Symptomatic pharmacotherapy of migraine.

This review summarizes data on the effectiveness of various symptomatic migraine pharmacotherapies and makes recommendations for treatment. A wide variety of agents are available for the symptomatic treatment of migraine headache, including over-the-counter analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), combination products, opiates, ergot alkaloids, corticosteroids, dopamine antagonists, and triptans. In the stepped-care approach, simple analgesics and NSAIDs are the recommended first step for the treatment of mild-to-moderate migraine headaches. Patients who do not respond to first-step treatments may be given ergots, combination products, dopamine antagonists, or triptans as the second step. Corticosteroids or opiates may be used as rescue treatment in patients who do not respond to second-step treatment. A stratified approach to care individualizes treatment based on the severity of the headache and other patient-specific factors. In a stratified approach, dihydroergotamine or triptans may be the first-step treatment for patients who present with a history of severe migraines that have responded poorly to previous treatments. Sumatriptan was the first triptan approved for the symptomatic treatment of migraine headache; newer triptans include zolmitriptan, naratriptan, and rizatriptan. Since sumatriptan is rapidly absorbed by the subcutaneous route, its time to onset of effect is shortest. Among triptan drugs that are administered orally, the relative time to onset may be shorter with rizatriptan than sumatriptan. Naratriptan has a longer time to onset but is associated with a lower rate of migraine recurrence than other triptans. graine headache, ergot alkaloids, triptans,     

Meta-analysis of the efficacy and safety of zolmitriptan in the acute treatment of migraine

OBJECTIVE: To assess the relative efficacy and safety of zolmitriptan in the treatment of acute migraine attacks. BACKGROUND: Zolmitriptan is a second-generation triptan developed for the treatment of migraine. Numerous randomized controlled trials (RCTs) have been carried out to compare different dosages and formulations of zolmitriptan against other treatments for acute migraine. METHODS: Random effects meta-analysis of 24 RCTs, including 15,408 patients suffering from acute migraine attacks. Subgroup analyses compared differences in response between different dosages and formulations of zolmitriptan, and other triptan comparators. RESULTS: Zolmitriptan 2.5 mg tablet was found to be as effective as almotriptan 12.5 mg, eletriptan 40 mg, sumatriptan 50 mg and 100 mg and more effective than naratriptan 2.5 mg in terms of 2-hour pain-free rates. Likewise, zolmitriptan 5 mg tablet was as effective as sumatriptan 50 mg and 100 mg in 2-hour pain-free rates. Compared against zolmitriptan 2.5 mg tablet, eletriptan 80 mg was more effective in achieving headache relief, pain-free and sustained pain-free responses, and rizatriptan 10 mg was more effective in terms of sustained pain-free rates. Zolmitriptan 2.5 mg tablet was associated with a lower risk of adverse events than eletriptan 80 mg but higher risk than naratriptan 2.5 mg and rizatriptan 10 mg. Zolmitriptan 5 mg tablet was superior to zolmitriptan 2.5 mg tablet in achieving 1- and 2-hour pain-free response. There were no significant differences in 1- and 2-hour headache relief and adverse event rates between the different formulations of zolmitriptan 2.5 mg. CONCLUSIONS: Zolmitriptan 2.5 mg tablet is an effective treatment for acute attacks of migraine showing similar efficacy to almotriptan 12.5 mg, eletriptan 40 mg, and sumatriptan 50 mg, and being more effective than naratriptan 2.5 mg in terms of pain-free response at 2 hours post dose. Zolmitriptan 2.5 mg tablet was also as effective as rizatriptan 10 mg in terms of headache relief and pain-free response but less effective in terms of sustained pain-free response.     

Patterns of use of triptans and reasons for switching them in a tertiary care migraine population

