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PubMed1993

Inhibition by sumatriptan of central trigeminal neurones only after blood-brain barrier disruption.

1. The 5-hydroxytryptamine (5-HT1)-like agonist, sumatriptan, is highly efficient in the relief of migraine headache and its accompanying symptoms. 2. Experimental evidence has indicated that its site of action may be on the cranial vessels or on the trigeminal innervation of the cranium, or both, since sumatriptan does not pass the blood-brain barrier easily under normal circumstances. It is, however, not clear whether the blood-brain barrier is normal or abnormal during a migraine attack. 3. In this study, single unit activity and trigeminal somatosensory evoked potentials in central trigeminal neurones were monitored during electrical stimulation of the superior sagittal sinus. 4. Intravenous administration of sumatriptan (100 micrograms kg-1) did not alter trigeminal evoked activity unless the permeability of the blood-brain barrier had been increased by infusion of an hyperosmolar mannitol solution. After blood-brain barrier disruption, sumatriptan decreased the peak-to-peak amplitude of evoked potentials by 40 +/- 6% and the probability of firing of single units by 30 +/- 9%. Mannitol infusions alone in control animals caused no changes in evoked potentials or single unit activity. 5. The data suggest that in normal circumstances sumatriptan does not have sufficient access to trigeminal neurons to alter their function.

Animals↗

PubMedDate not supplied

Preemptive oral treatment with sumatriptan during a cluster period.

This multinational, multicenter, randomized, double-blind, placebo-controlled study in 169 patients investigated the effect of a 7-day period of preemptive treatment with oral sumatriptan (100 mg tid) on the frequency and severity of cluster headache attacks occurring during an established cluster headache period. Safety and tolerability were also assessed. Cluster headache patients who were not taking prophylactic medication and had experienced seven or more attacks in the preceding observation week, treated a cluster headache attack at home with subcutaneous sumatriptan 6 mg using an autoinjector device. Patients were then randomized to take sumatriptan 100 mg or placebo at 8-hourly intervals for a 7-day period. Cluster headaches occurring during this period could be treated 5 minutes after onset with rescue medication (100% oxygen or simple analgesics). Diary cards were used to record details of the cluster headache pattern during the observation and study treatment weeks. Preemptive oral treatment with sumatriptan 100 mg tid for 7 days did not produce a significant reduction in the number or severity of cluster headache attacks occurring during an established cluster headache period. Oral treatment with sumatriptan 100 mg tid over a 7-day period was not associated with an increased or altered adverse event profile from that previously reported.

Administration, Oral↗

PubMed2004

Relationship between chronic tension-type headache, cranial hemodynamics, and cerebrospinal pressure: study involving provocation with sumatriptan.

OBJECTIVE: To study the relationship between chronic tension-type headache, cranial hemodynamics, and cerebrospinal pressure. BACKGROUND: Cerebrospinal pressure has been found to be above 200 mm in about 50% of patients with chronic tension-type headache. METHODS: Heart rate, blood pressure, common carotid artery diameter and blood flow, and craniovascular resistance and pain at regular intervals before, during, and after head-down tilt-a procedure which increases cerebrospinal pressure, were recorded. After head-down tilt, subcutaneous injections of either placebo or 6 mg of sumatriptan were administered. Chronic tension-type headache intensity before and after withdrawal of 20 mL of cerebrospinal fluid was documented. Cerebrospinal pressure and chronic tension-type headache intensity were measured after subcutaneous injection of 6 mg of sumatriptan. RESULTS: Head-down tilt provoked an increase of headache compared with baseline. Common carotid artery blood flow decreased and craniovascular resistance increased after sumatriptan injection, but not after placebo injection. The pain decreased after head-down tilt and placebo injection, but not after sumatriptan injection. Chronic tension-type headache intensity decreased in all 4 patients studied after withdrawal of 20 mL of cerebrospinal fluid. Cerebrospinal pressure increased in 5 patients with chronic tension-type headache after subcutaneous injection of 6 mg of sumatriptan with slight or no increase of pain. CONCLUSION: The results indicated that cerebrospinal pressure or intracranial venous pressure (or both) are related to chronic tension-type headache.

