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Biomedical subjects

Roger Cady

Publications and source records attributed to Roger Cady.

At least 19 recordsLinked to original sources
PubMed2006

A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults.

OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of a single 4-mg dose of sumatriptan SC for the acute treatment of adult patients experiencing a migraine attack with moderate to severe pain. METHODS: In this randomized, double-blind, placebo-controlled study, subjects included men and women aged 18 to 60 years who had migraine with or without aura, as defined by the 1988 International Headache Society criteria. Subjects received either sumatriptan 4 mg SC or placebo SC for a migraine attack with headache pain of moderate to severe intensity. The primary efficacy measurement was pain relief at 2 hours. Secondary efficacy measures included the severity of headache pain at 10, 20, 30, 40, 50, 60, and 90 minutes postadministration. Clinical assessments of pain severity and adverse events were made by way of questioning and observation of subjects and were completed at 10, 20, 30, 40, 50, 60, 90, and 120 minutes postadministration. RESULTS: Five hundred seventy-seven subjects (87% female and 94% white) participated in this study. Three hundred eighty-four received sumatriptan and 193 received placebo. At 120 minutes postadministration, sumatriptan 4 mg SC was associated with greater proportions of patients who experienced pain relief (70% vs 22%; P<0.001) or were pain free (50% vs 11%; P<0.001). In addition, there were statistically significant differences between sumatriptan 4 mg SC and placebo for multiple secondary end points, including pain relief as early as 10 minutes postadministration (11% vs 6%; P=0.039), pain-free status as early as 30 minutes postadministration (10% vs 3%; P<0.001), nausea as early as 30 minutes postadministration (39% vs 49%; P=0.021), and photophobia as early as 10 minutes postadministration (80% vs 87%; P=0.046). The most common adverse events in the sumatriptan 4-mg SC and placebo groups, respectively, were injection-site reactions (43% and 15%), tingling (12% and 3%), dizziness or vertigo (10% and 5%), and warm or hot sensation (8% and 2%). Treatment groups were not statistically compared for adverse events. CONCLUSIONS: Sumatriptan 4 mg SC was effective for the acute treatment of migraine attacks and was generally well tolerated in these patients.

Adolescent↗
PubMed2006

Oral sumatriptan for the acute treatment of probable migraine: first randomized, controlled study.

OBJECTIVE: To evaluate the efficacy and tolerability of sumatriptan tablets in adults who meet International Headache Society (IHS) criteria for probable migraine but who do not meet IHS criteria for migraine with or without aura. BACKGROUND: Headaches with some but not all of the features of migraine meet criteria for probable migraine, a form of migraine recognized by the IHS. Probable migraine attacks are also prevalent and frequently underdiagnosed. METHODS: This was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Adults (18 to 65 years) with a 1-year history of headaches that met 2004 IHS criteria for probable migraine without aura (same operational definition as 1988 IHS migrainous disorder) were eligible for enrollment. All patients were triptan- and ergot-naïve and had never been diagnosed with migraine. Patients were randomized in a 1:1:1:1 fashion to receive sumatriptan 25, 50, or 100 mg conventional tablets or matching placebo and were instructed to treat a single moderate or severe probable migraine attack. A post hoc analysis was conducted to evaluate the population of patients who achieved headache relief sustained throughout the immediate posttreatment period. Patients who reported relief within 2 hours and subsequently lost headache relief within 4 hours were considered nonresponders. RESULTS: At 2 hours, more patients treated with sumatriptan achieved headache relief, the primary efficacy measure, compared with placebo, but differences only approached statistical significance for 100 mg (P= .053). The 2-hour headache relief rate in the sumatriptan 25 or 50 mg groups was not significantly different than placebo. The time to use of rescue was significantly shorter in the placebo group compared with the sumatriptan 100 mg group (P= .002). The time to use of rescue in the sumatriptan 25 or 50 mg groups was not significantly different than placebo. More patients treated with placebo (22%) lost headache relief within 4 hours compared with patients treated with sumatriptan 25 mg (17%), 50 mg (14%), or 100 mg (7%). A post hoc analysis demonstrated that at 2 hours, headache relief sustained through 4 hours (S 0-4 hours) was achieved in 44%, 49%, and 57% of patients treated with sumatriptan 25, 50, and 100 mg, respectively, compared with 34% of patients treated with placebo (P < .05 for sumatriptan 50 and 100 mg vs. placebo). All doses of sumatriptan were well tolerated and no serious adverse events were reported. CONCLUSION: These results suggest that oral sumatriptan may be effective and is well tolerated for the acute treatment of probable migraine without aura, however, the difference between sumatriptan and placebo was not statistically significant for the a priori defined primary endpoint.

