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P Winner

Publications and source records attributed to P Winner.

18 recordsLinked to original sources
PubMed2004

Randomized, placebo-controlled trial of rofecoxib in the acute treatment of migraine.

OBJECTIVE: To investigate the clinical profile of rofecoxib, a long-acting (approximately 17-hour half-life) selective cyclo-oxygenase-2 inhibitor, for the acute treatment of migraine. METHODS: A randomized, double-blind, placebo-controlled, parallel-group study was conducted. Patients age > or =18 treated a moderate or severe migraine headache with placebo (n = 182), rofecoxib 25 mg (n = 183), or rofecoxib 50 mg (n = 192). The primary efficacy measure was headache relief (mild or no pain) 2 hours after dose. RESULTS: The proportions of patients with migraine headache relief at 2 hours after dose were 34.3% for placebo, 54.0% for rofecoxib 25 mg (p < 0.001 vs placebo), and 56.7% for rofecoxib 50 mg (p < 0.001 vs placebo). Rofecoxib 25 and 50 mg were superior to placebo in providing pain freedom at 2 hours, 24-hour sustained headache relief, and 24-hour sustained pain freedom; in reducing photophobia, phonophobia, nausea (50 mg only), and functional disability at 2 hours after dose; and in improving some quality-of-life scores over 24 hours. More patients on rofecoxib 50 mg reported adverse events (39.6%) than patients on rofecoxib 25 mg (26.8%) or placebo (23.6%) regardless of drug relatedness; however, the incidences of drug-related adverse events were similar between treatment groups. These adverse events were generally mild or moderate in severity. The most commonly reported adverse events were dry mouth, dizziness, somnolence, nausea, dyspepsia, paresthesia, and asthenia, with similar incidences between treatment groups. CONCLUSION: Rofecoxib 25 and 50 mg were effective and generally well tolerated for the acute treatment of migraine attacks.

Acute Disease↗
PubMed2003

Demographic and migraine characteristics of adolescents with migraine: Glaxo Wellcome clinical trials' database.

OBJECTIVE: To describe the demographics and migraine characteristics of patients in the Glaxo Wellcome adolescent clinical trials' database. METHODS: Data from 8 sumatriptan (tablet and nasal spray) and naratriptan (tablet) trials (6 placebo controlled and 2 open label) were reviewed. Adolescents aged 12 to 17 years who had participated in migraine clinical trials and used at least 1 dose of study medication were summarized using descriptive statistics. Patient demographic (gender, age, race, height, and weight) and migraine (diagnosis, pain location and intensity, time and day of migraine onset and treatment, and associated symptoms) characteristics were examined. RESULTS: One thousand nine hundred thirty-two adolescents with migraine were identified; mean age was 14.1 years (standard deviation, 1.64; range, 11 to 18) and 54% of patients were female. More males were represented in the 12- to 14-year-old group (646 [73%] of 885) than in the 15- to 17-year-old group (234 [26%] of 885). Most patients reported migraine without aura (67%, 1121 of 1672), unilateral migraine pain (58%, 458 of 787), and pulsating pain (74%, 582 of 790). Migraine was aggravated by physical activity in most of the adolescents (88%, 526 of 598). Most migraine attacks (73%, 1363 of 1858) began between 6 am and 6 pm, and proportionately more attacks occurred Monday through Wednesday. Pretreatment vomiting was experienced by 5% (97 of 1830) of patients, nausea by 53% (983 of 1849), and photophobia or phonophobia (or both) by 88% (1628 of 1858) of patients. The incidence of associated symptoms was directly related to pretreatment headache severity. CONCLUSIONS: In this large clinical trials' database, adolescents had migraine without aura characterized by unilateral and pulsating pain and aggravated by activity. The incidence of associated symptoms was directly related to pretreatment pain intensity. More migraines occurred Monday through Wednesday during typical school hours. These data may facilitate clinicians' efforts to tailor migraine therapy to the needs of this patient population.

Adolescent↗
PubMed2001

Pediatric headache.

