Imigran scientific update |
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Expert Opin Pharmacother. 2010 Jun 22. [Epub ahead of print]
Evers S.
University of Münster, Department of Neurology, Albert-Schweitzer-Str. 33, 48129 Münster, Germany
Pharmacotherapy of cluster headache.
Importance of the field: Cluster headache belongs to the trigemino-autonomic cephalgias and is one of the most devastating idiopathic pain syndromes. Despite its extreme severity and its prevalence of about 0.1%, little attention has been paid to this painful syndrome by either basic or clinical research. Areas covered in this review: All clinical trials on the acute and prophylactic drug treatment of cluster headache are reviewed, including review articles and book chapters. What the reader will gain: The treatment of cluster headache is based on acute and prophylactic drug treatment. Oxygen inhalation, subcutaneous or intranasal sumatriptan, and intranasal zolmitriptan are recommended to stop an attach. For prophylaxis, verapamil is drug of first choice. Other drugs efficacious in cluster headache are steroids, lithium, some anticonvulsants and methysergide. Recently, interventional procedures have been studied for the treatment of refractory cluster headache. In the future, new anticonvulsants and unconventional ways of immunotherapy should be evaluated. Take home message: In most cases, cluster headache can be treated sufficiently (i.e., with sufficient quality of life) by an individual concept of acute and prophylactic drug treatment.
Can Fam Physician. 2010 Jun;56(6):537-9.
Duong S, Bozzo P, Nordeng H, Einarson A.
Leslie Dan Faculty of Pharmacy, University of Toronto, Canada.
Safety of triptans for migraine headaches during pregnancy and breastfeeding.
QUESTION: A patient who just found out that she is pregnant and suffers from migraine headaches informs me that she has been taking naratriptan. She indicates that she is planning on breastfeeding her baby and might need to continue treatment. How safe are the medications from this class of drugs during pregnancy and breastfeeding? ANSWER: Accumulated data suggest that exposure to sumatriptan during pregnancy does not increase the risk of birth defects above the baseline rate. There are currently insufficient data to confirm the safety of other triptans; however, evidence to date is reassuring. Information regarding safety of triptans while breastfeeding is limited but also reassuring, as the minimal amounts excreted into the milk are insufficient to cause any adverse effects on the breastfeeding infant.
Nanomedicine (Lond). 2010 Jun;5(4):575-87.
Jain R, Nabar S, Dandekar P, Hassan P, Aswal V, Talmon Y, Shet T, Borde L, Ray K, Patravale V.
Department of Pharmaceutical Sciences & Technology Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai 400 019, India.
Formulation and evaluation of novel micellar nanocarrier for nasal delivery of sumatriptan.
AIM: The investigation was aimed at designing a micellar nanocarrier of sumatriptan for nose-to-brain delivery and to identify the probable pathway of drug transport to the brain. MATERIALS & METHODS: Micellar nanocarriers were formulated using various safe and acceptable excipients. Optimized formulation was characterized for particle size by multiangle dynamic light scattering, small-angle neutron scattering and cryo-transmission electron microscopy. (99m)Tc was used as a radiolabeling agent to radiolabel sumatriptan for in vivo studies. RESULTS: Various characterization studies demonstrated the nanometric, homogenous and spherical nature of the developed micellar nanocarrier. Biodistribution and autoradiography studies in rats showed a significantly higher brain uptake of sumatriptan micellar nanocarrier as compared with sumatriptan solution. CONCLUSION: Preliminary investigations in rats indicated the potential of the developed micellar nanocarrier for nose-to-brain delivery of sumatriptan. These investigations in lower animals provided an excellent lead to further evaluate the formulation in higher animals and finally in clinical settings.
Arch Cardiol Mex. 2009 Dec;79 Suppl 2:83-94.
Sánchez-López A, Centurión D, Lozano-Cuenca J, Muñoz-Islas E, Cobos-Puc LE, Villalón CM.
Departamento de Farmacobiología, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional.
[Role of serotonin receptors in vascular tone in the pithed rat] [Article in Spanish]
Serotonin (5-hydroxytryptamine; 5-HT) has been shown to produce vascular sympatho-inhibition in a wide variety of isolated blood vessels by activation of prejunctional 5-HT1 receptors. After considering the mechanisms involved in modulating neuroeffector transmission, the present review analyzes the experimental findings identifying the pharmacological profile of the 5-HT receptors that inhibit the sympathetically-induced vasopressor responses in pithed rats. Thus, 5-HT-induced sympatho-inhibition has been shown to be: (i) unaffected by physiological saline or by the selective antagonists ritanserin (5-HT2), MDL72222 (5-HT3) or tropisetron (5-HT3/4); (ii) blocked by methysergide, a non-selective 5-HT1/2 receptor antagonist; and (iii) potently mimicked by 5-carboxamidotryptamine (5-CT), a non-selective 5-HT1 receptor agonist, as well as by the selective agonists 8-OH-DPAT (5-HT1A), indorenate (5-HT1A), CP93,129 (5-HT1B), and sumatriptan (5-HT1B/1D). These findings show the involvement of prejunctional 5-HT1 receptors. With the use of selective antagonists, it has been shown subsequently that the sympatho-inhibition induced by indorenate, CP93, 129, and sumatriptan was selectively antagonized by WAY100635 (5-HT1A), cyanopindolol (5-HT1A/1B), and GR127935 (5-HT1B/1D), respectively. These results demonstrate that the 5-HT1 receptors mediating sympatho-inhibition on the systemic vasculature of pithed rats resemble the pharmacological profile of the 5-HT1A, 5-HT1B, and 5-HT1D subtypes.
