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PubMed1998

Sumatriptan. An updated review of its use in migraine.

UNLABELLED: Sumatriptan is a selective agonist at serotonin 5-HT1-like receptors, including 5-HT1B/1D subtypes. It is an effective treatment for acute migraine attacks and the injectable form has also shown efficacy in the treatment of cluster headaches. In placebo-controlled clinical trials, sumatriptan, administered subcutaneously, orally, intranasally or rectally was significantly more effective than placebo in relieving migraine headache and in producing resolution or reduction of other symptoms associated with migraine, including nausea, photophobia and phonophobia. Improvements in clinical disability were also significantly greater after sumatriptan than after placebo. Headache recurred in 21 to 57% of patients who received oral or subcutaneous sumatriptan, but most patients responded to a second dose of the drug. Results of comparative trials showed that subcutaneous sumatriptan 6 mg was significantly more effective than either patients' usual antimigraine treatments or intranasal dihydroergotamine mesylate 1 mg in relieving migraine headache. Subcutaneous sumatriptan 6 mg and subcutaneous dihydroergotamine mesylate 1 mg provided similarly effective migraine relief, but the headache recurrence rate was significantly higher after sumatriptan than after this formulation of dihydroergotamine mesylate. Response rates achieved after oral sumatriptan were similar to those reported after treatment with oral naratriptan, rizatriptan or lysine acetylsalicylate plus metoclopramide. Treatment of acute migraine attacks with oral or subcutaneous sumatriptan leads to less loss of workplace productivity than other antimigraine therapies. Several pharmacoeconomic analyses showed that gains in workplace productivity in sumatriptan recipients ranged from 12.1 to 89.8 hours per patient per year. Significant improvements from baseline in overall health-related quality-of-life scores were also experienced by sumatriptan recipients. Sumatriptan is generally well tolerated. Nausea, vomiting, malaise and fatigue are the most common adverse events with oral sumatriptan. Injection site reactions occur in 10 to 40% of patients receiving the drug subcutaneously. A bitter taste at the back of the mouth occurs frequently after intranasal administration. Serious adverse events occur in about 0.14% of patients with migraine treated with sumatriptan. As the drug is associated with the rare development of cardiovascular effects, it is contraindicated in patients with a history of cardiovascular disease. CONCLUSIONS: Despite its relatively high acquisition cost, reductions in lost workplace productivity experienced by patients treated with sumatriptan may result in savings in the overall cost of migraine to society. Thus, sumatriptan is a useful first- or second-line treatment option for patients with moderate or severe migraine.

Administration, Intranasal↗
PubMed1996

Pattern of sumatriptan use and overuse in general practice.

OBJECTIVE: To investigate the frequency of use and misuse of sumatriptan, and to explore the characteristics of patients reporting overuse. SETTING: A postmarketing cohort study on adverse reactions to sumatriptan, performed with the assistance of drug-dispensing general practitioners in the Netherlands. METHODS: Questionnaires were sent to patients on sumatriptan of drug-dispensing general practitioners in the Netherlands. Use of sumatriptan was classified into five groups: < 1, 1-10, 11-20 and 21-30 times per month and a group of patients who reported daily use of sumatriptan more than 10 times per week. Patients in the latter group were regarded as "overusers". RESULTS: The request to the 1720 patients yielded a response rate of 1202 (70%). Of 952 (79%) of these patients, details of their sumatriptan intake were available. Most patients (718, 75%) took sumatriptan 1-10 times each month. However, 36 patients (4%, 95% CI 2.8-5.2%) took sumatriptan daily or more than 10 times each week. The group with the highest intake consisted mainly of males, and many patients who reported a poor efficacy of sumatriptan. Age was not related to use of sumatriptan. CONCLUSIONS: A small group of patients (4%) used sumatriptan too often. A high intake was associated with both male gender and a reported poor efficacy of sumatriptan, but not with age, reported adverse reactions, or headache attributed to sumatriptan. It is important to explain to patients that sumatriptan is only for the treatment of acute attacks, and not for prophylactic use. Drug consumption patterns have to be evaluated, in particular in patients who report low efficacy of sumatriptan.

Administration, Oral↗
PubMed1995

Subcutaneous sumatriptan for treatment of acute migraine in patients admitted to the emergency department: a multicenter study.