Headaches are frequent in children and adolescents and at times can be extremely disabling. Disability scales, such as the MIDAS scale, have been useful in helping follow adult patients. Modifications of this scale have been helpful in following pediatric and adolescent patients. Greater attention has been paid to epidemiology and classification of headache in children. Studies are being done on serotonin 1B/1D agonist for treating acute migraine, and this agent has been found to be efficacious despite a high placebo response. It is anticipated that FDA approval of sumatriptan nasal spray in adolescents is forthcoming. Despite advancements, there is no wonder drug. There continues to be a need for studying preventive therapies in a double-blind, placebo-controlled environment, and plans are under way for such studies. Many adult patients with chronic daily headaches report that their headaches began in childhood and adolescence. A better understanding of diagnostic criteria, early diagnosis, and more effective treatment may be the key to influencing the prevalence of headaches in adults. Continued research is the only answer to the questions raised by the most recent studies in this population.

Adolescent↗
PubMed2001

Development of a brief 24-hour adolescent migraine functioning questionnaire.

The objective was to develop a brief questionnaire to assess short-term functioning decrements in adolescents with acute migraine. One hundred twenty-three potential items were generated by literature review and by interviewing adolescent migraineurs and migraine specialists. To reduce the items, 127 adolescents were asked to identify which items affected their daily functioning in the 24 hours following onset of a migraine, and to rate them on a 5-point scale from "not very important" to "extremely important." Reduction to an 18-item questionnaire was performed by evaluating subject-perceived importance (number of times an item was chosen times mean importance score) in combination with principal components factor analysis. Five domains were identified: (1) activities, (2) social functioning, (3) cognitive functioning, (4) migraine headache symptoms, and (5) emotional functioning. Questions regarding school loss and school performance during a migraine were added to the final questionnaire as a separate outcome measure. The correlation between the five domains as measured by the Spearman correlation coefficient ranged from 0.17 to 0.49 suggesting some, but minimal, overlap. Cronbach alpha for individual domains ranged from.50 to.84. The questionnaire was pilot-tested in 12 adolescent migraineurs to determine ease of administration and comprehension and revised to improve clarity.

Acute Disease↗
PubMed2001

Development and validation of the Headache Needs Assessment (HANA) survey.

OBJECTIVE: To develop and validate a brief survey of migraine-related quality-of-life issues. The Headache Needs Assessment (HANA) questionnaire was designed to assess two dimensions of the chronic impact of migraine (frequency and bothersomeness). METHODS: Seven issues related to living with migraine were posed as ratings of frequency and bothersomeness. Validation studies were performed in a Web-based survey, a clinical trial responsiveness population, and a retest reliability population. Headache characteristics (eg, frequency, severity, and treatment), demographic information, and the Headache Disability Inventory were used for external validation. RESULTS: The HANA was completed in full by 994 adults in the Web survey, with a mean total score of 77.98 +/- 40.49 (range, 7 to 175). There were no floor or ceiling effects. The HANA met the standards for validity with internal consistency reliability (Cronbach alpha =.92, eigenvalue for the single factor = 4.8, and test-retest reliability = 0.77). External validity showed a high correlation between HANA and Headache Disability Inventory total scores (0.73, P<.0001), and high correlations with disease and treatment characteristics. CONCLUSIONS: These data demonstrate the psychometric properties of the HANA. The brief questionnaire may be a useful screening tool to evaluate the impact of migraine on individuals. The two-dimensional approach to patient-reported quality of life allows individuals to weight the impact of both frequency and bothersomeness of chronic migraines on multiple aspects of daily life.

Activities of Daily Living↗
PubMed2001

Triptans in childhood and adolescence.

The triptans are medications that are the most important advance, to date, in the treatment of migraine. Their use in adolescents is highlighted, including indications, dosages, benefits, and adverse effects.

Administration, Intranasal↗
PubMed2000

One-year tolerability and efficacy of sumatriptan nasal spray in adolescents with migraine: results of a multicenter, open-label study.