Ann Emerg Med. 2009 Dec 31. [Epub ahead of print]
Kostic MA, Gutierrez FJ, Rieg TS, Moore TS, Gendron RT.
Department of Emergency Medicine, Naval Medical Center, Portsmouth, VA; Department of Pediatrics (Emergency Medicine), Medical College of Wisconsin, Milwaukee, WI.
A Prospective, Randomized Trial of Intravenous Prochlorperazine Versus Subcutaneous Sumatriptan in Acute Migraine Therapy in the Emergency Department.
STUDY OBJECTIVE: Intravenous (IV) prochlorperazine with diphenhydramine is superior to subcutaneous sumatriptan in the treatment of migraine patients presenting to the emergency department (ED). METHODS: In this randomized, double-blind, placebo-controlled trial, after providing written informed consent, patients presenting to the ED with a chief complaint of migraine received a 500-mL bolus of IV saline solution and either 10 mg prochlorperazine with 12.5 mg diphenhydramine IV plus saline solution placebo subcutaneously or saline solution placebo IV plus 6 mg sumatriptan subcutaneously. Pain intensity was assessed with 100-mm visual analog scales (visual analog scale at baseline and every 20 minutes for 80 minutes). The primary outcome was change in pain intensity from baseline to 80 minutes or time of ED discharge if subjects remained in the ED for fewer than 80 minutes after treatment. Sedation and nausea were assessed every 20 minutes with visual analog scale scales, and subjects were contacted within 72 hours to assess headache recurrence. RESULTS: Sixty-eight subjects entered the trial, with complete data for 66 subjects. Baseline pain scores were similar for the prochlorperazine/diphenhydramine and sumatriptan groups (76 versus 71 mm). Mean reductions in pain intensity at 80 minutes or time of ED discharge were 73 mm for the prochlorperazine/diphenhydramine group and 50 mm for those receiving sumatriptan (mean difference 23 mm; 95% confidence interval 11 to 36 mm). Sedation, nausea, and headache recurrence rates were similar. CONCLUSION: IV prochlorperazine with diphenhydramine is superior to subcutaneous sumatriptan in the treatment of migraine.
Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(12):71-5.
Azimova IuE, Tabeeva GR.
[Trimigren in stopping migraine attacks: an open prospective multicenter comparative study of rectal suppository and tablet forms of sumatriptan] [Article in Russian]
Efficacy and safety of sumatriptan in rectal suppository (50 mg) and tablet forms (50 mg) in stopping migraine attacks has been studied in 80 patients with migraine with or without aura. Dynamics of migraine pain intensity measured with the VAS 30 min, 1, 2, 6 and 24 h after the first dose of drug was a primary index of efficacy. Secondary indices were the VAS intensity of nausea, vomiting, photophobia, phonophobia, duration of each migraine attack, quality of life parameters of a patient during the migraine attack assessed with the 24-hour questionnaire, severity of migraine course on the MIDAS, percentage of patients with complete regression of migraine pain, at least in 2 out of 3 attacks. To assess drug safety, any adverse effects, data of instrumental methods (clinical and biochemical blood tests, clinical urine test), EKG were taken into account. Rectal suppository had the more rapid effect on headache reduction compared to tablets. Changes of intensity of concomitant symptoms (nausea, vomiting, photophobia, phonophobia) as well as other secondary indices of drug efficacy were similar in both groups. In the group treated with rectal suppository, 9 (22.5%) patients had 12 adverse effects. In the group treated with tablets, 22 adverse effects were noted in 15 (37.5%) patients. Adverse effects related to the cardio-vascular system were observed less often in the group treated with rectal suppository (6.6 and 32%, respectively, p=0,004).
JAMA. 2009 Dec 9;302(22):2451-7.
Cohen AS, Burns B, Goadsby PJ.
Headache Group, Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square London, England.
High-flow oxygen for treatment of cluster headache: a randomized trial.
