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1.
Int J Clin Pract ; 62(12): 1889-99, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19166436

RESUMO

AIMS: To evaluate treatment satisfaction, efficacy and functional ability of the rapid release formulation of sumatriptan 100 mg tablets (sumatriptan RT 100 mg) in an early intervention paradigm in patients who were dissatisfied with low-dose sumatriptan and not completely satisfied with their current migraine regimen. METHODS: Experienced migraineurs who reported a mild migraine pain phase, dissatisfaction with the previous sumatriptan treatment and some dissatisfaction with their current treatment regimen had no experience with sumatriptan at the 100 mg dose were enrolled in an open-label, single group study. Subjects were instructed to treat four migraine attacks within 30 min of the onset of mild pain. Treatment satisfaction was measured with the Patient Perception of Migraine Questionnaire Revised version (PPMQ-R) questionnaire. RESULTS: More than half of the subjects were either very satisfied or satisfied with the efficacy of early intervention sumatriptan RT 100 mg after each attack and at the follow-up study visit. The mean total PPMQ-R score was 75.2 out of 100. Between 63% and 73% of subjects were pain-free within 4 h of dosing. Between 79% and 90% of subjects reported an ability to function normally within 4 h of taking the study medication. CONCLUSION: Subjects who were previously unsatisfied with lower doses of sumatriptan and less than very satisfied with their current treatment regimen were more likely to be satisfied or very satisfied with sumatriptan RT 100 mg in an early intervention paradigm. Results were consistent across four migraine attacks and at a follow-up visit. The treatment satisfaction results corresponded with positive results on efficacy measures and a functional status measure.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Satisfação do Paciente , Agonistas do Receptor de Serotonina/administração & dosagem , Sumatriptana/administração & dosagem , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Comprimidos , Resultado do Tratamento , Adulto Jovem
2.
Neurology ; 58(9 Suppl 6): S27-31, 2002 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-12011271

RESUMO

Article abstract Migraine is a heterogeneous condition that causes symptoms that vary both among individuals and within individuals from attack to attack. We examined and reviewed several important lessons on the diagnosis of migraine learned from the distribution of headache types and patterns of treatment response in the Spectrum Study, including recruitment and diagnostic issues. The accuracy of an initial diagnosis, assigned by a clinician in the context of a clinical trial, was compared with the results of a final diagnosis, assigned by a neurologist, reviewing the initial evaluation as well as headache diaries for up to 10 attacks. Several lessons can be learned from the Spectrum Study. Recruitment difficulties teach us that disabling tension-type headache is difficult to find, suggesting that it is rare. Examination of the final diagnosis given after diary evaluations suggests that a diagnosis of migraine can usually be confirmed for patients with disabling headache. After reclassification of the final sample of 432 subjects, 24/75 (32%) patients initially clinically classified as having disabling episodic tension-type headache proved to have migraine or migrainous headache after a diary review. Among study participants, 90% of subjects with disabling headache (HIMQ score >250) had a migraine-related disorder. Treatment response suggests that, in migraineurs, tension-type headaches may have a pathophysiology similar to that of migraine. The diary data show that mild headaches in patients with disabling migraine often evolve into full-blown migraine. The Spectrum Study supports the view that, for patients with disabling episodic headache, migraine is often the correct diagnosis. In clinical practice, the suspicion of migraine should be high for patients experiencing episodic disabling headache. Assessment of headache-related disability may assist practitioners in making a diagnosis of migraine.


Assuntos
Transtornos de Enxaqueca/diagnóstico , Cefaleia do Tipo Tensional/diagnóstico , Diagnóstico Diferencial , Avaliação da Deficiência , Humanos
3.
Neurology ; 43(7): 1363-8, 1993 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-8392150

RESUMO

This double-blind, placebo-controlled, multicenter, crossover study investigated the efficacy and tolerability of sumatriptan administered for up to three separate migraine attacks. One hundred twenty adults received sumatriptan (SC, 6 mg; three attacks) and placebo (one attack). Patients completed questionnaires assessing the impact of migraine on their lives and the performance of sumatriptan relative to their usual acute therapies. Sumatriptan statistically outperformed placebo on all efficacy measures, including pain severity; presence/absence of nausea, vomiting, phonophobia, and photophobia; rescue medication use; and clinical disability. Efficacy was consistently maintained with repeated administration. For all attacks, pain relief 90 minutes postdose occurred in 86% to 90% of sumatriptan-treated patients, compared with 9% to 38% of placebo-treated patients. Sumatriptan was well tolerated, and the frequency and severity of adverse events did not change with repeated administration. Patients' perceptions of sumatriptan were consistent with clinical data demonstrating the drug's high degree of efficacy and tolerability.