OBJECTIVE: The objective of this study was to determine the 1-year tolerability and efficacy of sumatriptan nasal spray (NS) at doses of 5, 10, and 20 mg for the treatment of acute migraine in adolescents. METHODS: This was a prospective, multicenter, open-label, 1-year, multiple-attack study. Adolescents (aged 12-17 years) with a > or =6-month history of migraine with or without aura, 2 to 8 moderate or severe migraines per month, and a typical migraine duration of > or =4 hours were eligible for participation. After initial treatment with sumatriptan 10 mg, the dose could be adjusted down to 5 mg or up to 20 mg at the investigator's discretion to optimize tolerability or efficacy. Patients could treat an unlimited number of moderate or severe migraine attacks, provided there was a 24-hour headache-free period between treated attacks and a 2-hour period between doses of sumatriptan NS. A second dose of sumatriptan NS was available for headache recurrence 2 to 24 hours after initial treatment; no more than 2 doses could be used within a 24-hour period. Adverse events, vital signs, electrocardiographic and physical findings, and laboratory variables were assessed. Headache response (reduction of moderate/severe predose pain to mild/no pain) and pain-free response (reduction of moderate/severe predose pain to no pain) were reported by patients 2 hours after dosing. RESULTS: A total of 437 patients treated > or =1 migraine; 3272 total attacks were treated, with 3675 drug exposures (mean, 1.1 dose/attack). Patients had a mean age of 14.1 years, 91% were white, and 53% were female. Seven patients used the 5-mg dose; meaningful conclusions concerning this dose could not be made. Drug-related adverse events were reported in 33% of attacks with the 10-mg dose and 31% with the 20-mg dose; most were related to taste disturbance. Adverse events did not increase with a second dose or over time. Four percent (16/437) of patients withdrew due to drug-related adverse events. One serious adverse event, a facial-nerve ischemic event (10-mg dose), was considered drug related. No drug-related changes in vital signs or electrocardiographic findings were observed. Headache response 2 hours after dosing was reported by 76% of patients taking the 10-mg dose and 72% of those taking the 20-mg dose. Pain-free response 2 hours after dosing was reported by 43% and 40% of patients in the 10- and 20-mg groups, respectively. CONCLUSIONS: Based on these results, sumatriptan NS at doses of 10 and 20 mg was well tolerated and effective in the 1-year treatment of multiple migraine attacks in adolescents.

Administration, Intranasal↗
PubMed2000

A randomized, double-blind, placebo-controlled study of sumatriptan nasal spray in the treatment of acute migraine in adolescents.

OBJECTIVE: To compare the efficacy and tolerability of sumatriptan nasal spray (NS; 5 mg, 10 mg, and 20 mg) with placebo for the treatment of acute migraine in adolescents. METHODS: A randomized, double-blind, placebo-controlled, single-attack study was conducted in 653 US adolescents (12-17 years of age). Patients with at least a 6-month history of migraine, who met International Headache Society criteria for migraine (with or without aura) were eligible for participation. Headache relief 2 hours postdose, complete relief, presence or absence of associated symptoms, headache recurrence, and use of rescue medications were recorded. The primary efficacy endpoint was headache relief 2 hours postdose sumatriptan NS (20 mg) versus placebo. Safety and tolerability were assessed by examining adverse events, changes in electrocardiograms, vital signs, physical examinations, and clinical laboratory tests. RESULTS: Headache relief 1 hour postdose was significantly greater for patients using 10 mg (56%) and 20 mg (56%) of sumatriptan NS compared with placebo (41%). Headache relief 2 hours postdose was significantly greater for patients using 5 mg of sumatriptan NS (66%) compared with placebo (53%), and approached statistical significance for 20 mg (63%) compared with placebo (53%). Complete relief 2 hours postdose was significantly greater for patients using 20 mg of sumatriptan NS compared with placebo (36% vs 25%, respectively). Each dose of sumatriptan (5 mg, 10 mg, and 20 mg) was superior to placebo with respect to the cumulative percentages of patients first reporting headache relief within 2 hours of dosing (Kaplan-Meier). The sumatriptan 20-mg dose was superior to placebo with respect to the cumulative percentages of patients first reporting complete relief within 2 hours of dosing (Kaplan-Meier). Photophobia and phonophobia were significantly reduced 2 hours postdose for sumatriptan NS (20 mg), compared with placebo (36% vs 48% and 25% vs 44%, respectively). Taste disturbance was the most commonly reported adverse event (2%, 19%, 30%, and 26% for placebo, 5 mg, 10 mg, and 20 mg, respectively). No drug-related serious adverse events or clinically relevant changes in laboratory parameters, electrocardiograms, or vital signs were reported. CONCLUSIONS: Sumatriptan NS is effective and well-tolerated for the treatment of acute migraine in adolescents, with the 20-mg dose providing the best overall efficacy and tolerability profiles.

