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PubMed1998

[Interaction between sumatriptan and selective serotonin uptake inhibitors].

Migraine is common among patients who suffer from depression, and this category of patients often needs drug treatment for both diseases. A pharmacist consulted the Regional Drug Information Centre in the western part of Norway (RELIS 3) about the combined use of sumatriptan and fluoxetine, as the product information on sumatriptan warns of a possible interaction between these drugs. This possibility was evaluated by the Drug Information Centre, and it was concluded that the combination of sumatriptan and a selective serotonin reuptake inhibitor is not contraindicated. This conclusion was based on both theoretical and clinical considerations.

Antidepressive Agents, Second-Generation↗
PubMed2000

Comparison of a fixed combination of domperidone and paracetamol (Domperamol) with sumatriptan 50 mg in moderate to severe migraine: a randomised UK primary care study.

Migraine is a common and debilitating condition routinely managed in primary care. A number of treatment options--both acute and prophylactic--are currently available but may differ in terms of efficacy, tolerability and cost. The aim of this study was to compare the effectiveness and tolerability of a fixed combination of domperidone and paracetamol (Domperamol; Servier), which has anti-nauseant and anti-emetic activity, with sumatriptan 50 mg in moderate to severe migraine. To do this, 120 patients were recruited from 23 primary care practices throughout the UK and were enrolled into the six-month trial. Patients were randomised at entry to one of the comparator regimens (used to treat their first migraine attack) and then crossed over to the alternative treatment for their second attack. Detailed diary cards were completed for each attack using a scale of pain severity. At two hours and four hours post-dose, the two treatments showed comparable efficacy (< or = 15% difference) in relieving headache and reducing nausea and vomiting. Both were well tolerated and there were no serious adverse effects. In the management of migraine patients typically seen in routine general practice, this trial showed that the effects of Domperamol and sumatriptan 50 mg were broadly comparable. Since Domperamol is considerably less expensive than sumatriptan (and other triptans), a first-line role for this agent appears appropriate.

Acetaminophen↗
PubMed1996

[The combination of oral lysine-acetylsalicylate and metoclopramide compared with oral sumatriptan in the treatment of migraine attacks. A randomized, double-blind, placebo-controlled clinical trial].

A combination of lysine acetylsalicylate (equivalent to 900 mg aspirin) and 10 mg metoclopramide (LAS + MTC) was compared with oral sumatriptan (100 mg) and placebo in 421 patients with migraine in a randomized, double-blind, clinical trial. LAS + MTC was as effective as sumatriptan with a decrease in headache from severe or moderate to mild or none in 57% and 53%, respectively, for the first migraine attack treated, the primary efficacy parameter. Both treatments were better than placebo (success rate 24%, p < 0.001). LAS + MTC was better tolerated than sumatriptan (adverse events in 18% and 28%, respectively, p < 0.05).

Administration, Oral↗
PubMed2000

Determination of antimigraine compounds rizatriptan, zolmitriptan, naratriptan and sumatriptan in human serum by liquid chromatography/electrospray tandem mass spectrometry.

Development of a rapid, sensitive and selective method for the determination of antimigraine drugs from human serum is essential for understanding the pharmacokinetics of these drugs when administered concurrently. Solid phase extraction (SPE) using Oasis HLB was used to extract the drugs (sumatriptan, naratriptan, zolmitriptan and rizatriptan) and the internal standard bufotenine from serum. A method based on liquid chromatography/tandem mass spectrometry (LC/MS/MS) was developed and validated to simultaneously quantitate these antimigraine drugs from human serum. The precursor and major product ions of the analytes were monitored on a triple quadrupole mass spectrometer with positive ion electrospray ionization (ESI) in the multiple reaction monitoring (MRM) mode. The base peak in all the analytes is formed by alpha cleavage associated with protonation of the secondary amine. Mechanisms for the formation of the collision-induced dissociation products of these antimigraine compounds are proposed. Linear calibration curves were generated from 1-100 ng/mL with all coefficients of determination greater than 0.99. The inter- and intraday precision (%RSD) were less than 9.3% and accuracy (%error) was less than 9.8% for all components. The limits of detection (LOD) for the method were 250 pg/mL for sumatriptan and 100 pg/mL for the remaining analytes based on a signal-to-noise ratio of 3.

Bufotenin↗
PubMed2005

Iontophoretic transdermal delivery of sumatriptan: effect of current density and ionic strength.

