1.A Comparative Trial of Oral and Subcutaneous Sumatriptan in Acute Treatment of Migraine: a multicenter trial.
Seol Heui HAN ; Kyoon HUH ; In Soo JOO ; Jae Il KIM ; Seung Min KIM ; Geun Ho LEE ; Joon Shik MOON ; Ae Young LEE ; Hyung Kook PARK ; Hyun Gil SHIN
Journal of the Korean Neurological Association 1998;16(5):644-653
BACKGROUND: The efficacy of sumatriptan(SMN) in acute management of migrane has been well established. In Korea, however, a clinical study comparing the utility of oral(PO) and subcutaneous(SQ) regimen had not been conducted yet. This study was directed to compare the two regimens of SMN in terms of the efficacy as well as the adverse events in a singed-out Korea patient group. METHODS: The 91 migrane patients were recruited and randomly assigned to either PO or SQ regimen as the initial treatment of acute migrane attack. Then, they were forwarded to the other regimen as an open cross-over trial. The treatment responses and adverse events were assessed and rated by the subjects. RESULTS: Eighty one patient successfully tried at least one regimen of SMN. Overall, the proportion of excellent treatment response was 90.7%(PO) and 94.1%(SQ), with the occurrence of adverse events being 67.4%(PO) and 76.5%(SQ) respectively. In 18 patients who were able to complete cross-over procedure, the efficacy was 94.4% both in PO and SQ regimen, with the occurrence of adverse events 72.2% in both of two regimen. Although the SQ regimen tends to induce faster treatment response regardless of the cross-over completion, it bears no statistical significance. CONCLUSION: We conclude that the PO and SQ regimens of SMN show very comparable clinical utility in achieving therapeutic responses as well as in producing adverse events. The treatment efficacy was excellent but higher occurrence of side effects in this study, although mostly in mild degree, suggests that optimal dose adjustment strategy needs to be elaborated in Korea.
Humans
;
Korea
;
Migraine Disorders*
;
Sumatriptan*
;
Treatment Outcome
2.Oral Sumatriptan for Acute Treatment of Migraine A Single-blind Placebo-controlled Study.
Kwang Deog JO ; Myoung Chong LEE
Journal of the Korean Neurological Association 1995;13(1):77-83
The efficacy and safety of oral sumatriptan as a 100mg conventional tablet was evaluated in the acute treatment of migrame in a single-blind, randomized, placebocontrolled, parallel-group study. Thirty patients were assigned to the sumatriptan group And other 30 to placebo group. Each patient was treated a total of three attacks. Patients recorded details of each attack and response to treatment on a diary card. Sumatriptan was significantly more effective than placebo in relieving headache(moderate/severe reduced to mild/none) at 4 hr(67.2 vs 15.4%; P< 0.001). Overall therapeutic effect of sumatriptan was excellent(89.6 vs 23%; P< 0.001). Compared with placebo, more patients on sumatriptan were pain7free by 2 hr(33.6 vs 0%; P< 0. 001) and 4 hr (25.7 vs 2. 0%; P< 0.001). The proportion of patients who required rescue medication was significantly (P< 0. 001) lower 'in the sumatriptan group when compared with the placebo group(2.4 vs 21%). The overall incidence of patients reporting a dverse events was 39% in sumatriptan group and 10% in placebo (P= 0. 005). The most commonly reported events in the sumatriptan-treated patients were nausea and/or vomiting, chest discomfort, general weakness, tightness of head; these were however generally mild, transient and tolerable. It is concluded that oral sumatriptan is an effective, well-tolerated prompt remedy for acute attacks of migraine.
Head
;
Humans
;
Incidence
;
Migraine Disorders*
;
Nausea
;
Sumatriptan*
;
Thorax
;
Vomiting
3.Improvement of Migraine by Cervical Epidural Block: A case report.
Ki Seok KIM ; Woo Yong LEE ; Seung Hoon WOO ; Ki Hyeok HONG
The Korean Journal of Pain 2005;18(1):64-68
Migraine is a disabling headache that can occur with or without aura. We present here a case of migraine that was effectively managed by a series of cervical epidural blocks. A 41-year-old woman who had suffered from severe headache on her left temporal area for 12 years visited our pain clinic. Her 11-point numeric pain rating scale was 10 out of 10 at the first visit and the symptoms were associated with homonymous visual disturbances, paresthesia on the left face, shoulder and arm, and general weakness. For the first 5 years after the headaches began, her headache was relatively well controlled by acetaminophen; after then, the acetaminophen wasn't effective. After wandering from this hospital to the next one in search of relief, she managed to visit our pain clinic. We tried several blocks including cervical epidural block, and she was continuously medicated with sumatriptan. Her headache was gradually relieved. Now, her 11-point numeric rating scale is 1-2 out of 10 at the most during her headache attacks.