Adolescent↗

PubMed1993

Effect of subcutaneous sumatriptan, a selective 5HT1 agonist, on the systemic, pulmonary, and coronary circulation.

BACKGROUND: Sumatriptan (GR43175) is a selective 5-hydroxytryptamine (5HT1) receptor agonist effective in the acute treatment of migraine. Recent in vitro experiments suggest that it has vasoactive properties in vascular beds distinct from the cerebral circulation. The object of this study was to assess the vasoactive effects of the standard 6-mg subcutaneous dose of sumatriptan used in migraine on the systemic and pulmonary circulations and the coronary artery vasculature. METHODS AND RESULTS: Ten patients undergoing diagnostic coronary arteriography were studied with digital subtraction angiography and invasive hemodynamic monitoring. After subcutaneous injection of sumatriptan, there was no significant change in heart rate or ECG morphology. There was a significant rise in the systemic (20%, p < 0.05 by ANOVA) and pulmonary artery (40%, p < 0.05 by ANOVA) pressures. There was no change in cardiac output, but there was a significant increase in total systemic (27%, p < 0.05) and total pulmonary vascular resistance (40%, p < 0.05). Sumatriptan caused a significant reduction (p < 0.001 by ANOVA) in mean absolute coronary artery diameter, from 4.36 +/- 1.60 mm at baseline to 3.67 +/- 1.49 mm (16%) at 10 minutes and to 3.63 +/- 1.49 mm (17%) at 30 minutes after injection. There were no clinical sequelae. CONCLUSIONS: Sumatriptan, a 5HT1 receptor agonist administered by the subcutaneous route, causes a vasopressor response in the systemic and pulmonary arterial circulations and coronary artery vasoconstriction.

Adult↗

PubMed2005

Efficacy of almotriptan 12.5 mg in achieving migraine-related composite endpoints: a double-blind, randomized, placebo-controlled study in patients controlled study in patients with previous poor response to sumatriptan 50 mg.

BACKGROUND: Triptans are not identical and migraine sufferers respond differently to different triptans. Few studies have evaluated the efficacy of switching triptans in migraine patients who have shown poor response to another agent. OBJECTIVE: To investigate the efficacy and tolerability of almotriptan 12.5 mg in patients who did not achieve 2-h pain relief with sumatriptan 50 mg. METHODS: This double-blind, placebo-controlled study recruited patients with IHS-defined migraine and at least 2 previous unsatisfactory responses to sumatriptan. Those who did not achieve pain relief (moderate or severe pain decreasing to mild or no pain) 2 h after taking oral sumatriptan 50 mg on an open-label basis for the treatment of their first migraine attack during this trial (Attack 1) were randomized to receive either oral almotriptan 12.5 mg or placebo for the treatment of their next migraine attack (Attack 2). RESULTS: Of 302 patients receiving sumatriptan 50 mg for the treatment of their first migraine attack, 221 (73%) did not achieve 2-h pain relief and were randomized to almotriptan 12.5 mg or placebo for the treatment of Attack 2. The majority (70%) of randomized patients treating their headache in Attack 2 reported severe pain at baseline characterizing this as a difficult-to-treat population. In the intent-to-treat population (n = 198), significantly more patients in the almotriptan group compared with the placebo group achieved 2-h complete relief (free from pain and migraine-associated symptoms) at 2 h (17.1% vs. 4.4%; p < 0.05) and sustained pain free (20.9% vs. 9.0%; p < 0.05). Adverse events of mild-to-moderate intensity occurred in 7.1% of patients in the almotriptan group compared to 5.1% in the placebo group (not statistically different). CONCLUSION: Almotriptan is more effective than placebo and similarly well-tolerated for the acute treatment of migraine in patients who responded poorly to oral sumatriptan.

Administration, Oral↗

PubMed2006

Prevalence of migraine and response to sumatriptan in patients self-reporting tension/stress headache.

