Oral Zolmitriptan Research Articles

Efficacy of Oxygen Treatment Using Home Oxygen Concentrators for the Treatment of Cluster Headaches: A Randomized, Crossover, Multicenter Study.

Oxygen treatment is the first-line acute treatment for cluster headaches (CHs), but this can be impeded by insurance coverage and oxygen-tank maintenance. Oxygen concentrators filter nitrogen from ambient air to produce oxygen-rich gas, and can therefore be an alternative to conventional oxygen therapy using a tank. We investigated the effectiveness and safety of using two home oxygen concentrators and compared them with using oral zolmitriptan for the acute treatment of CHs. Forty patients with episodic CHs in an active cluster period were enrolled in this randomized, crossover, multicenter study. Two attacks during the cluster period were treated using oxygen delivered by connecting two home oxygen concentrators, whereas the other two attacks were treated using oral zolmitriptan (5 mg) in a random sequence. The primary endpoint was substantial pain reduction (0 or 1 on a five-point rating scale from 0 to 4 points) at 15 min after treatment. In total, 125 attacks among 32 patients were randomized and treated (63 attacks using oxygen and 62 using zolmitriptan) according to the study protocol. More attacks treated using oxygen reached the primary endpoint than did those treated using zolmitriptan (31.7% [20/63] vs. 12.9% [8/62], p=0.013). After 30 min, 57.1% of the patients who received oxygen and 38.7% who received zolmitriptan reported pain relief (p=0.082). All patients treated using oxygen reported an improvement in pain, and 61.3% preferred oxygen while only 9.7% preferred zolmitriptan. No adverse events occurred during the oxygen treatment. Oxygen treatment administered using two home oxygen concentrators resulted in better pain relief than oral zolmitriptan in patients with episodic CHs. Our results suggest that home oxygen concentrators are capable of efficiently supplying oxygen in a similar manner to using an oxygen tank.

Triptan non-response in specialized headache care: cross-sectional data from the DMKG Headache Registry

BackgroundTriptans are effective for many migraine patients, but some do not experience adequate efficacy and tolerability. The European Headache Federation (EHF) has proposed that patients with lack of efficacy and/or tolerability of ≥ 2 triptans (‘triptan resistance’) could be considered eligible for treatment with the novel medications from the ditan and gepant groups. There is little data on the frequency of ‘triptan resistance’.MethodsWe used patient self-report data from the German Migraine and Headache Society (DMKG) Headache Registry to assess triptan response and triptan efficacy and/or tolerability failure.Results A total of 2284 adult migraine patients (females: 85.4%, age: 39.4 ± 12.8 years) were included. 42.5% (n = 970) had failed ≥ 1 triptan, 13.1% (n = 300) had failed ≥ 2 triptans (meeting the EHF definition of ‘triptan resistance’), and 3.9% (n = 88) had failed ≥ 3 triptans. Compared to triptan responders (current use, no failure, n = 597), triptan non-responders had significantly more severe migraine (higher frequency (p < 0.001), intensity (p < 0.05), and disability (p < 0.001)), that further increased with the level of triptan failure. Responders rates were highest for nasal and oral zolmitriptan, oral eletriptan and subcutaneous sumatriptan.ConclusionIn the present setting (specialized headache care in Germany), 13.1% of the patients had failed ≥ 2 triptans. Triptan failure was associated with increased migraine severity and disability, emphasizing the importance of establishing an effective and tolerable acute migraine medication. Acute treatment optimization might include switching to one of the triptans with the highest responder rates and/or to a different acute medication class.Trial registrationThe DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

Oral paracetamol versus zolmitriptan to treat acute migraine attack in the emergency department

