Imigran scientific update |
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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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Drug category:Anti-Migraine agents
 Imigran scientific update
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