OBJECTIVE: This study was conducted to evaluate the prevalence of migraine and its responsiveness to migraine-specific therapy in patients with self-reported tension-type headache. METHODS: Patients were adults (n = 423) consulting one of 54 North American study sites including primary care clinics, neurology clinics, and headache clinics. The study comprised an initial diagnosis phase to determine the headache diagnosis of patients entering the study with self-reported tension/stress headache, including that previously diagnosed by a health care provider. Patients reporting tension/stress headache were evaluated and diagnosed as having migraine with or without aura, probable migraine, tension-type headache, or another headache type. Exclusion criteria included prior diagnosis of migraine or probable migraine and the presence of headache for at least 15 days monthly during either of the 2 months before screening. The initial phase was followed by a randomized, double-blind treatment phase to evaluate the efficacy of sumatriptan 100 mg tablets for the treatment of a single migraine attack in those meeting International Headache Society (IHS) criteria for migraine during the diagnosis phase. RESULTS: Of 423 patients reporting tension/stress headache at study entry, 84% (n = 357) were diagnosed at the clinic visit as fulfilling IHS criteria for migraine without aura or migraine with aura, and 65% (n = 276) were diagnosed with migraine only (i.e., with no other concurrent headache diagnosis). Three hundred thirty-two (332) patients entered the double-blind treatment phase. Headache relief rates 2h post-dose, the primary efficacy endpoint, did not significantly differ between sumatriptan and placebo (p = 0.099). However, improvements were significantly (p < 0.05) greater with sumatriptan than placebo on several other headache-related efficacy measures. CONCLUSIONS: Migraine headache may go unrecognized in patients with self-reported tension headache. Among patients having self-reported tension headache and diagnosed with migraine during the study, response to acute treatment with sumatriptan was inconclusive. Improvement with sumatriptan versus placebo was observed for some measures and not for others. The results should be interpreted in the context of study limitations including use of patient self-reports to assess headache diagnosis and possible lack of representativeness arising from the predominantly white sample.

Adolescent↗

PubMed2005

A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines.

OBJECTIVE: To compare the efficacy of 20 mg of IV metoclopramide, given up to four times over 2 hours as needed for persistent headache, with 6 mg of subcutaneous sumatriptan for the emergency department treatment of migraine headaches. METHODS: This was a randomized, double-blind, clinical trial with two intervention arms. The primary endpoint was change in pain intensity as measured by an 11-point pain scale at 2 hours. Secondary endpoints included change in pain intensity at 24 hours and rates of pain-free headache relief at 2 and 24 hours. RESULTS: Two hundred two patients were screened, and 78 of 91 eligible patients were randomized. The two groups had comparable pain scores at baseline. By 2 hours, the change in pain intensity for the metoclopramide group was 7.2 compared with 6.3 for the sumatriptan group (95% CI for difference: -0.2 to 2.2). When compared at 24 hours, the metoclopramide group had improved by 6.1 compared with baseline and the sumatriptan group had improved by 5.0 (95% CI for difference: -0.6 to 2.8). At 2 hours, pain-free rates were 59% in the metoclopramide arm and 35% in the sumatriptan arm (95% CI for difference of 24%: 2 to 46%). The most common side effects at both time points were weakness, dizziness, and drowsiness, which were distributed evenly between the two groups. There were no reports of chest pain within the first 2 hours. The incidence of restlessness, stiffness, and abnormal movements was distributed equally between the two groups. CONCLUSIONS: When compared at 2 and 24 hours, aggressive (20 mg dosed up to four times) IV metoclopramide and 6 mg of subcutaneous sumatriptan relieved migraine headache pain comparably. Some secondary endpoints suggest that metoclopramide may be the preferable therapy for migraines presenting to the emergency department.

Adult↗

PubMed1999

Intranasal sumatriptan for the acute treatment of migraine in children.