Iontophoretic transdermal delivery of sumatriptan was investigated in vitro. Among the conditions tested, 0.25 mA/cm2 and low ionic strength (NaCl 25 mM) was the best experimental condition to increase its transport across the skin. The flux increased 385-fold respective to passive diffusion, thus resulting in a transdermal flux of sumatriptan of 1273+/-83 nmol/cm2 h.

Administration, Cutaneous↗
PubMed1993

Determination of sumatriptan succinate in plasma and urine by high-performance liquid chromatography with electrochemical detection.

Methods are described for the determination of sumatriptan succinate (1) in plasma and urine. Prior to chromatography, plasma is subjected to liquid/liquid extraction and urine is diluted in pH 7 buffer without further pretreatment. Both procedures use reversed-phase high-performance liquid chromatography with electrochemical detection. The analytical range for the plasma assay is 1-30 ng/mL and that for the urine assay is 0.2-12 micrograms/mL. The assays are linear over the analytical ranges and specific with respect to endogenous interference and the major metabolite (2) of sumatriptan. For the plasma assay, intra-assay data (n = 6) indicate a maximum coefficient of variation (CV) and bias across the calibration range of 6.0 and 3.0%, respectively. The interassay CV (n = 4) is approximately 15% at the bottom of the calibration range, falling to 4% or less at 8 ng/mL and above. Bias is approximately 12% at the bottom, reducing to < 2% at 8 ng/mL and above. The urine intra-assay data indicate a maximum CV and bias of 8.9 and 8.3%, respectively. The interassay is CV 15% for the lowest calibrant, reducing steadily across the calibration range to < 2% for the top calibration value, and bias is < 7% across the range.

Chromatography, High Pressure Liquid↗
PubMed2001

Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring Programme.

PURPOSE: The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. METHODS: The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. RESULTS: Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. CONCLUSION: Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information.

Attitude↗
PubMed2005

Effects of sumatriptan and eletriptan on diseased epicardial coronary arteries.

BACKGROUND: Triptans are contraindicated in patients with known or suspected coronary artery disease (CAD); however, few studies have evaluated triptans in patients with obstructive CAD to quantify the vasoconstrictive effect on diseased coronary vessels. METHODS: Patients undergoing percutaneous transluminal coronary angioplasty for symptomatic single-vessel CAD were randomised to one of three parallel cohorts to receive (1) 6 mg intravenously (IV) infused eletriptan plus subcutaneous (SC) placebo, (2) IV infused placebo plus 6 mg SC sumatriptan or (3) IV infused placebo plus SC placebo, as simultaneous administrations in a double-blind manner. Serial arteriograms, hemodynamic indices, electrocardiography and triptan plasma concentrations were obtained. RESULTS: . Fifteen minutes after triptan challenge, median (95% confidence interval) changes in coronary artery diameter (CADM) at the focal point of the stenosed segment were: dilation of 2.6% (-5.0, 11.4), eletriptan 6 mg IV (n = 18); constriction of 6.8% (-12.6, 0.4), sumatriptan 6 mg SC (n = 17), and constriction of 4.5% (-7.0, 7.9), placebo (n = 10). One patient had angiographic evidence of a new thrombus at the stenosis site, necessitating termination of study infusion and successful stenting of the lesion. There was no correlation between effects on CADM and triptan concentration, or between hemodynamic or electrocardiograph changes and the presence (n = 13) or absence (n = 33) of chest pain. CONCLUSIONS: Triptans had very little effect on diseased epicardial coronary arteries in a small group of angina sufferers with established CAD. Results should be interpreted cautiously since there may be instances where even modest triptan-associated epicardial constriction is sufficient to precipitate myocardial ischemia in patients with severe obstructive CAD.

Adult↗
PubMed1993

Transmural myocardial infarction with sumatriptan.

For sumatriptan, tightness in the chest caused by an unknown mechanism has been reported in 3-5% of users. We describe a 47-year-old woman with an acute myocardial infarction after administration of sumatriptan 6 mg subcutaneously for cluster headache. The patient had no history of underlying ischaemic heart disease or Prinzmetal's angina. She recovered without complications.

Cluster Headache↗
PubMed1995

Is myofascial pain of the temporal muscles relieved by oral sumatriptan? A cross-over pilot study.

There is evidence that serotonin may be implicated in the pathophysiology of myofascial pain (MFP). Because of this, we used oral sumatriptan (Imitrex, Glaxo), a peripherally acting agonist of 5-HT1D receptors, in a double-blind, randomized, placebo-controlled double crossover pilot study of 7 patients with episodic MFP of the temporalis muscles. The results showed that there was a significant reduction in pain intensity and increase in pain relief over time with both the active medication and the placebo, but no significant difference between treatments. All but 1 patient reported that they are not interested in retaking the same medication. These data suggest that oral sumatriptan may not be the drug of choice in the control of episodic MFP.