STUDY OBJECTIVE: To assess the efficacy of SC sumatriptan injection versus placebo in the treatment of acute migraine in ED patients and that of open-label 100 mg sumatriptan PO tablets for recurrent migraine. DESIGN: Randomized, double-blind, placebo-controlled, multi-center trial. SETTING: Twelve EDs in the United States. PARTICIPANTS: Adult patients presenting to the ED from September 1992 through April 1993 with a diagnosis of migraine as determined by International Headache Society criteria. Patients were randomized to receive 6 mg sumatriptan SC or placebo. Patients were monitored for improvement in headache severity using a four-point scale and for time to meaningful relief using a stopwatch. The time to discharge from the ED was recorded. An open-label 100 mg sumatriptan PO tablet was given to all patients on discharge from the ED for use at home if the headache recurred within 24 hours. RESULTS: One hundred thirty-six patients were enrolled. Seventy-five percent of patients treated with sumatriptan achieved meaningful relief compared with 35% treated with placebo (P < .001). The median time to meaningful relief was 34 minutes in the group that received sumatriptan. Seventy percent of patients in the sumatriptan group versus 35% in the placebo group reported mild or no pain at discharge (P < .001). Migraine-associated symptoms such as nausea, photophobia, and phonophobia were significantly reduced in the sumatriptan group (P < .005). The median time to discharge from the ED was shorter for the sumatriptan group than for the placebo group (60 versus 96 minutes, respectively; P = .001). At baseline, 15% of patients in the sumatriptan group and 19% of patients in the placebo group reported mild or no clinical disability. At the time of discharge, patients with mild or no disability increased to 75% in the sumatriptan group compared with 44% in the placebo group (P = .001). Fifty-seven of 92 patients (62%) with mild or no pain at discharge took open-label oral sumatriptan for headache recurrence, and 37 (65%) experienced meaningful relief within 2 hours. Median time to meaningful relief after oral sumatriptan was 65 minutes. CONCLUSION: Sumatriptan (6 mg SC) is effective in treating acute migraine in the ED. Oral sumatriptan (100 mg) is effective in treating headache recurrence within 24 hours.

Acute Disease↗
PubMed1999

Use and overuse of sumatriptan. Pharmacoepidemiological studies based on prescription register and interview data.

The serotonin agonist sumatriptan was marketed in Denmark in 1992 for the treatment of acute attacks of migraine and cluster headache. The clinical development program of the drug was impressive. However, knowledge of the long-term use of sumatriptan in unselected patients was lacking. Misuse of sumatriptan was reported in single patients shortly after the introduction of the drug. The aim of the present thesis was, therefore, to provide an epidemiological description of sumatriptan use with particular emphasis on overuse. The author conducted three studies, two of which were exclusively based on population-based data from a regional (Odense Pharmacoepidemiological Database) and a national (Registry of Drug Statistics, Danish Medicines Agency) prescription registry. Both registries record patient-specific information, thus enabling the conduct of longitudinal studies of drug use. The regional registry covers the county of Funen (reimbursable prescription drugs only), while the national registry records information on all prescriptions presented in the entire country. Consumption was described by means of the Defined Daily Dose (DDD) unit. One DDD of sumatriptan amounts to 100 mg orally or 6 mg subcutaneously. Subjects were classified as recipients of single or multiple prescriptions. Individuals in the latter category were characterized by the 30-day period with the most intensive dispensing of sumatriptan (peak use): low (less than 30 DDD/30 days), intermediate (30-59 DDD/30 days) and high-peak users (60 or more DDD/30 days). In 1995, 33,206 users of sumatriptan were identified in Denmark, corresponding to a 1-year period prevalence of use of 7.8 per 1,000 inhabitants (only persons aged > or = 16 years were included). A female-to-male ratio of 3.8:1 was found. Use was most common among women aged 35-54 years and was highest among 45 to 49-year-olds for both sexes. The standardized period prevalence of sumatriptan use varied regionally between the Danish counties from 6.4 to 9.6 per 1,000 inhabitants. The period prevalence of sumatriptan use in the county of Funen was highly comparable with that of the entire nation. Among the 43,389 sumatriptan users presenting prescriptions for sumatriptan in Denmark in 1994 and 1995, 507 (1.1%) and 1726 (4.0%) belonged to the high and intermediate-peak-use group, respectively. Patients belonging to these two groups were responsible for 38% of the total consumption of sumatriptan. For patients in the high-peak-use group the median span between first and last prescription was 693 days while the median quantity of sumatriptan purchased was 648 DDD. Highly comparable patterns of long-term intense sumatriptan use were found in the data from the regional registry, which covered the 27-month period after the introduction of the drug (February 1992). The register data were highly suggestive of overuse, but lacked essential information, e.g., the indication for use. A third study was therefore conducted using a combination of register and interview data. During a 14-day period, current users of sumatriptan were recruited through community pharmacies in the county of Funen. Respondents returned a signed consent form, including their unique personal identification number (CPR), allowing us to retrieve patient-specific data from the regional registry. For each respondent, all available relevant prescription data for the period 1992-96 were retrieved. Subjects were classified into high, intermediate, and low-peak-use groups according to register data from the 4-year period. The register data were used to evaluate representativity after anonymizing nonrespondent data. The response rates were 33% (7/21) in the high-peak-use group, 47% (30/64) in the intermediate-peak-use group, and 56% (196/350) in the low-peak-use group. Respondents and nonrespondents in the three groups were comparable with regard to age and use of other drugs. (ABSTRACT TRUNCATED)

Cluster Headache↗
PubMed2000

A comparative trial of zolmitriptan and sumatriptan for the acute oral treatment of migraine.

