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Journal articles on the topic 'Sumatriptana'

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Published: 4 June 2021

Last updated: 10 February 2022

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1

Vincent, Maurice B., Linda R. White, Inger Johanne Bakken, and Ottar Sjaastad. "Sumatriptan Relaxes Isolated Porcine Ophthalmic Artery, But Inhibits VIP-Induced Relaxation." Cephalalgia 13, no. 6 (December 1993): 378–82. http://dx.doi.org/10.1046/j.1468-2982.1993.1306378.x.

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Sumatriptan, a 5-hydroxytryptamine (5HT)1-like receptor agonist, is a new antimigraine drug which is also effective in cluster headache (CH), a disorder with marked ocular circulatory abnormalities. Sumatriptan could putatively exert a therapeutic effect in this vascular bed. The present study is an attempt to assess sumatriptan's vasoactivity in isolated porcine ophthalmic artery (POA) and to verify whether it has similar activity to 5HT, and whether it interferes with the vasodilation induced by calcitonin gene-related peptide (CGRP) and vasoactive intestinal peptide (VIP). In contrast to 5HT, sumatriptan induced only slight contraction in POA at high concentrations. However, in some artery segments pre-contracted with PGF22a, sumatriptan induced a slight and short-lasting but marked relaxation. In addition, relaxations induced by VIP were inhibited significantly by sumatriptan, whereas CGRP effects were not influenced by the drug. Such reactions suggest that sumatriptan's effect in CH is probably unrelated to direct ocular arterial vasoconstriction.

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2

Mandema, JW, E. Cox, and J. Alderman. "Therapeutic Benefit of Eletriptan Compared to Sumatriptan for the Acute Relief of Migraine Pain — Results of a Model-Based Meta-Analysis that Accounts for Encapsulation." Cephalalgia 25, no. 9 (September 2005): 715–25. http://dx.doi.org/10.1111/j.1468-2982.2004.00939.x.

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

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Visser, W. Hester, Michel D. Ferrari, Evelyn M. Bayliss, Susan Ludlow, and Alison J. Pilgrim. "Treatment of Migraine Attacks with Subcutaneous Sumatriptan: First Placebo-Controlled Study." Cephalalgia 12, no. 5 (October 1992): 308–13. http://dx.doi.org/10.1046/j.1468-2982.1992.1205308.x.

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The results of the very first large-scale placebo-controlled dose-response trial with the novel selective 5-hydroxytryptamine1-like (5HT 1-like) receptor agonist sumatriptan are presented. We studied the efficacy and tolerability of subcutaneous injections of 1 mg, 2 mg and 3 mg of sumatriptan in alleviating migraine attacks in a double-blind, placebo-controlled, parallel-group, multicentre clinical trial. Six-hundred and ninety patients were randomized and 685 received study medication. At 30 min, reduction of headache severity to mild or none (primary efficacy endpoint) was achieved in 22% (95% CI: 15-28%) of placebo-treated patients and in 39% (CI: 31-46%) of patients treated with 1 mg sumatriptan, 44% (CI: 36-51%) treated with 2 mg sumatriptan and 55% (CI: 48-63%) treated with 3 mg sumatriptan. Differences from placebo were 17% (CI: 8-27%) for 1 mg sumatriptan, 22% (CI: 13-32%) for 2 mg sumatriptan and 34% (CI: 24-44%) for 3 mg sumatriptan ( p < 0.001 for all three comparisons). Other migraine symptoms were also more effectively treated by sumatriptan than by placebo. Subsequently, an open-label 3 mg dose subcutaneous sumatriptan was given to partial or non-responders. Thirty minutes after this open dose the response rate to sumatriptan had improved to between 70 and 80%. Adverse events after sumatriptan were minor and short-lived. We conclude that subcutaneous sumatriptan is well tolerated in doses up to 3 + 3 mg and may rapidly abort migraine attacks.

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4

Tfelt-Hansen, P. "Efficacy and Adverse Events of Subcutaneous, Oral, and Intranasal Sumatriptan Used for Migraine Treatment: A Systematic Review Based on Number Needed To Treat." Cephalalgia 18, no. 8 (October 1998): 532–38. http://dx.doi.org/10.1046/j.1468-2982.1998.1808532.x.