Acute Disease↗
PubMed1999

Pediatric headaches: what's new?

The evolution of headache from childhood into adulthood is receiving greater attention as questions arise regarding prevalence and long-term remission rates. Presenting symptoms of headache in childhood and adolescence tend to differ from those in adults, making it difficult to obtain high sensitivity ratings using the present standard International Headache Society criteria specifically with regard to migraine. The new treatment options that have been available for adults for several years are now being studied in childhood and adolescent populations. Are they safe and effective, and is there a need to alter dosages in this population? The interest in chronic daily headache in childhood and adolescence is increasing because studies in this population may help us to advance our knowledge with regard to adult chronic daily headache.

Adolescent↗
PubMed1997

Multicenter prospective evaluation of proposed pediatric migraine revisions to the IHS criteria. Pediatric Headache Committee of the American Association for the Study of Headache.

Eighty-eight children and adolescents were prospectively evaluated at eight specialty clinics comparing the diagnostic criteria of the International Headache Society (IHS) and the proposed revised (IHS-R) classification to the clinical diagnosis. The proposed revisions to the IHS classification for pediatric migraine include: duration-1 hour to 48 hours; location--bifrontal/bitemporal or unilateral; and symptoms--to include photophobia or phonophobia. A comparison of the diagnostic rates of pediatric migraine with and without aura of the total sample revealed IHS (66%) versus IHS-R (93%) and comparison of a subset of those patients less than 12 years of age (n = 39) revealed IHS (49%) versus IHS-R (87%). Significant improvement in the diagnostic sensitivity of migraine in the pediatric population was obtained by specific modifications to the IHS criteria pertaining to duration, location, and the symptoms of photophobia and phonophobia in an ongoing multicenter prospective study. These revisions may help to form the basis for future research guidelines and for further modifications to improve the diagnostic sensitivity of pediatric migraine maintaining the IHS model.

Adolescent↗
PubMed1996

A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine.

OBJECTIVE: To assess the efficacy and tolerability of subcutaneous dihydroergotamine mesylate (DHE-45) vs subcutaneous sumatriptan succinate (Imitrex) for the treatment of acute migraine with or without aura. DESIGN: Double-blind, randomized trial with parallel treatment arms. SETTING: Clinics and private neurology practices. SUBJECTS: Patients of either sex, with migraine with or without aura, between the ages of 18 and 65 years. INTERVENTIONS: Patients with moderate or severe head pain were randomized to receive either 1 mg of subcutaneous dihydroergotamine mesylate or 6 mg of subcutaneous sumatriptan succinate. Patients rated head pain, functional ability, nausea, and vomiting at baseline and at 0.5, 1, 2, 4, and 24 hours after the injection. Presence or absence of headache at 3 hours was calculated from collected data. If pain persisted after 2 hours, a second injection of the same study medication was allowed, and self-ratings were repeated 30 and 60 minutes later. Follow-up data were collected at 24 hours. MAIN OUTCOME MEASURES: Relief of head pain and recurrence of successfully treated headache. RESULTS: There were 295 evaluable patients. At 2 hours, 73.1% of the patients treated with dihydroergotamine and 85.3% of those treated with sumatriptan had relief (P = .002). There was no statistical difference in headache relief between the groups at 3 or 4 hours. Headache relief was achieved by 85.5% of those treated with dihydroergotamine and by 83.3% of those treated with sumatriptan by 4 hours. By 24 hours 89.7% of dihydroergotamine-treated patients and 76.7% of sumatriptan-treated patients had relief (P = .004). Headache recurred within 24 hours after treatment in 45% of the sumatriptan-treated patients and in 17.7% of the dihydroergotamine-treated patients (P < or = .001). CONCLUSIONS: Both sumatriptan and dihydroergotamine were effective in aborting migraine headaches. Headache recurrence was two and a half time as likely with sumatriptan as with dihydroergotamine.

