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PubMed2001

Mixing sumatriptan: a prospective study of stratified care using multiple formulations.

OBJECTIVE: To assess the acceptability, utility, and tolerability of a system of stratified care of acute migraine using multiple formulations of sumatriptan. BACKGROUND: Stratified care matches the treatment of a disease to its level of severity. Sumatriptan, with its multiple formulations, seems a logical option in a stratified care approach. Little data exists on the use of multiple formulations in a single patient population. DESIGN AND METHODS: A prospective, open-label, outpatient study recruited patients from a single center during the period from January 1998 through June 1998. Entry criteria included International Headache Society migraine diagnostic codes 1.1 or 1.2 and an established response to sumatriptan tablets or nasal spray. Patients who enrolled were allowed to use subcutaneous sumatriptan as either primary or rescue therapy for individual migraine attacks. RESULTS: Two hundred eighteen (80%) of 273 patients on tablets and 40 (85%) of 47 patients on nasal spray enrolled. During a period of 6 months, 61% of the patients on tablets and 85% of the patients using the nasal spray used at least one subcutaneous dose of sumatriptan. This system was efficacious and well tolerated. The majority of injections were used as rescue treatments following a failed oral or nasal dose. Two percent withdrew due to lack of efficacy, and 6% withdrew due to adverse events; however, 92% professed satisfaction with subcutaneous sumatriptan as an available tool for migraine management. CONCLUSION: A system of stratified care using multiple formulations of sumatriptan is efficacious, well tolerated, and preferable to a program involving a single form of the drug.

Aerosols↗
PubMed2001

Efficacy and tolerability of subcutaneous sumatriptan for acute migraine: a comparison between ethnic groups.

OBJECTIVE: To evaluate efficacy and tolerability of subcutaneous sumatriptan 6 mg versus placebo for acute migraine between ethnic groups. BACKGROUND: Patients in previous sumatriptan studies have been predominantly Caucasian and the effects of sumatriptan between different ethnic groups are unknown. METHODS: This was a multicenter, 3-phase, 12-attack study. Phases I and III (inclinic) were randomized, double-blind, placebo-controlled, crossover designs. Phase II (outpatient) was a single-blind design. Sumatriptan was compared to placebo across 2 groups (non-Caucasian and Caucasian) and individual ethnic subgroups (black, Hispanic, and others). Headache response, pain-free response, associated symptoms, and clinical disability were assessed. Tolerability assessments included the incidence of adverse events, physical examinations, vital signs, electrocardiograms, and clinical laboratory data. RESULTS: Two hundred patients treated at least one migraine attack (150 non-Caucasians: 46 blacks, 68 Hispanics, 36 others). Two hours postdose, significantly more inclinic sumatriptan-treated patients reported headache response (non-Caucasians, 81% versus 37% placebo; Caucasians, 87% versus 19% placebo; P<.001) and mild or no clinical disability, compared with placebo (non-Caucasians, 87% versus 50% placebo; Caucasians, 90% versus 38% placebo; P<.001). Blacks (80%), Hispanics (83%), and others (74%) reported similar patterns of headache response at 2 hours. Similar results were reported during the outpatient phase. The incidence of adverse events following sumatriptan during the inclinic phase was similar between ethnic groups (non-Caucasian, 75%; Caucasian, 79%) and higher than placebo (non-Caucasian, 51%; Caucasian, 31%). Overall, adverse events in the outpatient phase of the study were lower than in the inclinic phase. CONCLUSION: Sumatriptan injection is effective and well tolerated in non-Caucasians and Caucasians for the treatment of acute migraine attacks. Only minor differences in efficacy or tolerability were observed between blacks, Hispanics, and others.

Acute Disease↗
PubMed1995

Oral sumatriptan for the acute treatment of migraine: evaluation of three dosage strengths.

This randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and tolerability of oral sumatriptan (Imitrex tablets) in 259 migraineurs. In the clinic, patients received oral sumatriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a migraine attack. The results indicate that by 2 hours post-dose, 50 to 56% of patients treated with any of the three doses, compared with 26% of patients treated with placebo, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to 71% of sumatriptan-treated patients, compared with 38% of placebo-treated patients, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). Oral sumatriptan was similarly effective at relieving nausea and photophobia and at reducing clinical disability. The pattern and incidence of adverse events did not differ between treatment groups. All doses--25 mg, 50 mg, and 100 mg--of sumatriptan were effective and generally well tolerated. Dosing should be individualized according to the needs of the patient.