Sumatriptan is a highly effective treatment for migraine in adults but its efficacy in children has not been determined. Fourteen children with migraine (6.4 to 9.8 years of age; seven girls, six with aura) participated in a randomized double-blind placebo-controlled crossover study to evaluate the efficacy of sumatriptan nasal spray. After sumatriptan, 12 of 14 (versus 6 of 14 after placebo) reported a decrease in pain intensity (p = 0.031); complete headache relief was obtained in 9 of 14 after sumatriptan versus 2 of 14 after placebo (p = 0.016). Migraine-associated symptoms were also significantly reduced by sumatriptan.

Administration, Intranasal↗

PubMed2004

Treatment of migraine headaches with sumatriptan in pregnancy.

OBJECTIVE: To review the literature for treatment of migraine headaches with sumatriptan during pregnancy. DATA SOURCES: Studies and reports were located in International Pharmaceutical Abstracts (1970-September 2003) and MEDLINE (1966-week 3 September 2003). DATA SYNTHESIS: Research has been performed to evaluate the risk of teratogenesis after sumatriptan exposure in pregnant patients. Data have been collected in areas including placental transmission of sumatriptan, prospective pregnancy registries, open-labeled and controlled prospective studies, and a retrospective prescription-linked study. As of August 6, 2004, no randomized controlled trials have been conducted with exposure to sumatriptan during pregnancy. CONCLUSIONS: Teratogenesis occurs in approximately 150 000 births per year which represents an incidence of 3-5%. Available literature to date indicates that exposure to sumatriptan during pregnancy has no additional risk of birth defects compared with the incidence in the general population.

Abnormalities, Drug-Induced↗

PubMed2000

Cost-benefit analysis of sumatriptan tablets versus usual therapy for treatment of migraine.

We performed a systematic assessment of the costs and benefits of sumatriptan and usual therapy for migraine from society's perspective. A decision tree was constructed with probability estimates based on data from an open-label clinical trial assessing the economic and human impacts of sumatriptan and usual therapy on nursing personnel. Direct medical care costs including costs for drug, physician, and emergency room visits were considered. Benefits were estimated using the human capital approach based on the national average of weekly earnings and productivity loss estimated from a migraine clinical trial. The net benefits of sumatriptan and usual therapy for the treatment of a single migraine attack were estimated to be $50 and $20, respectively. The annual incremental net benefit of sumatriptan over usual therapy was estimated to be $114-540/patient. The price difference was offset by benefits of sumatriptan in reducing use of health care resources and productivity loss.

Absenteeism↗

PubMed1994

Sumatriptan clinical pharmacokinetics.

Sumatriptan is a novel serotonin 1 (5-hydroxytryptamine 1; 5-HT1)-like agonist which has been shown to be effective in the treatment of acute migraine. Single-dose pharmacokinetic studies reflect the way that sumatriptan will be used in routine practice, but relatively few studies have been published. Bioavailability is high (96%) following subcutaneous injection, but low (14%) following oral administration because of first-pass metabolism. Absorption is rapid after subcutaneous injection, with peak concentration reached in 10 minutes. After oral administration, multiple peak concentrations are observed, but a concentration that is 75% of the final peak concentration is usually reached within 45 minutes. Less than 20% of the drug is protein bound. The volume of distribution is greater than total body water at 170L. Total plasma clearance is rapid, with an elimination half-life of around 2 hours. There is one major metabolite (an indole acetic acid analogue) which is excreted in the urine as the free acid and its ester glucuronide conjugate. The pharmacokinetic profile of sumatriptan is not significantly affected by an acute migraine attack (absorption phase), old age or gender. Pharmacokinetic studies in individuals with hepatic and renal disease have not been published; however, care should be taken when sumatriptan is administered to patients with liver disease until such information is available. No significant interaction was found between sumatriptan and propranolol, flunarizine, pizotifen or alcohol (ethanol).

Animals↗

PubMed1996

Comparing dihydroergotamine mesylate and sumatriptan in the management of acute migraine. A retrospective cost-efficacy analysis.