Background: Treatment provided in an emergency department is aimed at alleviating pain immediately with minimized adverse effects as well as warding off further migraine attacks. The primary aim of this article is to compare the effectiveness of oral paracetamol versus zolmitriptan in treating acute migraine attacks. Methods: This prospective, randomized, and controlled study was carried out at a tertiary care hospital visited by 95,000 patients annually. The study recruited 200 participants who were randomized into two groups. One group received 1000 mg paracetamol while the other group received 2.5 mg zolmitriptan orally. Baseline pain scores were recorded using the Visual Analogue Scale (VAS) and Numeric Rating Scale (NRS) at 15, 30 and at 60 min following administration of the study drugs. Patients requiring further treatment were provided fentanyl at a dosage of 1 µg/kg as a rescue therapy. Results: A significant decrease was evident in VAS and NRS scores following the administration of the study drugs in both groups (P &lt; 0.001). The change in VAS pain scores after 15, 30 and 60 min was calculated as 17.0 ± 13.9, 41.2 ± 16.3 and 61.2 ± 17.5 mm, respectively, in the paracetamol group and 14.2 ± 11.7, 39.2 ± 17.9 and 59.2± 19.3 mm, respectively, in the zolmitriptan group, which did not indicate significant differences (P = 0.103, P = 0.425, P = 0.483, respectively). Likewise, NRS pain scores showed a downward trend in line with VAS pain scores and did not yield a significant difference (P = 0.422). No significant difference concerning rescue therapy was noted between the two groups (P = 0.596). Conclusion: Oral paracetamol and zolmitriptan prove to be similarly effective and have low incidence of acute side effects in treating acute migraine cases without aura.

Effect of Different Meltable Binders on the Disintegration and Dissolution Behavior of Zolmitriptan Oromucosal Fast Melt Tablets

Objective: Fast melt tablets and sublingual route have been widely used for providing quick onset of action with the avoidance of first pass metabolism. The objective of this work was to compare the effect of different meltable binders namely; polyethylene glycol (PEG) 4000, pluronic F127 and pluronic F68 on the performance of fast release tablets of the model drug zolmitriptan prepared using the melt granulation technique regarding disintegration time (DT) and dissolution rate (DR) as criteria for rapid absorption and hence quick onset of action. Zolmitriptan is a potent antimigraine drug. Current oral zolmitriptan tablets suffer from slow onset of action, poor bioavailability and large inter-subject variability. Methods: 33 factorial design was adopted. The effect of binder type, binder concentration and croscarmellose sodium (disintegrant) concentration were studied on DT and DR. Results: The three factors were found to significantly affect the DR and the inverse square root of DT and significant interactions were elucidated. Conclusion: Although satisfactory results were obtained regarding DR, modifications using different excipients and or preparation methods should be considered to comply with pharmacopoeia requirement for DT.

Acute Treatment Therapies for Pediatric Migraine: A Qualitative Systematic Review.

We sought to conduct a qualitative systematic review to evaluate the safety and efficacy of available treatments for pediatric patients with migraine or benign primary headache in the emergency department, in an effort to inform future practice. Scopus, Medline, and PubMed databases were searched for randomized controlled trials retrospective reviews, review articles, and case studies discussing migraine or benign primary headache management that were conducted in the emergency room or outpatient acute care setting in pediatric patients (less than 18-years old). Meeting abstracts and cited references within articles were also evaluated. Multiple variables were recorded, including type of treatment, study design, dosing, primary outcome, and side effects. Therapeutic gain was calculated in studies with a placebo arm. Treatments were subjectively assessed based on methodology and number of trials for a particular therapy. Thirty-one studies were included in the final analysis. Of these, 17 were randomized controlled trials, 9 were retrospective reviews, and 5 were prospective chart review studies. One pertained to IV fluids, 2 to nonspecific analgesic use, 5 to dopamine receptor antagonists, 2 to valproic acid, 1 to propofol, 1 to magnesium, 1 to bupivicaine, 13 to triptan medications, and 3 to dihydroergotamine (DHE). Treatments considered effective for acute migraine or benign primary headache in the analgesic category include ibuprofen, and to a lesser degree acetaminophen. Ketorolac was not compared to other NSAIDs, but was found to be less effective than prochlorperazine. Of the phenothiazines, prochlorperazine was considered most effective. Of the triptan medications, almotriptan, rizatriptan, zolmitriptan nasal spray, sumatriptan nasal spray, and combination sumatriptan/naproxen are effective agents for acute treatment. Treatments considered probably effective included IV fluids, chlorpromazine, valproate sodium, injectable sumatriptan, and IV DHE. Treatments with oral zolmitriptan showed inconsistent results, while treatments considered ineffective included isolated oral sumatriptan and oral DHE. There is insufficient evidence to comment on propofol, magnesium, and bupivicaine efficacy. Of the available evidence, ibuprofen, prochlorperazine, and certain triptan medications are the most effective and safe agents for acute management of migraine and other benign headache disorders in the pediatric population. Additional studies in this population are needed, and should take into consideration variables such as dosing, co-administered medications, treatment duration, and length of treatment effect.