Administration, Oral↗
PubMedDate not supplied

A literature review comparing the economic, clinical, and humanistic attributes of dihydroergotamine and sumatriptan.

The value of different pharmaceuticals in treating migraine is frequently based on clinical efficacy only. This article assumes a broader perspective and compares the clinical, economic, and humanistic attributes of two antimigraine medications, dihydroergotamine (DHE) and sumatriptan, based on a literature review. DHE is an established product with over 40 years of use in the treatment of migraine. Sumatriptan is a new product with a higher acquisition cost than DHE. Because sumatriptan costs more than DHE, the question must be asked. "Does sumatriptan provide advantages that offset this price differential?" This question reflects the growing concern among payers and patients over the cost and effectiveness of therapies. However, it is not easily answered. Direct comparative data are not available, and data sources are different for the two products. Moreover, the products are currently marketed in different dosage forms--intramuscular for DHE and subcutaneous for sumatriptan. The literature reviewed indicates that the clinical attributes of the two products are similar, with each having slightly different advantages and disadvantages. However, the DHE literature is generally limited to uncontrolled studies, whereas the sumatriptan literature reports the results of rigorously designed, randomized, double-blind, placebo-controlled clinical trials. Published data on the products' economic and humanistic attributes are limited. We concluded that the literature does provide important, albeit limited, data on the economic, clinical, and humanistic attributes of DHE and sumatriptan that permit restricted comparisons. The limitations of the data highlight the need for comparative studies of these products' multidimensional attributes both in controlled clinical trials and under actual practice conditions.

Clinical Trials as Topic↗
PubMed1993

Sumatriptan in the treatment of migraine.

The headache phase of the migraine attack is thought to be associated with a dilation of cranial blood vessels, particularly those in the dura mater, and an accompanying localized sterile inflammatory response. Serotonin, or 5-hydroxytryptamine (5-HT), is considered a possible mediator of this syndrome. Receptors for 5-hydroxytryptamine are present in cranial arteries and are widely distributed in the CNS. Studies indicate that sumatriptan, a 5-HT1 receptor agonist, is effective in treating acute migraine attacks. The mechanism of sumatriptan's therapeutic action is not completely understood. Evidence from animal and human studies suggests that sumatriptan constricts dural vessels and inhibits neuropeptide release from trigeminal nerve endings by activating 5-HT1 receptors. Clinically, sumatriptan is rapidly effective against all features of the headache phase in migraine in up to 80% of patients. The headache may recur, however, within 24 hours in about one third of patients, but this can be treated effectively with a subsequent dose of sumatriptan. Treatment with sumatriptan has been well tolerated with only minor, transient, acute side effects reported. At present, only limited information is available regarding long-term tolerability, safety, and efficacy. Sumatriptan should not be prescribed to patients with a cardiovascular history.

Humans↗
PubMed1993

Subcutaneous sumatriptan in acute treatment of migraine: a multicentre New Zealand trial.

AIM: To assess the effectiveness of subcutaneous sumatriptan (4 mg) in the acute treatment of migraine. METHODS: A randomised, double-blind, placebo controlled study was conducted in four New Zealand centres. On developing an acute attack of migraine, patients attended a centre where they were given either sumatriptan 4 mg or placebo by subcutaneous injection. Headache severity and clinical disability were measured over a 2 hour period. RESULTS: Fifty-one patients, aged 19-58 years with common or classical migraine were treated. Twenty-eight patients received 4 mg sumatriptan and 23 patients received placebo. Pretreatment headache severity was graded moderate in 76% and severe in 24%. Thirty-two percent of patients were sufficiently disabled to require bed rest and a further 48% had severe impairment of working ability. Sumatriptan was significantly more effective than placebo in relieving or reducing headache severity after 30 minutes. Sixty-four percent improved on sumatriptan compared to 27% on placebo. Functional disability, nausea, vomiting and photophobia were also greatly reduced. Adverse effects occurred in 17% of patients receiving placebo, and 82% receiving sumatriptan, the commonest being injection site reactions. CONCLUSION: Subcutaneous sumatriptan 4 mg is an effective and well-tolerated acute treatment in adult patients with moderate to severe common or classical migraine. The efficacy rate of 64% is lower than that found in recent controlled studies using a higher dose.