Acute Disease↗
PubMed1996

Idiopathic intracranial hypertension in a young child without visual symptoms or signs.

A 7-year-old boy presented with a 4-week history of daily headache. His parents reported that he was unable to attend school the week prior to presentation. Intermittent nausea without vomiting was reported, but no blurred vision, photophobia, or diplopia were described. There was no history of trauma or recent systemic illness. The physical examination showed mild neck discomfort, no papilledema, and normal cranial nerve, motor and sensory functioning. Both a CT scan of the sinuses and an MRI of the brain were normal. Although the opening pressure was elevated, the cerebrospinal fluid was also normal. In previous accounts of idiopathic intracranial hypertension in children, concomitant papilledema, visual symptoms and/or palsy of the sixth cranial nerve are described. This case demonstrates that idiopathic intracranial hypertension in a young child can present as a daily headache without any visual symptoms or signs.

Acetazolamide↗
PubMed1994

Concomitant administration of antiemetics is not necessary with intramuscular dihydroergotamine.

The influence of concomitant administration of an antiemetic agent on the course of nausea was assessed in a field trial of intramuscular dihydroergotamine for the treatment of acute migraine. Of 311 migraine patients enrolled onto the study, 62% (191 of 311) experienced nausea at the outset; 38% (119 of 311) did not. Of those with nausea at the outset, 54% (103 of 191) received an antiemetic. Of those without nausea at the outset, 25% (30 of 119) received an antiemetic. Thus, a total of 43% (133 of 311) of patients received a concomitant antiemetic, whereas 57% (177 of 311) received dihydroergotamine alone. When changes in the incidence of nausea were compared at 30 and 60 minutes after dihydroergotamine, an antiemetic effect was discerned in patients treated with or without a concomitant antiemetic. Antiemetic treatment yielded no significant difference in the percentage of patients experiencing nausea during the study. At baseline, 50% (88 of 177) of patients who received dihydroergotamine alone experienced nausea compared with 77% (103 of 133) of those who received an antiemetic. At the 30-minute point, 35% (61 of 173) of patients who received dihydroergotamine alone still experienced nausea versus 47% (62 of 133) of patients who received an antiemetic. At the 60-minute point, only 24% (42 of 174) of those given dihydroergotamine alone had nausea, compared with 38% (50 of 132) given concomitant antiemetic. Ongoing nausea seems to be a manifestation of the migraine process rather than an adverse effect associated with intramuscular dihydroergotamine.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1993

Office-based treatment of acute migraine with dihydroergotamine mesylate.

The Regional Migraine Field Trial assessed the efficacy and safety of dihydroergotamine mesylate (D.H.E. 45) for migraine in the office setting. Patients were admitted to the study provided they met the International Headache Society definition of migraine with or without aura. Thirty-eight neurologists enrolled 311 patients (274 women and 37 men) between the ages of 13 and 70 years in this open-design study. Ninety-five percent of the patients had moderate or severe headache pain at entry, and 62% had nausea. All patients received a single intramuscular injection of D.H.E. 45 1 mg. A second intramuscular injection of 1 mg was given 60 minutes after the first injection, if needed. An antiemetic was administered concomitantly with D.H.E. 45, if needed. Rescue therapy was given at the investigators' discretion. Efficacy was judged by the relief of pain, patients' ability to function, need for a second injection, need for rescue medication, and need for an antiemetic. At 30 and 60 minutes, 46% and 72% of patients had only mild or no head pain, respectively. At 24 hours, 77% of all patients had mild or no head pain. D.H.E. 45 also improved functional ability. At 30 and 60 minutes, 58% and 75% of patients had only mild or no disability, respectively. At 24 hours, 81% had mild or no impairment. Nausea was present in 62% of patients at the outset, 40% of patients at 30 minutes, and 30% at 60 minutes. An antiemetic was given to 43% of patients at the outset. The presence of nausea was similar whether or not patients received an antiemetic.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMedDate not supplied

Chronic daily headache in children and adolescents: current status and recommendations for the future. Pediatric Committee of the American Association for the Study of Headache.