The effect of zolmitriptan on cardiac autonomic modulation in patients with migraine: A double-blind, placebo-controlled, crossover study.

Triptans, which activate 5-hydroxytryptamine (5-HT)-1B/1D receptors in cerebral arteries, are very effective in aborting attacks of migraine. Although activation of 5-HT-1B/1D receptors diminishes the secretion of noradrenaline from cardiac sympathetic nerves, some studies report that they may cause chest discomfort, myocardial infarction and arrhythmias due to coronary vasospasm. The effect of zolmitriptan on cardiac autonomic modulation has not been evaluated in migraineurs. Ten patients with migraine (nine women, mean age 33 ± 4 years) were crossover randomized to 2.5 mg zolmitriptan or identical placebo at least 5 days apart. Both time domain parameters (the mean R-R interval, the standard deviation of RR interval [SDNN], and the root mean square of successive R-R interval differences) and frequency domain parameters (low frequency [LF], high frequency [HF], and LF/HF ratio) of heart rate variability (HRV) were obtained during supine position, controlled respiration and handgrip exercise before and 2 h after zolmitriptan or placebo administration. Baseline HRV parameters were similar for each occasion. Single dose zolmitriptan administration did not affect both time and frequency domain HRV parameters compared with the placebo. A single dose, 2.5 mg oral zolmitriptan administration did not change sympathetic and parasympathetic reactivity and sympathovagal balance in migraineurs.

What efficacy measures are clinically relevant and should be used in Cochrane Reviews of acute migraine trials? A viewpoint.

Cochrane Reviews are methodologically of high quality but the clinical relevance of analysed efficacy measures (EMs) should also be assessed. The clinical relevance of EMs used in one systematic Cochrane review of oral zolmitriptan for migraine headache was evaluated. The following EMs were used: pain free at two hours (30%), headache relief at two hours (60%), sustained pain free for 24 hours (19%) and sustained headache relief for 24 hours (39%). These EMs were also used in four other Cochrane reviews of acute migraine treatment. Of these EMs sustained headache relief for 24 h is not judged clinically relevant. Pain free and sustained pain free are clinically relevant, but the responses are rather low, demonstrating that there is a need for improvement of acute drug treatment in migraine.

Zolmitriptan for acute migraine attacks in adults.

