

Silberstein S, Tfelt-Hansen P, Dodick DW, Limmroth V, Lipton RB, Pascual J, Wang SJ, Anonymous00408. · Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA. [corrected] · Cephalalgia. · Pubmed #18294250 No free full text.

Abstract: In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) developed and published its first edition of the Guidelines on controlled trials of drugs in episodic migraine because only quality trials can form the basis for international collaboration on drug therapy, and these Guidelines would 'improve the quality of controlled clinical trials in migraine'. With the current trend for large multinational trials, there is a need for increased awareness of methodological issues in clinical trials of drugs and other treatments for chronic migraine. These Guidelines are intended to assist in the design of well-controlled clinical trials of chronic migraine in adults, and do not apply to studies in children or adolescents.

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.

Pascual J. · No affiliation provided · J Headache Pain. · Pubmed #16897616 No free full text.

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Pascual J, Berciano J. · No affiliation provided · An Med Interna. · Pubmed #10339838 No free full text.

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Pascual J. · University Hospital of Salamanca, Salamanca, Spain. · Cephalalgia. · Pubmed #18715328 No free full text.

Abstract: Although triptans represent the standard of care for migraine that is severe, disabling and/or suboptimally responsive to migraine non-specific analgesia, they are often underused in clinical practice. Simple analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) may provide effective treatment in some patients, but it is an inadequate response to these drugs that drives the therapeutic progression to triptans at the end of the traditional 'step-care' approach. However, there are several disadvantages to this approach. It may cause patients to lose confidence in their physician during this hierarchical 'trial-and-error' search for optimal treatment when prescribed medications are ineffective, leading them to cease consulting before triptans are tried. It may also result in a protracted time interval of suboptimal treatment, with unnecessary suffering in patients who are triptan candidates. The alternative approach of 'stratified care', in which medication is prescribed according to the severity of symptoms, enables triptans to be used earlier in the treatment plan, especially when triptan candidates are given a choice between simple analgesic/NSAID and triptan medication from the start. This raises the question about the efficacy of triptans in triptan-naïve (TN) patients. A recent exploratory post-hoc analysis compared the effect of almotriptan 12.5 mg in TN patients (n = 342) with that in triptan-experienced patients (n = 237). Almotriptan was effective in both cohorts with a consistent trend in favour of the efficacy of almotriptan in TN patients, notably for sustained pain freedom (SPF) and SPF plus no adverse events. Moreover, both headache recurrence at 24 h and the use of rescue medication was lower in the TN patients, whereas tolerability was equally good in both cohorts. These findings indicate that TN patients can expect excellent symptom control when they progress from non-specific analgesia to treatment with almotriptan and support the earlier use of triptans in line with the stratified care paradigm.

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.

Dowson AJ, Mathew NT, Pascual J. · King's Headache Services, King's College Hospital, London, UK. · Int J Clin Pract. · Pubmed #16805756 No free full text.

Abstract: Most of the data on triptan use are from clinical trials in which patients were instructed to wait until migraine headache pain was moderate/severe in intensity. In the real world, patients may hesitate to use a triptan until headache pain is moderate/severe because of the cost of these agents or limited supply allowed by their health service organisation. However, accumulating data indicate that early intervention with an oral triptan when headache pain is still mild may be the most effective acute treatment strategy. Economic analyses also support early triptan intervention in migraine attacks. Tolerability is expected to be particularly important in early intervention, as patients treating mild migraine pain may be more reluctant to risk adverse events. Thus, an agent selected for use as early intervention should have both a demonstrated efficacy in treating mild migraine headache and placebo-like tolerability. This article reviews retrospective and prospective clinical trials which investigated the use of triptans for early acute migraine therapy.

Stovner LJ, Zwart JA, Hagen K, Terwindt GM, Pascual J. · Department of Neuroscience, Norwegian University of Science and Technology, Trondheim. · Eur J Neurol. · Pubmed #16643310 No free full text.

