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PubMed2003

Pain-free efficacy after treatment with sumatriptan in the mild pain phase of menstrually associated migraine.

OBJECTIVE: To estimate the efficacy of sumatriptan 50-mg and 100-mg tablets in menstrually associated migraine when treatment is administered during the mild pain phase. METHODS: A randomized, double-blind, placebo-controlled, single-attack study was conducted. Menstrually associated migraine was defined as any migraine beginning on or between day -2 and day 4, with day 1 = first day of flow. Patients had at least a 1-year history of migraine as defined by International Headache Society criteria and reported regularly occurring menstrually associated migraines typically having a mild pain phase. Patients treated attacks within 1 hour of the onset of pain but only if the pain was mild at onset and while the pain was still mild. RESULTS: In the 349 women with menstrually associated migraine, sumatriptan was significantly more effective than placebo: 61% and 51% of patients who used sumatriptan 100 mg and 50 mg, respectively, were pain-free 2 hours after treatment compared with 29% of patients who used placebo (P <.001 for both comparisons). At 2 hours, 51% and 45% of patients who used sumatriptan 100 mg and 50 mg were free of pain and associated symptoms (photophobia, phonophobia, nausea, vomiting) compared with 25% of placebo patients (P <.001 for both comparisons). Adverse events were low for sumatriptan 100 and 50 mg, and both doses were generally well tolerated. CONCLUSION: Sumatriptan 50-mg and 100-mg tablets are generally well tolerated and effective in providing pain-free relief and relief of the associated symptoms of menstrually associated migraine when administered in the mild pain phase.

Administration, Oral↗
PubMed2003

A prospective double-blind study of nasal sumatriptan versus IV ketorolac in migraine.

We conducted a study to compare the efficacy in migraine headache of nasal sumatriptan and intravenous ketorolac. The study was a prospective, double-blind study done with a convenience sample of 29 patients presenting to the emergency department (ED) with acute migraine. Patients received either 20 mg of nasal sumatriptan or 30 mg of intravenous ketorolac. Patients scored the severity of their headache on a 100-mm visual analog scale (VAS) of pain prior to medication, and again 1 hour after medication. Differences between initial and 1-hour scores were analyzed. Before treatment, no difference existed between the groups in the intensity of headache. One hour after medication, the sumatriptan group had a decrease in pain score of 22.937 mm and the ketorolac group a decrease of 71.462 mm on the VAS. The decrease in pain score with ketorolac was significantly greater than that with sumatriptan (P < 0.001). The study therefore showed that both sumatriptan and ketorolac effectively reduced the pain associated with acute migraine headache, but that intravenous ketorolac produced a greater reduction in pain than did nasal sumatriptan.

Administration, Intranasal↗
PubMed2006

Pain free efficacy of sumatriptan in the early treatment of migraine.

BACKGROUND: There is evidence that headache response rates may be higher if triptans are used early when a migraine attack is still mild, as compared to when it is treated after pain has reached moderate or severe intensity. METHODS: In this randomized, double blind, placebo controlled, parallel group clinical trial, 361 patients took either placebo, sumatriptan 50 mg, or sumatriptan 100 mg in a single attack study. The primary outcome measure was pain-free status at two hours. RESULTS: In the intention to treat group, two hour pain free rates were 16%, 40%, and 50% in the placebo group, sumatriptan 50 mg group, and the sumatriptan 100 mg group respectively (p < 0.001, active treatment groups vs. placebo). CONCLUSIONS: Both sumatriptan 50 mg and 100 mg were significantly superior to placebo for the pain-free end point at two hours. The pain-free response rates in this trial where sumatriptan was taken while the headache was still mild were generally higher than in older clinical trials where headache was treated after reaching a moderate or severe intensity.

Adult↗
PubMed2001

Effect of intranasal sumatriptan on gastric tone and sensitivity to distension.