OBJECTIVE: This randomized, double-blind, parallel group multicenter study compared response rates and tolerability of zolmitriptan with sumatriptan in the acute treatment of migraine. METHODS: A sample consisting of 1445 outpatients with an established diagnosis of migraine was randomized to zolmitriptan, 2.5 mg or 5 mg, or sumatriptan, 25 mg or 50 mg. Patients took 1 tablet for moderate/severe migraine and a second identical tablet, if necessary, for recurrent headache of moderate/severe intensity 4 to 24 hours after the initial dose. Up to six attacks were treated during a 6-month period. The primary outcome measure was headache response 2 hours after the initial dose. Secondary end points included 1-hour and 4-hour headache response and pain relief over 24 hours. RESULTS: A headache response at 2 hours was noted in 67.1% of patients taking zolmitriptan, 2.5 mg, and 64.8% of those taking zolmitriptan, 5 mg, versus 59.6% of patients taking sumatriptan, 25 mg, and 63.8% of those taking sumatriptan, 50 mg. At 2 and 4 hours, the differences between zolmitriptan, 2.5 mg, and sumatriptan, 25 mg, were statistically significant (odds ratio=1.49 and 1.67, respectively; both P<.001). Statistically significant differences between zolmitriptan, 2.5 mg, and sumatriptan, 50 mg, were seen at 2 and 4 hours post dose (odds ratio=1.21 and 1.23, respectively; both P<.05). At 1 hour post dose, the headache response rate for zolmitriptan, 2. 5 mg, was numerically higher than response rates for sumatriptan, 25 mg and 50mg (odds ratio=1.16, odds ratio=1.06, though they failed to reach statistical significance; P=.061, P=.461 respectively). Differences between zolmitriptan, 5 mg, and sumatriptan, 25 mg, were statistically significant at 1, 2, and 4 hours (odds ratio=1.43, 1. 46, and 1.78, respectively; all P<.001) and at 1 and 4 hours versus sumatriptan, 50 mg (odds ratio=1.28, P=.002; odds ratio=1.29, P=.012, respectively). Although not statistically significant at 2 hours, more patients responded to zolmitriptan, 5 mg, than to sumatriptan, 50 mg (odds ratio=1.16, P=.064). Patients receiving zolmitriptan, 2. 5 mg or 5 mg, achieved more pain relief over 24 hours than patients receiving sumatriptan, 25 mg (odds ratio=1.47, and 1.54 respectively, both P<.001) or sumatriptan, 50 mg (odds ratio=1.17, P=.021; odds ratio=1.22, P=.005, respectively). All treatments were well tolerated. CONCLUSIONS: Zolmitriptan, 2.5 mg and 5 mg, was at least as effective as sumatriptan, 25 mg or 50 mg, for all parameters studied. Zolmitriptan, 2.5 mg, was significantly more effective than sumatriptan, 50 mg, in terms of headache response at 2 and 4 hours. Patients taking zolmitriptan were significantly more likely to have pain relief over 24 hours than those taking sumatriptan.

Acute Disease↗
PubMed2005

Sumatriptan and naproxen sodium for the acute treatment of migraine.

OBJECTIVE: To evaluate the efficacy and tolerability of treatment with a combination of sumatriptan 50 mg (encapsulated) and naproxen sodium 500 mg administered concurrently in the acute treatment of migraine. BACKGROUND: The pathogenesis of migraine involves multiple peripheral and central neural mechanisms that individually have been successful targets for acute (abortive) and preventive treatment. This suggests that multi-mechanism therapy, which acts on multiple target sites, may confer improved efficacy and symptom relief for patients with migraine. DESIGN AND METHODS: This was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, four-arm study. Participants (n = 972) treated a single moderate or severe migraine attack with placebo, naproxen sodium 500 mg, sumatriptan 50 mg, or a combination of sumatriptan 50 mg and naproxen sodium 500 mg. In the latter two treatment arms, the sumatriptan tablets were encapsulated in order to achieve blinding of the study. RESULTS: In the sumatriptan plus naproxen sodium group, 46% of subjects achieved 24-hour pain relief response (primary endpoint), which was significantly more effective than sumatriptan alone (29%), naproxen sodium alone (25%), or placebo (17%) (P < .001). Two-hour headache response also significantly favored the sumatriptan 50 mg plus naproxen sodium 500 mg therapy (65%) versus sumatriptan (49%), naproxen sodium (46%), or placebo (27%) (P < .001). A similar pattern of between-group differences was observed for 2-hour pain-free response and sustained pain-free response (P < .001). The incidence of headache recurrence up to 24 hours after treatment was lowest in the sumatriptan plus naproxen sodium group (29%) versus sumatriptan alone (41%; P = .048), versus naproxen sodium alone (47%; P= .0035), and versus placebo (38%; P= .08). The incidences of the associated symptoms of migraine were significantly lower at 2 hours following sumatriptan 50 mg plus naproxen sodium 500 mg treatment versus placebo (P < .001). The frequencies and types of adverse events reported did not differ between treatment groups, with dizziness and somnolence being the most common. CONCLUSIONS: This is among the first prospective studies to demonstrate that multi-mechanism acute therapy for migraine, combining a triptan and an analgesic, is well tolerated and offers improved clinical benefits over monotherapy with these selected standard antimigraine treatments. Specifically, sumatriptan 50 mg (encapsulated) and naproxen sodium 500 mg resulted in significantly superior pain relief as compared to monotherapy with either sumatriptan 50 mg (encapsulated) or naproxen sodium 500 mg for the acute treatment of migraine. Because encapsulation of the sumatriptan for blinding purposes may have altered its pharmacokinetic profile and thereby decreased the efficacy responses, additional studies are warranted that do not involve encapsulation of the active treatments and assess the true onset of action of multi-mechanism therapy in migraine. This study did show that the combination of sumatriptan and naproxen sodium was well tolerated and that there was no significant increase in the incidence of adverse events compared to monotherapy.