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Objectives: To evaluate the efficacy, speed of onset, and adverse events of 6 mg subcutaneous, 100 mg oral, and 20 mg intranasal sumatriptan in the treatment of migraine attacks. Design: Systematic review of placebo-controlled randomized clinical trials. Data sources: Thirty trials up to April 1997 retrieved from a systematic literature search (Medline, review papers, handsearching of journals, congress proceedings, manufacturer's database); no restriction on language. Outcome parameters: Numbers needed to treat (NNT) were calculated for relief of headache and for adverse events (when data were available). Therapeutic gain was used to evaluate speed of onset of action. Results: Subcutaneous sumatriptan was more efficacious, combined number needed to treat 2.0 at 1 h, than oral (3.0 at 2 h) and intranasal sumatriptan (3.1 at 2 h). For adverse events, the NNT was 3.0 for subcutaneous and 8.3 for oral sumatriptan. Only limited data on adverse events for intranasal sumatriptan were available. Therapeutic gain analysis during the first 2 h showed that subcutaneous sumatriptan was the fastest-acting form of administration. Conclusions: Subcutaneous sumatriptan in a dose of 6 mg is significantly more efficacious than 100 mg of oral sumatriptan, but causes more adverse events than oral sumatriptan. Subcutaneous sumatriptan is the form with the quickest onset of action. Intranasal sumatriptan has the same efficacy as oral sumatriptan and a quicker onset of action than the oral form, but with a limited therapeutic effect for the first 30 min after administration.

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5

Coulie, B., J. Tack, B. Maes, B. Geypens, M. De Roo, and J. Janssens. "Sumatriptan, a selective 5-HT1 receptor agonist, induces a lag phase for gastric emptying of liquids in humans." American Journal of Physiology-Gastrointestinal and Liver Physiology 272, no. 4 (April 1, 1997): G902—G908. http://dx.doi.org/10.1152/ajpgi.1997.272.4.g902.

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Sumatriptan, a 5-hydroxytryptamine1 (5-HT1) receptor agonist at enteric neuronal 5-HT receptors, causes a relaxation of the gastric fundus and inhibition of antral contractile activity. The present study examined the effect of sumatriptan on gastric emptying of solids and liquids in humans. In eight healthy subjects the gastric emptying rate for liquids and solids was measured using the carbon-labeled glycine and octanoic acid breath test after subcutaneous administration of placebo or sumatriptan. Sumatriptan increased the gastric half-emptying time of liquids (P < 0.0005) and induced a prolonged lag phase for liquids (P < 0.0005) in all subjects. Sumatriptan increased gastric half-emptying time (P < 0.005) and the lag phase of solids (P < 0.05) in all subjects. In two healthy subjects gastric emptying of liquids and solids after subcutaneous administration of sumatriptan was studied by radioscintigraphy. Radioscintigraphy confirmed the delayed emptying and the prolonged lag phases after sumatriptan. In conclusion, sumatriptan delays gastric emptying of solids and liquids in healthy subjects. Moreover, sumatriptan induces a lag phase for liquids. The mechanism by which sumatriptan alters gastric emptying remains to be studied.

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6

Caro, G., D. Getsios, JJ Caro, G. Raggio, M. Burrows, and L. Black. "Sumatriptan: Economic Evidence for Its Use in the Treatment of Migraine, the Canadian Comparative Economic Analysis." Cephalalgia 21, no. 1 (February 2001): 12–19. http://dx.doi.org/10.1046/j.1468-2982.2001.00130.x.

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The objective of this study was to evaluate economic and health effects of sumatriptan relative to customary therapy in Canada. The relationship between treatment and functionality was established based on analysis of existing data from a multinational study. A Monte Carlo model was developed to simulate 1 year for each of customary therapy and six sumatriptan formulations. Costs are expressed in 1998 Canadian dollars. Sumatriptan is expected to reduce the time spent with migraine symptoms and resulting time lost. Under customary therapy, the annual cost of lost time is estimated at £908 ($1973). With sumatriptan, these costs ranged from £406 ($882) with subcutaneous sumatriptan to £577 ($1254) with nasal sumatriptan 10 mg, saving £331–502 ($719–1091) in the annual cost of time lost. All these benefits are expected to be obtained at an additional drug cost ranging from £869 ($1889) for subcutaneous sumatriptan to £278 ($605) for sumatriptan suppository. The cost of sumatriptan treatment is significantly offset by a substantial reduction of costs associated with time lost due to migraine symptoms.

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Depré, M., C. MacLeod, J. Palcza, MO Behm, I. de Lepeleire, T. Han, D. Panebianco, et al. "Lack of hemodynamic interaction between CGRP-receptor antagonist telcagepant (MK-0974) and sumatriptan: Results from a randomized study in patients with migraine." Cephalalgia 33, no. 16 (June 24, 2013): 1292–301. http://dx.doi.org/10.1177/0333102413494272.