Acetaminophen
;
Adult
;
Arm
;
Epilepsy
;
Female
;
Headache
;
Humans
;
Migraine Disorders*
;
Pain Clinics
;
Paresthesia
;
Shoulder
;
Sumatriptan
4.Population pharmacokinetic analysis of the multiple peaks phenomenon in sumatriptan.
Joomi LEE ; Mi Sun LIM ; Sook Jin SEONG ; Sung Min PARK ; Mi Ri GWON ; Seunghoon HAN ; Sung Min LEE ; Woomi KIM ; Young Ran YOON ; Hee Doo YOO
Translational and Clinical Pharmacology 2015;23(2):66-74
The objective of this study was to develop a population pharmacokinetic (PK) model for sumatriptan, which frequently shows an atypical absorption profile with multiple peaks. Sumatriptan, a selective agonist for the vascular serotonin (5-HT1) receptor that causes vasoconstriction of the cerebral arteries, is used for the acute treatment of migraine attack with or without aura. Despite its relatively high between-subject variability, few reports have addressed PK modeling of sumatriptan. Plasma data obtained after a single 50-mg oral dose of sumatriptan in 26 healthy Korean male subjects were used. Blood samples were collected 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 12 h after dosing. Plasma sumatriptan concentrations were analyzed using UPLC/MS/MS. Population PK analysis was performed using plasma concentration data for sumatriptan with NONMEM (ver. 7.2). A total of 364 concentrations of sumatriptan were captured by a one-compartment model with first-order elimination, and a combined transit compartment model and first-order absorption with lag time was successful in describing the PK with multiple peaks in the absorption phase of sumatriptan. The creatinine clearance as a covariate significantly (P < 0.01) influenced the absorption fraction (f ). The final model was validated through a visual predictive check and bootstrapping with no serious model misspecification.
Absorption
;
Cerebral Arteries
;
Creatinine
;
Epilepsy
;
Humans
;
Male
;
Migraine Disorders
;
Plasma
;
Serotonin
;
Sumatriptan*
;
Vasoconstriction
5.A Case of Vasospastic Angina Pectoris Occurring Following Administration of Oral Imigran(R) for Migraine.
Ki Hyun CHOI ; Tae Yong KIM ; Jae Hyuk CHOI ; Jae Wook OK ; Jin Chan PARK ; Jane OH ; Yoon Kyung CHO ; Kyung Hwa HWANG ; Sang Wook LIM ; Dong Hoon CHA
Korean Circulation Journal 2001;31(10):1071-1074
Imigran(R) (sumatriptan), a 5-hydroxytryptamine (HT) derivative, is highly effective in aborting attacks of migraine and cluster headache. The drug is generally well tolerated. However tolerated, although up to 8% of patients consistently have demonstrate chest symptoms, including chest pressure, tightness, and pain, often mimicking angina pectoris. It has been suggested that these chest symptoms are caused by coronary vasoconstriction, and that this effect may be mediated by endothelial dysfunction. This can be reversed by the administration of glyceryl trinitrate. We report a case of vasospastic angina pectoris occurring after the administration of oral sumatriptan in a patient with migraine.
Angina Pectoris*
;
Cluster Headache
;
Humans
;
Migraine Disorders*
;
Nitroglycerin
;
Serotonin
;
Sumatriptan
;
Thorax
;
Vasoconstriction
6.A Case of Cyclic Vomiting Syndrome Improved by Sumatriptan .
Moon Ho LEE ; Eun Joo KIM ; Il Kwun CHUNG ; Hong Soo KIM ; Sang Heum PARK ; Sun Joo KIM
Korean Journal of Gastrointestinal Motility 1999;5(1):44-48
Cyclic vomiting syndrome is a rare disorder characterized by recurrent, prolonged episodes of severe nausea and vomiting with no apparent cause. The vomiting is self-limited and patients have asymptomatic periods of variable duration between episodes. This affects mainly in infancy and childhood, but some cases in adulthood were rarely reported. Cyclic vomiting syndrome remains poorly understood, but shares some of the same features as abdominal migraine and migraine. It seems to have a relationship of biochemical or neuraphysiological mechanism based on brain-gut interaction and some of hormonal disturbance. We describe the case of a 24-year-old female patient with several years history of recurrent episodes of severe vomiting diagnosed as cyclic vomiting syndrome. The patient was treated by sumatriptan and ceased vomiting dramatically. Gastric emptying time and electtogastrogram at the time of stopped vomiting revealed marked gastroparesis and follow-up test during prophylactic therapy in symptom-free interval was found to be normalized.
Female
;
Follow-Up Studies
;
Gastric Emptying
;
Gastroparesis
;
Humans
;
Migraine Disorders
;
Nausea
;
Sumatriptan*
;
Vomiting*
;
Young Adult
7.The Clinical Efficacy of Subcutaneous Sumatriptan (Imigran) for Acute Treatment of Migraine.