Adult↗
PubMed1995

Sumatriptan does not stimulate PRL and GH secretion in acromegaly.

OBJECTIVE: Serotoninergic receptors are involved in the regulation of PRL and GH secretion. We studied the effects of sumatriptan, a new 5-HT1D receptor agonist, on PRL and GH secretion in active acromegaly. EXPERIMENTAL DESIGN: After their informed consent, all subjects were submitted to sumatriptan or placebo administration in single blind and in a random order. The time interval between the tests was of 7 days. ENVIRONMENT: We examined all patients in the morning, after 12 hours of fasting. All subjects were in recumbent position during the tests. Pulse rate and blood pressure were monitored during the test. SUBJECTS: Eight acromegalics (42-65 years) and 10 age-matched (33-63 years) normal subjects. PROTOCOL: Blood samples were taken after needle insertion kept patent by slow saline solution infusion. PRL and GH secretion were evaluated after sumatriptan (6 mg sc) and placebo. Blood samples were taken before (45, 15 and 0 minutes) and every 15 minutes for 2 hours after sumatriptan or placebo administration. RESULTS: No significant changes in PRL secretion were observed after sumatriptan in both groups of subjects. A significant increase in GH levels after sumatriptan was observed in controls but not in acromegalics. An age-related negative trend in GH response to sumatriptan was observed in controls. CONCLUSIONS: Our study indicated that 5-HT1D receptors are not involved in PRL and GH secretion in middle-aged acromegalics.

Acromegaly↗
PubMed1995

[Sumatriptan--side effects and problems in routine clinical practice].

AIM: The study tried to investigate the efficacy, adverse events and possible risk factors of sumatriptan in daily clinical practice. PATIENTS AND METHODS: 72 outdoor patients, who had treated their headaches at least once with sumatriptan, partly prescribed to them by outdoor physicians, were asked about their experiences with the drug. According to the criteria of the International Headache Society (1988) 55 patients were suffering from migraine, 11 from cluster headache and 6 from tension-type headache. RESULTS: Migraine and cluster patients rated the drug as effective as described in literature. Adverse events were reported by 69% of the patients which was more frequent than in most clinic studies described. Adverse events were usually not serious and transient. They were reported significantly more often by migraine patients than by patients with cluster headache and might not all be correlated to the therapy of sumatriptan. CONCLUSION: Sumatriptan has shown to be effective in the treatment of an acute migraine- and cluster-headache. The risk as to severe adverse events, especially cardial adverse events, exists if contraindications for sumatriptan are not considered. Sumatriptan should therefore only be prescribed to carefully diagnosed migraine and cluster headache patients. It should, however, not be given to patients suffering from drug abuse, because they might just change over to sumatriptan.

Adult↗
PubMed1996

The central cholinergic system has a role in the antinociception induced in rodents and guinea pigs by the antimigraine drug sumatriptan.

The antinociceptive effect of the antimigraine drug sumatriptan was assessed in mice and rats (hot-plate, abdominal constriction and paw-pressure tests) and in guinea pigs (paw-pressure test). The ACh extracellular concentration also was detected in the hippocampus of freely moving rats by microdialysis experiments. Antinociception was induced by sumatriptan administered both parenterally (5-10 mg.kg-1 i.v.; 10-30 mg.kg-1 i.p.) and i.c.v. (50-100 micrograms per mouse). Sumatriptan antinociception was potentiated by physostigmine (0.05 mg.kg-1 i.p.) and was prevented by the muscarinic antagonist atropine (5 mg.kg-1 i.p.), the ACh depletor HC-3 (1 micrograms per mouse i.c.v.) and the 5-hydroxytryptamine1A antagonist 1-(2-methoxyphenyl)-4-[4-(2 phthalimido)butyl] piperazine (0.5 mg.kg-1 i.p.). Naloxone, 3-aminopropyl-diethoxy-methyl-phosphinc acid, 2-methoxy-4-amino-5-chlorobenzoic acid 2-(diethylamino) ethyl ester and reserpine, administered in doses suitable for blocking analgesi induced by morphine, baclofen, 5-hydroxytryptamine4 agonist and clomipramine, respectively, did not modify sumatriptan antinociception. Sumatriptan, administered in the range of antinociceptive doses, was able to increase the level of ACh present in extracellular hippocampal space. On the basis of these findings we can deduce that sumatriptan was able to induce antinociception by increasing cholinergic activation in the CNS. Such activation, as indicated by the antagonism exerted by 1-(2-methoxyl-phenyl)-4-[4-(2 pethalimido)butyl]piperazine, may depend on stimulation of 5-hydroxytryptamine1A autoreceptors. It remains to be clarified whether the antimigraine activity of sumatriptan in humans is totally dependent on cranial vessel vasoconstriction of whether its central cholinergic antinociception also plays a role.