Sumatriptan is able to improve symptoms of early satiety in dyspeptic patients by relaxing the gastric fundus. The aim of this study was to verify the efficacy of intranasal administration of sumatriptan on gastric sensory motor function, in order to provide a new pharmacotherapeutic approach to functional dyspepsia. Thirteen healthy subjects were investigated twice on separate days. A gastric barostat was used to study the effect of placebo and sumatriptan, 20 mg intranasally, on basal fundic tone. In addition, stepwise isobaric distensions were performed and perception was measured before and after administration of drugs. Placebo had no effect on gastric tone and on perception. Sumatriptan caused a small, but short-lasting gastric relaxation and had no significant effect on sensitivity to distension and gastric compliance. Unlike the subcutaneous formulation, the intranasal administration of sumatriptan had no effect on gastric sensory motor functions, and this probably reflects a low biovailability of intranasally administered sumatriptan.

Administration, Intranasal↗
PubMed2001

Comparative effects of frovatriptan and sumatriptan on coronary and internal carotid vascular haemodynamics in conscious dogs.

The effects of frovatriptan and sumatriptan on internal carotid and coronary vascular haemodynamics were investigated and compared in conscious dogs. Frovatriptan and sumatriptan (0.1 - 100 microg kg(-1)) induced a transient increase in external coronary artery diameter (eCOD) of up to 2.9+/-1.2 and 1.8+/-0.6%, respectively (both P:<0.05). This was followed by a prolonged and dose-dependent decrease in eCOD of up to -5.2+/-1.2 and -5.3+/-0.9% (both P:<0.05), with ED(50) values of 86+/-21 and 489+/-113 micromol kg(-1), respectively. In contrast, only a decrease in the external diameter of the internal carotid artery was observed (-6.0+/-0.6 and -6.2+/-1.4%, both P:<0.05, and ED(50) values of 86+/-41 and 493+/-162 micromol kg(-1), respectively). Frovatriptan was thus 5.7 fold more potent than sumatriptan at the level of both large coronary and internal carotid arteries. After endothelium removal by balloon angioplasty in coronary arteries, the initial dilatation induced by the triptans was abolished and delayed constriction enhanced. The selective antagonist for the 5-HT(1B) receptors SB224289 dose-dependently blocked the effects of sumatriptan on large coronary and internal carotid arteries whereas the selective antagonist for the 5-HT(1D) receptors BRL15572 did not affect any of these effects. In conclusion, frovatriptan and sumatriptan initially dilate and subsequently constrict large coronary arteries in the conscious dog, whereas they directly constrict the internal carotid artery. The vascular endothelium modulates the effects of these triptans on large coronary arteries. Finally, 5-HT(1B) but not 5-HT(1D) receptors are primarily involved in canine coronary and internal carotid vasomotor responses to sumatriptan.

Animals↗
PubMed2002

5-HT1B-receptors and vascular reactivity in human isolated blood vessels: assessment of the potential craniovascular selectivity of sumatriptan.

AIMS: 5-HT1B-receptor mediated vasoconstriction of cranial arteries is a potential mechanism by which 5-HT1B/1D-receptor agonists such as sumatriptan produce their antimigraine effects. 5-HT1B-receptors exist in other blood vessels which may give rise to unwanted vascular effects. Therefore we examined the distribution of 5-HT1B-receptor immunoreactivity (i.r.) in human blood vessels (including target and nontarget vessels) and confirmed the functionality of this receptor protein, by comparing the vasoconstrictor effects of sumatriptan and 5-HT (the endogenous ligand) in isolated vessels. METHODS: Blood vessels (middle meningeal, pial, temporal and uterine arteries and saphenous veins) were obtained from surgical patients (with consent). Sections of the vessels were prepared for routine immunohistochemical studies using specific 5-HT1B- and 5-HT1D-receptor antibodies. For functional studies, ring segments of the vessels were mounted in organ baths for isometric tension recording. RESULTS: 5-HT1B-receptor i.r. was detected on the smooth muscle layer in middle meningeal, pial and uterine arteries and in saphenous vein and sumatriptan produced contractions in these vessels with potency values (mean pEC50) of 7.00, 7.08, 6.44 and 6.61, respectively, the magnitude of contraction was greatest in the cranial arteries with Emax values of 100.7, 60.3, 23.0 and 35.9%, respectively (expressed as a percentage of the reference agonist 45 mm KCl). 5-HT1B-receptor i.r. was not detected in temporal artery and sumatriptan had no effect in this artery. 5-HT1D-receptor i.r. was not detected in any of the vessels studied. CONCLUSIONS: Sumatriptan can evoke vasoconstriction in antimigraine target vessels and also in nontarget vessels through an action at 5-HT1B-rcceptors. Sumatriptan acts preferentially to cause contraction in human cranial arteries compared with the other blood vessels we examined and this effect is likely to be shared by other drugs of this class.