Administration, Oral↗
PubMed2007

Diplotypes of the human serotonin 1B receptor promoter predict growth hormone responses to sumatriptan in abstinent alcohol-dependent men.

BACKGROUND: Some studies have associated alcohol dependence (AD) with the human serotonin (5-HT)(1B) receptor (HTR1B). This investigation explored the functional responsivity of HTR1B in abstinent AD men using a sumatriptan challenge, while measuring genetic heterogeneity in the HTR1B promoter. METHODS: Abstinent AD men (n = 27) and abstinent men without any alcohol use disorder (n = 19) were administered 6 mg of sumatriptan succinate, subcutaneously. Plasma samples collected over the following 2 hours were assayed for growth hormone (GH) concentrations. His DNA was genotyped for the A-161T and T-261G polymorphisms of the HTR1B promoter and diplotypes determined. RESULTS: Integrated GH responses were predicted by interactions of AD and promoter diplotypes, as well as subject ethnicity. The final model accounted for nearly 35% of the variance in GH responses. Post hoc evaluation revealed that AD was associated with a blunting of GH secretion only among individuals with the most common HTR1B diplotype (TT/TT). CONCLUSIONS: A blunting of GH responses in abstinent AD men was observed only among those with the most common HTR1B promoter diplotype. Less common promoter diplotypes appeared protective. Controlling for genetic background is a useful augmentation of case-control pharmacological challenge strategies designed to elucidate the psychobiology of AD and other complex disorders.

Adult↗
PubMed2006

In vitro and in vivo evaluation of the transdermal iontophoretic delivery of sumatriptan succinate.

The objective was to evaluate the transdermal delivery of the 5-HT(1B/1D) agonist, sumatriptan from an iontophoretic patch system, in vivo. Initial in vitro experiments were conducted to optimize formulation parameters prior to iontophoretic delivery in Yorkshire swine. It was found in vitro that increasing drug load in the patch from 9.7 to 39 mg had no statistically significant effect on cumulative delivery (cf. 305.6+/-172.4 vs. 389.4+/-80.4 microg cm(-2), respectively). However, for a given drug load (39 mg) increasing formulation pH from pH 4.7 to 6.8 significantly increased the cumulative amount of sumatriptan delivered across the skin (389.4+/-80.4 vs. 652.4+/-94.2 microg cm(-2)). A biphasic current profile comprising intensities of 1.8 mA from t=0 to t=180 min and 0.8 mA from t=181 min to t=360 min was used for the in vivo experiments. Drug levels in the blood were 13.7+/-4.5 and 53.6+/-10.2 ng ml(-1) at the 30 and 60 min time-points, rising to 90-100 ng ml(-1) during the 90-180 min time-period. The in vivo results show that the pharmacokinetics following transdermal iontophoretic delivery are comparable to those after oral, nasal or rectal administration, but do not match those upon subcutaneous injection.

Administration, Cutaneous↗
PubMed2004

Indomethacin, alone and combined with prochlorperazine and caffeine, but not sumatriptan, abolishes peripheral and central sensitization in in vivo models of migraine.

UNLABELLED: Recently it has been proposed that the throbbing pain of migraine is mediated by sensitization of peripheral trigeminovascular neurons, and that cutaneous allodynia of migraine is mediated by sensitization of central trigeminovascular neurons, and, moreover, that the triptans are less effective in aborting a migraine attack if the central sensitization is already established. The combination of indomethacin, prochlorperazine, and caffeine (IndoProCaf) is a drug of well-established use in the acute treatment of migraine. The aim of this study was to investigate whether the 3 active principles of IndoProCaf, alone and combined, compared to sumatriptan, were able to abolish the peripheral sensitization induced by kainic acid and the central sensitization induced by N-methyl-D-aspartate (NMDA) in in vivo models of hyperalgesia. The study showed that indomethacin or IndoProCaf is able to abolish both the kainic acid-induced and the NMDA-induced hyperalgesia. If administered at different times, IndoProCaf was always effective in reversing the kainic acid-induced hyperalgesia. Sumatriptan was not able to reverse either the kainic acid-induced or the NMDA-induced hyperalgesia. The efficacy of indomethacin, alone and combined with prochlorperazine and caffeine, in abolishing peripheral and central sensitization in in vivo models of hyperalgesia is a further explanation of the clinical efficacy of IndoProCaf in the treatment of migraine. PERSPECTIVE: This study suggests that, although triptans were shown to be able to abort migraine attacks only if given before the establishment of cutaneous allodynia and central sensitization, IndoProCaf should be able to abort migraine attacks independently from the time of administration, because it is able to abolish an already established peripheral and central sensitization.