Acute Disease↗
PubMed2006

Efficacy of Rizatriptan 10 mg administered early in a migraine attack.

OBJECTIVE: To determine if administration of rizatriptan 10 mg is superior to placebo for the early treatment of acute migraine, while the pain is mild. BACKGROUND: Past studies have suggested that treatment outcomes can be improved if a triptan is administered early in the time course of a migraine attack. METHODS: Two randomized, parallel, placebo-controlled, double-blind studies. TAME (Treat A Migraine Early)1 was conducted at 46 centers in the United States; TAME2, at 48 centers in the United States. Totally, 1030 adult patients with at least a 6-month history of migraine were studied. Patients were instructed to treat within 1 hour of migraine onset, while pain was mild. Patients maintained a headache diary in which they rated their levels of pain and disability, and recorded other symptoms of migraine. Primary endpoints were pain freedom at 2 hours and sustained pain freedom at 24 hours post-dose. RESULTS: In TAME1, 57.3% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 42.6% versus 23.2% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). In TAME2, 58.9% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 48.0% versus 24.6% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). All other efficacy endpoints favored rizatriptan. Repeat doses of the medicine were not allowed; patients may have delayed treatment; non-migraine headaches may have been treated. CONCLUSIONS: Rizatriptan 10 mg was superior to placebo when treating migraine early, while pain is mild, as measured by pain freedom at 2 hours and 24-hour sustained pain freedom.

Acute Disease↗
PubMed2006

Repression of stimulated calcitonin gene-related peptide secretion by topiramate.

OBJECTIVE: The goal of the proposed research was to determine the effect of topiramate on basal and stimulated release of calcitonin gene-related peptide (CGRP) from trigeminal ganglia neurons. BACKGROUND: CGRP is implicated in migraine headaches. Clinical evidence supports topiramate as an effective migraine prophylactic. In this study, the connection between topiramate and CGRP expression was investigated. METHODS: Primary cultures of rat trigeminal ganglia were utilized to determine the effects of topiramate on CGRP release stimulated by a depolarizing stimulus (KCl), nitric oxide, and/or protons. The amount of CGRP secreted into the culture media was determined using a CGRP-specific radioimmunoassay. RESULTS: Treatment of trigeminal cultures with KCl, nitric oxide donor S-nitroso-N-acetylpenicillamine, or protons (pH 5.5 media) caused a marked increase (3 to 5 fold) in the amount of CGRP release. Topiramate treatment repressed KCl-stimulated CGRP release in a time- and concentration-dependent manner. However, topiramate did not alter the amount of unstimulated or basal CGRP released from trigeminal neurons. In addition, topiramate inhibited nitric oxide and proton mediated CGRP secretion. CONCLUSIONS: Findings from these studies demonstrate that topiramate can directly repress the stimulated release of CGRP from sensory trigeminal neurons. We propose that topiramate's ability to prevent migraine attacks may involve inhibition of CGRP secretion from trigeminal neurons.

Animals↗
PubMed2006

Sumatriptan: update and review.

Sumatriptan is the first of a novel class of medications referred to as triptans. Since its approval for migraine in the 1990s, six other triptan products have received FDA approval. Despite the proliferation of triptans, sumatriptan remains the most frequently prescribed product in this therapeutic class. Sumatriptan has been instrumental in defining a biological basis for migraine. It is effective in treating migraine with or without aura, well tolerated and, when properly prescribed, safe. Sumatriptan injection is the only member of the triptan class approved for treatment of cluster headache. Studies with sumatriptan have also advanced the therapeutic intervention paradigm that permits patients to treat earlier and avoid substantial disability. Numerous pharmacoeconomic studies have demonstrated that sumatriptan decreases work loss productivity and improves quality of life.

Animals↗
PubMed2005

Cosensitization of pain and psychiatric comorbidity in chronic daily headache.