CONTEXT: Cluster headache is an excruciatingly painful primary headache syndrome, with attacks of unilateral pain and cranial autonomic symptoms. The current licensed treatment for acute attacks is subcutaneous sumatriptan. OBJECTIVE: To ascertain whether high-flow inhaled oxygen was superior to placebo in the acute treatment of cluster headache. DESIGN, SETTING, AND PATIENTS: A double-blind, randomized, placebo-controlled crossover trial of 109 adults (aged 18-70 years) with cluster headache as defined by the International Headache Society. Patients treated 4 headache episodes with high-flow inhaled oxygen or placebo, alternately. Patients were randomized to the order in which they received the active treatment or placebo. Patients were recruited and followed up between 2002 and 2007 at the National Hospital for Neurology and Neurosurgery, London, England. INTERVENTION: Inhaled oxygen at 100%, 12 L/min, delivered by face mask, for 15 minutes at the start of an attack of cluster headache or high-flow air placebo delivered alternately for 4 attacks. MAIN OUTCOME MEASURES: The primary end point was to render the patient pain free, or in the absence of a diary to have adequate relief, at 15 minutes. Secondary end points included rendering the patient pain free at 30 minutes, reduction in pain up to 60 minutes, need for rescue medication 15 minutes after treatment, overall response to the treatment and overall functional disability, and effect on associated symptoms. RESULTS: Fifty-seven patients with episodic cluster headache and 19 with chronic cluster headache were available for the analysis. For the primary end point the difference between oxygen, 78% (95% confidence interval, 71%-85% for 150 attacks) and air, 20% (95% confidence interval, 14%-26%; for 148 attacks) was significant (Wald test, chi(5)(2) = 66.7, P < .001). There were no important adverse events. CONCLUSION: Treatment of patients with cluster headache at symptom onset using inhaled high-flow oxygen compared with placebo was more likely to result in being pain-free at 15 minutes.
Pharmacol Rep. 2008 Nov-Dec;60(6):904-13.
Rehni AK, Singh TG, Jaggi AS, Singh N.
Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala-147002, Punjab, India.
Pharmacological preconditioning of the brain: a possible interplay between opioid and calcitonin gene related peptide transduction systems.
The present study has been undertaken to investigate the possible link between calcitonin gene related peptide (CGRP) and opioid receptor transduction systems in the neuroprotective mechanism of pharmacological preconditioning. Occlusion of the bilateral carotid artery for 17 min, followed by reperfusion for 24 h, was employed to produce ischemia and reperfusion (I/R) induced cerebral injury in mice. Cerebral infarct size was measured by using triphenyltetrazolium chloride staining. Memory was assessed using the Morris water maze (MWM) test. Degree of motor incoordination was evaluated using the inclined beam walk test, rota-rod test, and lateral push test. Morphine (8 mg/kg, ip), an opioid agonist, and capsaicin (0.1 mg/kg, iv), a CGRP releasing agent, were administered 24 h before surgery to separate groups of animals to induce pharmacological preconditioning. Bilateral carotid artery occlusion, followed by reperfusion, produced a significant increase in the cerebral infarct size and impaired memory as well as motor coordination. Morphine and capsaicin treatment produced both a significant decrease in the cerebral infarct size and a reversal of I/R-induced impairment of memory and motor-coordination. Morphine-induced (8 mg/kg, ip) neuroprotective effects were completely decreased by sumatriptan (8 mg/kg, ip, a CGRPrelease inhibitor) administered 1 h before and 6 h and 12 h after morphine administration. Capsaicin-induced neuroprotection was decreased by naloxone (5 mg/kg, ip, an opioid antagonist) administered 1 h before and 6 h and 12 h after capsaicin administration. These findings indicate that the transduction systems mediating morphine- and capsaicin-induced pharmacological preconditioning in brain are possibly interlinked with one another.
Headache. 2008 Oct 10. [Epub ahead of print]
Tfelt-Hansen P.
From the Danish Headache Centre, Department of Neurology, University of Copenhagen, Glostrup Hospital, Glostrup, Denmark.
Early Responses in Randomized Clinical Trials of Triptans in Acute Migraine Treatment. Are They Clinically Relevant? A Comment.
(Headache 2008;**:**-**) One can question the clinical relevance of early headache responses after oral and intranasal triptans. Thus, for pain-free the early responses were significant but in absolute values they were only a few percentages: the therapeutic gains (TGs) were 1.8% (95% CI = 0.3-3%) for oral almotriptan 12.5 after 30 minutes and 1.0% (95% CI = 0-2%) after intranasal zolmitriptan 5 mg after 15 minutes. These results are compared with subcutaneous sumatriptan 6 mg which has TGs of 11% (95% CI = 7-15%) to 14% (95% CI = 11-17%) for pain-free after 30 minutes. Subcutaneous sumatriptan has a 2 times higher response rate than intranasal zolmitriptan and is 5 times more effective than oral almotriptan at these early time points. It is concluded that if a very early and clinically relevant effect is desired then the migraine patient should use the subcutaneous administration form of sumatriptan.
Int J Clin Pract. 2008 Dec;62(12):1889-99.
Newman LC, Cady RK, Landy S, O'Carroll P, Kwong WJ, Burch SP, Nelsen AC, McDonald SA.
The Headache Institute, Roosevelt Hospital Center, New York, Albert Einstein College of Medicine Bronx, NY 10019, USA. lnewman@chpnet.org
Treatment satisfaction and efficacy of the rapid release formulation of sumatriptan 100 mg tablets utilising an early intervention paradigm in patients previously unsatisfied with sumatriptan.