Migraine is a common, disabling condition and a burden for the individual, health services, and society. Zolmitriptan is an abortive medication for migraine attacks, belonging to the triptan family. These medicines work in a different way to analgesics such as paracetamol and ibuprofen. To determine the efficacy and tolerability of zolmitriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and the Oxford Pain Relief Database, together with three online databases (www.astrazenecaclinicaltrials.com, www.clinicaltrials.gov, and apps.who.int/trialsearch) for studies to 12 March 2014. We also searched the reference lists of included studies and relevant reviews. We included randomised, double-blind, placebo- or active-controlled studies, with at least 10 participants per treatment arm, using zolmitriptan to treat a migraine headache episode. Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate risk ratios and numbers needed to treat for an additional beneficial effect (NNT) or harmful effect (NNH) compared with placebo or a different active treatment. Twenty-five studies (20,162 participants) compared zolmitriptan with placebo or an active comparator. The evidence from placebo-controlled studies was of high quality for all outcomes except 24 hour outcomes and serious adverse events where only limited data were available. The majority of included studies were at a low risk of performance, detection and attrition biases, but did not adequately describe methods of randomisation and concealment.Most of the data were for the 2.5 mg and 5 mg doses compared with placebo, for treatment of moderate to severe pain. For all efficacy outcomes, zolmitriptan surpassed placebo. For oral zolmitriptan 2.5 mg versus placebo, the NNTs were 5.0, 3.2, 7.7, and 4.1 for pain-free at two hours, headache relief at two hours, sustained pain-free during the 24 hours postdose, and sustained headache relief during the 24 hours postdose, respectively. Results for the oral 5 mg dose were similar to the 2.5 mg dose, while zolmitriptan 10 mg was significantly more effective than 5 mg for pain-free and headache relief at two hours. For headache relief at one and two hours and sustained headache relief during the 24 hours postdose, but not pain-free at two hours, zolmitriptan 5 mg nasal spray was significantly more effective than the 5 mg oral tablet.For the most part, adverse events were transient and mild and were more common with zolmitriptan than placebo, with a clear dose response relationship (1 mg to 10 mg).High quality evidence from two studies showed that oral zolmitriptan 2.5 mg and 5 mg provided headache relief at two hours to the same proportion of people as oral sumatriptan 50 mg (66%, 67%, and 68% respectively), although not necessarily the same individuals. There was no significant difference in numbers experiencing adverse events. Single studies reported on other active treatment comparisons but are not described further because of the small amount of data. Zolmitriptan is effective as an abortive treatment for migraine attacks for some people, but is associated with increased adverse events compared to placebo. Zolmitriptan 2.5 mg and 5 mg benefited the same proportion of people as sumatriptan 50 mg, although not necessarily the same individuals, for headache relief at two hours.

Triptans for acute cluster headache.

This is an updated version of the original Cochrane review published in Issue 4, 2010 (Law 2010). Cluster headache is an uncommon,severely painful, and disabling condition, with rapid onset. Validated treatment options are limited; first-line therapy includes inhaled oxygen. Other therapies such as intranasal lignocaine and ergotamine are not as commonly used and are less well studied. Triptans are successfully used to treat migraine attacks and they may also be useful for cluster headache. To assess the efficacy and tolerability of the triptan class of drugs compared to placebo and other active interventions in the acute treatment of episodic and chronic cluster headache in adult patients. We searched the Cochrane Central Register of Controlled Trials (CENTRAL),MEDLINE, EMBASE, ClinicalTrials.gov, and reference lists for studies from inception to 22 January 2010 for the original review, and from 2009 to 4 April 2013 for this update. Randomised, double-blind, placebo-controlled studies of triptans for acute treatment of cluster headache episodes. Two review authors independently assessed study quality and extracted data. Numbers of participants with different levels of pain relief,requiring rescue medication, and experiencing adverse events and headache-associated symptoms in treatment and control groups were used to calculate relative risk and numbers needed to treat for benefit (NNT) and harm (NNH). New searches in 2013 did not identify any relevant new studies.All six included studies used a single dose of triptan to treat an attack of moderate to severe pain intensity. Subcutaneous sumatriptan was given to 131 participants at a 6 mg dose, and 88 at a 12 mg dose. Oral or intranasal zolmitriptan was given to 231 participants ata 5 mg dose, and 223 at a 10 mg dose. Placebo was given to 326 participants.Triptans were more effective than placebo for headache relief and pain-free responses. By 15 minutes after treatment with subcutaneous sumatriptan 6 mg, 48% of participants were pain-free and 75% had no pain or mild pain (17% and 32% respectively with placebo).NNTs for subcutaneous sumatriptan 6 mg were 3.3 (95% CI 2.4 to 5.0) and 2.4 (1.9 to 3.2) respectively. Intranasal zolmitriptan 10mg was of less benefit, with 12% of participants pain-free and 28% with no or mild pain (3% and 7% respectively with placebo).NNTs for intranasal zolmitriptan 10 mg were 11 (6.4 to 49) and 4.9 (3.3 to 9.2) respectively. Based on limited data, subcutaneous sumatriptan 6 mg was superior to intranasal zolmitriptan 5 mg or 10 mg for rapid (15 minute)responses, which are important in this condition. Oral routes of administration are not appropriate.