Chronic migraine occurs in approximately 20% of migraineurs, typically developing over a period of many years. The pathophysiology of this transformation is unknown. However, experts have associated chronic headache with analgesic overuse, physical injury, and psychologic trauma. Research in post-traumatic stress disorder has found that hippocampal sensitivity to stress alters and often amplifies future pain behaviors. Although the most obvious difference between migraine and chronic migraine is the frequency of headaches, this article discusses chronic migraine as a more pervasive neurologic disease in which the patient's neurologic and psychologic function fails to return to a normal baseline. The sensory and affective components of pain are cosensitized, producing other neurologic and psychologic symptoms during and between episodes of headache. A staging paradigm is suggested that defines patients and assesses their overall neurologic function. The goal of this classification is to identify cosensitization early and pinpoint migraine patients who are at risk of developing chronic migraine.

Chronic Disease↗
PubMed2005

Initiating and optimizing acute therapy for migraine: the role of patient-centered stratified care.

Migraine is a chronic, intermittently disabling condition that affects physical, mental, and social aspects of health-related quality of life. Because patients seeking assistance with migraine most often present to primary care providers, these healthcare professionals play critical roles in the diagnosis and treatment process. A comprehensive migraine management plan involves a partnership between the patient and healthcare professional where treatment goals and strategies are established. Elements of such a plan should include preventive strategies to reduce the frequency and effects of future attacks as well as the use of acute treatments to address the immediate need for relief during an attack. Approaches to prevention include education, lifestyle modification, and, often, appropriate medication. Many medications have been used for acute treatment. Nonspecific agents include nonsteroidal anti-inflammatory drugs (NSAIDs), single or combination analgesics (sometimes including antiemetics or caffeine), and narcotics. Migraine-specific medications include ergot alkaloids and triptans (5-hydroxytryptamine(1B/1D) agonists). Various professional organizations have created guidelines to help providers in choosing appropriate management interventions. Clinical approaches to the patient with migraine include step care, whereby all patients begin on a simple or nonspecific treatment, stepping up to the next level of therapy if treatment is unsuccessful; or stratified care, whereby first-line therapy is tailored to the severity of the patient's pattern of headache. Studies have demonstrated that for more disabled headache patients, the stratified-care approach results in more robust headache response with less disability and greater cost-effectiveness than step care. Patient satisfaction studies demonstrate that the use of migraine-specific abortive medications (triptans) is associated with a higher satisfaction rate than over-the-counter preparations, NSAIDs, and analgesic combinations. Patients who initially reported satisfaction with the latter medications also reported a preference for triptan therapy. Healthcare professionals can assist patients, not only by choosing the most appropriate medication but also by assessing whether the level of benefit the patient is currently receiving could be improved.

Analgesics↗
PubMed2005

Migraine therapy: a survey of pharmacists' knowledge, attitudes, and practice patterns.

OBJECTIVE: Study pharmacists' knowledge, attitudes, and practice patterns with regard to migraine therapy. BACKGROUND: Pharmacists interact with headache sufferers at least 53,000 times daily, thus are well positioned to improve the less than optimal medication management of these disorders. Methods.-Two hundred self-administered surveys, distributed at a migraine symposium, assessing pharmacists' demographic characteristics and level of agreement or disagreement with treatment approaches were conducted. RESULTS: A total of 171 useable surveys (86%) were received. Of the sample, 35% were community pharmacists, 29% were hospital pharmacists, and the remainder were from other work environments. Exclusively among community pharmacists, 80% feel that headache is an important part of their practice, 85% make between one and five over-the-counter (OTC) headache product suggestions per day, and 12% make six or more daily OTC recommendations. Among all the sample's pharmacists, more than half feel migraine patients should try OTC drugs prior to prescription medications, only half ask patients about headache-related morbidity, and one-third feel migraine-specific medications should be reserved only for patients who initially fail nonspecific drugs. Few pharmacists utilize published migraine treatment guidelines. Approximately two-thirds of pharmacists do not feel migraine is a neurobiological illness. The majority is comfortable with their ability to identify people needing a physician referral. CONCLUSIONS: Our results show pharmacists, particularly those in community pharmacies, interact with headache sufferers multiple times daily. Most pharmacists were neither familiar with nor practice migraine therapies endorsed by evidence-based guidelines. Further training of pharmacists is warranted.