The annual cost of managing migraine totals billions of US dollars. This retrospective economic analysis of a clinical trial comparing subcutaneous dihydroergotamine mesylate (DHE) with subcutaneous sumatriptan in the treatment of acute migraine is appropriate because, although each product has been shown to be efficacious, the acquisition cost of sumatriptan is over 3 times that of DHE. Total costs in each treatment group were calculated and applied independently to 11 clinical trial efficacy measures. Three of the efficacy measures showed no statistically significant difference between treatment arms, leading to a decision to use the less expensive DHE. In 4 of the efficacy measures. DHE was the obvious choice because it is more efficacious and less expensive. For the final 4 efficacy measures, where sumatriptan is more efficacious and more expensive, incremental cost-efficacy ratios were calculated to determine the additional expenditure required to achieve outcomes associated with quick relief. Depending on the efficacy variable chosen and the assumptions used in the model, the incremental cost-efficacy ratios ranged from $US4000 to $US6700 per year (1993 dollars) for each additional patient who is successfully treated with sumatriptan compared with DHE. Therefore, in a population of 100 migraineurs, an additional 13 to 22 patients would achieve these short term benefits of sumatriptan, although it would cost an additional $US88 395 annually, given the assumptions made. Because each product has unique advantages, we conclude that the more cost-efficacious product is dependent on the outcome of interest and the amount that the patient or provider is willing to pay to achieve that outcome.

Adolescent↗

PubMed2003

Safety of sumatriptan in pregnancy: a review of the data so far.

The high prevalence of migraine in women during their reproductive years means that new drug treatments for migraine, such as the serotonin 5-HT(1B/1D) receptor agonists (the 'triptans'), are likely to be widely used by women of childbearing potential. Scrutiny of these agents in an effort to detect any signal of teratogenicity is thus important. A systematic review of the medical literature was conducted to identify information regarding the safety of sumatriptan during pregnancy. This agent was chosen to be investigated because it has been available for the longest and is the most widely used of the triptan class. Information was obtained regarding the impact of migraine on pregnancy outcome, and data on sumatriptan use in pregnancy were obtained from animal studies, preclinical drug trials, postmarketing surveillance efforts, prospective pregnancy registries, national birth registries and teratogen information services. Synthesis of information from these sources is sufficient to rule out a large increase in birth defects from sumatriptan use during pregnancy and is reassuring for cases where inadvertent exposure to sumatriptan during pregnancy has occurred. However, current information is not sufficient to rule out small increases in the risk for birth defects. For this reason, caution should be exercised in making a positive recommendation for the use of sumatriptan during pregnancy.

Animals↗

PubMed2002

Evidence against strong correlation between chest symptoms and ischemic coronary changes after subcutaneous sumatriptan injection.

OBJECTIVE: To evaluate the adverse events possibly caused by sumatriptan injection and explore the relationship between chest symptoms along with sumatriptan injection and coronary ischemia among Japanese patients with migraine. METHODS: A cumulative total of 112 subcutaneous injections in 62 patients were evaluated. ECG was continuously monitored before and until 5 minutes after injection on 92 occasions. PATIENTS: Sixteen men and 46 women aged from 16 to 60 (mean 39+/-12) years. Their clinical diagnoses were migraine with aura, migraine without aura, cluster headache, and others. RESULTS: Chest symptoms occurred following 17% of all injections and in 15% of all patients. None of these chest symptoms was accompanied by ECG changes. CONCLUSIONS: Although the risk of coronary ischemia with sumatriptan treatment is commonly stated, our data suggest that chest symptoms following sumatriptan injection are not strongly associated with coronary ischemia in the Japanese population. The mechanism of chest symptoms following sumatriptan administration should be further elucidated.

Adolescent↗

PubMed2006

Effect of 5-HT1 agonist (sumatriptan) on anorectal function in irritable bowel syndrome patients.