Zolmitriptan-induced acute myocardial infarction

Triptans are an established treatment for acute migraine attacks. By activating 5HT1B/1D receptors they lead to vasoconstriction of the cerebral blood vessels which are dilated during migraine attacks. Moreover, they reduce secretion of vasoactive peptides and conduction of pain stimuli over the cerebral cortex. In up to 7% of cases of treatment with triptans, thoracic pain occurs, although this is mostly transient, mild and without lasting ischemia. We present the case of a 45 year-old woman with a history of migraine with visual aura since the age of 20. She had no history of diabetes mellitus, hypertension, smoking or any other risk factors for cardiovascular events before she was admitted to our emergency room with typical chest pain. An electrocardiogram revealed anterior myocardial infarction following her monthly dose of oral zolmitriptan. Catherization revealed a normal coronary arterial system. The laboratory indices for cardiac risk were within normal ranges. The patient was advised to avoid triptans permanently on being discharged.

Zolmitriptan Induced Acute Coronary Syndrome: A Unique Case

Triptans have been used for the acute treatment of migraine headaches for many years. Although their use can lead to coronary vasospasm, there are very few reports of triptans actually leading to myocardial infarction in patients with normal coronaries. We hereby present a 58-year-old man who presented to the emergency room with chest pain. Electrocardiogram demonstrated ST segment depression in the inferior leads with diffuse spasm of the distal right coronary artery seen on angiography, which was easily reversed by intracoronary nitroglycerine. We believe this is the first reported case of a patient with a myocardial infarction after taking oral zolmitriptan in which coronary angiogram clearly demonstrated coronary vasospasm reversal after intracoronary nitroglycerine. A detailed search of the literature for reported cases of myocardial infarction after triptan use is also provided.

Acute and preventive pharmacologic treatment of cluster headache

Cluster headache (CH) is a rare and disabling primary headache disorder. CH attacks are unilateral, short, severe headaches associated with ipsilateral autonomic symptoms that occur in a periodic fashion. We provide a systematic review and meta-analysis of existing trials of pharmacotherapy for CH and evidence-based suggestions for acute abortive treatment and preventive therapy for cluster headache. Prospective, double-blind, randomized controlled trials of any pharmacologic agent for the symptomatic relief or prevention of CH were included in this evidence-based review. The main outcomes considered were headache response and pain-free response at 15 and 30 minutes for acute treatment trials, and the cessation of CH attacks within a specific time period or the number of days on which CH attacks occurred for preventive trials. Twenty-seven trials were included in the analysis. The American Academy of Neurology quality criteria were used to assess trial quality and to grade advisements. Based on the evidence, for acute treatment of CH, Level A advice can be given for subcutaneous sumatriptan 6 mg, zolmitriptan nasal spray 5 mg and 10 mg, and 100% oxygen 6-12 L/min. Level B advice can be given for sumatriptan nasal spray 20 mg and oral zolmitriptan 5 mg and 10 mg. For the prevention of CH, Level B advice can be given for intranasal civamide 100 microg daily and suboccipital steroid injections, and Level C advice can be given for verapamil 360 mg, lithium 900 mg, and melatonin 10 mg.

Acute and preventive pharmacologic treatment of cluster headache

Cluster headache (CH) is a rare and disabling primary headache disorder. CH attacks are unilateral, short, severe headaches associated with ipsilateral autonomic symptoms that occur in a periodic fashion. We provide a systematic review and meta-analysis of existing trials of pharmacotherapy for CH and evidence-based suggestions for acute abortive treatment and preventive therapy for cluster headache. Prospective, double-blind, randomized controlled trials of any pharmacologic agent for the symptomatic relief or prevention of CH were included in this evidence-based review. The main outcomes considered were headache response and pain-free response at 15 and 30 minutes for acute treatment trials, and the cessation of CH attacks within a specific time period or the number of days on which CH attacks occurred for preventive trials. Twenty-seven trials were included in the analysis. The American Academy of Neurology quality criteria were used to assess trial quality and to grade advisements. Based on the evidence, for acute treatment of CH, Level A advice can be given for subcutaneous sumatriptan 6 mg, zolmitriptan nasal spray 5 mg and 10 mg, and 100% oxygen 6-12 L/min. Level B advice can be given for sumatriptan nasal spray 20 mg and oral zolmitriptan 5 mg and 10 mg. For the prevention of CH, Level B advice can be given for intranasal civamide 100 microg daily and suboccipital steroid injections, and Level C advice can be given for verapamil 360 mg, lithium 900 mg, and melatonin 10 mg.