Abstract: The present review of epidemiologic studies on migraine and headache in Europe is part of a larger initiative by the European Brain Council to estimate the costs incurred because of brain disorders. Summarizing the data on 1-year prevalence, the proportion of adults in Europe reporting headache was 51%, migraine 14%, and 'chronic headache' (i.e. > or =15 days/month or 'daily') 4%. Generally, migraine, and to a lesser degree headache, are most prevalent during the most productive years of adulthood, from age 20 to 50 years. Several European studies document the negative influence of headache disorders on the quality of life, and health-economic studies indicate that 15% of adults were absent from work during the last year because of headache. Very few studies have been performed in Eastern Europe, and there are also surprisingly little data on tension-type headache from any country. Although the methodology and the quality of the published studies vary considerably, making direct comparisons between different countries difficult, the present review clearly demonstrates that headache disorders are extremely prevalent and have a vast impact on public health. The data collected should be used as arguments to increase resources to headache research and care for headache patients all over the continent.

Dahlöf CG, Pascual J, Dodick DW, Dowson AJ. · Institute of Clinical Neuroscience, Gothenburg Migraine Clinic, Gothenburg, Sweden. · Cephalalgia. · Pubmed #16556240 No free full text.

Abstract: A meta-analysis of pooled individual patient data from four randomized, placebo-controlled, double-blind trials comparing several doses of almotriptan (n = 1,908) with placebo (n = 386) was used to investigate the efficacy, speed of onset and tolerability of almotriptan in the acute treatment of migraine. As early as 30 min after dosing, almotriptan 12.5 mg was significantly more effective than placebo for pain relief (14.9% vs. 8.2%; P < 0.05) and pain free (2.5% vs. 0.7%; P < 0.05). At 2 h, pain-relief rates were 56.0%, 63.7% and 66.0% for almotriptan 6.25, 12.5 and 25 mg, respectively, compared with 35% for placebo; 2-h pain-free rates were 26.7%, 36.4% and 43.4% compared with 13.9% for placebo. All almotriptan dosages were significantly more effective than placebo in eliminating migraine-associated symptoms (P < 0.05) and in achieving sustained pain relief up to 24 h (P < 0.05). The incidence of adverse events after almotriptan 6.25 mg and 12.5 mg was not significantly different from that of placebo. This meta-analysis confirms the findings of individual clinical trials, while demonstrating for the first time, significant pain-free efficacy at 30 min compared with placebo.

Dahlöf CG, Linton-Dahlöf P, Lainez JM, Pascual J. · Clínica de la Migraña, Gotemburgo, Sweden. · Neurologia. · Pubmed #16163579 links to  free full text

Abstract: Migraine is a primary neurovascular headache which affects approximately 12% of the adult population. Migraine particularly affects women of working age and is associated with significant disability and reduced quality of life. During migraine attacks, the capacity to engage in daily activities such as child care, work, and social activities is reduced, and relationships with family members and friends become strained. In this respect, migraine places a heavy economic burden on both the individual and society. It is also known migraine is a risk factor for ischemic stroke in young women with migraine with aura. Recently, it was reported that some individuals that experience migraine with and without aura may be at an increased risk for subclinical lesions in certain areas of the brain. Cerebral white matter lesions (WMLs) are a common finding on cerebral MRI scans. Although, it appears that cerebral WMLs are more common in migraineurs than in the general population, the nature, association and the clinical significance of cerebral WMLs in migraineurs are not yet conclusive. Furthermore, there is no good evidence to support the notion that cerebral WMLs in migraineurs can predict subclinical or clinical stroke in these individuals. Needless to say, the need for more longitudinal and prospective migraine research is immense. The aim of the future migraine research should be to obtain more information about the natural course of migraine as well as evaluate the association between migraine and cerebral WMLs and their consequences. In addition, continuing genetic identification of key proteins involved in migraine will improve our understanding of this common and sometimes most debilitating disorder, which can strike during the most productive years of a person's life.