Acute Disease↗
PubMed1994

Sumatriptan. A reappraisal of its pharmacology and therapeutic efficacy in the acute treatment of migraine and cluster headache.

Sumatriptan is a potent and selective agonist at a vascular serotonin1 (5-hydroxytryptamine1; 5-HT1) receptor subtype (similar to 5-HT1D) and is used in acute treatment of migraine and cluster headache. Following administration of sumatriptan 100mg orally, relief of migraine headache (at 2 hours) was achieved in 50 to 67% of patients compared with 10 to 31% with placebo in controlled clinical trials. In a comparative study, oral administration of sumatriptan 100mg consistently achieved significantly greater response rates than a fixed combination of ergotamine 2mg plus caffeine 200mg during 3 consecutive migraine attacks (66 vs 48% for first attack). Oral sumatriptan 100mg was also more effective than aspirin 900mg plus metoclopramide 10mg orally in a similar study. In the majority of controlled clinical trials, headache relief (at 1 hour after administration) was achieved in 70 to 80% of patients with migraine receiving sumatriptan 6mg subcutaneously compared with 18 to 26% of placebo recipients. Approximately 40% of patients who initially responded to oral or subcutaneous sumatriptan experienced recurrence of their headache, usually within 24 hours, but the majority of these patients responded well to a further dose of sumatriptan. Patients with cluster headache were treated for acute attacks with sumatriptan 6mg subcutaneously or placebo in 2 crossover trials. Headache relief was achieved within 15 minutes in 74 and 75% of patients receiving sumatriptan in these studies compared with 26 and 35%, respectively, with placebo. Patients receiving sumatriptan 12mg had a similar response rate as those receiving 6mg, but the higher dose was associated with an increased incidence of adverse events. Based on extensive safety data pooled from controlled clinical trials, sumatriptan is generally well tolerated and most adverse events are transient. The most frequently reported adverse events following oral administration include nausea, vomiting, malaise, fatigue and dizziness. Injection site reactions (minor pain and redness of brief duration) occur in approximately 40% of patients receiving subcutaneous sumatriptan, although the incidence appears to be markedly reduced when patients self-administer the drug with an auto-injector. Chest symptoms (mainly tightness and pressure) occur in 3 to 5% of sumatriptan recipients, but have not been associated with myocardial ischaemia except in a few isolated cases. Sumatriptan is contraindicated in patients with ischaemic heart disease, angina pectoris including Prinzmetal (variant) angina, previous myocardial infarction and uncontrolled hypertension, but is not contraindicated in patients with migraine and asthma. Data from long term studies in acute treatment of migraine and cluster headache suggest that sumatriptan remains effective and well tolerated over several months.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Oral↗
PubMed1997

Sumatriptan. A pharmacoeconomic review of its use in migraine.

Migraine is a common illness characterised by severe, often throbbing and/or unilateral headache, which may be accompanied by sensitivity to light or noise. A minority of migraine attacks are preceded by transient visual or sensory disturbances. Migraine is associated with reductions in health-related quality of life both during and between attacks. Despite methodological limitations in cost-of-illness studies, it is clear that the cost of migraine to society is substantial. Indirect costs (primarily workplace productivity losses) make up 75 to 90% of total costs. Direct costs, such as the cost of drug treatment, physician consultation, hospitalisation and emergency room treatment, make up most of the remainder. Sumatriptan is an effective and well tolerated agent in the treatment of migraine. Its main advantage over other agents used in the acute management of migraine appears to be its rapid onset of action. Sumatriptan reduces headache severity within 2 hours of oral administration in 50 to 67% of patients and within 1 hour of subcutaneous administration in 70 to 80% of patients. Headache recurs in approximately 40% of patients who initially respond to oral or subcutaneous sumatriptan; however, a second dose of the drug is effective against the symptoms of recurrence in a majority of patients. Some patients experience relief of non-headache migraine symptoms, including nausea, vomiting, photophobia and phonophobia. Adverse events reported after sumatriptan are generally mild and transient. Data from studies of patients who used their usual therapies and sumatriptan in nonblinded, sequential phases indicate that both workplace and nonworkplace productivity losses were reduced during sumatriptan therapy. A cost-benefit analysis applied to some of these workplace productivity data indicated that, including direct costs and productivity savings, sumatriptan was associated with a net reduction in total cost of migraine. In retrospective cost analyses, sumatriptan was associated with increased prescription costs: the effect of the drug on other direct treatment costs was less clear. A retrospective pharmacoeconomic model suggested that the cost-effectiveness of subcutaneous sumatriptan versus subcutaneous dihydroergotamine depended on which outcome measure was of greatest interest. For measures of rapid relief of migraine, sumatriptan was superior, but the cost of achieving rapid relief was substantial. Sumatriptan improved global quality-of-life scores compared with patients' usual therapy in a randomised crossover trial and appeared to do the same when the drugs were administered in nonblinded, sequential phases in trials which used general and migraine-specific quality-of-life instruments. Thus, sumatriptan is associated with a fast onset of action and improvements in health-related quality of life in patients with migraine. However, the cost of achieving rapid relief of migraine symptoms may be substantial. Compared with patients' usual treatments, sumatriptan appeared to reduce workplace and non-workplace productivity losses. However, few economic data from well controlled prospective comparisons of sumatriptan with other available agents are available to quantify the effect of sumatriptan on the overall cost of migraine.