Cerebral Veins↗
PubMed1992

Comparative effects of the antimigraine drugs sumatriptan and ergotamine on the distribution of cardiac output in anaesthetized pigs.

The haemodynamic effects of sumatriptan, a 5-HT1-like receptor agonist, and ergotamine, an agonist at alpha-adrenergic, dopamine as well as 5-HT receptors, were compared using intracardiac injection of radioactive microspheres of different sizes in anaesthetized pigs. Ergotamine (0.02 mg.kg-1) and sumatriptan (0.3 mg.kg-1) decreased systemic vascular conductance and cardiac output. Only ergotamine raised arterial blood pressure. Both sumatriptan and ergotamine decreased arteriovenous anastomotic, but not capillary, blood flow in the head and body skin. Arteriovenous and capillary blood flow in the dura mater and nasal mucosa and capillary blood flow in the brain, kidneys, adrenals, intestine, heart, spleen and muscle remained unchanged. However, kidney conductance was decreased by both drugs, spleen conductance by sumatriptan and heart, liver and adrenal conductances were decreased by ergotamine. Thus, both sumatriptan and ergotamine constricted arteriovenous anastomoses in the skin, but not in the dura mater or nasal mucosa. Ergotamine constricted the vasculature more than sumatriptan, although both drugs may differentially decrease vascular conductances in some organs.

Anesthesia↗
PubMed1992

Sumatriptan injection is superior to placebo in the acute treatment of migraine--with regard to both efficacy and general well-being.

The efficacy of subcutaneous injection of sumatriptan in the acute treatment of migraine was assessed in a double-blind, randomized, placebo-controlled cross-over study of 27 migraine patients. In addition, the patients were asked to give information about their well-being and subjective symptoms by means of a self-administered standardized questionnaire. A total of 22 migraine sufferers received a subcutaneous (sc) injection of 8 mg of sumatriptan and 24 received placebo. Of these patients, 19 received both treatments and thus completed the study. The primary efficacy end-point was a reduction in headache severity from severe or moderate to mild or no headache at 30, 60, 90 and 120 min. An effective response to treatment was achieved within 30 min in 63% and within 60 min in 84% of patients when treated with 8 mg sumatriptan sc, compared with 11% for placebo (p less than 0.001). Sumatriptan also provided significant relief from nausea and photophobia as compared with placebo. The proportion of patients that needed rescue medication after 120 min was significantly lower (p less than 0.001) with active treatment when compared with placebo. Sumatriptan was well tolerated and the majority of adverse events were mild and transient. The most frequent symptoms were those of malaise/fatigue or numbness. No changes in blood pressure or ECG readings were observed during the treatment. Compared with placebo, subcutaneous 8 mg sumatriptan also caused a substantial improvement in general well-being as revealed by the Minor Symptoms Evaluation Profile-acute (MSEP-acute) questionnaire.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1994

A randomized double-blind placebo-controlled crossover study of subcutaneous sumatriptan in general practice.