Drug Prescriptions↗
PubMed2005

Treating early versus treating mild: timing of migraine prescription medications among patients with diagnosed migraine.

INTRODUCTION: Although research suggests that early treatment of migraine headache when the pain is mild results in better outcomes for patients, many patients delay taking their acute-migraine medication until their headaches are moderate or severe. Understanding when and why patients use their migraine medications is an important first step to improve migraine management. METHODS: A prospective observational study, conducted at a major national retail pharmacy chain with stores across the United States between April 2001 and November 2002, enrolled men and women between 18 and 55 years of age with a physician diagnosis of migraine with or without aura. Baseline data on 690 patients included patient demographics, migraine history, medication use, tendency to avoid or delay treatment of a migraine attack, and reasons for delaying treatment. Reasons for delaying treatment were assessed via a checklist of nine potential reasons. In the follow-up survey completed after treatment of the next migraine attack, patients reported the timing of medication use in relation to pain onset and the severity of the migraine headache at the time they took the medication. RESULTS: Despite the severity of their typical migraine attacks, approximately 49% of the respondents answered, "yes" to the question, "Do you often avoid or delay taking your migraine medications when you start to experience a migraine attack?" The two most common rationales for avoiding or delaying treatment were "wanting to wait and see if it is really a migraine attack" (69%) followed by "only want to take medications if it is a severe attack" (46%). In the follow-up survey, regardless of medication used, about 85% of patients did not treat their next migraine attack until the headache pain was moderate or severe, although 74% treated within 1 hour of pain onset. CONCLUSION: These results suggest that patients with migraine often delay their treatment until they have identified their attack as a migraine. In addition, while many patients treated their follow-up headache early, they did not treat when the pain was mild. This suggests that there is an opportunity for physicians to educate their migraine patients on how to differentiate migraine from other headache types and about when and how to use their acute-migraine medication.

Adolescent↗
PubMed2004

Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy.

OBJECTIVES: To determine the effect of botulinum toxin type A on calcitonin gene-related peptide secretion from cultured trigeminal ganglia neurons. BACKGROUND: The ability of botulinum toxins to cause muscle paralysis by blocking acetylcholine release at the neuromuscular junction is well known. Previous studies and clinical observations have failed to demonstrate sensory changes related to botulinum toxins or the disease of botulism. Recent studies, however, have suggested that botulinum toxin type A injected into pericranial muscles may have a prophylactic benefit in migraine. This observation has renewed the debate of a mechanism of sensory inhibition mediated by botulinum toxin type A. METHODS: Primary cultures of rat trigeminal ganglia were utilized to determine whether botulinum toxin type A could directly decrease the release of calcitonin gene-related peptide, a neuropeptide involved in the underlying pathophysiology of migraine. Untreated cultures or cultures stimulated with a depolarizing stimulus (potassium chloride) or capsaicin, an agent known to activate sensory C fibers, were treated for 3, 6, or 24 hours with clinically effective doses of botulinum toxin type A or a control vehicle. The amount of calcitonin gene-related peptide secreted into the culture media following the various treatments was determined using a specific radioimmunoassay. RESULTS: A high percentage (greater than 90%) of the trigeminal ganglia neurons present in 1- to 3-day-old cultures was shown to express calcitonin gene-related peptide. Treatment with depolarizing stimuli (potassium chloride), a mixture of inflammatory agents, or capsaicin caused a marked increase (4- to 5-fold) in calcitonin gene-related peptide released from the trigeminal neurons. Interestingly, overnight treatment of trigeminal ganglia cultures with therapeutic concentrations of botulinum toxin type A (1.6 or 3.1 units) did not affect the amount of calcitonin gene-related peptide released from these neurons. The stimulated release of calcitonin gene-related peptide following chemical depolarization with potassium chloride or activation with capsaicin, however, was greatly repressed by the botulinum toxin, but not by the control vehicle. A similar inhibitory effect of overnight treatment with botulinum toxin type A was observed with 1.6 and 3.1 units. These concentrations of botulinum toxin type A are well within or below the range of tissue concentration easily achieved with a local injection. Incubation of the cultures with toxin for 24, 6, or even 3 hours was very effective at repressing stimulated calcitonin gene-related peptide secretion when compared to control values. CONCLUSIONS: These data provide the first evidence that botulinum toxin type A can directly decrease the amount of calcitonin gene-related peptide released from trigeminal neurons. The results suggest that the effectiveness of botulinum toxin type A in the treatment of migraine may be due, in part, to its ability to repress calcitonin gene-related peptide release from activated sensory neurons.