OBJECTIVE: To assess the reasons for switching triptans within migraine patients presenting to a specialty clinic. DESIGN AND METHODS: We reviewed data of migraineurs who (1) were currently using a triptan as acute treatment medication for migraine, and (2) had previously used at least one other triptan, or a different triptan formulation. All subjects were followed for at least 1 year. For every triptan/formulation used, the reasons for discontinuation were obtained. RESULTS: Our sample consisted of 386 patients, 339 of whom (87.8%) were females. Sumatriptan was first used by 349 (90.4%); zolmitriptan, by 238 (61.5%); rizatriptan, by 195 (50.5%); naratriptan, by 137 (35.4%); and almotriptan, by 31 (8.0%). Almotriptan was excluded from this analysis because of our small sample. We found significant differences among those who wanted to try another triptan to see if it would be better in those who first used sumatriptan 25 mg, compared to those first using sumatriptan 50 mg (P = .01), sumatriptan 100 mg (P < .001), sumatriptan nasal spray (NS) (P < .001), sumatriptan subcutaneous (SC) (P < .001), zolmitriptan 5 mg (P < .001), rizatriptan 10 mg (P < .001), and naratriptan (P = .001). Patients using rizatriptan, sumatriptan NS, and sumatriptan SC had significantly lower rates of reporting this answer. Subjects first using naratriptan were less likely to report recurrence than those using sumatriptan 25 mg (P = .004), sumatriptan 50 mg (P = .0005), sumatriptan 100 mg (P = .003), zolmitriptan (P = .02), and rizatriptan (P = .006). Incomplete relief was more frequently reported by those first using sumatriptan 25 mg and naratriptan. Inconsistency was a reason for switching in those initially using sumatriptan NS, sumatriptan 25 mg, and naratriptan and less frequently reported in those using zolmitriptan and sumatriptan SC. Side effects were major factors for those first using sumatriptan 100 mg, NS, and SC, and less for those using naratriptan and sumatriptan 25 mg. From those subjects that initially used sumatriptan SC and were switched to a different triptan or formulation, 19.5% returned to sumatriptan SC; for the other triptans/formulations, the percentages were: sumatriptan 25 mg, 7.8%; sumatriptan 50 mg or 100 mg, 42.3%; sumatriptan NS, 17.7%; zolmitriptan, 17.6%; rizatriptan, 16.5%; naratriptan, 9.4%. For those who used more than three triptans/formulations, the last triptan used was: sumatriptan, 29.5%; zolmitriptan, 31.8%; rizatriptan, 25.0%; naratriptan, 12.5%. CONCLUSIONS: A variety of treatment attributes are important in determining the reasons involved in switching a triptan. To assess this attributes can provide additional information to supplement the traditional tests of efficacy provided by randomized clinical trials.     

Acute Migraine Treatment in Adults

There are many options for acute migraine attack treatment, but none is ideal for all patients. This study aims to review current medical office‐based acute migraine therapy in adults and provides readers with an organized approach to this important facet of migraine treatment. A general literature review includes a review of several recent published guidelines. Acetaminophen, 4 nonsteroidal anti‐inflammatory drugs (NSAIDs) (ibuprofen, acetylsalicylic acid [ASA], naproxen sodium, and diclofenac potassium), and 7 triptans (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan) have good evidence for efficacy and form the core of acute migraine treatment. NSAID–triptan combinations, dihydroergotamine, non‐opioid combination analgesics (acetaminophen, ASA, and caffeine), and several anti‐emetics (metoclopramide, domperidone, and prochlorperazine) are additional evidence‐based options. Opioid containing combination analgesics may be helpful in specific patients, but should not be used routinely. Clinical features to be considered when choosing an acute migraine medication include usual headache intensity, usual rapidity of pain intensity increase, nausea, vomiting, degree of disability, patient response to previously used medications, history of headache recurrence with previous attacks, and the presence of contraindications to specific acute medications. Available acute medications can be organized into 4 treatment strategies, including a strategy for attacks of mild to moderate severity (strategy one: acetaminophen and/or NSAIDs), a triptan strategy for patients with severe attacks and for attacks not responding to strategy one, a refractory attack strategy, and a strategy for patients with contraindications to vasoconstricting drugs. Acute treatment of migraine attacks during pregnancy, lactation, and for patients with chronic migraine is also discussed. In chronic migraine, it is particularly important that medication overuse is eliminated or avoided. Migraine treatment is complex, and treatment must be individualized and tailored to the patient's clinical features. Clinicians should make full use of available medications and formulations in an organized approach.     

A comparison of preference for and efficacy of tablet formulations of sumatriptan (50 mg and 100 mg), naratriptan (2.5 mg), rizatriptan (10 mg), and zolmitriptan (2.5 mg) in the acute treatment of migraine

Abstract This randomized, multicenter, open-label, five-way crossover study was conducted to assess patients preference for tablet formulations of sumatriptan (50 mg and 100 mg), naratriptan (2.5 mg), rizatriptan (10 mg), and zolmitriptan (2.5 mg) in the acute treatment of migraine and to identify determinants of preference. Patients treated one mild, moderate, or severe migraine with each triptan. The results show that sumatriptan 100 mg was significantly preferred over the random preference rate of 20% (p<0.001) whereas sumatriptan 50 mg, naratriptan, rizatriptan, and zolmitriptan were not. Patients primary reason for preferring a medication was best relief of migraine pain, and the treatment that patients preferred corresponded to the medication that was most likely to confer for them a pain-free response 2 hours postdose. Across all patients, efficacy 2 hours postdose was comparable among triptans with the exception of naratriptan, which was slightly less effective than the other medications (pain-free response 2 hours postdose: 40% sumatriptan 100 mg, 37% sumatriptan 50 mg, 28% naratriptan 2.5 mg, 38% rizatriptan 10 mg, 36% zolmitriptan 2.5 mg). The medications were also similarly well-tolerated. These data demonstrate that information on patients medication preference supplements and does not duplicate data from traditional efficacy measures. Patient preference data are useful in tailoring migraine therapy to the needs of the individual patient.     