Acetylcholine↗
PubMed1998

[Evaluation of efficacy and tolerance sumatriptan at a dose of 50 mg in treatment of migraine attack].

Sumatriptan has been used successfully in the acute treatment of migraine since 1991. Most patients (70-80%) experience pain relief 2-4 hours after receiving 100 mg sumatriptan orally. During last few years efficacy of lower doses has been studied. Many authors proved that 50 mg of sumatriptan may be as effective as 100 mg. Our study confirmed that 50 mg oral dose of sumatriptan is sufficient in many patients. Headache relief was achieved in 58% of treated patients after single dose. The second dose of sumatriptan was effective in next 14% of patients. Totally headache relief after two doses of sumatriptan was achieved in 72% of patients. The sumatriptan 50 mg was well tolerated; only 10% of patients reported adverse events, which were minor and transient.

Administration, Oral↗
PubMed1999

Changes in resource use and outcomes for patients with migraine treated with sumatriptan: a managed care perspective.

BACKGROUND: Migraine headaches result in significant patient suffering and high costs to managed care organizations and employers. Studies that evaluate patient outcomes and the financial consequences of migraine treatment are important from a clinical and an economic perspective. METHODS: This prospective, observational study assessed the outcomes of migraineurs in a mixed model staff/ independent practice association managed care organization for patients previously diagnosed as having migraine who received their first prescription for sumatriptan. Data collected included medical as well as pharmacy claims and patient surveys to measure changes in satisfaction, health-related quality of life, workplace productivity, and nonworkplace activity after sumatriptan therapy was initiated. RESULTS: A total of 178 patients completed the study. Results showed significant decreases in the mean number of migraine-related physician office visits, emergency department visits, and medical procedures in the 6 months after sumatriptan therapy compared with the 6 months before sumatriptan was used (P<.05). Four of the health-related quality-of-life dimensions and the physical component summary score measured by the SF-36 (which is a valid, reliable general health status instrument) showed significant improvements at 6 months compared with patients' scores before use of sumatriptan (P<.05). Health-related quality of life measured by the disease-specific instrument MSQ (Migraine-Specific Quality of Life Questionnaire-Version 1.0, 1992 Glaxo Wellcome Inc, Research Triangle Park, NC) showed significant improvement at 3 and at 6 months compared with baseline scores (P<.05). There were also improvements in patient satisfaction and significant reductions in time lost from workplace productivity and nonworkplace activity. CONCLUSION: In the 6 months after sumatriptan therapy was initiated, health care resource use and time lost from workplace productivity and nonworkplace activity were reduced, while health-related quality of life and patient satisfaction scores improved for the managed care migraineurs enrolled in this study.

Activities of Daily Living↗
PubMed1992

Sumatriptan contracts large coronary arteries of beagle dogs through 5-HT1-like receptors.