Economics, Pharmaceutical↗
PubMed2005

Early intervention in migraine with sumatriptan tablets 50 mg versus 100 mg: a pooled analysis of data from six clinical trials.

BACKGROUND: In clinical trials evaluating sumatriptan in the treatment of moderate or severe migraine pain, the 50- and 100-mg doses have been comparably effective and well tolerated. OBJECTIVE: To assess the dose-efficacy relationship of sumatriptan tablets given early for mild pain, data from 6 randomized, double-blind, placebo-controlled, early-intervention studies of sumatriptan tablets 50 mg and 100 mg (5 of which have been published) were pooled for analysis. These constitute all the studies conducted to date of sumatriptan tablets prospectively given early for mild pain. METHODS: The primary efficacy end point in all the studies was the proportion of patients reporting a pain-free result (ie, mild, moderate, or severe pain reduced to none) 2 hours postdose. Other efficacy end points included the proportion of patients who were migraine free (ie, no pain and no associated symptoms of nausea, vomiting, photophobia, or phonophobia) 2 hours postdose; the proportion reporting worsening of pain (ie, moderate or severe pain) 2 hours postdose; and the proportion with a sustained pain-free result (ie, pain free from 2-24 hours postdose with no use of a second dose of study medication or of rescue medication). Tolerability was assessed by evaluating the incidence of individual adverse events. The investigators assessed each adverse event's relationship to study medication. RESULTS: The number of patients in the intent-to-treat population was 2297 (771 sumatriptan 50 mg, 759 sumatriptan 100 mg, 767 placebo). Patients' mean age ranged from 39.4 to 39.8 years across groups, and most patients were female (90%-92%) and white (89%-90%). A pain-free result 2 hours post dose was reported by significantly more patients who took either dose of sumatriptan tablets compared with placebo and by significantly more patients who took the 100-mg dose compared with the 50-mg dose (50 mg, 49%; 100 mg, 58%; placebo, 24%; P < 0.001, both sumatriptan doses vs placebo, and 100 mg vs 50 mg). A similar pattern was observed for migraine-free results 2 hours postdose (50 mg, 42%; 100 mg, 47%; placebo, 20%; P < 0.05, both sumatriptan doses vs placebo, and 100 mg vs 50 mg), worsening of pain 2 hours postdose (50 mg, 26%; 100 mg, 21%; placebo, 46%; P < 0.05, both sumatriptan doses vs placebo, and 100 mg vs 50 mg), and sustained pain-free results from 2 through 24 hours postdose (50 mg, 30%; 100 mg, 35%; placebo, 12%; P < 0.05, both sumatriptan doses vs placebo, and 100 mg vs 50 mg). Both doses of sumatriptan were well tolerated, and no dose-related trends in the incidence of individual drug-related adverse events were observed. CONCLUSIONS: In this analysis of pooled data from 6 clinical trials, sumatriptan tablets 50 mg and 100 mg administered early in a migraine attack while the pain was mild were well tolerated and significantly more effective than placebo. The 100-mg dose of sumatriptan was significantly more effective than the 50-mg dose.

Adult↗
PubMed2001

Patterns of ergotamine and sumatriptan use in the Netherlands from 1991 to 1997.

The objective of this study was to assess usage patterns of ergotamine and sumatriptan over a period of 6 years, primarily to evaluate the impact that sumatriptan has had on the prescription of ergotamine. This study used ergotamine and sumatriptan prescription data representing inhabitants of eight cities in the Netherlands and covering the period of 1991-1997. The yearly incidence of new users between 1991 and 1997 was estimated for both drugs as well as for the drug of first choice to be prescribed to patients initiating specific abortive migraine treatment with either ergotamine or sumatriptan. Intra-individual ergotamine and sumatriptan usage patterns, characterized by single (incidental), continuous (rate of retention) or switch use, were examined for five patient cohorts, each for a follow-up period of 1 year. During the year of sumatriptan introduction (1991-1992), the overall incidence of new use for both drugs was highest (5.4 per 1000 inhabitants). Hereafter, a substantial reduction of more than 50% was observed. From 1992 to 1996, the yearly incidence of ergotamine first-time use was significantly higher than that of sumatriptan and up to 1996 ergotamine was more than twice as likely than sumatriptan to be prescribed to patients initiating specific abortive treatment. Hereafter, sumatriptan was as likely as ergotamine to be prescribed as the drug of first choice, which coincided with the full reimbursement of sumatriptan tablets. Overall, neurologists were more likely than general practitioners (GPs), to prescribe sumatriptan as the drug of first choice. Approximately half of the total study population were identified as single-time users. This phenomonen occurred more frequently in the ergotamine cohorts. The sumatriptan cohorts displayed a slight yet significant stronger retention rate compared with the ergotamine cohorts. The overall impact of sumatriptan on ergotamine use in The Netherlands was marginal, predominantly due to GP's adherence to migraine treatment guidelines and reimbursement policies concerning sumatriptan tablets. Overall, incidental use was relatively high and may reflect the reported difficulties in diagnosing migraine, lack of patient-doctor consultation, or that anticipated benefits of the drug were not achieved. Further study is required to clarify these issues.