AIMS: To evaluate treatment satisfaction, efficacy and functional ability of the rapid release formulation of sumatriptan 100 mg tablets (sumatriptan RT 100 mg) in an early intervention paradigm in patients who were dissatisfied with low-dose sumatriptan and not completely satisfied with their current migraine regimen. METHODS: Experienced migraineurs who reported a mild migraine pain phase, dissatisfaction with the previous sumatriptan treatment and some dissatisfaction with their current treatment regimen had no experience with sumatriptan at the 100 mg dose were enrolled in an open-label, single group study. Subjects were instructed to treat four migraine attacks within 30 min of the onset of mild pain. Treatment satisfaction was measured with the Patient Perception of Migraine Questionnaire Revised version (PPMQ-R) questionnaire. RESULTS: More than half of the subjects were either very satisfied or satisfied with the efficacy of early intervention sumatriptan RT 100 mg after each attack and at the follow-up study visit. The mean total PPMQ-R score was 75.2 out of 100. Between 63% and 73% of subjects were pain-free within 4 h of dosing. Between 79% and 90% of subjects reported an ability to function normally within 4 h of taking the study medication. CONCLUSION: Subjects who were previously unsatisfied with lower doses of sumatriptan and less than very satisfied with their current treatment regimen were more likely to be satisfied or very satisfied with sumatriptan RT 100 mg in an early intervention paradigm. Results were consistent across four migraine attacks and at a follow-up visit. The treatment satisfaction results corresponded with positive results on efficacy measures and a functional status measure.
Am J Emerg Med. 2008 Nov;26(9):1029-34.
Trainor A, Miner J.
Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN 55415, USA.
Pain treatment and relief among patients with primary headache subtypes in the ED.
OBJECTIVE: The aim of this study is to determine if emergency physicians treat headache subtypes differently and if this difference affects pain relief. METHODS: This was a prospective observational, institutional review board-approved study of adults undergoing treatment for a primary headache. Before the treatment and 60 minutes after, patients completed a 100-mm Visual Analog Scale (VAS) describing their pain. Patients also completed a headache diagnosis worksheet that differentiated headache type based on International Headache Society criteria. Treatments were recorded. Data were analyzed using descriptive statistics, 95% confidence intervals, analysis of variance, and chi(2) tests as appropriate. RESULTS: A total of 184 patients were enrolled: 83 (45.1%) with migraine, 61 (33.2%) with migrainous, and 40 (21.7%) with tension-type headaches. There was no difference in the presenting VAS score or treatments of the 3 headache subtypes. The migraine group was most likely to receive any pain medication (78.31%), and the tension group the least likely to receive any pain medication (62.50%). A 50% decrease in VAS was achieved by only 32.5% of the patients. Sumatriptan, followed by droperidol, provided the greatest decrease in VAS scores. Oral and parenteral narcotics provided equivalent pain relief, with nonsteroidal anti-inflammatory drugs (NSAIDs) providing the least pain relief. CONCLUSION: There was no difference in the treatments used or pain relief achieved between migraine, migrainous, and tension-type headaches. The differentiation of primary headache subtypes does not appear to be important to their treatment in the acute setting of the emergency department.
Zh Nevrol Psikhiatr Im S S Korsakova. 2007;107(8):29-33.
Tabeeva GR, Azimova IuE.
[Efficacy of sumamigren at early and late stages of migraine attack] [Article in Russian]
Three migraine attacks have been studied in 30 patients aged 39.4+/-10.5 years. A significant decrease of headache and concomitant symptoms was found 1, 2 and 6 h after receiving of sumamigren (sumatriptan). The drug was effective in 2 out of 3 attacks in most of the patients (53.3%); in 3 attacks--in 26.7%; in 1 attack--in 6.7%. In 13.3% of the patients the drug did not exert a therapeutic effect. When administering at the early stage of the attack, the drug reduced the headache after 1 and 2 h more significantly comparing to patients receiving it at the later stage. In case of early prescription of sumamigren, the relapse of headache was observed in 7,8% and in later one--in 20.5% of patients. During the first 24 h of attack, patients switched to the drug at the early stage reported higher quality of life (mean score 45.1+/-14.6) than those with later prescription (71.4+/-18.3). It has been concluded that sumamigren is an effective medication for stopping the migraine attack, in particular at its the beginning.
Acta Gastroenterol Latinoam. 2007 Sep;37 Suppl 1:S25-8.
Iantorno G, Corti R, Fernández LM, Soifer L, Bilder C, Soifer G, De Los Santos AR, Gianoni C, Bernstein S, Secilio O.
Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo Buenos Aires, Argentina. guidoiantorno@yahoo.com.ar
[Diagnostic and therapeutic algorithm in functional dyspepsia] [Article in Spanish]
INTRODUCTION: Dyspepsia is a word that means bad digestion. In the conviction of which it is a question of an entity that it includes different disciplines, we realize a meeting consensus to discuss and to resolve a diagnostic and therapeutic algorithm of national order. OBJECTIVE: To agree on a national algorithm applicable to the functional dyspepsia. MATERIAL AND METHODS: In June 2005 a multidisciplinary group met to design and to propose a diagnostic and therapeutic algorithm for the functional dyspepsia. RESULTS: Priority gives to the medical-patient relationship and to the reinsurance. Then we divide the patients if they have signs of alarm. If they are present we studied them, if not we divide them, in accordance to the principal symptoms, in pain or epigastric discomfort. If they have pain we realized an endoscopy and a abdominal ultrasound scan. If they are positive, treatment of the disease. If the studies are negative or it has epigastric discomfort we propose a therapeutic test. Pain: H2 bloquers, wait 4 to 6 weeks, if it not response we propose a PPI, wait for 4 to 6 weeks, if there is no response psychiatric or psychological consultation. Discomfort: proquinetics, wait for 4 to 6 weeks if there are no answers, antidepressants in low doses, wait for 4 to 6 weeks if there are no answers, ca. bloquers, sumatriptan or trimebutina. In all cases we can add tranquillizers in anxious personality. CONCLUSIONS: A multidisciplinary dignostic and therapeutic consensus of national order for the patients with functional dyspepsia was obtained.