Assuntos
Indóis/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Agonistas do Receptor de Serotonina/uso terapêutico , Sulfonamidas/uso terapêutico , Adolescente , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Indóis/administração & dosagem , Indóis/efeitos adversos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/fisiopatologia , Recidiva , Agonistas do Receptor de Serotonina/administração & dosagem , Agonistas do Receptor de Serotonina/efeitos adversos , Sulfonamidas/administração & dosagem , Sulfonamidas/efeitos adversos , Sumatriptana , Inquéritos e Questionários , Fatores de Tempo
4.
Neurology ; 49(5): 1219-25, 1997 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-9371897

RESUMO

Previous studies demonstrated that zolmitriptan at doses of 1 to 25 mg was highly effective in treating acute migraine attacks. The 2.5-mg dose had a favorable therapeutic effect with high efficacy and good tolerability. The objective of this study was to further evaluate the efficacy of a single 2.5-mg dose of zolmitriptan (Zomig, formerly known as 311C90) for acute treatment of a single moderate or severe migraine attack. The study was a randomized, double-blind, placebo-controlled clinical trial. Female and male patients, 12 to 65 years old, with migraine (with or without aura) for > or = 1 year, one to six migraines per month, and age at onset < 50 years were included; 327 patients were screened and randomized to receive either zolmitriptan (n = 219) or placebo (n = 108). Patients treated a single moderate or severe migraine headache with 2.5 mg zolmitriptan or placebo and recorded clinical efficacy and adverse events on a diary form. Headache response at 2 hours was 62% for zolmitriptan compared with 36% for placebo (p < 0.001); at 4 hours, headache response was 70% with zolmitriptan and 37% with placebo (p < 0.001). Headache recurrence in patients treated with 2.5 mg zolmitriptan was 22% (versus placebo 30%). The headache response at 4 hours, pain-free rate, and response rate of nonheadache symptoms favored zolmitriptan over placebo. No serious adverse events were associated with zolmitriptan treatment. A 2.5-mg dose of zolmitriptan is clinically effective and well tolerated for the acute treatment of migraine.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Oxazóis/administração & dosagem , Oxazolidinonas , Agonistas do Receptor de Serotonina/administração & dosagem , Doença Aguda , Adolescente , Adulto , Idoso , Criança , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Oxazóis/efeitos adversos , Agonistas do Receptor de Serotonina/efeitos adversos , Triptaminas
5.
Mayo Clin Proc ; 75(8): 782-9, 2000 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-10943230

RESUMO

OBJECTIVE: To determine the effect of sumatriptan on migraine-related workplace productivity loss. PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, parallel-group trial, adult migraineurs self-injected 6 mg of sumatriptan or matching placebo to treat a moderate or severe migraine within the first 4 hours of a minimum of an 8-hour work shift. Outcome measures included productivity loss and number of patients returning to normal work performance 2 hours after injection and across the work shift, time to return to normal work performance, and time to headache relief. RESULTS: A total of 206 patients underwent screening, 140 (safety population) of whom returned for clinic treatment. Of these 140 patients, 119 received migraine treatment in the workplace (intent-to-treat population), 116 of whom comprised the study population. Of these 116 patients, 76 self-administered sumatriptan, and 40 self-administered placebo. Sumatriptan treatment tended to reduce median productivity loss 2 hours after injection compared with placebo (25.2 vs 29.9 minutes, respectively; P = .14). Significant reductions in productivity loss were obtained across the work shift after sumatriptan treatment compared with placebo (36.8 vs 72.6 minutes, respectively; P = .001). Significantly more sumatriptan-treated patients vs placebo-treated patients experienced shorter return to normal work performance at 2 hours (53/76 [70%] vs 12/40 [30%], respectively) and across the work shift (64/76 [84%] vs 23/40 [58%], respectively; P < .001). Significantly more sumatriptan-treated patients experienced headache relief 1 hour after injection compared with placebo-treated patients (48/76 [63%] vs 13/40 [33%], respectively; P = .004). CONCLUSION: Across an 8-hour work shift, sumatriptan was superior to placebo in reducing productivity loss due to migraine.