Adolescent↗
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↗
PubMed2005

Therapeutic benefit of eletriptan compared to sumatriptan for the acute relief of migraine pain--results of a model-based meta-analysis that accounts for encapsulation.

A novel model-based meta-analysis was used to quantify the dose-response relationship of sumatriptan and eletriptan for the proportion of patients that achieve migraine pain relief up to 4 h after treatment. The proportion of patients that became pain free was also evaluated. This analysis includes some unique features, allowing comparison of sumatriptan and eletriptan doses that have not been directly compared in a head to head study and also permitting comparison between the two drugs at multiple time points up to 4 h after treatment. Because the analysis allows comparison of response to blinded sumatriptan with that to marketed sumatriptan and contains timepoints as early as 0.5 h, it is especially suited to detection of possible effects of encapsulation on sumatriptan's therapeutic effectiveness and thus was employed to assess this also. Data from 19 randomized placebo controlled clinical trials were jointly analysed using a random-effects logistic regression model. The results of this analysis show a significant clinical benefit of eletriptan 40 mg compared to sumatriptan 100 mg at any point in time up to 4 h after treatment. The benefit of eletriptan 40 mg is greatest around 1.5-2 h after treatment with an absolute difference at 2 h of 9.1% (7.4-11.5%) more patients achieving pain relief and 7.3% (5.8-8.6%) more patient achieving pain free when compared to sumatriptan 100 mg. An absolute benefit of more than 5% of patients is maintained from 45 min up to 4 h after treatment for pain relief and from 1.5 h up to 4 h for pain free. Eletriptan 20 mg was superior to sumatriptan 50 mg and similar to sumatriptan 100 mg for pain relief while it was similar to sumatriptan 50 mg for pain free. The benefit of eletriptan 20 mg when compared to sumatriptan 50 mg is greatest around 1.5-2 h after treatment with an absolute difference at 2 h of 5.0% (2.9-8.1%) more patients achieving pain relief. An absolute benefit of more than 3% of patients was maintained from 1 h up to 3 h after treatment. No significant difference was found between eletriptan 20 mg and sumatriptan 50 mg for the fraction of patients that became pain free. No significant effect of encapsulation of sumatriptan was found on the time course of response up to 4 h after treatment when compared to commercial sumatriptan.

Capsules↗
PubMed2004

Pharmacokinetic profile of a new form of sumatriptan tablets in healthy volunteers.

OBJECTIVE: Rapid delivery of migraine-specific medication to its site(s) of action is thought to be crucial in preventing or minimizing sensitization of central pain pathways and thereby in optimizing pain-free outcomes in patients with migraine. Sumatriptan has been developed as a new tablet formulation to enhance the rate of systemic drug delivery by improving tablet disintegration and drug dispersion relative to those of conventional tablets. These enhanced formulation characteristics may be beneficial during occurrences of the gastric stasis that can accompany migraine. METHODS: This randomized, open-label, 4-way crossover study (n = 32) was conducted to determine whether the new formulation of sumatriptan 50 and 100 mg is bioequivalent to sumatriptan conventional tablets and to compare the pharmacokinetic profiles of the new formulation and the conventional tablet during the early (0-2 h) postdose interval in healthy volunteers. Pharmacokinetics during the early post-dose interval are important in determining a drug's onset of action, an important parameter to patients with migraine. RESULTS: The results confirm that the new formulation of sumatriptan and sumatriptan conventional tablets are bioequivalent as demonstrated by the finding that the 90% confidence intervals for the sumatriptan area under the concentration time curve to infinity and to the last evaluable time point (AUC(0- infinity ) and AUC(0-t), respectively) and maximum plasma concentration (C(max)) fell within the predetermined bounds defining bioequivalence (0.80-1.25) for both doses. Pharmacokinetic parameters measured early (0-2 h) after dosing reveal slightly faster absorption, on average, of the new sumatriptan formulation than sumatriptan conventional tablets although high intersubject variability was observed. For the new sumatriptan formulation, AUC(0-2) (AUC up to 2 h post dose) was, on average, 1% greater (50 mg) and 8% greater (100 mg) and maximal sumatriptan levels were attained, on average, 10 min earlier (50 mg) and 15 min earlier (100 mg) compared with the conventional tablet. Other measures including AUC(0-0.5) (AUC to 30 min post-dose), times to achieve sumatriptan concentrations of 5 and 10 ng/mL, and mean percentage C(max) 15, 20 and 30 min post-dose demonstrate an observable improvement in rate of drug absorption for the new form of sumatriptan compared with conventional tablets. CONCLUSION: The new form of sumatriptan is bioequivalent to sumatriptan conventional tablets and is absorbed more quickly than conventional tablets.

Adult↗
PubMed1995

Migraine and cluster headache--their management with sumatriptan: a critical review of the current clinical experience.