Recent Pat CNS Drug Discov. 2007 Jun;2(2):141-4.
Krymchantowski AV, Jevoux Cda C.
Headache Center of Rio. Rio de Janeiro, Brazil. abouchkrym@globo.com
The experience of combining agents, specially triptans and non steroidal anti-inflammatory drugs, for the acute treatment of migraine - a review.
BACKGROUND AND OBJECTIVES: Migraine is a highly prevalent neurological disorder with multiple mechanisms. Targeting a single mechanism has been found only partially effective for treating individual attacks. Recently, the role of combining agents for the acute migraine treatment has gained attention and the combination of a triptan plus a nonsteroidal anti-inflammatory drug (NSAID) has demonstrated better efficacy. This article focuses on the review of available literature for treating migraine attacks with two or more agents, related patents as well as analyzes the characteristics of the recently approved fixed combination sumatriptan-naproxen. METHODS: The following terms migraine, acute treatment, sumatriptan, naproxen and combination were searched on MEDLINE. In addition, abstracts presented in the major meetings carried out by the American Headache and the International Headache Societies along with the American Academy of Neurology were also evaluated. RESULTS: Although most of the few studies encountered were not controlled, there is a clear trend for the better efficacy in combining triptans with NSAID. Additionally, the results of two recent large and controlled studies using fixed combinations of sumatriptan (50mg and 85mg) with 500mg naproxen sodium confirm the initial observations of the clear superiority of this combination over the isolated use of each agent. The differences in the endpoints of 24-hour pain relief response as well as pain-free and pain-relief parameters at 2-hour time-points are the clearest efficacy measures. Tolerability was not different between the two studied drugs. CONCLUSIONS: Combining triptans with NSAID and other agents for the acute treatment of migraine suggests better outcome efficacy measures than the use of single agents. The fixed combination of sumatriptan and naproxen sodium offers improved 2-hour and 24-hour benefits over the monotherapy. Recently, issued FDA approval for marketing the combination (sumatriptan 50mg-naproxen 500mg) emphasizes the usefulness and safety of this new treatment for migraine attacks.
Clin Ther. 2007;29 Suppl:2511-9.
Schreiber CP, Cady RK.
Clinvest/Headache Care Center, Springfield, Missouri 65807, USA.
Diagnosis of menstrual headache and an open-label study among those with previously undiagnosed menstrually related migraine to evaluate the efficacy of sumatriptan 100 mg.
BACKGROUND: Headache associated with menses is often not formally diagnosed. OBJECTIVES: The goal of this study was to evaluate patients with menstrual headache who had never previously been diagnosed with migraine and assign 1988 International Headache Society (IHS) diagnoses to their menstrual headaches. Secondary objectives included evaluation of the treatment efficacy of newly diagnosed menstrually related migraine (MRM) with sumatriptan 100 mg and patient satisfaction with sumatriptan versus satisfaction with previous therapy. METHODS: Patients were recruited via advertisement in a local daily newspaper, and headache diagnosis and eligibility criteria of respondents were assessed by telephone. During telephone screening, IHS criteria for headache were applied to symptoms described by patients as menstrual headache. Those with previously undiagnosed headaches who fulfilled criteria for migraine without or with aura (IHS 1.1 or 1.2) and all inclusion/exclusion criteria at visit 1 were provided with sumatriptan 100 mg to treat 1 MRM. Patients were instructed to treat their next MRM as early as possible after the onset of headache. A treatment diary was provided with study medication for documentation of headache pain severity and associated symptoms; time of treatment and response at 30, 60, and 90 minutes and at 2, 4, 24, and 48 hours posttreatment; medication for persistence or recurrence; adverse effects; and onset of menstrual cycle. In analysis, headache response was defined as a reduction in pretreatment head pain from moderate or severe to mild or no pain. RESULTS: A total of 153 patients responded to an advertisement seeking menstrual headache sufferers. After the preliminary screening by telephone, 105 patients were assigned IHS diagnoses based on reported symptoms associated with their menstrual headache. Overall, 63% (66/105) fulfilled criteria for IHS 1.1 (migraine without aura), 12% (13/105) met criteria for IHS 1.2 (migraine with aura), and 5% (5/105) met criteria for IHS 1.7 (migrainous disorder). Of the 79 patients meeting the criteria for IHS 1.1 or 1.2, 45 patients were enrolled. Thirty-nine (mean age, 34.8 years; mean duration of experiencing menstrual headaches, 11.1 years) of the 45 patients treated 1 MRM with sumatriptan 100 mg per protocol (6 patients were lost to follow-up or withdrew consent). Headache response was reported by 70% of patients at 2 hours and 86% at 4 hours. The pain-flee response after treatment at the moderate or severe phase occurred in 41% of patients at 2 hours and in 61% at 4 hours. All 39 patients reported previous use of nonsteroidal anti-inflammatory medications for acute treatment of headache; in addition, 1 of the 39 also took acetylsalicylic acid/caffeine/butalbital, 1 took acetaminophen/caffeine/butalbital, 1 took ketorolac, and 1 took acetaminophen plus codeine. In terms of patient satisfaction, 69% of patients were satisfied with sumatriptan versus 15% of patients who were satisfied with their previous therapy. CONCLUSIONS: Seventy-five percent of women with previously undiagnosed menstrual headaches met diagnostic criteria for migraine in this small sample. Two hours after treatment with sumatriptan 100 rag, 70% of patients with headaches treated at moderate to severe pain had a pain relief response (reduction to mild or no pain).