Assuntos
Eficiência , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/economia , Agonistas do Receptor de Serotonina/economia , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/economia , Sumatriptana/uso terapêutico , Adulto , Análise Custo-Benefício , Método Duplo-Cego , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Ocupações/economia , Autoadministração , Agonistas do Receptor de Serotonina/administração & dosagem , Agonistas do Receptor de Serotonina/efeitos adversos , Sumatriptana/administração & dosagem , Sumatriptana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Local de Trabalho
6.
Mayo Clin Proc ; 76(11): 1093-101, 2001 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-11702897

RESUMO

OBJECTIVE: To investigate the cost-effectiveness and cost-benefit of initiating sumatriptan therapy in patients with acute migraine who were previously taking nontriptan drugs. PATIENTS AND METHODS: This is an economic analysis of a prospective, pretest-posttest, observational 6-month outcomes study of 178 patients with a physician diagnosis of migraine who received their first prescription for sumatriptan between October 1994 and August 1996 and were members of a mixed-model managed care organization in western Pennsylvania. Migraine-related resource use data were obtained from the managed care organization's medical and pharmacy claims databases. The primary outcome measure for this economic analysis was the total disability time that patients experienced because of migraine. Patients reported time missed from work and usual nonwork activities because of migraine on self-administered questionnaires at baseline and at 3 and 6 months after initiation of sumatriptan. RESULTS: Initiation of sumatriptan resulted in a decrease of 662 migraine-disability-days for work and 1236 migraine-disability-days for nonwork activities during the 6 months of the study (decrease from 27.8 to 17.2 days per person), totaling 1898 migraine-disability-days averted with sumatriptan therapy. Migraine-related medical costs were lower after sumatriptan was initiated ($18,351 vs $26,192), whereas migraine-related pharmacy costs were lower with prior nontriptan drug therapy ($22,209 vs $74,861). The overall net cost savings after sumatriptan was initiated in these patients was $222,332 ($1249 per patient) with a benefit-to-cost ratio of $5.67 gained for each health care dollar spent from a societal perspective. The incremental cost-effectiveness ratio was $25 for each additional migraine-disability-day averted by using sumatriptan vs nontriptan drug therapy. Sensitivity analysis showed that changes in medical costs had little effect on the ratios and that sumatriptan remained cost-beneficial across a wide range of patient wages. CONCLUSION: This study showed that initiation of sumatriptan in patients previously receiving nontriptan therapy was cost-effective and had an economic benefit for patients, employers, and society. Sumatriptan also helped patients and physicians achieve goals recommended by the US Headache Consortium by reducing patients' disability and thus improving their ability to function at work and nonwork activities.


Assuntos
Efeitos Psicossociais da Doença , Análise Custo-Benefício , Farmacoeconomia , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/economia , Sumatriptana/uso terapêutico , Vasoconstritores/uso terapêutico , Absenteísmo , Doença Aguda , Administração Oral , Adulto , Feminino , Humanos , Injeções Intravenosas , Masculino , Ocupações , Pennsylvania , Estudos Prospectivos , Sumatriptana/administração & dosagem , Vasoconstritores/administração & dosagem
7.
Clin Ther ; 18(4): 687-99, 1996.
Artigo em Inglês | MEDLINE | ID: mdl-8879897