OBJECTIVE: To evaluate the therapeutic response to sumatriptan in the acute migraine attack, MATERIAL AND METHODS: Two hundred and thirty migraineurs diagnosed by their general practitioners in accordance with their usual practice were included in the study. The patients treated two migraine attacks at home by subcutaneous injection of sumatriptan or placebo for the first attack and the alternative medication, i.e. placebo or sumatriptan, for the second attack (crossover). Following treatment, a neurology resident interviewed and examined the patients. RESULTS: When sumatriptan was compared to placebo, significantly more of the 209 evaluable patients reported headache relief at 1 h (56% vs 8%, p < 0.001) and 2 h (62% vs 15%, p < 0.001) after the first injection. Resolution of nausea, photophobia, and phonophobia was significantly more common in patients on sumatriptan than in those on placebo (p < 0.001 for all comparisons). The adverse events were usually transient and of mild or moderate severity; however, three patients withdrew due to adverse events. Ninety-five percent of patients evaluated by a neurology resident met the IHS criteria for migraine. CONCLUSION: In general practice, sumatriptan taken subcutaneously using an autoinjector at home was an effective and well tolerated acute treatment for migraine.

Adult↗
PubMed1996

Sumatriptan: vasoactive effect on human dural vessels, demonstrated by subselective angiography.

Sumatriptan, a selective 5-hydroxytryptamine (5HT1D)-receptor agonist, has recently been introduced in the pharmacotherapy of acute migrane attacks. The potential vasoactive effect of sumatriptan on human dural vessels in vivo, however, is still a matter of controversy. We investigated the effects of sumatriptan on dural vessels after subcutaneous or intra-arterial injection. During interventional angiography, the middle meningeal artery (MMA) of nine patients was catheterized with a microcatheter using the transfemoral route. Three MMA were entirely normal, two supplied a dural arteriovenous fistula (AVF) and four were transdural feeders to a brain arteriovenous malformation (AVM). Sumatriptan was injected either into the subcutaneous tissue of the right shoulder (6 mg, two patients) or into the catheterized MMA (2 mg, six patients). The substance caused a marked vasoconstriction of the three normal MMA, visible angiographically and confirmed by intravascular Doppler ultrasonography. Vasoconstriction was still present in the last angiogram obtained 15 min post-injection. Slightly hypertrophied feeders to dural AVF and to brain AVM showed some vasoconstriction in one and four patients, respectively. In two patients with markedly hypertrophied dural feeders to a dural AVF and to a brain AVM, respectively, rapid shunting probably prevented obvious vasoactive effects of sumatriptan. The data obtained by angiography and intravascular Doppler ultrasonography provide strong evidence that sumatriptan has a vasoconstrictive effect on normal as well as hypertrophied dural vessels.

Adult↗
PubMed1997

Responsiveness of non-IHS migraine and tension-type headache to sumatriptan.

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.

Adult↗
PubMed1999

Prospective large-scale study of the tolerability of subcutaneous sumatriptan injection for acute treatment of migraine.

To investigate prospectively serious adverse events associated with sumatriptan injection, we studied 12,339 typical migraineurs for up to 12 months each. This study imitated the ordinary clinical use of sumatriptan injection except that: (a) a short, written informed consent was required, (b) there was a centralized, automated dispensing service that audited each patient's product use, (c) patients were sometimes reviewed by telephone, and (d) drug supply and medical consultation were without charge. All adverse events were recorded regardless of etiology. There were 25 fatalities during the study, none being attributable to sumatriptan injection. Of six strokes in the study, two occurred soon after treatment of a migraine attack with sumatriptan injection; whether these were migraine-related or drug-related is discussed. None of the three myocardial infarctions was due to sumatriptan injection use. We conclude that sumatriptan injection is well tolerated when used in accordance with labeling.

Adolescent↗
PubMed1999

Tolfenamic acid decreases migraine recurrence when used with sumatriptan.

Although sumatriptan is an effective drug for the treatment of acute migraine attacks, recurrence has been cited as an important limitation for its use. Tolfenamic acid is also effective in the acute treatment of migraine attacks. We studied the recurrence rate of migraine attacks with the use of sumatriptan plus tolfenamic acid among patients who presented frequent recurrence with sumatriptan. Fifty migraineurs were retrospectively studied, all having treated at least 10 attacks with 100 mg P.O.; sumatriptan was effective in at least eight of them. The patients also presented recurrence in less than 24 h in at least five of the treated attacks. We then used sumatriptan 100 mg plus tolfenamic acid 200 mg P.O. during the first 60 min of the attack; 240 attacks were treated and there was recurrence in 57 (23.8%). With sumatriptan alone, 5 out of 8 attacks (62.5%) presented recurrence. We therefore conclude that the combination sumatritpan plus tolfenamic acid is effective in reducing the recurrence rate from 5 of 8 (62.5%) to 1.19 of 5 (23.8%). Further prospective studies with a double-blind design and a higher number of treated attacks are necessary to confirm these initial observations.