Pascual J. · Service of Neurology, University Hospital Marques de Valdecilla, Santander, Spain. · Eur Neurol. · Pubmed #15920336 No free full text.

Abstract: While randomized, double-blind, placebo-controlled trials are considered the gold standard of clinical evidence, they are limited by patient numbers, duration of patient exposure, and restricted patient populations. Data from controlled trials may not be generalizable to all individuals likely to take the drug under investigation. Postmarketing surveillance studies are designed to measure efficacy and safety in larger and more diverse populations, allowing them to detect less common and delayed adverse events. However, postmarketing surveillance studies are limited by their lack of randomization, open-label design that can result in patient and physician bias, incomplete follow-up, less than rigorous outcome measurement, and lack of a contemporaneous control group. With regard to acute treatment of migraine, clinical trials using per protocol primary endpoints do not reflect the more favorable experience with triptans in general practice. Postmarketing surveillance studies have been performed to determine whether the high levels of efficacy and tolerability of almotriptan reported in controlled clinical trials can been reproduced in routine practice. An observational study conducted in Spain with 2,074 migraine sufferers (4,183 attacks) reported a 2-hour pain-relief rate of 86.9%, a 2-hour pain-free rate of 51.5%, and a sustained pain-free rate of 46.0%; 1.1% of patients reported adverse reactions. A German postmarketing study in 899 patients (2,131 attacks) with acute migraine treated with almotriptan 12.5 mg reported 2-hour pain relief in 84.5% of attacks and 2-hour pain free in 41.4%; 1.1% of patients reported adverse reactions. The consistency of response (at least two out of three attacks successfully treated) with almotriptan 12.5 mg was 87.3%. Regarding satisfaction, 88.5% of patients were satisfied or very satisfied and 80.3% of patients stated that almotriptan was better compared to their prior therapy; 92% of physicians indicated that they would continue treating their patients' migraines with almotriptan. The results of these studies demonstrate that the high levels of efficacy and tolerability seen with almotriptan in controlled clinical trials are achieved in real-world clinical settings. In conclusion, a combination of controlled clinical trials, postmarketing surveillance studies, and physician's experience in the general population can give us a better understanding of the efficacy and tolerability of acute migraine agents.

Pascual J. · University Hospital Marques de Valdecilla, Santander, Spain. · Drugs Today (Barc). · Pubmed #15071618 No free full text.

Abstract: The clinical data of almotriptan, the new selective 5-HT(1B/1D) agonist developed for the symptomatic treatment of migraine, are reviewed here. The pharmacokinetic performance of almotriptan is compared with that of other currently available triptans. The dose exhibiting the best efficacy/tolerability ratio of almotriptan is 12.5 mg. Efficacy of this almotriptan dose is comparable to that of the "gold" standard triptan, but with a lower recurrence rate. Gender or the presence of food in the stomach does not influence almotriptan's pharmacokinetic profile, and no relevant interactions of almotriptan with other medications have been reported. The tolerability of almotriptan is similar to that of placebo. Almotriptan's high efficacy together with its excellent tolerability and safety profile confirm this new 5-HT(1B/1D) agonist as a drug of choice for the symptomatic treatment of migraine attacks.

Pascual J. · Service of Neurology, University Hospital Marqués de Valdecilla (UC), Spain. · Expert Opin Pharmacother. · Pubmed #15013934 No free full text.