RESUMO

The efficacy and tolerability of subcutaneous (SC) sumatriptan administered with the IMITREX (sumatriptan succinate) STATdose System, which circumvents the need for patients or health care professionals to handle a syringe, were evaluated in two randomized, double-masked, parallel-group, placebo-controlled, multicenter studies. In the clinic, 158 adults with migraine diagnosed according to International Headache Society criteria received SC sumatriptan (6 mg) or placebo delivered with the IMITREX STATdose System for treatment of a migraine attack. By 120 minutes after SC dosing, 73% and 79% of sumatriptan-treated patients, compared with 28% and 37% of placebo-treated patients in studies 1 and 2, respectively, experienced headache relief (a statistically significant difference). Clinical disability scores 120 minutes after dosing showed that 75% and 85% of sumatriptan-treated patients, compared with 30% and 42% of placebo-treated patients, were normal or only mildly impaired (a statistically significant difference). Similar efficacy rates were observed for nausea, phonophobia, and photophobia. No serious or unusual adverse events occurred, and no clinically relevant abnormalities in laboratory test values were reported. Based on these results, we concluded that SC sumatriptan (6 mg) administered using the IMITREX STATdose System is effective for the treatment of migraine. The efficacy and tolerability profiles of SC sumatriptan administered with this device are similar to those reported for SC sumatriptan administered with a conventional syringe.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Sumatriptana/administração & dosagem , Adulto , Método Duplo-Cego , Tolerância a Medicamentos , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Sumatriptana/efeitos adversos , Sumatriptana/uso terapêutico
8.
Clin Ther ; 23(2): 284-91, 2001 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-11293561

RESUMO

BACKGROUND: Early treatment of migraine with sumatriptan 50 mg and 100 mg, while pain is mild, has been reported to enhance pain-free response 2 hours and 4 hours postdose and sustained pain-free response 2 to 24 hours postdose compared with treatment when pain has become moderate to severe. Early treatment with sumatriptan 50 mg and 100 mg also resulted in less redosing, which translated to a reduction in the mean number of doses used per migraine episode. OBJECTIVE: We examined the economic implications of early treatment with sumatriptan 50 mg and 100 mg while pain is mild versus treatment when pain has become moderate to severe. METHODS: Using data from retrospective analyses of a dose-ranging clinical trial of sumatriptan (protocol S2CM09) involving 1003 patients, we estimated the mean cost per treatment success for a hypothetical population of 1000 migraine patients who received treatment with sumatriptan 50-mg or 100-mg tablets early while pain was mild versus treatment when pain had become moderate to severe. RESULTS: With a conservative estimate of migraine frequency of 1.5 episodes per month, the total cost of early migraine treatment with sumatriptan 50 mg and 100 mg was reduced by $31.68 and $20.16, respectively, per patient per year. The average cost per pain-free treatment success was reduced by 32% to 57% with sumatriptan 50 mg and 100 mg if migraines were treated while pain was mild in intensity versus when pain had become moderate to severe. CONCLUSIONS: Treatment of migraine with sumatriptan 50-mg and 100-mg tablets is effective regardless of whether pain is mild, moderate, or severe. However, initiating treatment while pain is mild may be more cost-effective than delaying treatment until pain has become moderate to severe.


Assuntos
Transtornos de Enxaqueca/economia , Sumatriptana/economia , Vasoconstritores/economia , Controle de Custos , Custos de Medicamentos , Transtornos de Enxaqueca/tratamento farmacológico , Dor/tratamento farmacológico , Estudos Retrospectivos , Sumatriptana/administração & dosagem , Sumatriptana/uso terapêutico , Vasoconstritores/administração & dosagem , Vasoconstritores/uso terapêutico
9.
Clin Ther ; 22(9): 1035-48, 2000 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-11048903