Animals↗
PubMed1997

Growth hormone response to sumatriptan (5-HT1D agonist) challenge in seasonal affective disorder: effects of light therapy.

To explore the role of serotonergic system in seasonal affective disorder (SAD), we compared growth hormone (GH) responses to a challenge with a novel 5-HT1D receptor agonist sumatriptan between 11 patients with SAD and nine healthy controls. Of the 11 patients with SAD, nine had repeat sumatriptan challenge following treatment with light therapy. The results showed that GH responses were significantly blunted during winter depression in patients with SAD compared to healthy controls. The GH responses normalized following treatment with light therapy to similar levels in controls. The results of this study provide a support for the role of serotonergic system in pathophysiology of SAD and in the mechanism of action of light therapy.

Adult↗
PubMed1989

Development and validation of a liquid chromatographic-mass spectrometric assay for the determination of sumatriptan in plasma.

Sumatriptan succinate is a novel compound currently in development for the acute treatment of migraine. During early studies in man a sensitive and selective assay was required, which had to be developed rapidly, to determine plasma concentrations following an intravenous infusion. Thermospray liquid chromatography-mass spectrometry combined with the advanced automated sample processor was selected to achieve this. Although the assay was required quickly criteria for intra- and inter-assay accuracies and precisions of +/- 10% had to be achieved. These were obtained only by using a co-eluting deuterium-labelled internal standard. Attempts to use a homologue as an internal standard, which did not co-elute with sumatriptan, gave inferior results. The assay was linear over the calibration range 2-50 ng/ml with a limit of quantification of 2 ng/ml. The application of the technique to the analysis of samples from a volunteer study is demonstrated.

Chemical Phenomena↗
PubMed2001

Determination of degradation products of sumatriptan succinate using LC-MS and LC-MS-MS.

Acid, base, heat, oxidation and UV irradiation stress methods were applied to study the stability of the bulk drug form of sumatriptan succinate. Liquid chromatography coupled with mass spectrometry (LC-MS and LC-MS-MS) was used to analyze the degraded samples and tentative structural identifications were assigned based upon known reactivity of the drug, molecular weight measurements and MS-MS fragmentation patterns. Sumatriptan succinate was found to be stable to exposure of acid, base, oxidation and UV irradiation at ambient conditions, but was found to degrade under acidic, basic and oxidative conditions when heated to 90 degrees C.

Chromatography, Liquid↗
PubMed1998

Dimerization of sumatriptan as an efficient way to design a potent, centrally and orally active 5-HT1B agonist.

A new bivalent ligand of formula 3 which results from the covalent coupling of two sumatriptan molecules with a p-xylyl spacer at the level of the sulfonamide nitrogen has been prepared and evaluated as a 5-HT1B/1D receptors agonist. In vitro experiments at 5-HT1B human cloned receptors (Ki = 0.64 nM; EC50 = 0.58 nM) and at the level of the contraction of the New Zealand white rabbit saphenous vein (pD2 = 6.6) demonstrate the superior potency of dimer 3 as a 5-HT1B receptor agonist when compared to sumatriptan or zolmitriptan. Interestingly enough, the new bivalent agonist 3 was found to induce hypothermia in the guineapig upon oral administration suggesting good oral activity and access to the brain.

Animals↗
PubMed1998

Abnormal 5-HT1D receptor function in major depression: a neuropharmacological challenge study using sumatriptan.

BACKGROUND: Sumatriptan, a specific agonist at 5-HT1D receptors, stimulates release of growth hormone (GH) and inhibits release of prolactin (PRL). METHODS: We gave sumatriptan (6 mg subcutaneously) to 11 patients with unipolar major depression and 11 control subjects matched for age, sex, weight and menstrual cycle phase. Serum GH and PRL were measured at 0, 15, 30, 45, 60 and 90 min after injection. RESULTS: The maximal rise in GH was significantly reduced in the depressed patients, with 60% showing no increase over baseline compared with 18% of controls. There were no significant differences in PRL responses. CONCLUSIONS: These results suggest reduced sensitivity of 5-HT1D receptors in major depression. Our results and those of studies investigating 5-HT1A receptors imply that both 5-HT1A and 5-HT1D autoreceptors may show reduced function in major depression.

Adult↗