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Objective The objective of this article is to assess the effects of sumatriptan monotherapy, telcagepant monotherapy, and their combination on blood pressure (BP) in migraine patients during a headache-free period. Methods A double-blind, placebo-controlled, four-period, single-dose, randomized crossover study in 24 migraine patients was conducted. In each period, patients received a single oral dose of sumatriptan 100 mg alone, telcagepant 600 mg alone, sumatriptan 100 mg coadministered with telcagepant 600 mg, or placebo. Semi-recumbent BP was measured pre-dose and at seven post-dose timepoints over a period of six hours. Individual time-weighted averages in mean arterial pressure (MAP) were evaluated using a linear mixed-effects model. The pharmacokinetics of sumatriptan alone and in the presence of telcagepant were also evaluated using limited sampling times. Results The mean difference in time-weighted (0–2.5 h) MAP (90% confidence interval) was 1.2 mmHg (−0.2, 2.7) between telcagepant and placebo, 4.0 mmHg (2.5, 5.5) between sumatriptan and placebo, and 1.5 mmHg (0.0, 3.0) between telcagepant with sumatriptan vs sumatriptan alone. When coadministered with telcagepant, the AUC0–6h and Cmax of sumatriptan were increased by 23% and 24%, respectively. The small MAP increases observed after coadministration could possibly be associated with the slight elevations in sumatriptan levels. Conclusion Telcagepant does not elevate mean MAP, and coadministration of telcagepant with sumatriptan results in elevations in MAP similar to those observed following administration of sumatriptan alone in migraineurs during the interictal period. When coadministered, telcagepant slightly increases the plasma levels of sumatriptan, but without an apparent clinically meaningful effect.

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8

de Hoon, Jan, Anne Van Hecken, Corinne Vandermeulen, Marissa Herbots, Yumi Kubo, Ed Lee, Osa Eisele, Gabriel Vargas, and Kristin Gabriel. "Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers." Cephalalgia 39, no. 1 (May 21, 2018): 100–110. http://dx.doi.org/10.1177/0333102418776017.

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Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg. Blood pressure was measured pre-dose and at prespecified times post-dose. The primary endpoint was individual time-weighted averages of mean arterial pressure, measured from 0 hours to 2.5 hours after the first dose of sumatriptan. Pharmacokinetic parameters for sumatriptan were evaluated by calculating geometric mean ratios (erenumab and sumatriptan/placebo and sumatriptan). Adverse events and anti-erenumab antibodies were also evaluated. Results A total of 34 subjects were randomized and included in the analysis. Least squares mean (standard error) time-weighted averages of mean arterial pressure were 87.4 (1.0) mmHg for the placebo and sumatriptan group and 87.4 (1.2) mmHg for the erenumab and sumatriptan group. Mean difference in mean arterial pressure between groups was −0.04 mmHg (90% confidence interval: −2.2, 2.1). Geometric mean ratio estimates for maximum plasma concentration of sumatriptan was 0.95 (90% confidence interval: 0.82, 1.09), area under the plasma concentration–time curve (AUC) from time 0 to 6 hours was 0.98 (90% confidence interval: 0.93, 1.03), and AUC from time 0 to infinity was 1.00 (90% confidence interval: 0.96, 1.05). No clinically relevant safety findings for co-administration of sumatriptan and erenumab were identified. Conclusion Co-administration of erenumab and sumatriptan had no additional effect on resting blood pressure or on pharmacokinetics of sumatriptan. Trial registration: ClinicalTrials.gov, NCT02741310.

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9

Vachharajani, NN, W.-C. Shyu, PS Nichola, and DW Boulton. "A Pharmacokinetic Interaction Study Between Butorphanol and Sumatriptan Nasal Sprays in Healthy Subjects: Importance of the Timing of Butorphanol Administration." Cephalalgia 22, no. 4 (May 2002): 282–87. http://dx.doi.org/10.1046/j.1468-2982.2002.00359.x.

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Sumatriptan and butorphanol nasal sprays are commonly used agents for the management of migraine headaches. Under certain circumstances, these two agents may be administered closely in time. However, the possibility of a pharmacokinetic interaction and the safety of this regime have not been examined. In this crossover design study, 24 healthy subjects received the following four treatments, each separated by at least 7 days: 1 mg butorphanol (Stadol NS7®); 20 mg sumatriptan (Imitrex® Nasal Spray); or both formulations together with butorphanol administered either 1 or 30 min after sumatriptan. Serial plasma samples were collected for 24 h post-dose and analysed for butorphanol and/or sumatriptan by HPLC-MS/MS. Butorphanol plasma concentrations were reduced when it was administered 1 min (mean 28.6% decrease in AUC0-∞) , but not 30 min, after sumatriptan. The pharmacokinetics of sumatriptan were not substantially altered by butorphanol. The combination of nasally administered sumatriptan and butorphanol appeared safe. However, if butorphanol nasal spray is administered < 30 min after sumatriptan nasal spray, the analgesic effect of butorphanol may be diminished due to reduced nasal absorption resulting from probable transient vasoconstriction of nasal blood vessels by sumatriptan.

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Babes, Alexandru, Cristian Neacsu, Michael JM Fischer, and Karl Messlinger. "Sumatriptan activates TRPA1." Cephalalgia Reports 2 (January 1, 2019): 251581631984715. http://dx.doi.org/10.1177/2515816319847155.