Eur J Paediatr Neurol. 2007 Apr 9;
Callenbach PM, Pels LP, Mulder PG, Linssen WH, Gooskens RH, van der Zwan JL, Brouwer OF; For the SUM30042 Trial Group.
Department of Neurology, University Medical Centre Groningen, University of Groningen, P.O. Box 30 001 9700 RB Groningen, The Netherlands.
Sumatriptan nasal spray in the acute treatment of migraine in adolescents and children.
About 4-10% of children and adolescents suffer from migraine. In the last few years, several studies have been performed to assess the efficacy and safety of
triptans for the acute treatment of migraine in children and adolescents. Only sumatriptan nasal spray has been approved for the treatment of acute migraine
with or without aura in adolescents aged 12-17 years in Europe. This review describes the results of the studies with sumatriptan nasal spray that have been
performed in children and adolescents, including a study performed in the Netherlands.
Headache. 2007 Apr;47(4):475-9.
Bigal M, Rapoport A, Aurora S, Sheftell F, Tepper S, Dahlof C.
Albert Einstein College of Medicine--Neurology, Bronx, NY 10461, USA.
Satisfaction with current migraine therapy: experience from 3 centers in US and Sweden.
OBJECTIVE: To assess the level of satisfaction and determinants of satisfaction or dissatisfaction of patients presenting in tertiary care, in regard to
their usual care (UC) for the acute treatment of migraine. DESIGN/METHODS: Patients seen in 3 headache centers were assessed by means of 21 attributes
related to their UC. Questions covered satisfaction with efficacy (including onset of relief, degree of relief, consistency of action, ease of use),
tolerability (lack of side effects overall, CNS side effects, other side effects), and willingness to continue using the same medication and to change to
another medication. All questions were answered on a 5-point scale (where 1 was strongly agree, 2 was agree, 3 was neutral, 4 was disagree, and 5 was
strongly disagree). RESULTS: We assessed 183 subjects (74.8% women, mean age = 39.3 years). UC consisted, as a single drug or combination, of: triptan
conventional tablets--62%; triptan disintegrating tablets--8%; sumatriptan nasal spray 9%; sumatriptan injection, 9%; nontriptans--19.6%. Most (54%) had no
benefit within the first hour of treatment. The maximum benefit took more than 1 hour to be reached in 69%, and more than 2 hours in 36%. After the maximum
benefit had been reached, pain worsened in 61%. Although 58% were satisfied with the degree of relief, 37% were dissatisfied with the speed of effect, 50%
with the recurrence of pain, and 42% with the need for a second dose. Most were satisfied with the tolerability (56%). Finally, most (79.7%) said they were
willing to try another acute medication. CONCLUSIONS: An important subset of patients, including a large subgroup of patients using triptans, is dissatisfied
with their UC. Clinical trials assessing patients' preference should be conducted to complement the information from clinical trials.
J Headache Pain. 2007 Apr;8(2):127-34.
Tfelt-Hansen P
Dept. of Neurology, Glostrup Hospital, DK-2600, Glostrup, Denmark.
Acute pharmacotherapy of migraine, tension-type headache, and cluster headache.
In most migraine patients acute therapy is needed. Migraine can be treated either with specific drugs, the triptans and ergot alkaloids, or with NSAIDs.
Triptans are a major step foreward in migraine therapy. The therapeutic gain for headache relief is 50% for subcutaneous sumatriptan whereas it is 30-40% for
most oral triptans. After oral triptans sustained pain free is only 30%. There is thus still ample room for improvement of acute therapy in migraine. For
tension-type headache there is no specific therapy and it is treated with NSAIDs. Only 17-32% become pain free after these drugs. For attacks of cluster
headache oxygen and subcutaneous sumatriptan can be used. Intranasal triptans can be an alternative.
Headache. 2007 May;47(5):683-92.
Smith T, Blumenthal H, Diamond M, Mauskop A, Ames M, McDonald S, Lener S, Burch S.
Mercy Health Research and Ryan Headache Center, St. Louis, MO, USA.
Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes.