Treatment of Children With Migraine in the Emergency Department

To evaluate which treatment could be effective in the emergency department (ED) for children with migraine and status migrainosus, we carried out a qualitative systematic review of randomized controlled trials (RCTs) that evaluated treatment that could be used for those conditions. Databases (Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Controlled Trials Register, MedLine, and EMBASE) were searched for RCTs that evaluated treatment of migraine in children (<18 years of age). Guidelines published on the subject were checked for missed references. Characteristics of the identified studies as well as primary outcome (headache relief), other recognized primary outcomes, and adverse events were abstracted. Quality of the RCTs was evaluated using the Jadad score. Of the 14 trials included in the review, only 1 was performed in an ED after other treatments have failed. In that situation, prochlorperazine was more effective than ketorolac in relieving pain at 1 hour. Other treatments were evaluated by neurologists on their outpatients who started the studied drugs early at the beginning of the migraine without previous treatment. In that situation, ibuprofen (n = 3) and acetaminophen (n = 1) were better than placebo for pain relief. The efficacy of intranasal sumatriptan (n = 4), oral rizatriptan (n = 3), and oral zolmitriptan (n = 2) for pain relief was unclear. Oral sumatriptan (n = 1) and oral dihydroergotamine (n = 1) were not effective. There is a lack of studies addressing the question of treatment in the ED for children experiencing migraine. Although other treatments were found effective in children with migraine, none was evaluated in the ED except prochlorperazine and ketorolac.

Oral Zolmitriptan in the Short-Term Prevention of Menstrual Migraine

To evaluate the efficacy and tolerability of oral zolmitriptan as a short-term preventative therapy for menstrual migraine. This was a randomized, double-blind, parallel group, placebo-controlled, multicentre, two-phase study. The results of the second phase are reported here (the first phase evaluated zolmitriptan in the acute treatment of menstrual migraine and is reported elsewhere). Women who successfully completed phase I (with either a positive or negative outcome, and who still fulfilled the inclusion criteria) were randomized to zolmitriptan 2.5 mg oral tablet three times daily, zolmitriptan 2.5 mg twice daily or placebo three times daily. Patients were treated for three consecutive menstrual cycles, starting 2 days prior to the expected onset of menses, for 7 days in total. Two hundred and fifty-three patients completed phase I and were eligible for phase II. The intention-to-treat population comprised 244 patients (zolmitriptan three times daily [n = 83]; zolmitriptan twice daily [n = 80]; placebo [n = 81]). Both zolmitriptan regimens demonstrated superior efficacy versus placebo, as measured by the proportion of patients with a >or=50% reduction in the frequency of menstrual migraine attacks (zolmitriptan three times daily [58.6%], p = 0.0007 vs placebo; zolmitriptan twice daily [54.7%], p = 0.002 vs placebo; placebo three times daily [37.8%]). The mean frequency of breakthrough migraine attacks per menstrual cycle was reduced accordingly. Fewer breakthrough attacks were treated with escape medication in the zolmitriptan three times daily (61.6% of attacks; p = 0.0004 vs placebo) and twice daily (60.7%; p = 0.0055 vs placebo) treatment groups than in the placebo group (74.4%). Short-term preventative therapy with zolmitriptan was well tolerated. Zolmitriptan 2.5 mg oral tablet is effective and well tolerated as a short-term preventative therapy for menstrual migraine attacks.