RESUMO

OBJECTIVE: This study assessed the efficacy of sumatriptan 50- and 100-mg tablets in the treatment of migraine attacks while the pain is mild rather than moderate/severe. BACKGROUND: Results from The Spectrum Study suggested that early treatment of migraine attacks with sumatriptan 50-mg tablets while the pain is mild might enhance pain-free response and reduce headache recurrence. METHODS: Retrospective analyses of headaches treated during mild pain were performed using data from 3 studies of sumatriptan tablets (protocols S2CM09, S2BT25, and S2BT26). Our primary interest was pain-free response 2 and 4 hours after dosing; secondary interests were use of a second dose of medication, clinical disability (as measured on a 4-point disability scale), migraine-associated symptoms, meaningful pain relief (patient defined), time to meaningful relief, sustained pain-free response, and proportion of attacks in which pain had worsened 2 and 4 hours after dosing, all of which were compared in headaches treated during mild versus moderate/severe pain. RESULTS: In S2CM09, 92 patients treated 118 headaches during mild pain. Rates of pain-free response were higher 2 hours after dosing with sumatriptan 50 mg (51%) or 100 mg (67%; P < 0.05) compared with placebo (28%), and were higher with early treatment of mild pain compared with treatment of moderate/severe pain at 2 hours (sumatriptan 50 mg: mild pain, 51%; moderate/severe pain, 31%; P < 0.05; sumatriptan 100 mg: mild pain, 67%; moderate/severe pain, 36%) and 4 hours (50 mg: 75% vs 56%; 100 mg: 90% vs 61%; P < 0.05). Early intervention also resulted in less redosing than when moderate/severe pain was treated (50 mg: 21% vs 32%; 100 mg: 20% vs 29%). More attacks treated early with sumatriptan 50 or 100 mg were associated with normal function 4 hours after dosing compared with placebo (70% and 93% vs 46%, respectively). Sustained pain-free response rates 2 to 24 hours after early dosing with sumatriptan 50 or 100 mg were also higher (34% and 53%, respectively) compared with treatment of moderate/severe pain (19% and 24%, respectively). Early treatment with sumatriptan 100 mg produced significantly higher pain-free rates at 2 hours after dosing (P < 0.001) than did ergotamine plus caffeine (S2BT25: 69% vs 34%, respectively) or aspirin plus metoclopramide (S2BT26: 73% vs 25%, respectively). CONCLUSIONS: Sumatriptan 50- and 100-mg tablets are effective whether pain is mild or moderate/severe. However, treatment with sumatriptan while pain is mild provides high pain-free response rates while reducing the need for redosing, benefits not seen with ergotamine plus caffeine or aspirin plus metoclopramide.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Dor/tratamento farmacológico , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/uso terapêutico , Relação Dose-Resposta a Droga , Método Duplo-Cego , Humanos , Transtornos de Enxaqueca/complicações , Dor/etiologia , Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos
10.
Lipids ; 13(2): 161-4, 1978 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-204847

RESUMO

Cholinephosphotransferase [EC 2.7.8.2] activity of rat liver microsomes, with 1,2-di-0-[3H]acyl glycerol or 1-0-hexadecanoyl [U-14C]ethanediol as substrate, was inhibited by N,N-dimethylaminoethyl p-chlorophenoxyacetate (centrophenoxine). Inhibition progressed in a linear fashion with increasing drug levels and was complete at 30 mM concentration. It appears that the microsomal enzyme was largely affected by the drug itself because the hydrolysis products of centrophenoxine, viz., N,N-dimethylaminoethanol and p-chlorophenoxyacetic acid, were less inhibitory.


Assuntos
Diacilglicerol Colinofosfotransferase/antagonistas & inibidores , Glicolatos/farmacologia , Meclofenoxate/farmacologia , Fosfotransferases/antagonistas & inibidores , Animais , Relação Dose-Resposta a Droga , Microssomos Hepáticos/enzimologia , Ratos
11.
Clin Cornerstone ; 1(6): 21-32, 1999.
Artigo em Inglês | MEDLINE | ID: mdl-10682185

RESUMO

Migraine is one of the most common and misunderstood disease encountered in general medical practice. An estimated 23 million Americans suffer disabling migraines, yet only a minority are diagnosed (1,2). An even smaller percentage receive optimal care. Migraine extracts a significant personal, psychologic, social, and economic toll from migraineurs and their families. An estimated 150 million workdays are lost annually due to headache at an estimated cost of $6 to $17 billion (3,4). Recent advances in understanding of the pathophysiology and acute therapy provide the potential to markedly reduce the impact of migraine. Available abortive medications have efficacy rates as high as 80%, but only a minority of afflicted patients currently receive these therapies. While reducing headache pain, they also restore function, enabling an individual to return to work, family, and personal commitments (5). Future progress in migraine management resides in early identification and optimization of migraine treatment. This article focuses on diagnosis and treatment.