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Background: Migraine therapy with sumatriptan may cause adverse side effects like pain at the injection site, muscle pain, and transient aggravation of headaches. In animal experiments, sumatriptan excited or sensitized slowly conducting meningeal afferents. We hypothesized that sumatriptan may activate transduction channels of the “irritant receptor,” the transient receptor potential ankyrin type (TRPA1) expressed in nociceptive neurons. Methods: Calcium microfluorometry was performed in HEK293t cells transfected with human TRPA1 (hTRPA1) or a mutated channel (TRPA1-3C) and in dissociated trigeminal ganglion neurons. Membrane currents were recorded in the whole-cell patch clamp configuration. Results: Sumatriptan (10 and 400 µM) evoked calcium transients in hTRPA1-expressing HEK293t cells also activated by the TRPA1 agonist carvacrol (100 µM). In TRPA1-3C-expressing HEK293t cells, sumatriptan had hardly any effect. In rat trigeminal ganglion neurons, sumatriptan, carvacrol, and the transient receptor potential vanillod type 1 agonist capsaicin (1 µM) generated robust calcium signals. All sumatriptan-sensitive neurons (8% of the sample) were also activated by carvacrol (14%) and capsaicin (48%). In HEK293-hTRPA1 cells, sumatriptan (100 µM) evoked outwardly rectifying currents, which were almost completely inhibited by the TRPA1 antagonist HC-030031 (10 µM). Conclusion: Sumatriptan activates TRPA1 channels inducing calcium inflow and membrane currents. TRPA1-dependent activation of primary afferents may explain the painful side effects of sumatriptan.

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MCCANN, Gerald P., Helen CAHILL, Stephen KNIPE, Douglas F. MUIR, Paul D. MACINTYRE, and W. Stewart HILLS. "Sumatriptan reduces exercise capacity in healthy males: a peripheral effect of 5-hydroxytryptamine agonism?" Clinical Science 98, no. 6 (May 17, 2000): 643–48. http://dx.doi.org/10.1042/cs0980643.

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5-Hydroxytryptamine (5-HT; serotonin) has been implicated in the perception of exercise-induced fatigue. Sumatriptan is a selective 5-HT1B/D receptor agonist which does not cross the blood–brain barrier. The aim of the present study was to determine the effect of sumatriptan on exercise capacity. Ten healthy male subjects (mean age 28.4±10.8 years) performed a maximal treadmill exercise test according to the Bruce protocol with expired gas analysis on two occasions. Either 6 mg of sumatriptan or placebo was administered subcutaneously in a randomized, double-blind, placebo-controlled, cross-over design. Exercise time was greater after placebo compared with sumatriptan [914 and 879 s respectively; 95% confidence interval (CI) of difference 12.1 s, 59.1 s; P = 0.008]. There was no significant effect on peak oxygen consumption (placebo, 50.6±6.3 ml·min-1·kg-1; sumatriptan, 51.7±7.6 ml·min-1·kg-1). Sumatriptan administration resulted in decreases in both heart rate (sumatriptan, 188±14 beats/min, placebo, 196±12 beats/min; 95% CI of difference 12.6, 2.6; P = 0.008) and respiratory exchange ratio (sumatriptan, 1.23±0.06; placebo, 1.26±0.07; 95% CI of difference 0.05, 0.01; P = 0.01) at peak exercise. There were no significant differences in blood pressure, heart rate or submaximal oxygen consumption between sumatriptan and placebo treatments at any stage of exercise. Thus sumatriptan reduces maximal exercise capacity in normal males. The failure to demonstrate any haemodynamic or cardiorespiratory effect suggests that sumatriptan enhances perception of fatigue by a peripheral mechanism affecting 5-HT modulation.

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Rahimtoola, H., ACG Egberts, H. Buurma, CC Tijssen, and HG Leufkens. "Patterns of Ergotamine and Sumatriptan Use in the Netherlands from 1991 to 1997." Cephalalgia 21, no. 5 (June 2001): 596–603. http://dx.doi.org/10.1046/j.1468-2982.2001.00212.x.

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

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Hikita, Toshiyuki, Hiroko Kodama, Sono Kaneko, Kaori Amakata, Kaori Ogita, Daishi Mochizuki, Fumiaya Kaga, Natsue Nakamoto, Yasushi Fujii, and Akira Kikuchi. "Sumatriptan as a treatment for cyclic vomiting syndrome: A clinical trial." Cephalalgia 31, no. 4 (December 8, 2010): 504–7. http://dx.doi.org/10.1177/0333102410390398.

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Background and objective Cyclic vomiting syndrome (CVS) is associated with migraine. This study aimed to evaluate the efficacy of sumatriptan in treating CVS. Methods Twelve patients were enrolled in this trial. Sumatriptan was administered either subcutaneously [(age × 4 + 20)/100×3mg] or by nasal spray (NS; 20 mg). Response to the treatment was classified as complete, effective, or noneffective. Results Eleven patients, who presented with 35 attacks, were treated by subcutaneous injection of sumatriptan. The treatment was responsive in 19 attacks. The efficacy of sumatriptan was high in attacks that occurred in cases with a family history of migraine compared to those without (p = .0482). Five patients were treated with sumatriptan NS for six attacks. The treatment was completely responsive in two of six attacks. We observed no adverse effects associated with sumatriptan treatment in this trial. Conclusions We conclude that sumatriptan has potential efficacy in treating of patients with CVS.