Pharmacological treatment of attacks in juvenile migraine

Although migraine is a common complaint in childhood and adolescence, there is a lack of controlled clinical studies regarding treatment. In the young patient, the pharmacological approach should be preceded by setting up non-pharmacological measures which include behavioural intervention. The sole use of symptomatic therapies should be limited to patients who complain of up to four partially or totally disabling attacks, or those who suffer from headache for more than 4 days per month. The therapeutic armamentarium includes non-specific symptomatic drugs, such as analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), as well as anti-emetics and specific drugs, such as the triptans. Analgesics and NSAIDs are the most frequently used drugs in childhood and adolescence for the symptomatic treatment of migraine attacks of slight or moderate intensity. The first-choice drug for those under 12 years of age is acetaminophen. Among NSAIDs, two double-blind, randomized, placebo-controlled studies were conducted for ibuprofen, supporting its efficacy. In the past, ergot derivatives played an important role in the treatment of spontaneous migraine attacks, particularly in adults, but after the triptan revolution their role was strongly confined to a small number of patients. Although they are considered first-choice drugs for moderate and severe migraine attacks in adults, triptans are still under study in migraine patients under 18 years of age. The Health Ministry rules do not approve their use in patients under 18 years. They can only be given legally if the therapeutic plan for their use is previously approved by the Ethics Committee and after informed consent from the patient/parents. Promising results have been obtained, particularly for sumatriptan in nasal spray formulation as well as for zolmitriptan and rizatriptan, showing a high tolerability and safety profile.     

Acute pharmacotherapy of migraine,tension-type headache,and cluster headache

Abstract 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.     

Comparison of naratriptan and sumatriptan in recurrence-prone migraine patients. Naratriptan International Recurrence Study Group

OBJECTIVE: This randomized, double-blind, crossover study was undertaken to compare the incidence of headache recurrence after treatment with naratriptan or sumatriptan in migraine patients with a history of frequent headache recurrence (recurrence in > or =50% of successfully treated attacks). BACKGROUND: Although the selective 5-hydroxytryptamine, (5-HT1) agonist sumatriptan is effective and well tolerated for acute treatment of migraine in most patients, headache recurrence within 24 hours of initial successful treatment with sumatriptan and other medications has been reported in approximately 35% of patients. The novel 5-HT1 agonist naratriptan possesses pharmacologic and pharmacokinetic characteristics that may address the issue of headache recurrence. METHODS: Men and women aged 18 to 65 years with a > or =1-year history of migraine with or without aura were randomly assigned to treat 1 moderate or severe migraine attack in a nonclinical setting with one 2.5-mg naratriptan tablet and 1 attack with one 100-mg sumatriptan tablet. A pain-free interval of > or =24 hours was required between attacks. At 4 hours, patients not using rescue medication and experiencing headache recurrence could take a second, identical dose of study medication to treat recurrence. No more than 2 tablets of study medication were permitted in any 24-hour period. RESULTS: A total of 253 patients treated > or =1 migrane attack and were included in the safety analysis; the 225 patients who treated both attacks were included in the efficacy analysis. Of the 164 naratriptan-treated and 181 sumatriptan-treated patients experiencing headache relief after > or =1 attack, headache recurrence 4 to 24 hours after treatment was reported by 74 naratriptan-treated patients (45%) and 101 sumatriptan-treated patients (57%; not statistically significant). (One naratriptan- and 3 sumatriptan-treated patients who experienced headache relief did not record recurrence status and were not included in the denominator for the percentage calculation.) In a subset of patients experiencing headache relief after 2 attacks, headache recurrence 4 to 24 hours after initial dosing was reported by 55 naratriptan- and 77 sumatriptan-treated patients (41% and 57%, respectively; P = 0.005). The overall incidence of adverse events was 22% after treatment with naratriptan and 33% after treatment with sumatriptan. This incidence did not increase after use of a second dose of naratriptan (20%) or sumatriptan (31%). CONCLUSION: These data suggest that naratriptan is a long-acting and well-tolerated addition to currently available medications for the treatment of acute migraine.     