Abstract: Rizatriptan is a second-generation triptan marketed as 5 and 10 mg tablets and rapidly disintegrating wafer formulations. In > 5000 acute migraine patients enrolled in short-term trials and almost 1800 patients in long-term, open-label trials treating approximately 47000 attacks, rizatriptan was effective and well-tolerated. Controlled head-to-head data and a meta-analysis of 53 randomised, placebo-controlled trials of oral triptans in > 24000 patients have shown that rizatriptan 10 mg offers efficacy advantages over oral sumatriptan 50 and 100 mg and other oral triptans, both in terms of speed of onset of action and consistency. These advantages may reflect its improved pharmacological profile over sumatriptan in terms of higher oral bioavailability and a shorter time to maximum concentration. The wafer formulation offers the convenience of being administered without water. As a result of its superior efficacy profile and generally good tolerability, rizatriptan can be considered as a first-line treatment for acute migraine.

Pascual J, Valle N. · Service of Neurology, University Hospital Marqués de Valdecilla (UC), 39008 Santander, Spain. · Curr Pain Headache Rep. · Pubmed #12720603 No free full text.

Abstract: Pseudomigraine with temporary neurologic symptoms and lymphocytic pleocytosis is a self-limited syndrome of unknown origin characterized by headache accompanied by transient neurologic symptoms and cerebrospinal fluid lymphocytosis. Patients with this condition are between 15 and 40 years of age. The syndrome is more frequent in men. The clinical picture encompasses one to 12 episodes of changing variable neurologic deficits accompanied by moderate to severe headache and occasional fever. These headaches are described as predominantly throbbing and bilateral with a variable duration (mean, 19 hours). The average duration of the transient neurologic deficit is 5 hours. Sensory (78% episodes), aphasic (66%), and motor (56%) disturbances are the most common. Migraine-like visual symptoms are relatively rare (18% episodes). Patients are asymptomatic between episodes and after the symptomatic period (duration > 3 months). Lymphocytic pleocytosis (10 to 760 cells mm(3)) and increased cerebrospinal fluid protein are found with negative bacteriologic, viral, fungal, and immunologic studies. Brain computed tomography and magnetic resonance imaging are normal, but an electroencephalogram frequently shows focal slowing over the symptomatic brain area. Single photon emission computed tomography reveals transient focal areas of decreased uptake consistent with the clinical symptoms. It is possible that pseudomigraine with temporary neurologic symptoms and lymphocytic pleocytosis could result from an activation of the immune system secondary to a recent viral infection, which would produce antibodies against neuronal or vascular antigens. This autoimmune attack may induce an aseptic leptomeningeal vasculitis, accounting for the headache and the transient symptoms likely through a spreading depression-like mechanism.

Pascual J. · Service of Neurology, University Hospital Marqués de Valdecilla, Santander, Spain. · Curr Med Res Opin. · Pubmed #12463281 No free full text.

Abstract: In this manuscript we review the key basic and clinical data of almotriptan, the new selective 5-HT(1B/D) agonist developed for the symptomatc treatment of migraine. Among triptans, almotriptan has the highest oral bioavailability, with more than two-thirds of the administered dose absorbed within the first hourboth inside and outside a migraine attack. Gender or the presence of food in the stomach do not influence this pharmacokinetic profile, and its clean metabolism results in no relevant interactions with other medications. The dose exhibiting the best efficacy/ tolerability ratio is 12.5 mg. Efficacy parameters with this dose are very comparable to those of sumatriptan 100 mg, with a recurrence rate in the lower range. The tolerability of almotriptan is similar to that for placebo. The incidence of chest symptoms is very low (<1%), even though this drug remains contraindicated in patients with ischaemic cardiomyopathy. In summary, almotriptan's promising basic profile together with its excellent tolerability/safety profile and good efficacy confirm this new 5-HT(1B/D) agonist as a drug of choice for the symptomatic treatment of migraine attacks.

Dahlöf CG, Dodick D, Dowson AJ, Pascual J. · Gothenburg Migraine Clinic, Sociala Huset, Sweden. · Headache. · Pubmed #12005302 No free full text.