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Tfelt-Hansen, Peer. "Sumatriptan for the Treatment of Migraine Attacks-A Review of Controlled Clinical Trials." Cephalalgia 13, no. 4 (August 1993): 238–44. http://dx.doi.org/10.1046/j.1468-2982.1993.1304238.x.

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Sumatriptan, a 5HT1-like receptor agonist, is a completely new treatment principle for migraine. In an extensive international programme of controlled clinical trials, sumatriptan, 6 mg subcutaneously and 100 mg orally, was superior to placebo in reducing headache and associated symptoms. The response rate for subcutaneous sumatriptan (70–84% after 1 h and 81–87% after 2 h) was higher than for oral sumatriptan (50–67% after 2 h). Additional doses did not increase efficacy. Oral sumatriptan was superior to Cafergot (2 mg ergotamine plus 200 mg caffeine) and somewhat better than aspirin (900 mg) plus metoclopramide (10 mg). Recurrence of migraine occurred in approximately 40% of attacks. Side effects were generally mild and short-lived in the controlled clinical trials. However, in clinical practice sumatriptan has subsequently caused rare cases of heart ischemia and sumatriptan is contraindicated in patients with a history of ischemic heart disease.

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van der Post, J., MT Schram, RC Schoemaker, MSM Pieters, E. Fuseau, A. Pereira, S. Baggen, AF Cohen, and JMA van Gerven. "Cns Effects of Sumatriptan and Rizatriptan in Healthy Female Volunteers." Cephalalgia 22, no. 4 (May 2002): 271–81. http://dx.doi.org/10.1046/j.1468-2982.2002.00344.x.

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This study investigates the CNS effects of sumatriptan and rizatriptan, with temazepam as an active comparator, in healthy female volunteers. Sixteen volunteers completed a randomized, double-blind, crossover study and on four separate occasions received either 100 mg sumatriptan, 20 mg rizatriptan or 20 mg temazepam. The main parameters were eye movements, EEG, body sway, visual analogue scales and a cognitive test battery. Rizatriptan and sumatriptan decreased saccadic peak velocity by 18.3 (95% CI: 5.7, 30.8) and 15.0 (2.2, 27.9)°/sec, respectively, about half the decrease induced by temazepam (35.0 (22.1, 47.8)°/sec). Body sway increased (30% for rizatriptan (16%, 45%) and 14% for sumatriptan (1%, 27%), respectively). Temazepam caused larger, similar effects. In contrast to temazepam, sumatriptan and rizatriptan decreased reaction times of recognition tasks and increased EEG alpha power (significant for sumatriptan, 0.477 (0.02, 0.935). Therapeutic doses of sumatriptan and rizatriptan caused CNS effects indicative of mild sedation. For EEG and recognition reaction times the effects were opposite to temazepam, indicating central stimulation.

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Ferrari, MD, MH James, D. Bates, A. Pilgrim, E. Ashford, BA Anderson, and G. Nappi. "Oral Sumatriptan: Effect of a Second Dose, and Incidence and Treatment of Headache Recurrences." Cephalalgia 14, no. 5 (October 1994): 330–38. http://dx.doi.org/10.1046/j.1468-2982.1994.1405330.x.

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Oral sumatriptan in a dose of 100 mg aborts about 60% of migraine attacks within 2 h, but the headache may recur within 24 h. We investigated: (i) the incidence of headache recurrence after oral sumatriptan, (ii) whether a second tablet of sumatriptan at 2 h increases initial efficacy and/or (iii) prevents headache recurrence and (iv) whether a further tablet of sumatriptan treats headache recurrence. In a randomized, parallel-group clinical trial, 1246 patients treated one to three migraine attacks (with or without aura) with 100 mg oral sumatriptan. Two hours later they all took a double-blind randomized second tablet of sumatriptan (group I) or placebo (group II). Patients who initially improved, but then experienced headache recurrence took a further double-blind randomized tablet of sumatriptan or placebo. Proportions of patients who improved from moderate/severe headache to mild/none were similar in groups I and II at 2 h (55 vs 56%) and 4 h (80 vs 77%). Incidences of headache recurrence (moderate/severe-any grade of headache) and median times to headache recurrence were also similar: 22–32% at 16 h in group I and 25–33% at 16.5 h in group II. Sumatriptan was superior to placebo in treating headache recurrence: 74 vs 49% ( p = 0.017) in group I and 70 vs 30% ( p = 0.0001) in group II. Thus, one-fourth of patients experience headache recurrence at about 16 h after successful treatment of a migraine attack with 100 mg oral sumatriptan. A second tablet of sumatriptan at 2 h does not increase initial efficacy and neither prevents nor delays headache recurrence. A further tablet of sumatriptan is, however, highly effective in treating headache recurrence. All dose regimens were well tolerated.