Sumatriptan is a potent and selective agonist at the vascular 5HT1 receptor which mediates constriction of certain large cranial blood vessels and/or inhibits the release of vasoactive neuropeptides from perivascular trigeminal axons in the dura mater following activation of the trigeminovascular system. The mode of action of this drug in migraine and cluster headache is discussed. On the basis of a detailed review of all published trials and available data from post-marketing studies, the efficacy, safety, tolerability and the place of oral and subcutaneous sumatriptan in the treatment of both conditions are assessed. A number of double-blind clinical trials have demonstrated that sumatriptan 100 mg administered orally is clearly superior to placebo in the acute treatment of migraine headache and achieves significantly greater response rates than ergotamine or aspirin. In other studies, 70 to 80% of patients receiving sumatriptan 6 mg sc experienced relief of migraine headaches by 1 or 2 h after administration, and patients consistently required less rescue medication for unresolved symptoms. Sumatriptan was also effective in relieving associated migraine symptoms like nausea and vomiting. Sumatriptan was equally effective regardless of migraine type or duration of migraine symptoms. Overall, approximately 40% of patients who initially responded to oral or subcutaneous sumatriptan experienced recurrence of their headache usually within 24 h, effectively treated by a further dose of this drug. In 75% of patients with cluster headache treated with sumatriptan 6 mg sc, relief was achieved within 15 min. Based on pooled study data, sumatriptan is generally well tolerated and most adverse events are transient. Adverse events following oral administration include nausea, vomiting, malaise, fatigue and dizziness. With the subcutaneous injection, injection site reactions occur in approximately 30%. Chest syumptoms are reported in 3 to 5% but have been associated with myocardial ischaemia only in rare isolated cases. The recommended dosage of sumatriptan at the onset of migraine symptoms is 100 mg orally or 6 mg subcutaneously. The recommended dosage for cluster headache is 6 mg sumatriptan sc. Sumatriptan must not be given together with vasoconstrictive substances, e.g., ergotamines, or with migraine prophylactics with similar properties, e.g., methysergide. Sumatriptan should not be given during the migraine aura. It is contraindicated in patients with ischaemic heart disease, previous myocardial infarction, Prinzmetal (variant) angina and uncontrolled hypertension.

Clinical Trials as Topic↗
PubMed1997

Safety, tolerability, and pharmacokinetics of sumatriptan suppositories following single and multiple doses in healthy volunteers.

A suppository formulation of the 5HT1 agonist sumatriptan could prove an important therapeutic option in migraine patients who dislike or poorly tolerate injectable therapy and where oral tablet administration is unsuitable because of severe migraine-related vomiting. Two independent double-blind, randomized clinical studies were conducted to evaluate the safety, tolerability and pharmacokinetics of sumatriptan suppositories following ascending single doses (four different dose levels) and multiple doses. In the four-period, crossover, single-dose study, 24 healthy male subjects were randomized to receive a suppository containing 12.5, 25, 50, or 100 mg on separate occasions 3-14 days apart. The suppositories were generally well tolerated; transient asthenia, drowsiness, and headache were the most frequently reported adverse events, and these were not dose-related. Peak plasma concentrations (Cmax) of sumatriptan were proportional to dose from 25 to 100 mg; area under the plasma concentration-time curve (AUC infinity) values were proportional to dose except at the highest doses, when they were greater than those predicted from lower doses. For all doses, the tmax of sumatriptan occurred within 2.5 h, and the t1/2 was approximately 2 h. In the two-period, placebo-controlled, crossover, repeat-dose study, 12 healthy adult male subjects were randomized to receive either a 50-mg sumatriptan suppository or placebo suppository, administered rectally twice a day, for 11 doses (5 1/2 days). Adverse events were no more frequent with sumatriptan than with placebo, and stool guaiac, rectal examinations, and physical examinations remained normal. No significant differences were noted between Day 1 and Day 6 values in the AUC, Cmax, time of peak serum concentration (tmax), elimination half-life (t 1/2), fraction of the dose excreted in the urine (fe), or renal clearance (Clr) of sumatriptan or its pharmacologically inactive indole acetic acid metabolite. Serum metabolite concentrations were two to three-fold higher than corresponding sumatriptan concentrations. No clinically significant accumulation of sumatriptan or its metabolite occurred. Overall, these studies show that sumatriptan administration via a suppository formulation is well tolerated, allows rapid absorption of sumatriptan, results in sumatriptan Cmax values that are proportional to dose from 25 to 100 mg, and is not associated with accumulation of sumatriptan or its metabolite.

Adolescent↗
PubMed1997

Safety, tolerability, and pharmacokinetics of sumatriptan in healthy subjects following ascending single intranasal doses and multiple intranasal doses.