The effects of 5-hydroxytryptamine (5-HT), 5-carboxamidotryptamine (5-CT), methysergide and sumatriptan were studied on endothelium-denuded rings of beagle dog large coronary arteries. Submicromolar concentrations of the compounds contracted the rings with the order of potency 5-CT > 5-HT > sumatriptan = methysergide. Concentrations greater than 2 microM of both 5-HT and 5-CT, and 60 mumol/l methysergide also caused concentration-dependent relaxation. Sumatriptan did not cause relaxation. Peak intrinsic activities relative to the plateau contraction to sumatriptan (1.00), were 5-CT 0.47, 5-HT 0.87 and methysergide 0.51. Ketanserin 1 mumol/l affected neither contractile responses nor relaxant responses to 5-CT, methysergide and sumatriptan and only caused marginal blockade of the contractile effects of 5-HT. Methiothepin 200 nM shifted the concentration-contractile response curves by around 2 log units, as expected from its affinity for 5-HT1-like receptors. The rank order of contractile potency of the agonists, the antagonism by methiothepin and the resistance to blockade by ketanserin are consistent with a nearly exclusive involvement of 5-HT1-like receptors. Isolated large coronary arteries from beagle dogs may be a suitable model for the study of human coronary artery 5-HT1-like receptors that are involved in the spasm observed with 5-HT and sumatriptan.

Animals↗
PubMed1996

Paroxetine treatment and the prolactin response to sumatriptan.

We studied the effect of the selective serotonin re-uptake inhibitor (SSRI), paroxetine (20 mg daily for 16 days) on the neuroendocrine, cardiovascular, thermic and subjective responses to the 5-HT1D receptor agonist, sumatriptan (6 mg, SC). Compared to placebo injection, sumatriptan lowered plasma prolactin and oral temperature and increased diastolic blood pressure. While paroxetine increased baseline prolactin concentration, it had no effect on any of the responses to sumatriptan. In addition, paroxetine did not alter concentrations of sumatriptan in plasma. No adverse reactions resulted from the combination of sumatriptan and paroxetine. Our findings suggest that combined treatment with sumatriptan and paroxetine in the doses used in this study is not necessarily contra-indicated. In addition, short-term SSRI treatment may not desensitise 5-HT1D autoreceptors in humans.

Adult↗
PubMed1992

Sumatriptan and 5-benzyloxytryptamine: contractility of two 5-HT1D receptor ligands in canine saphenous veins.

Sumatriptan and 5-benzyloxytryptamine are ligands with high affinity for 5-HT1D receptors in the caudate nucleus. Both compounds contracted canine saphenous veins, in vitro. Benzyloxytryptamine was less potent as a contractile agonist than sumatriptan which was less potent than serotonin. In high concentrations (greater than 10(-5) M) serotonin-induced contraction resulted, in part, from activation of alpha-adrenoceptors as determined by blockade of contraction with prazosin (10(-6) M) and idazoxan (10(-6) M). Likewise, benzyloxytryptamine but not sumatriptan also activated contractile alpha-receptors in the canine saphenous vein. Furthermore, benzyloxytryptamine antagonized contraction to sumatriptan in an apparently non-competitive fashion. Thus, benzyloxytryptamine, although possessing some alpha-receptor agonist activity, like sumatriptan, can interact with serotonin receptors in canine saphenous veins. Although effects of sumatriptan and benzyloxytryptamine quantitatively differed in canine saphenous veins, both agents showed similar affinity and agonist efficacy at 5-HT1D receptors in brain. These studies may reflect potential differences between the 5-HT1D receptor in brain and the 5-HT1-like receptor in canine saphenous veins.

Animals↗
PubMed1993

What intracranial tissues in humans contain sumatriptan-sensitive serotonin 5-HT1-type receptors?

We investigated the presence of sumatriptan-sensitive serotonin (5-HT)1 receptors in different human tissues by using a radioligand-binding technique with [3H]5-HT. Sumatriptan displaced [3H]5-HT from frontal cortical and striatal membranes in a biphasic manner, with a high-affinity site corresponding to binding to the 5-HT1D receptor. In blood platelet membranes, sumatriptan displaced [3H]5-HT with a 100-fold lower affinity. Sumatriptan failed to displace [3H]5-HT in membranes from large cerebral arteries, pial vessels, coronary arteries and dura mater. These findings suggest that either there are no sumatriptan-sensitive 5-HT1 receptors on intracranial blood vessels or they are so small in number that they cannot be detected by the radioligand-binding technique. Other mechanisms, possibly centrally mediated, may be responsible for the antimigraine action of sumatriptan.

Adult↗
PubMed2006

Acute effects of sumatriptan on aortic blood pressure, stiffness, and pressure waveform.