The Pediatric Committee of the American Association for the Study of Headache was created in 1994 to develop a plan for comprehensively addressing global issues of headache in childhood. It was the impression of clinicians and researchers with an interest in childhood headaches that a clearer focus was needed to facilitate progress in the study and management of pediatric headache. It was further felt that approaches to treatment and outcomes, as well as assessment and classification schema for pediatric patients needed to be examined separately. The goal of the committee is to integrate anecdotal, clinical, and research expertise into a plan for addressing headaches in the pediatric population in the future. During the last 5 years, substantial attention has been devoted to chronic daily headache, primarily in adult populations. It is the purpose of this paper to review the literature of chronic daily headache in children, and propose areas for further exploration, given the recent emergence of interest in this diagnostic entity.

Adolescent↗
PubMedDate not supplied

Comparison of butorphanol nasal spray and fiorinal with codeine in the treatment of migraine.

Butorphanol tartrate is a synthetic mixed agonist-antagonist opioid analgesic. Its transnasal dosage form, which may be self-administered when the use of an opioid analgesic is appropriate, was previously shown to provide rapid relief of migraine pain. In this double-blind, parallel-group, outpatient study, we compared butorphanol nasal spray 1 mg followed in 1 hour by an optional second 1-mg dose with the orally administered analgesic, Fiorinal with Codeine (one capsule containing butalbital 50 mg, caffeine 40 mg, aspirin 325 mg, and codeine phosphate 30 mg). Patients (N=321) were assigned by randomization to one of two treatment groups (butorphanol or Fiorinal with Codeine) and instructed to self-administer medication when migraine pain reached an intensity of moderate or severe and to record study-related events in a diary for 24 hours posttreatment. Efficacy analyses were performed on data from 275 patients who took study medication and returned a patient diary; 136 in the butorphanol group and 139 in the Fiorinal with Codeine group. During the first 2 hours after treatment, butorphanol was more effective than Fiorinal with Codeine in treating migraine pain as measured by pain intensity difference scores, percentage of responders (pain decreased to mild or none), percentage of pain-free patients, and degree of pain relief, with a more rapid time to onset of 15 minutes. A similar percentage of patients in the two groups used rescue medication during the first 4 hours, after which more butorphanol-treated than Fiorinal with Codeine-treated patients used rescue medication. Butorphanol patients had more side effects, less improvement in digestive symptoms, and less improvement in functional ability than Fiorinal with Codeine patients.

Administration, Intranasal↗
PubMedDate not supplied

Classification of pediatric migraine: proposed revisions to the IHS criteria.

The International Headache Society classification lends itself to modification to significantly improve the diagnostic sensitivity of migraine in the pediatric population. Children and adolescents require special modifications relating to duration, location, quality of intensity, and symptoms related to photophobia and phonophobia. We propose specific criteria for pediatric migraine with and without aura which are more sensitive. Forty-five children and adolescents seen at a headache center were evaluated, retrospectively, comparing diagnostic criteria of the International Headache Society, Vahlquist, and the proposed revised IHS classification for clinical diagnosis by a single examiner (pediatric neurologist)--comparing diagnostic rates for migraine of the total sample: IHS (53%), Vahlquist (69%), and IHS-R (80%) and evaluating a subset of those patients less than 12 years (n = 22): IHS (50%), Vahlquist (68%), and IHS-R (73%). The proposed revisions to IHS for pediatric migraine were more sensitive than existing criteria. These revisions may help to form the basis for future research guidelines and for further modifications to improve the diagnostic sensitivity of pediatric migraine using the IHS model.

Adolescent↗