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Kunka, RL, EK Hussey, S. Shaw, P. Warner, B. Aubert, I. Richard, PA Fowler, and GE Pakes. "Safety, Tolerability, and Pharmacokinetics of Sumatriptan Suppositories Following Single and Multiple doses in Healthy Volunteers." Cephalalgia 17, no. 4 (June 1997): 532–40. http://dx.doi.org/10.1046/j.1468-2982.1997.1704532.x.

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

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Kowacs, PA, EJ Piovesan, CE Tatsui, MC Lange, LC Ribas, and LC Werneck. "Prolonged Migraine Aura Without Headache Arrested by Sumatriptan. A Case Report with Further Considerations." Cephalalgia 19, no. 4 (May 1999): 241–42. http://dx.doi.org/10.1046/j.1468-2982.1999.019004241.x.

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The case of a 42-year-old woman with prolonged migraine visual aura without headache, whose long-lasting episodes of visual aura were successfully controlled by oral sumatriptan, is reported. Effectiveness of sumatriptan was unequivocal, since, after taking sumatriptan, duration of aura would drop from 1.5 h to approximately 20 min. This case suggests that sumatriptan may cross the blood-brain barrier and block spreading depression.

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Silberstein, Stephen, Susan A. McDonald, Jerome Goldstein, Sheena Aurora, Shelly E. Lener, Jonathan White, Michael C. Runken, Jane Saiers, Frederick Derosier, and Richard B. Lipton. "Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: A randomized study." Cephalalgia 34, no. 4 (October 9, 2013): 268–79. http://dx.doi.org/10.1177/0333102413508242.

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Objective Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium ( n = 222 intent-to-treat (ITT)) or placebo ( n = 221 ITT/complete case analysis a ) in this randomized, double-blind, parallel-group study. Results Sumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, p < 0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, p < 0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response four hours postdose ( p < 0.001), pain-free response maintained one to two hours postdose ( p = 0.034) and two to four hours postdose ( p < 0.001), headache relief four hours postdose ( p < 0.001), headache relief maintained two to four hours postdose ( p = 0.015), sustained headache relief two through 24 hours postdose ( p = 0.002), and rescue medication use ( p < 0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). Conclusion Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.

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Muzzi, Mirko, Riccardo Zecchi, Giuseppe Ranieri, Matteo Urru, Lorenzo Tofani, Francesco De Cesaris, Alessandro Panconesi, and Alberto Chiarugi. "Ultra-rapid brain uptake of subcutaneous sumatriptan in the rat: Implication for cluster headache treatment." Cephalalgia 40, no. 4 (December 18, 2019): 330–36. http://dx.doi.org/10.1177/0333102419896370.

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Background In spite of the substantial therapeutic efficacy of triptans, their site of action is still debated. Subcutaneous sumatriptan is the most efficacious symptomatic treatment for cluster headache (CH) patients, showing therapeutic onset within a few minutes after injection even in migraine patients. However, whether subcutaneous sumatriptan is able to reach the CNS within this short time frame is currently unknown. Methods Here, by means of liquid chromatography/mass spectrometry, we investigated peripheral and brain distribution of subcutaneous sumatriptan soon after injection in rats at a dose equivalent to that used in patients. Tissue sumatriptan contents were compared to those of oxazepam, a prototypical lipophilic, neuroactive drug. Results We report that sumatriptan accumulated within brain regions of relevance to migraine and CH pathogenesis such as the hypothalamus and the brainstem as soon as 1 and 5 minutes after injection. Notably, sumatriptan brain distribution was faster than that of oxazepam, reaching concentrations exceeding its reported binding affinity for 5HT1B/D receptors, and in the range of those able to inhibit neurotransmitter release in vivo. Conclusion Our findings indicate that sumatriptan distributes within the CNS soon after injection, and are in line with prompt pain relief by parenteral sumatriptan in CH patients.

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Connor, Helen E., Carole M. Stubbs, Wasyl Feniuk, and Patrick P. A. Humphrey. "Effect of Sumatriptan, a Selective 5-HT1-like Receptor Agonist, on Pial Vessel Diameter in Anaesthetised Cats." Journal of Cerebral Blood Flow & Metabolism 12, no. 3 (May 1992): 514–19. http://dx.doi.org/10.1038/jcbfm.1992.70.

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The action of sumatriptan, a selective 5-HT1-like receptor agonist that is effective for the acute treatment of migraine, was compared on pial vessel diameter following perivascular or intravenous administration to anaesthetised cats. Sumatriptan (0.01–10 μ M), when microinjected perivascularly, caused a decrease in pial artery diameter (maximum change of –19 ± 9%; mean ± SD) but had no effect on the diameter of pial veins. Sumatriptan (1 μ M)-induced pial artery vasoconstriction was unaffected by coadministration of ketanserin (1 μ M) or ondansetron (1 μ M) but was significantly (p < 0.01) attenuated by methiothepin (1 μ M). Intravenous infusion of a clinically effective dose of sumatriptan (64 μg/kg/10 min) caused selective carotid vasoconstriction (22 ± 6% increase in carotid vascular resistance with little or no change in blood pressure or heart rate) and no change in pial artery diameter, although sumatriptan (1 μ M) administered perivascularly in these animals before and after the infusion caused pial artery vasoconstriction. These results demonstrate that perivascularly administered sumatriptan causes pial artery vasoconstriction via activation of 5-HT1-like receptors. However, intravenously administered sumatriptan does not cause pial artery vasoconstriction, which suggests that sumatriptan does not readily penetrate the cerebrovascular intima.