BACKGROUND AND OBJECTIVES: Sumatriptan, a 5-hydroxytryptamine (HT)(1B/1D) receptor agonist, is an effective acute antimigraine drug. Because of its vasoconstrictor activity, it is contraindicated in patients at high risk for adverse cardiovascular events. Acute antimigraine drugs without vasoconstrictor effects are currently being developed, and sensitive, noninvasive techniques by which to detect drug-induced vascular effects would facilitate their clinical development. The effects of sumatriptan on aortic blood pressure, stiffness, and pressure waveform have not been assessed previously in detail. METHODS: A randomized, placebo-controlled, double-blind, 4-way crossover study was performed in 12 healthy subjects. Each subject received 25, 50, and 100 mg sumatriptan and placebo as single oral doses. Vascular measurements, including oscillometric blood pressure measurement, arterial ultrasound, systolic pulse contour analysis, and aortic pulse wave velocity measurement, were performed at baseline and 30, 90, and 150 minutes after drug administration. RESULTS: Compared with placebo and expressed as weighted mean +/- SD, 100 mg sumatriptan increased aortic systolic blood pressure by 6 +/- 5 mm Hg (P < .01), aortic pulse wave velocity by 0.5 +/- 0.5 m/s (P < .01), and aortic augmentation index by 13% +/- 6% (P < .0001). The increase in aortic systolic blood pressure was larger compared with the increase in brachial systolic blood pressure (P < .0001). Significant vascular effects were already detected after the lowest dose of sumatriptan by systolic pulse contour analysis and arterial ultrasound. CONCLUSION: These findings show that therapeutic doses of sumatriptan acutely increase aortic blood pressure, stiffness, and augmentation index. Noninvasive systolic pulse contour analysis and arterial ultrasound may facilitate detection of drug-induced vascular effects in early clinical trials.

Adult↗
PubMed2004

Effect of sumatriptan in different models of pain in rats.

The effect of sumatriptan in two standard algesimetric tests and in a model of cephalalgia was evaluated in rats. The pain threshold was measured by the hot-plate and the writhing tests; cephalalgia was produced by injecting bradykinin (10 microg in a volume of 10 microl) into a common carotid artery. Sumatriptan was subcutaneously (s.c.) injected at the doses of 4, 8, 24 or 42 mg/kg; morphine (5 or 10 mg/kg s.c.) and indomethacin (5 or 10 mg/kg s.c) were used as standard analgesic drugs. Sumatriptan had no analgesic activity either in the hot-plate test or in the writhing test. On the other hand, at 24 and 42 mg/kg it dose-dependently reduced the response to the intracarotid injection of bradykinin (vocalization and tachypnea), this effect being prevented by the 5-HT(1B) receptor antagonist, isamoltane. The 5-HT(1D) receptor antagonist BRL15572 prevented the effect of sumatriptan on bradykinin-induced tachypnea, but not the effect of sumatriptan on bradykinin-induced vocalization. These data demonstrate that sumatriptan is significantly effective in a reliable animal model of cephalalgia, while having no systemic analgesic activity.

Animals↗
PubMed1996

Pharmacokinetic and pharmacodynamic profiles of sumatriptan in migraine patients with headache recurrence or no response.

OBJECTIVES: Sumatriptan is effective in the acute treatment of migraine. However, about 15% of patients with migraine do not experience headache relief after sumatriptan, and up to 40% may experience recurrence of headache within 24 hours. We studied whether pharmacokinetic or pharmacodynamic differences may explain these different clinical effects. METHODS: We compared the pharmacokinetic profiles of subcutaneous sumatriptan in 14 patients who consistently had headache relief without headache recurrence, in 12 patients who had headache recurrence in every attack, and in six patients who did not have headache relief after sumatriptan. Because the antimigraine action of sumatriptan may be mediated through vasoconstriction of cranial blood vessels, we also compared in these patients changes in blood vessel diameter and blood velocity in the common, internal, and external carotid arteries. RESULTS: Despite sufficient power of the study, no important differences in pharmacokinetic and pharmacodynamic profiles between the three patient groups were detected. CONCLUSION: Headache recurrence and lack of headache relief after sumatriptan do not appear to be explained by pharmacokinetic or pharmacodynamic differences between patients, which may be an important finding for the development of novel antimigraine drugs.

Adolescent↗