Objective.-To describe the pain relief, satisfaction, and health-related quality of life results of moderate or severe migraines treated with a
sumatriptan/naproxen sodium combination tablet. Methods.-Sumatriptan and naproxen sodium as a single-dose formulation tablet was used to treat moderate to
severe migraines over a 12-month period in a phase 3, open-label, multicenter study (n = 565) in patients with at least 6 months' history of migraine
headaches. Results.-Seventy percent of all attacks were treated with 1 dose of sumatriptan/naproxen sodium. Overall subjects treated 24,485 attacks; of
these, 81% attacks achieved pain relief and 60% pain-free by 2 hours. At 3 months, the percentage of patients satisfied or very satisfied increased from
baseline on all 8 Patient Perception of Migraine Questionnaire (PPMQ) items and remained high throughout the study. Mean Migraine-Specific Quality of Life
Questionnaire (MSQ) domain scores also increased by 13-15 points from baseline during this time and remained high. Conclusions.-Sumatriptan/naproxen sodium
provides consistent relief of migraine attacks over 12 months, resulting in improved patient satisfaction and migraine specific quality of life.
Expert Opin Emerg Drugs. 2006 Sep;11(3):419-27.
Goadsby PJ.
Institute of Neurology, Headache Group, The National Hospital for Neurology and Neurosurgery,
Migraine: emerging treatment options for preventive and acute attack therapy.
This review discusses emerging treatments of migraine in the context of what is now available.
At present, patients are treated with a range of acute attack medicines or preventive
treatments, with many having significant drawbacks. Important unmet needs are acute attack
treatments that act by exclusively neural mechanisms with no vascular effects, and effective,
well tolerated preventive medicines. Calcitonin gene-related peptide receptor antagonist,
vanilloid receptor antagonists and nitric oxide synthase inhibitors are all in clinical trials
for acute migraine. Tonaberset (a gap-junction blocker), an inducible nitric oxide synthase
inhibitor and botulinum toxin A are in clinical trials for preventive therapy. Device-based
approaches using neurostimulation of the occipital nerve are being studied, although the first
study of patent foramen ovale closure for migraine prevention failed.
CNS Drugs. 2006;20(10):813-20.
Hamalainen ML.
Department of Pediatric Neurology, Hospital for Children and Adolescents, Helsinki University
Migraine in children and adolescents : a guide to drug treatment.
Migraine is a common disorder in children and adolescents, with a prevalence of 5 and 10%,
respectively. Some patients may have recognisable factors that trigger or aggravate migraine
attacks, such as flickering or bright lights, strong smells and noise, and where possible
these should be avoided. It is also wise to maintain a lifestyle where children receive
regular meals and get sufficient sleep. If used, acute pharmacological treatment should be
given at the onset of an attack, followed by a rest or sleep. According to recent literature,
paracetamol (acetaminophen) and ibuprofen can be recommended for the acute treatment of
migraine attacks in children and adolescents, and sumatriptan nasal spray can be recommended
for adolescents. The oral formulation of sumatriptan has not shown efficacy in paediatric
patients, and the subcutaneous injection, although somewhat effective, is not an ideal
formulation for this patient group. There are too few data on the efficacy of the other
'triptans' to recommend their use in children and adolescents. There are less data on the use
of prophylactic drugs in paediatric patients. In systematic studies, only flunarizine, which
is not available in many countries, and propranolol have been found to be effective. A pilot
placebo-controlled study suggests that topiramate might also be effective. Several other
agents are commonly used to prevent migraine attacks in children (e.g. amitriptyline, valproic
acid [sodium valproate]) despite a lack of robust research into their efficacy.
Curr Med Res Opin. 2004 Dec;20(12):2021-9.
Barbanti P, Carpay JA, Kwong WJ, Ahmad F, Boswell D.
Department of Neurological Sciences, La Sapienza University, Rome, Italy.
Effects of a fast disintegrating/rapid release oral formulation of sumatriptan on functional ability in patients with migraine.
BACKGROUND: A new oral form of sumatriptan has been developed to facilitate tablet disintegration and drug dispersion and to mitigate the effects of gastric stasis that can accompany migraine. OBJECTIVE: To evaluate the effects on functional ability of the new fast disintegrating/rapid release formulation of sumatriptan. METHODS: Sumatriptan 50 mg (n = 137), 100 mg (n = 142), or placebo (n = 153) was administered early when pain was mild for the acute treatment of a single migraine attack in a randomized, double-blind, parallel-group, placebo-controlled clinical trial. For this report, main health-outcomes endpoints (which were secondary endpoints for this clinical trial that was primarily designed to assess pain-free efficacy) included functional ability measured through 2 h postdose on a 5-point scale and lost time equivalents, a composite measure of migraine-associated time missed from activities, and reduced effectiveness at activities through 24 h postdose. RESULTS: Normal functional ability was restored in a significantly (p < 0.05) greater percentage of patients treated with sumatriptan than placebo beginning 45 min postdose for sumatriptan 100 mg and 1 h postdose for sumatriptan 50 mg. During the 24 h after initial dosing, the median (range) lost time equivalents for the combination of paid work activities and activities outside of paid work were significantly lower in the groups treated with sumatriptan (1.1 [0-10] sumatriptan 100 mg; 0.8 [0-36] sumatriptan 50 mg) compared with placebo (2.9 [0-24]) (p < or = 0.01 each sumatriptan group versus placebo). The corresponding mean +/- SD values for lost time equivalents were 1.9 +/- 2.3 and 2.5 +/- 4.7 for sumatriptan 100 mg and 50 mg, respectively, compared with 3.5 +/- 4.3 for placebo. CONCLUSION: A new oral sumatriptan formulation confers rapid, sustained restoration of functional ability in the acute treatment of migraine so that patients can return rapidly to normal functioning at work and outside of work.