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Wienholtz, Nita Katarina Frifelt, Casper Emil Christensen, Ditte Georgina Zhang, Hande Coskun, Hashmat Ghanizada, Mohammad Al-Mahdi Al-Karagholi, Jens Hannibal, Alexander Egeberg, Jacob P. Thyssen, and Messoud Ashina. "Early treatment with sumatriptan prevents PACAP38-induced migraine: A randomised clinical trial." Cephalalgia 41, no. 6 (February 10, 2021): 731–48. http://dx.doi.org/10.1177/0333102420975395.

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Objective To determine whether early treatment with sumatriptan can prevent PACAP38-induced migraine attacks. Methods A total of 37 patients with migraine without aura were enrolled between July 2018 to December 2019. All patients received an intravenous infusion of 10 picomole/kg/min of PACAP38 over 20 min followed by an intravenous infusion of 4 mg sumatriptan or placebo over 10 min on two study days in a randomised, double-blind, placebo-controlled, crossover study. Results Of 37 patients enrolled, 26 (70.3%) completed the study and were included in analyses. Of the 26 patients, four (15%) developed a PACAP38-induced migraine attack on sumatriptan and 11 patients (42%) on placebo ( p = 0.016). There were no differences in area under the curve for headache intensity between sumatriptan (mean AUC 532) and placebo (mean AUC 779) ( p = 0.35). Sumatriptan significantly constricted the PACAP38-dilated superficial temporal artery immediately after infusion (T30) compared with infusion of placebo ( p < 0.001). Conclusions and relevance: Early treatment with intravenously administered sumatriptan prevented PACAP38-induced migraine. Prevention of migraine attacks was associated with vasoconstriction by sumatriptan in the earliest phases of PACAP provocation. These results suggest that sumatriptan prevents PACAP38-induced migraine by modulation of nociceptive transmission within the trigeminovascular system. Trial Registration: ClinicalTrials.gov (NCT03881644).

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Croop, Robert, Andrea Ivans, Matt S. Anderson, Joseph Stringfellow, Richard Bertz, Michael Hanna, Francine Healy, David A. Stock, Vladimir Coric, and Richard B. Lipton. "A phase 1 randomized study of hemodynamic effects and pharmacokinetic interactions during concomitant use of rimegepant and sumatriptan in healthy adults." Cephalalgia Reports 4 (January 1, 2021): 251581632110079. http://dx.doi.org/10.1177/25158163211007922.

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Objective: This randomized, partially-blinded, placebo-controlled study evaluated hemodynamic effects, pharmacokinetic interactions, and safety of concomitant administration of oral rimegepant and subcutaneous sumatriptan. Methods: Healthy non-smokers aged ≥18 and ≤40 years (men) or ≥18 and ≤50 years (women) were enrolled. On Day 1, subjects received 12 mg of sumatriptan as 2 subcutaneous 6 mg injections separated by 1 hour. From Days 2 to 4, subjects received rimegepant or placebo once daily (randomized 6 to 1, rimegepant to placebo). On Day 5, subjects received rimegepant or placebo, followed 2 hours later by 2 subcutaneous 6 mg injections of sumatriptan, separated by 1 hour. Sumatriptan was administered at the same times as on Day 1. Results: All 42 dosed subjects were analyzed. There were no significant differences in the time-weighted average of mean arterial pressure, diastolic blood pressure, or systolic blood pressure between treatment with rimegepant + sumatriptan and sumatriptan alone. Co-administration of rimegepant and sumatriptan had no effect on the pharmacokinetics of either drug. Overall, 93% (39/42) of subjects experienced ≥1 adverse event; injection site reaction was most common (60% [29/42]). Conclusions: Concomitant administration of oral rimegepant and subcutaneous sumatriptan to healthy adults was without hemodynamic or pharmacokinetic interaction and was safe and well tolerated.

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Wilkinson, M., V. Pfaffenrath, J. Schoenen, H.-C. Diener, and TJ Steiner. "Migraine and Cluster Headache-Their Management with Sumatriptan: A Critical Review of The Current Clinical Experience." Cephalalgia 15, no. 5 (October 1995): 337–57. http://dx.doi.org/10.1046/j.1468-2982.1995.1505337.x.

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

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Fullerton, Terence, and Fran M. Gengo. "Sumatriptan: A Selective 5-Hydroxytryptamine Receptor Agonist for the Acute Treatment of Migraine." Annals of Pharmacotherapy 26, no. 6 (June 1992): 800–808. http://dx.doi.org/10.1177/106002809202600611.