Animals↗
PubMed2004

Inpatient treatment of headache: an evidence-based assessment.

OBJECTIVE: To evaluate inpatient treatment of headache in the United States. PARTICIPANTS: Participants were selected by the meeting chairpersons, Drs. Diamond and Silberstein as well as Dr. Freitag. Criteria for selection included participation in an inpatient treatment program, headache specialists not affiliated with an inpatient treatment program, clinician with interest in headache but not affiliated with a dedicated headache treatment program. The single meeting held in New York was by invitation only. All invitees were provided with opportunity to present their views and participate in the recommendations of the Consortium. The list of participants at the meeting were: Harvey Blumenthal, MD, Roger Cady, MD, James Couch, MD, Seymour Diamond, MD, Frederick G. Freitag, DO, R. Michael Gallagher, DO, Al Lake III, PhD, Richard Lipton, MD, NinanMathew,MD, Alan Rapoport, MD, Jay Rosenberg, MD, Joel Saper, MD, Stephen Silberstein, MD. Funding for theproject was provided by the US Headache Guidelines Consortium Project through the American Academy of Neurology and the National Headache Foundation. EVIDENCE: Each of the authors were part of the writing committee each with specific areas that they were responsible for conducting the literature reviews and submitting a portion of the original document for editing and review. Dr. Freitag coordinated this process and assembled the first draft of the article for circulation and review among the authors and chairpersons. In the absence of class I evidence consensus expert opinion was fundamental to the process. CONCLUSIONS: The treatment of headache is commonly delivered in the outpatient office environment. There exists a group of patients who have been refractive to outpatient treatment and in whom in patient care may be appropriate. The factors that determine the optimal treatment setting, the methodology of the treatment and the results of such treatment have come under increasing scrutiny secondary to the cost of treatment in the hospital. The US Headache Consortium guidelines project in conjunction with the national headache foundation believed that the need existed to objectively examine the issues surrounding inpatient treatment. The epidemiology of chronic headache is important to understand in this context since essentially all patients that are treated in hospital have high frequency headache often associated with significant disability. This severity of illness produces both health care costs but also is responsible for significant impact on businesses and the economy. The method of treatment of headache in the hospital environment can follow several paths based on the accessibility of the resources specific to headache treatment. While there exist these differing paths of treatment only treatment in a dedicated headache treatment unit has been investigated in depth here in the US though reports from other countries that do not have dedicated inpatient treatment lends support to options in headache treatment. Some have suggested that inpatient treatment is not required even in recidivist patients and limited reports have examined aggressive outpatient treatment as an option in headache management. None of the studies reported to date provide class one evidence for efficacy either inpatient or outpatient. Recommendations are made to assess headache treatment in patients with high frequency headaches to garner better scientific evidence for differing treatment approaches.

Adult↗
PubMed2004

Rizatriptan 5 mg for the acute treatment of migraine in adolescents: results from a double-blind, single-attack study and two open-label, multiple-attack studies.

OBJECTIVE: To examine the short- and long-term efficacy and tolerability of rizatriptan 5 mg in adolescents with migraine. METHODS: Two studies were conducted in patients aged 12 to 17 years. The first study was a randomized, double-blind, placebo-controlled, single-attack study followed by a randomized, 1-year, open-label extension. The second study was a randomized, 1-year, open-label study. In the single-attack study, patients treated a moderate or severe migraine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234) or placebo (n = 242). Patients were instructed to use the study medication only on nonschool days. Headache severity, associated symptoms, and functional disability were assessed by the patient at 0.5, 1, 1.5, 2, 3, and 4 hours after the initial dose. In the 1-year studies, patients treated up to 6 migraine attacks per month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. RESULTS: In the single-attack study, the proportion of patients with pain relief at 2 hours was not significantly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer patients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significantly higher in the rizatriptan group than in the placebo group (74% vs. 58%, P = 0.022). In the multiple-attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not significantly different from that of placebo or standard care. CONCLUSIONS: Rizatriptan 5 mg was not more effective than placebo in the treatment of a single migraine attack in adolescents, but appeared to be more effective than standard care for treating multiple attacks occurring over 1 year in these patients. Rizatriptan 5 mg was well tolerated in adolescents during short-term and long-term use.