AIM: To evaluate the effect of sumatriptan, a selective 5-HT1 agonist, on anorectal function in irritable bowel syndrome (IBS) patients. METHODS: Twenty-two IBS patients selected according to the Rome II criteria (F 15, M 7; mean age 29.3+/-6.8, range 22-44 years) were examined. The study was blind, randomized and placebo-controlled with a crossover design. Anorectal manometry and rectal balloon distension test were performed before and after the administration of placebo and sumatriptan. RESULTS: The administration of sumatriptan caused a significant increase in the resting anal canal pressure from 9.2+/-2.0 kPa to 13.1+/-3.3 kPa (P<0.0001) connected with the increase in the anal sphincter length and high pressure zone. After sumatriptan injection a remarkable increase in the threshold for the first sensation from 27+/-9 mL to 34+/-12 mL (P<0.05) and urge sensation from 61+/-19 mL to 68+/-18 mL (P<0.01) was observed. Sumatriptan did not affect either the volume evoking the rectoanal inhibitory reflex or the results of the straining test. CONCLUSION: 5-HT1 receptors participate in the regulation of anorectal function. Elucidation of the role of 5-HT1 receptors in the pathophysiological mechanisms of IBS may have some therapeutic implications.

Adult↗

PubMed1999

A dose-defining study of sumatriptan suppositories in the acute treatment of migraine.

In this dose-ranging, randomised, multinational, multicentre, double-blind, placebo-controlled, parallel group study, 431 patients treated a single migraine attack with study medication: sumatriptan suppository 6 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, or placebo. Patients were treated in the clinic with a single dose in suppository form. All doses of sumatriptan, except 6 mg, were significantly better than placebo (p < 0.004) and achieved similar rates of headache relief within two hours of dosing. The highest response rate was in the 25 mg group (72%) compared with placebo (37%) (p < 0.001). Fewer patients required rescue medication in the active groups (1% 100 mg to 13% 6 mg) compared with placebo (17%), and more patients were able to work and function normally two hours after dosing (41%, 100 mg; 20%, placebo). The overall incidence of adverse events was similar in the placebo, 6 mg and 12.5 mg groups (14-17%) but higher in the 25 mg, 50 mg and 100 mg groups (25%, 32% and 29% respectively). Analysis of plasma sumatriptan levels indicated rapid rectal absorption for all doses (median tmax = 1.0 hr). It is concluded that sumatriptan, in doses above 6 mg, is an effective and well tolerated treatment for acute migraine. From this study doses of 12.5 mg and 25 mg sumatriptan were identified as having the best efficacy/safety profile and were evaluated further.

Adolescent↗

PubMed1999

Zolmitriptan: new product. Similar to sumatriptan.

(1) Zolmitriptan is an antimigraine drug similar to sumatriptan. (2) The clinical file mainly comprises placebo-controlled dose-finding studies recommending an optimal oral dose of 2.5 mg. (3) Zolmitriptan has been compared with sumatriptan in a trial that showed no difference in efficacy. In particular, the recurrence rate of headache after initial relief was not lower on zolmitriptan than on sumatriptan. (4) The safety profile of zolmitriptan is similar to that of sumatriptan. The contraindications relating to a history of cardiovascular disease must be respected because of the vasoconstrictive effect of the drug. (5) Zolmitriptan has the same drug interactions as sumatriptan. Moreover, zolmitriptan should not be used during migraine attacks by patients on propranolol.

Clinical Trials as Topic↗

PubMedDate not supplied

Sumatriptan overuse in episodic cluster headache: lack of adverse events, rebound syndromes, drug dependence and tachyphylaxis.

This observational study was designed to examine the pattern of sumatriptan use in patients with cluster headache using more than the recommended daily dose of subcutaneously injected (s.c.) sumatriptan. Thirteen patients suffering from episodic cluster headache were asked to record the characteristics of their attacks and drug intake for 1 year. All reported a high daily frequency of attacks (more than 3 per day) and the related overuse of s.c. sumatriptan. The results show that the overall incidence of adverse events among patients receiving sumatriptan injections for the treatment of cluster headache is low. The extended administration of this drug in episodic cluster headache did not result in tolerance problems or tachyphylaxis. Only 4 patients experienced minor adverse events and recovered more slowly than the others. They suffered from migraine without aura and cluster headache, and showed a family history of migraine. Even though they must be viewed with caution, due to the observational nature of the study and the low number of patients included, these results suggest that the profile of sumatriptan may differ in cluster headache compared with migraine.

Adult↗