Assuntos
Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/terapia , Antagonistas Adrenérgicos beta/uso terapêutico , Antidepressivos Tricíclicos/uso terapêutico , Biorretroalimentação Psicológica , Bloqueadores dos Canais de Cálcio/uso terapêutico , Humanos , Transtornos de Enxaqueca/genética , Transtornos de Enxaqueca/prevenção & controle , Educação de Pacientes como Assunto , Recidiva , Fatores de Risco , Agonistas do Receptor de Serotonina/uso terapêutico
12.
Cleve Clin J Med ; 64(7): 373-83, 1997.
Artigo em Inglês | MEDLINE | ID: mdl-9223767

RESUMO

The following is a summary of guidelines created under the auspices of the National Headache Foundation, in an effort to improve the care of headache patients in primary care practice. The guidelines represent the consensus of an advisory panel of practitioners chosen by the NHF for their expertise in four specialty areas. A complete set of guidelines can be obtained by calling the National Headache Foundation at 1-800-843-2256 or by writing to them at 428 W. St. James Pl., 2nd Floor, Chicago, IL 60614-2750; the cost is $10.


Assuntos
Cefaleia/diagnóstico , Cefaleia/terapia , Atenção Primária à Saúde/normas , Humanos , Qualidade de Vida , Encaminhamento e Consulta
13.
J Fam Pract ; 36(1): 85-91, 1993 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-8380430

RESUMO

Migraine periodically disables millions of Americans and thus has a significant economic impact on society. Successful treatment of migraine requires that the physician understand the pathophysiology underlying migraine and educate the migraineur in the management of this chronic pain syndrome. Recent advances in the receptor biochemistry of serotonin have given important insight into the mechanisms of migraine pain and treatment. An understanding of these mechanisms has resulted in treatment strategies that address the mechanism of headache control rather than just symptom control. Advances in pharmacologic therapy include a newly developed highly selective serotonin agonist called sumatriptan, which appears to be a promising addition to the armamentarium of abortive migraine treatments. Further data correlating the role of daily analgesics and ergotamines in transforming episodic migraine into chronic daily headache represent another significant advance in migraine management. Clinical trials of sumatriptan are reviewed, and the role of daily analgesic and ergotamine use is discussed in relation to advances in migraine pathophysiology and available demographic data on migraine.


Assuntos
Indóis/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Agonistas do Receptor de Serotonina/uso terapêutico , Sulfonamidas/uso terapêutico , Vasoconstritores/uso terapêutico , Analgésicos/uso terapêutico , Ergotamina/uso terapêutico , Humanos , Transtornos de Enxaqueca/etiologia , Transtornos de Enxaqueca/fisiopatologia , Sumatriptana
14.
J Fam Pract ; 42(1): 36-42, 1996 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-8537803

RESUMO

BACKGROUND: The debilitating effects of migraine might be reduced in patients using an effective migraine medication. The serotonin (5HT1) receptor agonist sumatriptan has been shown in clinical trials to alleviate headache and associated symptoms in the majority of patients treated. METHODS: Three hundred forty-four (344) patients with migraine were allowed to treat an unlimited number of migraine attacks for up to 24 months with subcutaneous sumatriptan (6 mg). Open-label oral sumatriptan (100 mg) could be used between 1 hour and 24 hours after the initial injection for treatment of recurrent or persistent headache. On four occasions during the treatment period, patients completed the Medical Outcomes Study Short Form-36 Health Survey, a general health status instrument; the Migraine-Specific Quality of Life Questionnaire, a disease-specific instrument; and a series of questions designed to measure the impact of migraine on productivity and disability. RESULTS: Treatment with sumatriptan was associated with significant (P < .05) improvements relative to baseline in three of the Short Form-36 Health Survey quality-of-life dimensions (Bodily Pain, General Health Perceptions, and Social Functioning) and three of the Migraine-Specific Quality of Life Questionnaire dimensions (Role Function-Restrictive, Role Function-Preventive, and Emotional Function). Significant (P < .05) improvements in patient-rated productivity and reductions in patient-rated disability also occurred during the trial. CONCLUSIONS: Patients using sumatriptan to treat migraines for up to 24 months experienced improvements in disability and productivity as well as in health-related quality of life as measured either by a general health status instrument or a disease-specific instrument.