Adult↗
PubMedDate not supplied

Sumatriptan and cerebral blood flow velocity changes during migraine attacks.

Transcranial Doppler studies on the effects of sumatriptan on cerebral hemodynamics have shown conflicting results. We evaluated blood flow velocity changes in 21 patients suffering from migraine with (n = 4) or without aura (n = 17) during a spontaneous attack, before and after treatment with sumatriptan. Flow velocity in the internal and external carotid, middle cerebral, and basilar arteries was measured by means of transcranial Doppler. During the attack, measurements were taken before subcutaneous sumatriptan injection, then after 30 minutes, 2 hours, and 24 hours. An additional measurement was taken 1 week later, in a headache-free state. We found a significant reduction of flow velocity during the attack in the middle cerebral artery on both sides (P < 0.05). After sumatriptan administration, flow velocity increased in the internal carotid artery on both sides (P < 0.05) and in the middle cerebral artery on the headache side (P = 0.0001), but not in the external carotid and basilar arteries (P > 0.05). Flow velocity changes may reflect the vasodilation present at the onset of the migraine attack followed by vasoconstriction in the internal carotid and middle cerebral arteries after sumatriptan treatment. Since vasoconstriction occurs in responders and nonresponders to treatment, it is unlikely to be the primary mechanism by which sumatriptan relieves headache.

Adolescent↗
PubMed1998

Tolfenamic acid rapid release versus sumatriptan in the acute treatment of migraine: comparable effect in a double-blind, randomized, controlled, parallel-group study.

The efficacy and safety of tolfenamic acid and oral sumatriptan in the acute treatment of migraine was studied at five neurological centers in Finland. One hundred forty-one patients experiencing 289 migraine attacks, fulfilling the diagnostic criteria for migraine with or without aura as defined by the International Headache Society, were randomized. For first attacks, 77% of patients receiving tolfenamic acid experienced a reduction of the initial severe or moderate headache to mild or no headache after 2 hours, as compared to 79% in the sumatriptan group and 29% in the placebo group. No significant difference was found between active treatments (P = 0.85, 95% CI [-22%, 18%]), however, both active treatments were significantly better than placebo; P = 0.001, 95% CI (26%, 69%) for tolfenamic acid and P = 0.001, 95% CI (28%, 71%) for sumatriptan. For second attacks, results were similar with 70% of patients receiving tolfenamic acid experiencing relief, as compared to 64% in the sumatriptan group and 39% in the placebo group. No significant differences were observed in accompanying symptoms. Both drugs were well tolerated with the frequency of adverse events; 30% for tolfenamic acid and 41% for sumatriptan, a nonsignificant difference. In this study, tolfenamic acid and oral sumatriptan are comparably effective in the acute treatment of migraine. When comparably effective, factors like individual effect, tolerance, and cost of treatment should be considered when prescribing migraine medication.

Acute Disease↗
PubMed1998

Practicability and acceptance of subcutaneous self-administration of the selective serotonin agonist sumatriptan.