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OBJECTIVE: The clinical pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and associated drug interactions of the novel antimigraine drug sumatriptan are reviewed. DATA SOURCES: English-language publications pertaining to sumatriptan were identified via a search of the MEDLINE computerized database. STUDY SELECTION: Open and controlled clinical studies were reviewed in assessing clinical efficacy, although only the results of controlled, randomized trials form the basis for the conclusions pertaining to the effectiveness of sumatriptan. DATA EXTRACTION: The primary measure of drug effectiveness in all clinical studies was significant improvement in headache severity scores. Secondary measures included functional ability, time to relief, rescue medication use, associated symptoms of nausea/vomiting and photo/phonophobia, and, in some studies, headache recurrence rate. These data were obtained from each published clinical trial and used in the overall analysis of sumatriptan efficacy. DATA SYNTHESIS: Sumatriptan is a serotonin agonist that has been studied for the acute treatment of migraine and cluster headache. The drug appears to work via specific serotonin receptors to mediate selective vasoconstriction within the cranial vasculature and to prevent the release of inflammatory mediators from trigeminal nerve terminals. The recommended dose of sumatriptan is 6 mg given subcutaneously at the onset of headache; an oral formulation is under investigation. In the published clinical trials of the oral and subcutaneous dosage forms to date, sumatriptan was effective in reducing headache severity from moderate/severe to mild/absent in approximately 70–80 percent of patients treated with active drug, compared with only 20–30 percent in the placebo groups, and 48 percent in the oral ergotamine tartrate/caffeine (Cafergot)-treated group. Secondary measures of effectiveness also favored sumatriptan. There may be a higher rate of headache recurrence with sumatriptan compared with placebo or Cafergot, although further study is necessary to confirm this observation. Adverse effects associated with sumatriptan administration generally were mild and transient and included tingling, warm/hot sensations, and pressure and tightness in the chest and neck. No significant drug interactions have yet been identified. CONCLUSIONS: Sumatriptan appears to represent a safe and effective alternative to the ergot alkaloids for the abortive treatment of acute migraine. However, further clinical trials, especially those yielding comparative data with current antimigraine agents, are needed to determine the full therapeutic contribution of sumatriptan.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1225 (October 2008): 24. http://dx.doi.org/10.2165/00128415-200812250-00082.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 770 (September 1999): 10. http://dx.doi.org/10.2165/00128415-199907700-00035.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 447 (April 1993): 11. http://dx.doi.org/10.2165/00128415-199304470-00057.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 450 (May 1993): 15. http://dx.doi.org/10.2165/00128415-199304500-00074.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 451 (May 1993): 12. http://dx.doi.org/10.2165/00128415-199304510-00061.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 462 (July 1993): 11. http://dx.doi.org/10.2165/00128415-199304620-00062.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 429 (November 1992): 12. http://dx.doi.org/10.2165/00128415-199204290-00067.

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Perry, Caroline M., and Anthony Markham. "Sumatriptan." Drugs 55, no. 6 (1998): 889–922. http://dx.doi.org/10.2165/00003495-199855060-00020.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1084 (January 2006): 24. http://dx.doi.org/10.2165/00128415-200610840-00080.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1091 (March 2006): 21. http://dx.doi.org/10.2165/00128415-200610910-00062.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1097-1098 (April 2006): 24. http://dx.doi.org/10.2165/00128415-200610970-00072.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1100 (May 2006): 21–22. http://dx.doi.org/10.2165/00128415-200611000-00069.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 796 (April 2000): 10. http://dx.doi.org/10.2165/00128415-200007960-00033.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 801 (May 2000): 11. http://dx.doi.org/10.2165/00128415-200008010-00032.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 813 (August 2000): 10. http://dx.doi.org/10.2165/00128415-200008130-00027.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1024 (October 2004): 14. http://dx.doi.org/10.2165/00128415-200410240-00041.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1026 (November 2004): 13–14. http://dx.doi.org/10.2165/00128415-200410260-00040.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 1039 (February 2005): 13. http://dx.doi.org/10.2165/00128415-200510390-00037.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 706 (June 1998): 12. http://dx.doi.org/10.2165/00128415-199807060-00036.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 721 (October 1998): 12. http://dx.doi.org/10.2165/00128415-199807210-00039.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 532 (December 1994): 14. http://dx.doi.org/10.2165/00128415-199405320-00056.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 535 (January 1995): 12. http://dx.doi.org/10.2165/00128415-199505350-00050.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 541 (March 1995): 12. http://dx.doi.org/10.2165/00128415-199505410-00048.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 557 (July 1995): 12. http://dx.doi.org/10.2165/00128415-199505570-00039.

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&NA;. "Sumatriptan." Reactions Weekly &NA;, no. 560 (July 1995): 12. http://dx.doi.org/10.2165/00128415-199505600-00036.

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