Abstract: Almotriptan, the new selective 5-HT1B/1D agonist, has a higher oral bioavailability than any other triptan, with more than two thirds of the administered dose absorbed within the first hour both inside and outside of a migraine attack. Gender or the presence of food in the stomach does not affect its pharmacokinetic profile, and the compound has no clinically relevant interactions with other drugs. Among the available triptans, response rates at 2 hours range from 50% to 80%, with 20% to 50% of patients pain-free. Almotriptan 12.5 mg provides similar efficacy, with significant advantage over placebo at 30 minutes and a reliable consistency (75% in two of three attacks). Headache typically recurs in 25% to 45% of patients with most triptans. The recurrence rate with almotriptan 12.5 mg, 18% to 27%, is among the lowest reported. The tolerability of almotriptan 12.5 mg is close to that of placebo with a low incidence of central nervous system side effects and chest symptoms. In conclusion, almotriptan's consistent pharmacokinetics and good efficacy, in combination with excellent tolerability, make it an attractive choice in the acute treatment of migraine attacks.

Pascual J, Colás R, Castillo J. · Service of Neurology, University Hospital Marqués de Valdecilla, Santander 39008, Spain. · Curr Pain Headache Rep. · Pubmed #11676887 No free full text.

Abstract: Daily or near-daily headache is a widespread problem in clinical practice. The general term of chronic daily headache (CDH) encompasses those primary headaches presenting more than 15 days per month and lasting more than 4 hours per day. CDH includes transformed migraine (TM), chronic tension-type headache (CTTH), new daily persistent headache (NDPH), and hemicrania continua (HC). Around 40% of patients attending a specialized headache clinic meet CDH diagnostic criteria, of which 80% are women. In these clinics about 60% of patients suffer from TM, 20% from CTTH, and 20% meet NDPH criteria. Most, some 80%, overuse symptomatic medications. One should be very cautious on extrapolating these numbers to the general population. CDH prevalence in the general population seems to be around 4% to 5% (up to 8% to 9% for women). Regarding the prevalence of CDH subtypes, NDPH is rare (0.1%), whereas the prevalence of TM (1.5% to 2%) and CTTH (2.5% to 3%) is clearly higher. In contrast to data from specialized clinics, only around a quarter of CDH subjects in the general population overuse analgesics; the prevalence of CDH subjects with analgesic overuse being 1.1% to 1.9% of the general population. Most of these patients with analgesic overuse are TM patients.

Pascual J. · Servicio de Neurología. Hospital Universitario Marqués de Valdecilla. Santander. · Med Clin (Barc). · Pubmed #11412623 No free full text.

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Leira R, Pascual J. · Servicio de Neurología, Hospital Clínico Universitario, Santiago de Compostela, La Coruña. · Neurologia. · Pubmed #10730063 No free full text.

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Pascual J. · Servicio de Neurología, Hospital Universitario Marqués de Valdecilla, Santander. · Neurologia. · Pubmed #10659603 No free full text.

Abstract: The options for migraine treatment have increased in the recent years and will expand in the near future. In this work both recent and future options for migraine treatment are critically reviewed. Firstly the late advances in the symptomatic treatment of migraine, including the new 5-HT1B/D agonists "triptans" appeared after sumatriptan, are reviewed. Possible alternative, such as selective 5-HT1D and 5-HT1F agonists, are also discussed. In the second part of this manuscript the new, possible options for the preventive treatment of migraine comprising "antiepileptics", such as valproic acid, gabapentin and topiramate, calcium-antagonists, such as cyclandelate and dotarizin, and a miscellany, including riboflavin, are analysed. Finally, possible compounds for the future, such as the selective inhibitors of neurokinin receptors or drugs acting upon neuronal calcium channels, are commented. From this review we conclude that while there have been relevant advances in the symptomatic treatment of migraine, there is a need for the development of better preventive compounds.

