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Biomedical subjects

J Saiers

Publications and source records attributed to J Saiers.

9 recordsLinked to original sources
PubMed2002

Sumatriptan nasal spray for migraine: a review of studies in patients aged 17 years and younger.

This review considers the epidemiology, clinical manifestations and functional consequences of migraine in children and adolescents and surveys the studies establishing the efficacy and tolerability of sumatriptan nasal spray in this patient population. Although therapeutic advances in paediatric and adolescent migraine have lagged behind those in adult migraine, the first systematic studies of migraine medications in young patients have brought about progress in the past five years. These studies show that therapeutic approaches suitable for adult patients are not always applicable to paediatric and adolescent patients. Because of the unique characteristics of paediatric and adolescent migraine, it has been difficult to demonstrate in young patients the efficacy of oral sumatriptan and other triptan tablets, which are the medications of choice for adult migraine. With sumatriptan, this finding has proven to be a consequence of the form in which the drug was administered rather than the inherent properties of the drug. The availability of sumatriptan nasal spray allows the benefits of migraine-specific therapy to be extended to children and adolescents. In both well-controlled, single-episode studies and long-term, multiple-episode studies, sumatriptan nasal spray has been effective and well tolerated for the acute treatment of migraine in children and adolescents. Except for unpleasant taste, which is not significantly distressing to patients, sumatriptan nasal spray has a tolerability profile similar to thatof placebo in young patients.

Administration, Intranasal↗
PubMed2000

Tolerability of sumatriptan: clinical trials and post-marketing experience.

Through December 1998, sumatriptan had been used to treat more than 236 million migraine attacks world-wide. In clinical trials alone, more than 88000 migraine patients had treated more than 300000 migraine attacks with sumatriptan, and 2000 normal healthy volunteers had been exposed to the drug. This paper describes the safety and tolerability profile of sumatriptan in three sections: adverse events reported in clinical trials, special issues, and spontaneous post-marketing reports of adverse reactions. Data from the extensive clinical trials programme coupled with information from nearly 10 years of experience in clinical practice demonstrate that sumatriptan is generally well-tolerated, with an acceptable benefit-risk ratio when used properly. Significant cardiovascular and cerebrovascular events are rare but have been observed. This fact highlights the need for careful patient selection and vigilant adherence to the prescribing recommendations for sumatriptan. The wealth of clinical trials and post-marketing information for sumatriptan may be useful in guiding prescribing decisions for members of this class of drugs.

Cardiovascular Diseases↗
PubMed1999

Sumatriptan is effective in the treatment of menstrual migraine: a review of prospective studies and retrospective analyses.

Menstrual migraine may be debilitating, long-lasting, and refractory to treatment. Because the efficacy and tolerability of abortive and prophylactic treatment options for menstrual migraine have generally not been evaluated in controlled clinical trials, treatment choices are often made on the basis of personal experience and anecdotal reports. This article reviews evidence from retrospective analyses and prospective studies showing that sumatriptan injection and tablets are effective and well tolerated in menstrual migraine. (1) Sumatriptan injection 6 mg was as effective in the treatment of menstrual migraine attacks as it was for nonmenstrual attacks in a retrospective analysis of data from two randomized, double-blind, placebo-controlled, parallel-group trials (n = 1104). In the menstrual migraine group, 80% of women treated with sumatriptan injection 6 mg compared with 19% of placebo-treated patients reported headache relief 1 h postdose (p < 0.001). (2) Sumatriptan injection 6 mg was effective in the acute treatment of menstrual migraine attacks in a prospective, double-blind, placebo-controlled, parallel-group, two-attack study (n = 226). Across the two attacks, 70-71% of patients treating menstrual migraine attacks with sumatriptan injection 6 mg compared with 22-24% of placebo-treated patients reported headache relief 1 h postdose (p < 0.001). (3) Sumatriptan tablets 100 mg were effective in the acute treatment of menstrual migraine attacks in a prospective, double-blind, placebo-controlled, crossover study in women diagnosed with menstrual migraine (n = 115). For menstrual migraine attacks, headache relief 4 h postdose was reported by 67% of sumatriptan-treated patients compared with 33% of placebo-treated patients. Sumatriptan injection and tablets were generally well tolerated in these studies, in which adverse events were characteristic of those typically observed in sumatriptan acute migraine clinical trials. These data demonstrate that sumatriptan injection and tablets are effective and well tolerated in the treatment of menstrual migraine.

Female↗
PubMed1999

A double-blind placebo-controlled study assessing the efficacy and tolerability of 50 mg sumatriptan tablets in the acute treatment of migraine. Sumatriptan Tablets S2CM07 Study Group.

BACKGROUND: Oral sumatriptan 50 mg has been found to have good efficacy and tolerability in the acute treatment of migraine but has been less well studied than the 100 mg dose. METHODS: This was a double-blind, parallel-group study (Glaxo Wellcome protocol number S2CM07) comparing the efficacy and safety of sumatriptan 50 mg tablets with placebo in the acute treatment of migraine. Patients treated three migraine attacks with study medication; a second, optional dose was available for treating recurrent headache. Of the 560 patients randomized, 485 treated at least one attack, 411 at least two attacks, and 362 three attacks. The primary efficacy measure was the proportion of patients who had obtained complete or almost complete headache relief at 4 h after dosing. RESULTS: For all attacks, a significantly greater proportion of patients experienced headache relief at 4 h with sumatriptan 50 mg tablets than with placebo (59% to 62% versus 32% to 42%; P = 0.005). The same was true at 3 h across all attacks, and at 2 h for attacks 1 and 2 (49% versus 23% and 45% versus 29%, respectively). Although sumatriptan and placebo were associated with similar incidences of recurrence, sumatriptan was associated with a longer time to recurrence. The incidence of adverse events with sumatriptan was similar to that with placebo, and there was no increase in adverse events associated with use of a second dose to treat recurrence. CONCLUSIONS: Sumatriptan 50 mg tablets are well tolerated and efficacious in relieving migraine headache.