J Neurol. 2005 Mar 11.
Ferrari MD, Goadsby PJ, Lipton RB, Dodick DW, Cutrer FM, McCrory D, Williams P.
Dept. of Neurology, Leiden University Medical Centre, 9600, 2300, RC Leiden, The Netherlands, M.D.
The use of multiattribute decision models in evaluating triptan treatment options in migraine.
BACKGROUND : The physician treating patients with migraine is now able to choose from among seven triptans-almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan and zolmitriptan. These differ, to greater or lesser degrees, on a range of clinical attributes important for treatment selection. OBJECTIVE : To outline the basic principles of Multiattribute Decision Making (MADM) and describe how one such method-TOPSIS (Technique for Order Preference by Similarity to the Ideal Solution)-can be applied to evaluate the currently available triptans. METHODS : In an example application, summary data from a recent meta-analysis of 53 published and unpublished placebo-controlled trials of the oral triptans were combined in TOPSIS models with computer-generated attribute importance weights representing the entire range of possible values, That is, the relative performance of the triptans was explored across all logically possible combinations of relative importance of the treatment attributes available from the meta-analysis, and uncertainty was assessed based on the confidence intervals from the meta-analysis. RESULTS : When compared across the entire range of values for relative attribute importance, almotriptan, eletriptan and rizatriptan were more similar to a hypothetical ideal triptan and were more likely to appear in the top three closest to the hypothetical ideal, than were naratriptan, sumatriptan, and zolmitriptan. CONCLUSION : Using the TOPSIS model, almotriptan, eletriptan and rizatriptan were more likely to appear in the top three closest to the hypothetical ideal triptan.
Am Fam Physician. 2005 Feb 15;71(4):717-24.
Beck E, Sieber WJ, Trejo R.
Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, California, USA.
Management of cluster headache.
Cluster headache, an excruciating, unilateral headache usually accompanied by conjunctival injection and lacrimation, can occur episodically or chronically, and can be difficult to treat. Existing effective treatments may be underused because of underdiagnosis of the syndrome. Oxygen and sumatriptan have been demonstrated to be effective in the acute treatment of cluster headaches. Verapamil has been shown to be effective for prophylaxis. For cluster headache completely refractory to all treatments, surgical modalities and newer interventions such as the implantation of stereotactic electrodes may be useful. Patients should be encouraged to avoid possible triggers such as smoking or alcohol consumption, especially during the duster period. The intensity of duster headache pain leads to ethical concerns among researchers over the use of placebo, making randomized controlled trials difficult. As new technology and genetic studies clarify the etiology of duster headache, it is possible that more specific therapies will emerge.
Expert Rev Neurother. 2004 Mar;4(2):199-209.
Sheftell FD, Bigal ME, Tepper SJ, Rapoport AM.
The New England Center for Headache, PC 778 Long Ridge Road, Stamford, CT 06902 1251, USA.
Sumatriptan: a decade of use and experience in the treatment of migraine.
The migraine-specific triptans have revolutionized the treatment of migraine and are usually the drugs of choice to treat a migraine attack in progress. Sumatriptan (Imitrex) has been available for the longest time within the class, is most flexible in form and has been given successfully to the most number of patients. It is useful for the full range of attacks experienced by a migraine suffer. The aim of this review is to provide an overview of the first 10 years of the use of sumatriptan.
Prescrire Int. 2005 Apr;14(76):45-7.
Nasal sumatriptan: new dosage. For adolescents with migraine: too little benefit.
(1) The reference first-line drug therapy for migraine attacks in adolescents is a non specific analgesic such as paracetamol or a nonsteroidal antiinflammatory drug like ibuprofen. Two specific analgesics are authorised for use in this setting in France, namely ergotamine and dihydroergotamine. (2) Nasal sumatriptan is the first triptan to be licensed for this age group in France. (3) Evaluation data includes three flawed placebo-controlled trials. (4) Effects were modest at best. Only one of the three trials showed that sumatriptan was more likely than placebo to give complete pain relief within two hours. The three trials fail to show that sumatriptan is effective against symptoms such as nausea and vomiting, photophobia and phonophobia. (5) The principal known adverse effects of sumatriptan are chest tightness, flushing, and increased blood pressure. (6) In the only trial report containing relevant information, unpleasant taste was the only adverse effect more commonly associated with sumatriptan than with placebo. (7) Postmarketing follow-up revealed a number of serious adverse effects, including stroke, myocardial infarction and loss of vision. (8) The packs containing 6 or 12 spray vials carry a risk of overuse and self-induced headache. (9) In practice, sumatriptan must not be used to treat migraine attacks in adolescents.
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