Tfelt-Hansen P, Saxena PR, Dahlöf C, Pascual J, Láinez M, Henry P, Diener H, Schoenen J, Ferrari MD, Goadsby PJ. · Department of Neurology, Glostrup Hospital, Copenhagen, Denmark. The · Brain. · Pubmed #10611116 links to  free full text

Abstract: Ergotamine has been used in clinical practice for the acute treatment of migraine for over 50 years, but there has been little agreement on its place in clinical practice. An expert group from Europe reviewed the pre-clinical and clinical data on ergotamine as it relates to the treatment of migraine. From this review, specific suggestions for the patient groups and appropriate use of ergotamine have been agreed. In essence, ergotamine, from a medical perspective, is the drug of choice in a limited number of migraine sufferers who have infrequent or long duration headaches and are likely to comply with dosing restrictions. For most migraine sufferers requiring a specific anti-migraine treatment, a triptan is generally a better option from both an efficacy and side-effect perspective.

Pascual J, Leira R, Láinez JM, Alberca R, Titus F, Morales F, Díez-Tejedor E, García de Polavieja J. · Servicio de Neurología, Hospital Universitario Marqués de Valdecilla, Santander. · Neurologia. · Pubmed #10377720 No free full text.

Abstract: OBJECTIVES: The response to the different antimigraine medications is variable. In this study we have analysed the profile of prescription of these antimigraine medications, both preventive and symptomatic, by a group of spanish neurologists and examined the subjective efficacy of these compounds. PATIENTS AND METHODS: Neurologists from 7 hospitals in different spanish regions interviewed 305 patients (at least 40 per hospital) who met migraine diagnostic criteria. They used an ad hoc questionnaire in which the antimigraine medications, both symptomatic and preventive, taken by the patients, as well as their subjective response were registered. Patients with transformed migraine or tension-type headache more than 2 days per week were excluded. RESULTS: Analgesics, non-steroidal anti-inflammatory drugs, ergotics and sumatriptan had been taken by 99, 69, 54 and 40% of the 305 interviewed patients, respectively. A subjective good response was refered to by 9% of patients who had taken analgesics, 23% of patients who had taken non-steroidal anti-inflammatory drugs, 39% of those who had taken ergotics and 63% of patients with sumatriptan. The current symptomatic treatment was: analgesics 34% of cases, non-steroidal anti-inflamatory drugs 26%, ergotics 13% and sumatriptan 63%. Regarding preventive treatments, 108 patients (35%) had been treated with calcium-antagonists, 87 (29%) with beta-blockers, 55 (18%) with amitriptyline and only 7 (2.2%) with valproic acid. The percentages of good responses to these drugs were: 55% for beta-blockers, 42% for calcium-antagonists and 31% for amitriptyline. CONCLUSIONS: Our data confirm that analgesics are not efficacious in the majority of migraine patients and that the advent of sumatriptan has clearly improved the quality of migrane symptomatic treatment, even though about one-third of migraine patients do not respond to this drug. This study confirm that calcium-antagonists are the antimigraine preventive treatment most frequently prescribed in our country, even though their subjective efficacy is lower than that of beta-blockers.

García ML, Baos V, Láinez M, Pascual J, López-Gil A. · CS Mendiguchía Carriche, Primary Care, Madrid, Spain. · Headache. · Pubmed #18194304 No free full text.