Acute Disease↗
PubMed2004

Migraine treatment with rizatriptan and non-triptan usual care medications: a pharmacy-based study.

OBJECTIVE: To compare the effectiveness of rizatriptan to other non-triptan medications in the relief of migraine headache in usual care settings. BACKGROUND: Although rizatriptan has been shown to provide effective relief of migraine symptoms in clinical trials, limited data exist directly comparing its effectiveness with non-triptan medications. METHODS: Migraineurs aged 18 to 55 who had been prescribed a new antimigraine drug (rizatriptan 10 mg or a selected class of non-triptan oral medications) were recruited to participate in the study through a national retail pharmacy chain. Participants completed a baseline questionnaire at the enrollment and reported their treatment experiences by filling out the treatment diary after using the newly prescribed medication. The treatment outcomes of patients receiving rizatriptan were compared with those receiving non-triptan medications. Logistic regression analysis was applied to test statistical significance with adjustment for potential confounding factors. RESULTS: Of the 728 patients who entered the study, 693 (95.2%) completed the treatment diary. Patients treated with rizatriptan (192) and non-triptans (501) reported the following outcomes, respectively--onset of headache relief within 30 minutes post-dose: 25% versus 18%; self-defined significant headache relief within 2 hours post-dose: 71% versus 54%; pain free or mild pain at 2 hours post-dose: 58% versus 47%; completely symptom-free within 2 hours of post-dose: 32% versus 20%; return to usual activities within 2 hours post-dose: 39% versus 35%; and satisfied with treatment: 67% versus 55% (P <.05 in all comparisons with exception of returning to usual activities). CONCLUSION: Rizatriptan was significantly more effective than non-triptans in the relief of migraine headaches for patients obtaining prescribed migraine medications from a retail pharmacy. Additional studies at other usual care settings may be needed to confirm the findings.

Acute Disease↗
PubMed2004

Randomized, placebo-controlled comparison of early use of frovatriptan in a migraine attack versus dosing after the headache has become moderate or severe.

OBJECTIVE: To evaluate whether frovatriptan would provide greater relief if given early during a migraine attack. RESEARCH DESIGN AND METHODS: Adults with a history of migraine of at least 1 year, and who had 2-8 headaches in the previous month were recruited from 19 US centres for a prospective, placebo-controlled crossover study over 2 migraine attacks. Dose 1 was taken at the onset of mild migraine headache, Dose 2 was taken at least 2 h later if the headache progressed to moderate/severe. Patients were randomized to receive Dose 1 frovatriptan then Dose 2 placebo or Dose 1 placebo followed by Dose 2 frovatriptan. Treatment order was reversed for the second attack. This schedule enabled a comparison of frovatriptan with placebo and a comparison of early and later treatment with frovatriptan. MAIN OUTCOME MEASURES: Freedom from pain at 2 h for frovatriptan versus placebo as Dose 1; use of Dose 2 and/or rescue medication, pain severity, functional impairment and headache recurrence. RESULTS: In 241 patients who each treated 2 migraine attacks, Dose 1 frovatriptan was more effective than placebo in terms of the proportion of patients who were pain free at 2 h (28% vs 20%, p = 0.04). This benefit was sustained up to 4 h post-dose (p = 0.003). Early use of frovatriptan significantly reduced re-medication (p < 0.001). Twenty-four-hour headache recurrence was low in both early (4%) and later use (6%) groups. Sustained pain-free response occurred in 40% of frovatriptan early use patients compared with 31% of later use patients (p < 0.05). Early use prevented headache progression: 69%-78% had mild/no headache 2-4 h after Dose 1 frovatriptan compared with 54%-63% taking Dose 1 placebo (p < 0.001). Early use reduced pain burden and functional disability (p < or = 0.001). More patients rated early use of frovatriptan as excellent or good (57% vs 46%). CONCLUSIONS: Early use of frovatriptan resulted in a higher, earlier and sustained pain-free response, prevented progression to moderate/severe headache and reduced pain burden and functional disability.

Adult↗
PubMed2004

Migraine headache misconceptions: barriers to effective care.