To cater to the special situation of much reduced oral bioavailability which occurs in severe migraine attacks with pronounced nausea and vomiting, sumatriptan can also be used in a subcutaneous form that can be self-administered. The aim of this study was to analyze the practicability and acceptance of a method of self-administration ("Glaxo-Pen") for treatment of severe migraine attacks by subcutaneous injection of sumatriptan. The Glaxo-Pen was compared with the conventional autoinjector for subcutaneous administration of sumatriptan. The multicenter study was conducted under practical conditions by 150 office-based physicians in Germany. Patients who commonly suffered from severe migraine attacks were given a careful explanation of how to use the device ("Glaxo-Pen") for self-administration of subcutaneous sumatriptan and were able to practice using it under guidance. They were given a Glaxo-Pen with two sumatriptan refills to take with them for treating their own migraine attacks. The patients used a headache diary to document administration outside the practice session. A total of 376 patients were included in the study. The major findings were that 80% of the patients rated the Glaxo-Pen "very easy" or "easy" to use, and only 6.4% rated it "difficult" or "very difficult." Compared with the conventional autoinjector, the Glaxo-Pen was rated "much better" or "better" by 77.9% of patients. Only 8.5% considered the Glaxo-Pen "worse" or "much worse" than the conventional autoinjector. The figures show that the great majority of patients found it easy to use sumatriptan for treating severe migraine attacks by self-administration under practical conditions. Thus, especially for patients who suffer from severe nausea, vomiting, or diarrhea during migraine attacks, this method of delivery is an easily used means of arresting migraine attacks.

Adult↗
PubMedDate not supplied

Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 mg and 50 mg in migraine. Rizatriptan Protocol 046 Study Group.

Rizatriptan is a selective 5-HT1B/1D receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine. This double-blind, placebo-controlled, crossover study compared rizatriptan 5 mg versus sumatriptan 25 mg, and rizatriptan 10 mg versus sumatriptan 50 mg. A total of 1329 patients were allocated to one of five groups for treatment of two attacks: rizatriptan 5 mg/sumatriptan 25 mg; sumatriptan 25 mg/rizatriptan 5 mg; rizatriptan 10 mg/sumatriptan 50 mg; sumatriptan 50 mg/rizatriptan 10 mg; placebo/placebo. For each attack, patients rated headache severity, presence of associated symptoms, and functional disability prior to dosing and at intervals through 4 hours thereafter. Patients also rated their satisfaction with medication. Rizatriptan 5 mg and 10 mg provided faster relief of headache pain and greater relief of migraine symptoms than the 25-mg and 50-mg doses of sumatriptan, respectively. The response to rizatriptan was better than sumatriptan on additional measures including functional disability and satisfaction with medication. All active treatments were highly effective compared to placebo and acted as early as 30 minutes after dosing. All active treatments were well-tolerated and showed comparable safety profiles.

Adult↗
PubMed2000

Pregnancy outcome following prescription for sumatriptan.

BACKGROUND: Some 2.5% of fertile Danish women use sumatriptan, and the drug is also taken during pregnancy. Although sumatriptan reacts selectively in brain vessels, the possibility of reactions with placental blood flow and uterotonic activity cannot be ruled out. The aim of our study was to examine the association between sumatriptan exposure during pregnancy and the risk of preterm delivery and low birth weight. METHODS: Data from the Pharmaco-Epidemiological Prescription Database of North Jutland county regarding all women who had given birth in the county of North Jutland from 1991 to 1996 were linked to the Danish Medical Birth Registry. Women who were exposed to sumatriptan during pregnancy were identified (n = 34), and using logistic regression models their pregnancy outcome was compared with two groups of pregnant women: (1) healthy women (n = 15 955) and (2) migraine controls (n = 89), defined as migraine patients who did not redeem prescriptions for migraine treatment during pregnancy. RESULTS: The risk of preterm delivery was elevated among women exposed to sumatriptan compared with migraine controls (odds ratio [OR] 6.3, 95% confidence interval [CI] 1.2-32.0) and healthy women (OR 3.3, 95% CI 1.3-8.5). The odds ratio for having a newborn with a low birth weight was increased (OR 3.0, 95% CI 1.3-7.0) for all migraine patients who delivered at term (n=115) compared with the outcome of healthy pregnancies. CONCLUSIONS: We found that sumatriptan exposure during pregnancy was associated with an increased risk of preterm delivery and low birth weight. These findings may be due to drug exposure, but they may also reflect the impact of disease severity rather than the treatment itself, or confounding, or chance.

Adult↗