Acute Disease↗
PubMed1998

Consistency of response to sumatriptan nasal spray across patient subgroups and migraine types.

With an onset of headache relief as early as 15 min postdose compared with placebo, sumatriptan nasal spray is an important treatment option for patients who seek rapid headache relief and/or a convenient dosing form, whose migraine-associated nausea and vomiting render the use of an oral medication impractical, and those who prefer not to use an injectable form of migraine medication. Although the efficacy and tolerability of sumatriptan nasal spray are documented, the consistency of response to sumatriptan nasal spray across patient subgroups and migraine subtypes of importance to the prescribing clinician have not been described. To provide this information, data from four randomized, double-blind, parallel-group, placebo-controlled, multicenter studies (Glaxo Wellcome protocol numbers S2B-340, S2B-341, S2B-342, and S2B-T50), conducted between January 1993 and December 1994, were pooled and retrospectively analyzed to determine whether the efficacy and tolerability of sumatriptan nasal spray vary with gender, ethnic origin, age, weight, migraine type, concomitant or prior medication use, or pretreatment headache duration. Two-thousand-three-hundred-and-ninety-five (2395) patients treated a moderate or severe migraine with study medication in the four studies. The results demonstrate that sumatriptan nasal spray 20 mg and 10 mg were effective and well tolerated in the acute treatment of migraine consistently across a variety of patient and migraine subgroups. No clinically significant differences in headache relief or adverse event rates were observed for any of the subgroups examined. Approximately two-thirds of patients treated with sumatriptan nasal spray 20 mg compared with approximately one-third of placebo-treated patients reported headache relief 2 h postdose regardless of patient or migraine subgroup. The relationship between active treatment and placebo with respect to the overall incidence of adverse events also did not differ between patient or migraine subgroups. There is no evidence based on this analysis that sumatriptan nasal spray dosage should be adjusted in any of the subgroups examined.

Administration, Intranasal↗
PubMed1996

Analgesic rebound headache in clinical practice: data from a physician survey.

BACKGROUND: Frequent, excessive use of over-the-counter or prescription analgesics may lead to analgesic rebound headache. Little is known about the magnitude of the health problem posed by analgesic rebound headache, its epidemiology, the characteristics of analgesic rebound headache sufferers, or about physicians' approaches to treatment. METHODS: Four hundred seventy-three practitioners, who had previously expressed an interest in the treatment of headache, were mailed a questionnaire designed to capture information about the frequency and management of analgesic rebound headache and about the characteristics of analgesic rebound headache sufferers. RESULTS: Completed questionnaires were returned by 174 practitioners (37%) from 40 states, the District of Columbia, and Puerto Rico. More than 40% of respondents indicated that analgesic rebound headache was present in at least 20% of their patients. On average, the physicians reported that 73% of patients with analgesic rebound headache were women. Analgesic rebound headache was most likely to occur in patients aged 31 to 40 years. No one analgesic was consistently identified as causative, although acetaminophen, butalbital + aspirin + caffeine, and aspirin were commonly used by patients. Eighty percent of respondents indicated that depression was commonly observed in analgesic rebound headache sufferers; 77% indicated that physical conditions (especially gastrointestinal symptoms) were commonly observed. A variety of therapeutic strategies, including pharmacotherapy, were used in the management of analgesic rebound headache. CONCLUSION: Analgesic rebound headache was recognized as a distinct entity and a substantive component in more than 40% of the practices of 174 surveyed practitioners. General practitioners, who see a wide variety of patient types with a spectrum of complaints, need to be able to diagnose analgesic rebound headache by taking a good history.

Adult↗
PubMedDate not supplied

Sumatriptan injection and tablets in clinical practice: results of a survey of 707 migraineurs.

This report from the Gothenburg Migraine Clinic in Sweden describes the results of a telephone survey of over 700 patients using open-label sumatriptan tablets or sumatriptan injection for the treatment of migraine. The information is based on the patients' cumulative experience of more than 76,000 subcutaneous injections, 56,000 tablets 100 mg, and 20,000 tablets 50 mg. The results demonstrate that sumatriptan tablets were preferred by a greater proportion of patients than sumatriptan injection. However, sumatriptan injection was perceived as the most effective dosing form by the greatest proportion of patients. Among patients who found sumatriptan injection to be the most effective dosing form, the most frequently cited reasons were efficacy and speed of action. Among patients who found sumatriptan tablets to be the most effective dosing form, the most frequently cited reasons were fewer side effects and lack of experience with other dosing forms. Approximately half of sumatriptan users indicated that sumatriptan use was associated with decreases in the numbers of days with migraine, days at work with migraine, and days off work/normal activities due to migraine. When they worked during a migraine attack, patients estimated that they were 76% effective after taking sumatriptan compared with 47% effective with other medications and 49% effective with no medication. In general, side effects were reported less frequently among sumatriptan tablet users compared with injection users. Asked to compare sumatriptan with the best migraine treatment that they had used before, 94% of patients indicated that sumatriptan was better or much better than their previous therapies. These data provide important information from the clinical practice setting to complement the data from sumatriptan clinical trials.

Adolescent↗