Migraine headaches affect 12% of the adult population in the United States and cause a significant economic loss due to decreased workplace productivity Although interactions between pharmacists and individuals with headache are common, few pharmacists receive adequate training regarding migraine therapy. We refute several misconceptions that hinder effective care, such as that migraine is a vascular disease, triptans cause rampant cardiacrelated morbidity and even mortality, a best oral triptan exists, sinus and tension headaches are prevalent, and migraine is a minor economic problem. Our pathophysiologic understanding demonstrates that migraine is a neurologic process of the trigeminovascular system, of which vascular effects are secondary. This process can result in a myriad of clinical signs and symptoms, often leading to a misdiagnosis of sinus or tension headache. The last decade's experience with triptans in more than half a billion people worldwide reveals a benign adverse-effect profile, particularly when taken early in an attack. Published reports and real-world experiences illustrate that these drugs do not merit fears of triptan-induced cardiac consequences in appropriately selected individuals. Society's productivity loss due to migraine is measured in billions of dollars. Restoring a patient's ability to function normally is now recognized as the primary treatment goal, not merely relieving pain. Thus, the overreliance on "pain killer" drugs such as butalbital-containing products and the continued underutilization of migraine-specific drugs need to be addressed. Opportunities exist for pharmacists and other health care providers to dispel continually propagated migraine misconceptions and familiarize themselves with advances in therapy. Such actions will benefit patients, the health care system, and society as a whole.

Adult↗
PubMed2003

An open-label study to assess changes in efficacy and satisfaction with migraine care when patients have access to multiple sumatriptan succinate formulations.

BACKGROUND: Because a patient's migraines often differ in duration, intensity, and accompanying symptoms, as well as the conditions and circumstances at the time of the headache, the mode for treatment also may change. OBJECTIVE: The goal of this study was to determine whether migraine management is improved by providing 3 formulations of sumatriptan succinate to patients, together with education to assist them in selecting the most appropriate formulation for specific attacks. METHODS: This was an open-label study conducted in 3 family practice settings. Patients were recruited who had at least a 1-year history of migraine meeting International Headache Society criteria and experienced 2 to 6 attacks per month within the previous 3 months. Patients received instructions on oral, intranasal, and subcutaneous (SC) sumatriptan and were provided with all 3 formulations to treat 6 headaches. Migraine features, formulation used, reason for selecting specific formulation, migraine symptom relief, and use of follow-up doses were recorded in diaries. At follow-up, patients completed a questionnaire assessing satisfaction with access to multiple formulations. RESULTS: Of the 33 enrolled patients (26 women, 7 men; mean age, 38.5 years [range, 23-54 years]), 25 (75.8%) completed all visits. Of 149 headaches treated, 39 (26.2%) were mild at onset, 70 (47.0%) were moderate, and 40 (26.8%) were severe. Eighty (53.7%) headaches were treated with tablets, 35 (23.5%) with nasal spray, and 34 (22.8%) with SC injection. Primary reasons for selecting specific formulations included "fewer side effects" for tablets, "convenience" for nasal spray, and "quick onset of action" for SC injection. Twenty-one (84.0%) patients reported being either very satisfied or satisfied with their ability to manage their headaches. Physicians reported that 18 of 24 (75.0%) patients had an improved attitude toward managing their headaches. All formulations were well tolerated. Eight (32.0%) patients reported adverse events, the 2 most common being chest pressure and fatigue. CONCLUSION: The patients in this study reported greater satisfaction with migraine management when given access to multiple sumatriptan formulations and education regarding their appropriate use.

Administration, Intranasal↗
PubMed2002

Primary headaches: a convergence hypothesis.

After reviewing the historic differentiation between migraine and tension-type headache, the authors note that the similarities between these two types of primary headaches outweigh the differences, and so hypothesize that these headaches share a common pathophysiology. The convergence hypothesis for primary headaches links the clinical features of an evolving headache to current pathophysiological models. The authors suggest that successive symptoms experienced clinically reflect an escalating pathophysiological process, beginning with the premonitory period and progressing into tension-type headache and, if uninterrupted, finally into migraine. The clinical manifestations of other headache types, such as so-called sinus headache or temporomandibular headache, may also be explained by this model. A convergence hypothesis for primary headaches has important implications for earlier recognition, diagnosis, and treatment.

Diagnosis, Differential↗