Jae Hyung JOO ; Sang Chan LEE ; Sang Min SUNG ; Dae Soo JUNG ; Kyu Hyun PARK
Journal of the Korean Neurological Association 1995;13(3):543-550
Sumatripan is a selective agonist at the 5-hydroxytryptamine (5HT,) -like receptor. An open, uncontrolled study was conducted to evaluate the therapeutic response of Korean patients to sumatriptan 6mg using an autoinjector for acute migraine attacks. 38 migraineurs were diagnosed by neurologists and included in the study. However, 7 patients were withdrawn as they failed to have an attack and one more or one additional patient was withdrawn due to syncope immediately after the first injection Patients recorded details of each attack and the response to treatment in a diary card. A total of 64 attacks in 30 patients were finally 'mcluded to evaluate the efficacy of treatment. Sumatriptan was very effective at relieving acute migraine attacks of various severity and the associated symptoms (nausea, vomiting, photophobia and phonophobia). Within two and a half hours after injection, 97% (62/64) showed a significant improvement of symptoms from moderate/severe at baseline to mild/none after treatment. There is no significant statistical difference of response of treatment about each type of migraine (classic migraine vs common migraine, chisquare test, ;? = 3. 84, p = 0. 650). Adverse events occurred 46% (30/65) of attacks. These were usually mild and transient, the most common being chest discomfort, pain at site of injection, nausea/vomiting, neck pain/stiffness, dizziness, sensation of weakness and tingling. In conclusion, sumatriptan taken by subcutaneous injection using an automjector was highly effective, fast acting and well tolerated in the treatment of acute migraine.
Dizziness
;
Humans
;
Injections, Subcutaneous
;
Migraine Disorders*
;
Migraine without Aura
;
Neck
;
Photophobia
;
Sensation
;
Serotonin
;
Sumatriptan*
;
Syncope
;
Thorax
;
Vomiting
8.Determination of sumatriptan in human plasma using liquid chromatography-mass spectrometry for pharmacokinetic study in healthy Korean volunteers.
Seungil CHO ; Moonyoung JEGAL ; Boram OHK ; Bo Kyung KIM ; Mi Ri GWON ; Woo Youl KANG ; Sook Jin SEONG ; Hyun Ju KIM ; Hae Won LEE ; Young Ran YOON
Translational and Clinical Pharmacology 2017;25(2):106-111
This study describes the development of an analytical method to determine sumatriptan levels in human plasma using high performance liquid chromatography (HPLC) coupled with triple quadrupole tandem mass spectrometry (MS/MS) and its application to a pharmacokinetic study in healthy Korean volunteers. A single 50 mg dose of sumatriptan was orally administered to twelve healthy volunteers (nine women and three men). The HPLC-MS/MS analytical method was validated with respect to its specificity, linearity, sensitivity, accuracy, precision, recovery, and stability. The calibration curve was linear over a concentration range of 0.3–100 ng/mL (r > 0.999). The lower limit of quantitation for sumatriptan in plasma was 0.3 ng/mL. The accuracy and precision of the analytical method were acceptable within 15% at all quality control levels. We compared plasma concentration-time curves as well as pharmacokinetic parameters such as the area under the curve (AUC) and maximum plasma concentration (C(max)). Both the mean AUC and C(max) of sumatriptan were 1.56 times higher in women than in men. These differences could be largely explained by the difference in body weight (44%) between women and men. The outcomes may provide insights into developing appropriate individualized treatment strategies.
Area Under Curve
;
Body Weight
;
Calibration
;
Chromatography, Liquid
;
Female
;
Healthy Volunteers
;
Humans*
;
Male
;
Methods
;
Plasma*
;
Quality Control
;
Sensitivity and Specificity
;
Spectrum Analysis*
;
Sumatriptan*
;
Tandem Mass Spectrometry
;
Volunteers*
9.Cyclic Vomiting Syndrome: A Functional Disorder.
Pediatric Gastroenterology, Hepatology & Nutrition 2015;18(4):224-229
Cyclic vomiting syndrome (CVS) is a functional disorder characterized by stereotypical episodes of intense vomiting separated by weeks to months. Although it can occur at any age, the most common age at presentation is 3-7 years. There is no gender predominance. The precise pathophysiology of CVS is not known but a strong association with migraine headaches, in the patient as well as the mother indicates that it may represent a mitochondriopathy. Studies have also suggested the role of an underlying autonomic neuropathy involving the sympathetic nervous system in its pathogenesis. CVS has known triggers in many individuals and avoiding these triggers can help prevent the onset of the episodes. It typically presents in four phases: a prodrome, vomiting phase, recovery phase and an asymptomatic phase until the next episode. Complications such as dehydration and hematemesis from Mallory Wise tear of the esophageal mucosa may occur in more severe cases. Blood and urine tests and abdominal imaging may be indicated depending upon the severity of symptoms. Brain magnetic resonance imaging and upper gastrointestinal endoscopy may also be indicated in certain circumstances. Management of an episode after it has started ('abortive treatment') includes keeping the patient in a dark and quiet room, intravenous hydration, ondansetron, sumatriptan, clonidine, and benzodiazepines. Prophylactic treatment includes cyproheptadine, propranolol and amitriptyline. No mortality has been reported as a direct result of CVS and many children outgrow it over time. A subset may develop other functional disorders like irritable bowel syndrome and migraine headaches.