The delivery of sumatriptan doses intranasally could add greater flexibility in the treatment of migraine than is possible with the currently available subcutaneous and oral sumatriptan preparations. Two independent double-blind, randomized, placebo-controlled clinical studies were conducted to evaluate the safety, tolerability and pharmacokinetics of intranasally administered sumatriptan following ascending single doses (three different dose levels) and multiple doses. In the four-way, crossover, ascending-dose study, 20 healthy female subjects were randomized to receive on separate occasions single intranasal spray doses of 5, 10, or 20 mg sumatriptan (as the hemisulphate salt) or placebo into one nostril. Adverse events were mild and consisted mainly of bitter taste at the back of the throat and events typical of sumatriptan administered by other routes (headache, lightheadedness and tingling). Area under the plasma sumatriptan concentration versus time curve (AUC infinity) and peak plasma concentration (Cmax) increased with the dose. Dose proportionality was demonstrated between 5 and 10 mg but not across the dose range 5-20 mg. Time to maximum plasma concentration (tmax) was variable due to multiple peaking. The elimination half-life (t1/2), approximately 2 h, was unaffected by the magnitude of dose. In the two-period, multiple-dose, crossover study, 12 healthy adult male and female subjects were randomized to receive either sumatriptan hemisulphate 20 mg or placebo, administered intranasally as a spray three times a day for 4 days. The two dosing periods were separated by 3 to 14 days. Multiple doses of sumatriptan were well tolerated, with no serious adverse events occurring or withdrawals due to adverse events. All patients reported a mild to moderate drug-related disturbance of taste. Nasal examinations remained normal, and olfactory function was unaffected. The AUC over the first 8 h following dosing (AUC8) and fraction of the dose excreted in the urine (fe; 6.2% vs 3.6%) were similar on Days 1 and 4. Day 4 values were significantly higher (p < or = 0.05) for Cmax (16.9 ng/ml vs 13.1 ng/ml), renal clearance (Clr; 19.0 l/h vs 14.2 l/h), and t1/2 (2.18 h vs 1.93 h), and shorter for tmax (0.88 h vs 1.75 h). Some accumulation (22%) occurred over the 4 days of dosing. Serum concentrations of the pharmacologically inactive indole acetic acid metabolite of sumatriptan were fourfold to fivefold higher than corresponding sumatriptan concentrations. Overall, these studies show that the sumatriptan intranasal spray formulation is well tolerated, allows rapid absorption of sumatriptan, and results in only a clinically insignificant degree of sumatriptan accumulation upon repeated dosing.

Administration, Intranasal↗
PubMed2003

Single use of sumatriptan: a patient interview study.

OBJECTIVE: To investigate the possible reasons associated with the use of a single prescription of sumatriptan. BACKGROUND: A few population-based studies concerning the usage patterns of sumatriptan have revealed a relatively high incidence (approximately 40%) of sumatriptan users who utilize only a single prescription of the drug. DESIGN AND METHODS: Using automated prescription data from 11 community pharmacies, we identified single and multiple sumatriptan prescription recipients. The data were collected from May 1, 1998, to April 30, 2000. Several patient- and medication-related variables possibly associated with single recipiency of sumatriptan were analyzed. In addition, single recipients of sumatriptan were invited for an interview and asked a number of questions related to their clinical status and their experience with the medication. RESULTS: Four hundred ninety-five, first-time users of sumatriptan were identified during the patient selection period, of whom 38% were single recipients of sumatriptan. Of the latter, 102 patients were considered eligible for interview. Reasons for terminating treatment after only 1 prescription included: inefficacy and/or occurrence of side effects, 78% (n=79); uncertain diagnosis of migraine, 39.2% (n=40); and reduction in headache frequency, 33.3% (n=34). Almost half of the population had terminated treatment without having consulted their physician. More than half relied upon the use of over-the-counter (OTC) analgesics after having tried sumatriptan. Compared to multiple users of sumatriptan, single recipients were far less likely to have used another form of migraine treatment prior to (odds ratio, 0.35; [95% confidence interval, 019 to 0.67]) and after (odds ratio, 0.34 [95% confidence interval, 0.19 to 0.63]) initiating sumatriptan. Furthermore, single recipients had demonstrated an increased tendency towards benzodiazepine use prior to receiving sumatriptan (odds ratio, 1.80 [95% confidence interval, 1.00 to 3.28]). CONCLUSIONS: Single use of a sumatriptan prescription reveals some issues that may impact negatively the provision of effective migraine management. These include: rapidly developing dissatisfaction with the treatment provided and a lower tendency to seek out medical care. Our results also suggest that the drug may be used (inappropriately) as a diagnostic tool.

Adult↗
PubMed2006

Sumatriptan fast-disintegrating/rapid-release tablets.

Sumatriptan is a serotonin 5-HT(1B/1D) receptor agonist that is used for the acute treatment of migraine attacks. A new fast-disintegrating/rapid-release sumatriptan tablet (sumatriptan FDT/RRT) has been developed with the goal of speeding absorption and onset of effect compared with standard sumatriptan tablets. Bioequivalence of sumatriptan FDT/RRT tablets to standard sumatriptan tablets was established in healthy volunteers. Initial data suggest that sumatriptan FDT/RRT tablets may disintegrate faster and get emptied from the stomach faster than standard sumatriptan tablets. In a randomised, double-blind, multicentre, early intervention trial in adults with mild migraine, significantly more sumatriptan FDT/RRT 50 and 100mg recipients than placebo recipients were pain free or migraine free 2 hours after receiving study medication. Compared with placebo, pain relief was significantly greater with sumatriptan FDT/RRT 100mg at 25 and 17 minutes following administration, and with sumatriptan FDT/RRT 50mg at 50 and 30 minutes following administration, in two randomised, double-blind, multicentre trials in adults with moderate to severe migraine. Sumatriptan FDT/RRT tablets were generally well tolerated; the tolerability profile was similar to that reported for standard sumatriptan tablets in other studies.

Adult↗