Assuntos
Nível de Saúde , Transtornos de Enxaqueca/tratamento farmacológico , Qualidade de Vida , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/uso terapêutico , Doença Aguda , Adolescente , Adulto , Idoso , Pessoas com Deficiência , Eficiência/efeitos dos fármacos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/fisiopatologia , Transtornos de Enxaqueca/psicologia , Agonistas do Receptor de Serotonina/farmacologia , Sumatriptana/farmacologia
16.
Cephalalgia ; 17(5): 588-90, 1997 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-9251874

RESUMO

In a long-term efficacy and safety study, 424 patients were treated with sumatriptan (6 mg sc) for 1,904 migraine attacks. The patients were diagnosed with migraine based on IHS criteria but individual migraine attacks treated in the study were physician diagnosed; not necessarily required to meet IHS criteria. A re-analysis of the treatment response to open label sumatriptan (6 mg sc) indicated that 43 patients had treated at least one migraine that fulfilled IHS criteria for tension-type headache. Analysis of this population revealed they treated 232 headaches. Of these headaches, 114 were classified per IHS criteria as migraine; 76 as tension-type; and 42 as non-IHS migraine (not classifiable as IHS migraine or IHS tension-type headache). Of the 114 migraines, a positive response to sumatriptan occurred in 109 (96%) cases; of the 76 tension-types, 73 responded to sumatriptan (97%); of the 42 non-IHS migraine, 40 (95%) responded to sumatriptan. An equivalent response to sumatriptan among three diagnostic groups of headache supports the concept of a common biologic mechanism involving 5HT1 receptors that spans a range of clinical presentations.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/uso terapêutico , Cefaleia do Tipo Tensional/tratamento farmacológico , Adulto , Feminino , Humanos , Estudos Longitudinais , Masculino
17.
Arch Fam Med ; 3(9): 766-72, 1994 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-7987510

RESUMO

BACKGROUND: Sumatriptan is effective for the treatment of acute migraine. However, headache may recur in about 30% of patients within 24 hours of successful treatment. OBJECTIVE: To evaluate the efficacy of oral sumatriptan, 100 mg, in the treatment of headache recurring within 24 hours of achieving headache resolution with subcutaneous sumatriptan, 6 mg. STUDY DESIGN: Subcutaneous sumatriptan was administered for up to 12 migraine attacks in a randomized, double-blind, parallel-group study. Patients whose headache was completely resolved 90 minutes after subcutaneous dosing received either oral sumatriptan or placebo at the onset of recurrent headache. Patients whose headache was not completely resolved were offered rescue medication, including sumatriptan. Patients rated headache severity for 24 hours. SETTING: Fifteen US outpatient clinics. MAIN OUTCOME MEASURE: Percentage of patients with relief of recurrent headache and adverse events. RESULTS: Approximately 90% of patients achieved relief of headache (severe or moderate headache reduced to mild or no headache) by 90 minutes after unblinded subcutaneous administration of sumatriptan. Efficacy rates were at least 80% regardless of whether the headache fulfilled the International Headache Society criteria for migraine. About 64% of patients achieved complete relief. Oral sumatriptan, 100 mg, relieved moderate or severe recurrent headache within 4 hours in up to 81% of patients. Oral sumatriptan administered as rescue medication to patients not headache-free did not relieve persistent headache. The incidence, pattern, and severity of adverse events after combined subcutaneous and oral administration of sumatriptan were similar to those after subcutaneous administration alone. CONCLUSIONS: Oral sumatriptan was consistently effective in the treatment of headache recurrence.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Sumatriptana/uso terapêutico , Administração Oral , Adolescente , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Recidiva , Sumatriptana/administração & dosagem , Sumatriptana/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
18.
Qual Life Res ; 12(8): 903-12, 2003 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-14651411

RESUMO

BACKGROUND: While item response theory (IRT) offers many theoretical advantages over classical test theory in the construction and scoring of patient based measures of health few studies compare scales constructed from both methodologies head to head. OBJECTIVE: Compare the responsiveness to treatment of migraine specific scales scored using summated rating scale methods vs. IRT methods. METHODS: The data came from three clinical studies of migraine treatment that used the Migraine Specific Quality of Life Questionnaire (MSQ). Five methods of quantifying responsiveness were used to evaluate and compare changes from pre- to post-treatment in MSQ scales scored using Likert and IRT scaling methods. RESULTS: Changes in all MSQ scale scores from pre- to post-treatment were highly significant in all three studies. A single index scored from the MSQ using IRT methods was determined to be more responsive than any one of the MSQ subscales across the five methods used to quantify responsiveness. Across 13 of the 15 tests (5 responsiveness methods * 3 studies) conducted, the single index scored from the MSQ using IRT methods was the most responsive measure. CONCLUSIONS: IRT methods increased the responsiveness of the MSQ to the treatment of migraine. The results agree with the psychometric evidence that suggest that it is feasible to score a single index from the MSQ using IRT methods. This approach warrants further testing with other measures of migraine impact.