Amitriptyline
;
Benzodiazepines
;
Brain
;
Child
;
Clonidine
;
Cyproheptadine
;
Dehydration
;
Endoscopy, Gastrointestinal
;
Hematemesis
;
Humans
;
Irritable Bowel Syndrome
;
Magnetic Resonance Imaging
;
Migraine Disorders
;
Mortality
;
Mothers
;
Mucous Membrane
;
Ondansetron
;
Propranolol
;
Sumatriptan
;
Sympathetic Nervous System
;
Vomiting*
10.Responses of Trigeminal Ganglion Neurons to Electrical and Mechanical Stimulation of the Middle Meningeal Artery, Superior Sagittal Sinus and Transverse Sinus in Rats.
Kyung Jin LEE ; Jin Whang KIM ; Jung Ki CHO ; Hae Kwan PARK ; Sung Chan PARK ; Kyung Keun CHO ; Hyoung Kyun RHA ; Joon Ki KANG ; Chang Rak CHOI
Journal of Korean Neurosurgical Society 1999;28(6):752-761
The intracranial blood vessels of the dura and the pia receive sensory afferent innervations from trigeminal nerve which has been believed to play a critical role in the mediation of vascular headache such as migraine. The purpose of this study was to discover the mechanism by which the interaction between trigeminal ganglion neurons and the function of cerebral blood vessels. Using electrophysiological recording, we studied the responses of trigeminal ganglion neurons to electrical stimulation of middle meningeal artery(MMA), superior sagittal sinus(SS) and transverse sinus(TS) in rats. Sumatriptan is a highly selective agonist for 5-HT1D receptor subtype which mediates vasoconstriction of cerebral blood vessels. We observed responses to electrical stimulation in trigeminal ganglion neurons and meningeal blood flow(MBF) after intravenous injection of sumatriptan. The results were as follows: 1) The presumed mean conduction velocities of the cells activated MMA, SS and TS by electrical stimulation were approximately 1.5, 2.9 and 2.9m/s, respectively. These were presumed to be nociceptive small myelinated or unmylinated sensory fibers. 2) The action potential discharges of trigeminal ganglion neurons on MMA, SS and TS in the experimental control groups were 671+/-39.49, 856+/-63.95 and 494+/-21.54microV, respectrely. The action potential discharges of sumatriptan groups on MMA, SS and TS(393+/-20.10, 562+/-32.26 and 262+/-18.94microV, respectively) were significantly decreased compared to that of the experimental control groups. 3) The mean MBF of normal control group was 63.29+/-7.54ml/100g/min. The mean MBF of the experimental control groups on MMA, SS and TS were 97.13+/-9.91, 104.28+/-12.54 and 91.82+/-6.41ml/100g/min, respectively(p<0.05). MBF of sumatriptan group before stimulation was significantly decreased(compared to normal: 37.17+/-4.76ml/100g /min vs 63.29+/-7.54ml/100g/min). The mean MBF of sumatriptan groups on MMA, SS and TS were 57.11+/-4.48, 66.56+/-6.23 and 56.07+/-5.00ml/100g/min, respectively. Compared to that of the experimental control groups, the MBF of the sumatriptan groups were significantly decreased. In conclusion, the activation of trigeminal sensory afferents by the electrical stimulation of the dural vessel may create vasodilatation and increase cerebral blood flow which may lead to vascular headaches via trigeminal ganglion to brain stem This pathway can be important for understanding the neural mechanism for the development of pharmacological and surgical approach to alleviate vascular headache.
Action Potentials
;
Animals
;
Blood Vessels
;
Brain Stem
;
Electric Stimulation
;
Headache
;
Injections, Intravenous
;
Meningeal Arteries*
;
Migraine Disorders
;
Myelin Sheath
;
Negotiating
;
Neurons*
;
Rats*
;
Receptor, Serotonin, 5-HT1D
;
Sumatriptan
;
Superior Sagittal Sinus*
;
Trigeminal Ganglion*
;
Trigeminal Nerve
;
Vascular Headaches
;
Vasoconstriction
;
Vasodilation