TREATMENT OF CHILDHOOD MIGRAINE ATTACKS WITH ORAL ZOLMITRIPTAN AND IBUPROFEN

In their article, Evers et al. state, “Oral zolmitriptan 2.5 mg offered significant pain relief and pain freedom vs placebo. This study shows that an oral triptan can be efficacious in …

Efficacy and Tolerability of Oral Zolmitriptan in Menstrually Associated Migraine: A Randomized, Prospective, Parallel-Group, Double-blind, Placebo-Controlled Study

Efficacy and Tolerability of Oral Zolmitriptan in Menstrually Associated Migraine: A Randomized, Prospective, Parallel-Group, Double-blind, Placebo-Controlled Study

Treatment of childhood migraine attacks with oral zolmitriptan and ibuprofen

The authors conducted a double-blind, placebo-controlled, crossover study to investigate the efficacy of oral zolmitriptan in the treatment of migraine in children and adolescents. Patients (n = 32) received placebo, zolmitriptan 2.5 mg, and ibuprofen 200 to 400 mg to treat three consecutive migraine attacks. Pain relief rates after 2 hours were 28% for placebo, 62% for zolmitriptan, and 69% for ibuprofen (p < 0.05). Both drugs are well tolerated with only mild side effects.

Efficacy and Tolerability of Zolmitriptan Oral Tablet in the Acute Treatment of Menstrual Migraine

To determine the efficacy and tolerability of zolmitriptan 2.5 mg oral tablet as an acute treatment for menstrual migraine attacks. This was a two-phase, multicentre, randomised, double-blind, placebo-controlled, parallel-group outpatient study (Phase I is reported here). The study was conducted at 27 sites in the USA. Eligible women were randomised (1 : 1) to receive either zolmitriptan 2.5 mg oral tablet or placebo, and instructed to acutely treat up to two menstrual migraine attacks per menstrual period for up to three menstrual cycles with a single dose of study medication. Menstrual migraine was operationally defined as an attack occurring within the time period of 2 days prior to the expected onset of menses to 5 days after the onset of menses. Participants were asked to treat migraine headaches of moderate or severe intensity only that occurred >24 hours after the end of the last migraine attack and that had not been acutely treated with other medications. Information regarding each migraine attack was recorded by patients in treatment diary cards. The primary efficacy variable was 2-hour headache response (defined as a 2-point drop on a 4-point scale) for all attacks treated. Secondary variables included 1- and 4-hour headache response rate; 1-, 2- and 4-hour headache response based on a 100 mm visual analogue scale (VAS); pain-free rate at 1, 2 and 4 hours; use of escape medication; the proportion of patients with recurrence within 24 hours of initial treatment; and tolerability. The intention-to-treat population comprised 334 patients (zolmitriptan [n = 174]; placebo [n = 160]). Patients treated 625 attacks with zolmitriptan and 529 attacks with placebo. Twice as many patients who took zolmitriptan achieved a 2-hour headache response compared with placebo recipients (65.7% vs 32.8%; p < 0.0001). Furthermore, a significantly higher headache response was observed with zolmitriptan than placebo at all timepoints assessed. Significantly more zolmitriptan recipients were pain-free 2 hours post-dose compared with placebo recipients (p < 0.0001). The use of escape medication was considerably lower in zolmitriptan recipients (42.6% vs 71.3%; p < 0.0001). Based on the reduction in VAS score of > or = 30 mm from baseline, significantly more zolmitriptan recipients achieved headache response compared with placebo recipients at 1, 2 and 4 hours post-dose (all p < 0.0001). Recurrence was reported in 29.1% of zolmitriptan-treated attacks versus 45.1% of placebo-treated attacks (p = 0.0009), with median time to recurrence of 8.5 and 4.0 hours, respectively. Zolmitriptan was well tolerated. Oral zolmitriptan is effective and well tolerated for the acute treatment of menstrual migraine attacks. The results are similar to those seen with zolmitriptan in studies of the general migraine population.

Myalgia and Cramps Associated With Zolmitriptan

To report a patient with myalgia and cramps possibly induced by the antimigrainous agent zolmitriptan. A 27-year-old woman with episodes of common migraine developed cramps and generalized myalgia after the use of intranasal zolmitriptan 5 mg to treat 3 episodes of migraine. This side effect had not occurred with oral zolmitriptan 2.5 mg. Myalgia and cramps should be considered a possible dose-dependent adverse effect of zolmitriptan.