Assuntos
Ensaios Clínicos como Assunto , Transtornos de Enxaqueca/fisiopatologia , Perfil de Impacto da Doença , Adulto , Feminino , Humanos , Masculino , Transtornos de Enxaqueca/tratamento farmacológico , Psicometria , Qualidade de Vida , Agonistas do Receptor de Serotonina/administração & dosagem , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/administração & dosagem , Sumatriptana/uso terapêutico , Estados Unidos
19.
Headache ; 40(10): 792-7, 2000.
Artigo em Inglês | MEDLINE | ID: mdl-11135022

RESUMO

OBJECTIVE: To evaluate the effectiveness of sumatriptan, 50-mg tablets, versus placebo for early intervention while head pain was mild in patients with disabling migraine. METHODS: A post hoc analysis was performed in a subgroup of patients from a large, randomized, placebo-controlled study of patients with disabling headache who treated while pain was mild. Pain-free response 2 and 4 hours postdose, headache recurrence, and safety were examined. Significance tests were performed only for the first-treated attacks. RESULTS: Twenty-six patients with disabling headache treated 46 mild and 166 moderate or severe headaches. For the first-treated headaches while pain was mild, pain-free rates were significantly higher for sumatriptan than placebo 4 hours postdose (78% versus 0%, P =.02), but not 2 hours postdose (52% versus 0%, P =.22). Across all headaches treated while pain was mild, pain-free responses were higher for sumatriptan than placebo 4 hours (85% versus 17%) and 2 hours (50% versus 0%) postdose compared with placebo. When the same patients treated headaches while pain was moderate or severe, pain-free rates were lower than that reported for treatment during mild pain. There was a trend toward lower headache recurrence in headaches treated while pain was mild compared with moderate or severe pain (13% versus 18%). No drug-related adverse events were reported in the headaches treated while pain was mild. CONCLUSIONS: Patients with disabling migraine may benefit from early intervention with sumatriptan, 50 mg, while pain is mild.


Assuntos
Pessoas com Deficiência , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/fisiopatologia , Sumatriptana/uso terapêutico , Vasoconstritores/uso terapêutico , Administração Oral , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Sumatriptana/efeitos adversos , Fatores de Tempo , Vasoconstritores/efeitos adversos
20.
JAMA ; 265(21): 2831-5, 1991 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-1851894

RESUMO

Sumatriptan succinate, a 5-HT1D receptor agonist, constricts human cranial arteries. Two parallel-group trials for treatment of acute migraines were conducted in the United States. Adult patients were randomized and given either 6 mg of sumatriptan succinate subcutaneously (n = 734) or placebo (n = 370). At 1 hour, sumatriptan was significantly more effective than placebo in reducing moderate or severe headache pain to mild or no pain (70% vs 22%), in completely relieving headaches (49% vs 9%), and in improving clinical disability (76% vs 34%). Sumatriptan also reduced nausea and photophobia significantly better than placebo. Patients with residual migraines received another injection; those who had originally received sumatriptan received either a second active injection (n = 187) or placebo (n = 178), while those who had received placebo received a second placebo injection (n = 335). Statistical evidence for benefit of second sumatriptan injection is absent. Adverse events associated with sumatriptan were tingling, dizziness, warm-hot sensations, and injection-site reactions. Sumatriptan is effective and well tolerated in patients with acute migraine.


Assuntos
Indóis/administração & dosagem , Transtornos de Enxaqueca/tratamento farmacológico , Sulfonamidas/administração & dosagem , Vasoconstritores/administração & dosagem , Doença Aguda , Adulto , Método Duplo-Cego , Feminino , Humanos , Indóis/efeitos adversos , Indóis/uso terapêutico , Injeções Subcutâneas , Masculino , Sulfonamidas/efeitos adversos , Sulfonamidas/uso terapêutico , Sumatriptana , Vasoconstritores/efeitos adversos , Vasoconstritores/uso terapêutico
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