Abstract: BACKGROUND: Migraine is frequently undertreated. The 4-item Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire is a simple and reliable tool to identify patients requiring a change in current acute migraine treatment. Objective: To investigate the responsiveness of the Migraine-ACT tool, and compare it with that of the Migraine Disability Assessment (MIDAS) questionnaire, for patients with migraine at 1100 primary care sites in Spain. METHODS: Patients eligible for this open-label, 2-visit prospective study reported migraine for >1 year and >or=1 migraine attack per month and were new to the clinic or on follow-up care for <6 months. Validated Spanish versions of the Migraine-ACT and MIDAS questionnaires were administered, and patient satisfaction with treatment was recorded, at baseline and at 3 months. RESULTS: A total of 3272 patients, 78% female, were enrolled, and 2877 (88%) returned for the 3-month visit. Investigators changed baseline migraine treatment for 72% of returning patients; 85% and 80% of these patients had improved Migraine-ACT and MIDAS scores at 3 months, respectively. Patients who reported being completely or very satisfied with migraine treatment numbered 492 (15%) at baseline and 1406 (49%) at 3 months. Migraine-ACT and MIDAS score agreement for improvement at 3 months was poor (kappa = 0.339). Both the mean MIDAS score and the distribution of Migraine-ACT scores improved over the course of 3 months; however, Migraine-ACT scores were significantly (P < .001) more sensitive (83% vs 75%) and specific (72% vs 58%) than MIDAS scores. The area under the curve in the receiver-operating characteristic analysis was significantly (P < .0001) greater for Migraine-ACT (0.82) as compared with the MIDAS (0.70) questionnaire. CONCLUSIONS: These results suggest that the Migraine-ACT questionnaire can be used more reliably than the MIDAS questionnaire for detecting improvements in treatment of new and follow-up patients with migraine.

Pascual J, Diener HC. · Service of Neurology, University Hospital, Salamanca, Spain. · Curr Med Res Opin. · Pubmed #17723158 No free full text.

Abstract: OBJECTIVE: To evaluate the efficacy of oral almotriptan 12.5 mg as an acute treatment for migraine with a focus on triptan-experienced versus triptan-naïve patients. RESEARCH DESIGN AND METHODS: Four recent Almirall-sponsored clinical trials of oral almotriptan 12.5 mg in acute migraine, in which data regarding previous acute therapy were collected, are reviewed. The results and conclusions are limited by the open-label and post hoc design of some of these trials and analyses. RESULTS: In two trials, almotriptan 12.5 mg was used to treat migraine sufferers who were dissatisfied with or were receiving inadequate results with their previous therapy. One of these trials enrolled only patients whose dissatisfaction with their current therapy was confirmed by a validated questionnaire; the other looked at almotriptan 12.5 mg efficacy in patients with previous poor response to sumatriptan. In the other two trials, patients had been achieving satisfactory results with their migraine therapy; one was a randomized, double-blind clinical trial of almotriptan 12.5 mg and zolmitriptan 2.5 mg, the other was an open-label almotriptan 12.5 mg satisfaction trial. Almotriptan 12.5 mg is shown to be effective, well-tolerated, and preferred to previous agents in both patients who were satisfied with, and those who were dissatisfied with, their previous therapy. CONCLUSIONS: Almotriptan should, therefore, not only be considered as first-line therapy for acute migraine but should also be considered for patients who are not satisfied with or not receiving optimal relief from their current acute therapy.

Relja M, Poole AC, Schoenen J, Pascual J, Lei X, Thompson C, Anonymous00105. · Department of Neurology, Medical School University of Zagreb, Zagreb, Croatia. · Cephalalgia. · Pubmed #17428299 No free full text.

Abstract: Our aim was to evaluate the safety and efficacy of botulinum toxin type A (BoNTA; BOTOX) for prophylaxis of episodic migraine. In this double-blind, placebo-controlled study, patients were randomized to 225, 150 or 75 U of BoNTA or placebo after a 30-day placebo run-in for three 90-day treatment cycles. The primary efficacy end-point was the mean reduction from baseline in the frequency of migraine episodes at day 180 in the placebo non-responder stratum. All groups (N = 495) improved, with no significant differences. At day 180, the frequency of migraine episodes was reduced from baseline means of 4.3, 4.7, 4.7 and 4.4 by 1.6, 1.7, 1.5 and 1.4 for BoNTA 225 U, 150 U and 75 U and placebo, respectively. The primary end-point was not met. Treatment-related adverse events were transient and mild to moderate. BoNTA treatment was safe and well tolerated but did not result in significantly greater improvement than placebo in this study. Several factors may have confounded the results.