Patients with migraine prefer zolmitriptan orally disintegrating tablet to sumatriptan conventional oral tablet

The Zolmitriptan Evaluation versus Sumatriptan Trial (ZEST) assessed patient preference for 2.5 mg zolmitriptan orally disintegrating tablet (ODT) or 50 mg sumatriptan conventional tablet in 218 patients with significant migraine disability. Significantly more patients preferred zolmitriptan ODT to sumatriptan conventional tablet (60.1% vs 39.9%; p = 0.0130). In terms of efficacy, significantly more patients considered zolmitriptan ODT to be an effective migraine treatment than sumatriptan conventional tablet (77% vs 63%; p = 0.0063). When asked about specific formulation attributes, significantly more patients selected zolmitriptan ODT as the least disruptive therapy (83.6% vs 16.4%), the easiest to take (85.5% vs 14.5%), the most convenient to take (86.1% vs 13.9%), and the one which enabled them to maintain an active lifestyle (65.5% vs 34.5%), compared with the sumatriptan conventional tablet (all comparisons p < 0.001). Zolmitriptan ODT is a convenient and beneficial alternative to conventional tablets and is preferred to sumatriptan conventional tablets by migraineurs.     

Optimal balance of efficacy and tolerability of oral triptans and telcagepant: a review and a clinical comment

Dose–response curves for headaches relief and adverse events (AEs) are presented for five triptans: sumatriptan, zolmitriptan, naratriptan, almotriptan, and frovatriptan, and the CGRP antagonist telcagepant. The upper part of the efficacy curve of the triptans is generally flat, the so-called ceiling effect; and none of the oral triptans, even in high doses, are as effective as subcutaneous sumatriptan, In contrast, AEs increases with increasing dose without a ceiling effect. The optimal dose for the triptans is mainly determined by tolerability. Telcagepant has an excellent tolerability and can be used in migraine patients with cardiovascular co-morbidity. Based on the literature the triptans and telcagepant are rated in a table for efficacy and tolerability.     

Comparative aspects of triptans in treating migraine

Triptans, beginning with sumatriptan, have revolutionized the treatment of migraine. New triptans in several formulations will soon become available in the United States. Although the similarities of these 5-hydroxytryptamine (5-HT) 1B/1D receptor agonists outweigh their differences, important differences in pharmacokinetics and clinical responses do exist. Subcutaneous sumatriptan has the most rapid onset of action and greatest efficacy but the most adverse effects. Intranasal sumatriptan also has rapid onset of action, but at 2 hours its efficacy is comparable to that of oral zolmitriptan. Of the oral triptans, rizatriptan seems to have the greatest early efficacy. Both rizatriptan and zolmitriptan are now available as rapidly dissolving wafers. Almotriptan, the newest of the triptans, has a response rate similar to that of oral sumatriptan and may produce fewer adverse effects. Naratriptan and frovatriptan, with their slow onset, high tolerability, and long half-lives, may have a role in aborting prolonged migraine attacks and in headache prevention. Eletriptan at higher doses (80 mg) has a response rate approaching that of rizatriptan but may be limited by potential side effects. The many triptans available offer the opportunity to individualize migraine treatment, depending on the patient's attack characteristics, tolerance, and preferences.     

Comparative aspects of triptans in treating migraine

Triptans, beginning with sumatriptan, have revolutionized the treatment of migraine. New triptans in several formulations will soon become available in the United States. Although the similarities of these 5-hydroxytryptamine (5-HT)_IB/ID receptor agonists outweigh their differences, important differences in pharmacokinetics and clinical responses do exist.Subcutaneous sumatriptan has the most rapid onset of action and greatest efficacy but the most adverse effects. Intranasal sumatriptan also has rapid onset of action, but at 2 hours its efficacy is comparable to that of oral zolmitriptan. Of the oral triptans, rizatriptan seems to have the greatest early efficacy. Both rizatriptan and zolmitriptan are now available as rapidly dissolving wafers. Almotriptan, the newest of the triptans, has a response rate similar to that of oral sumatriptan and may produce fewer adverse effects. Naratriptan and frovatriptan, with their slow onset, high tolerability, and long half-lives, may have a role in aborting prolonged migraine attacks and in headache prevention. Eletriptan at higher doses (80 mg) has a response rate approaching that of rizatriptan but may be limited by potential side effects.The many triptans available offer the opportunity to individualize migraine treatment, depending on the patient's attack characteristics, tolerance, and preferences.     

Naratriptan: an alternative for migraine.

OBJECTIVE: To critically evaluate the literature regarding naratriptan's clinical pharmacology, efficacy, safety, and indications. DATA SOURCE: A MEDLINE search was conducted for the period from January 1990 to June 1998. Key words used included naratriptan, triptan, serotonin agonists, migraine, and migraine therapy. In addition, pertinent references cited in articles obtained from MEDLINE and product information for triptans were reviewed. STUDY SELECTION AND DATA EXTRACTION: All original and review articles and abstracts pertaining to naratriptan were reviewed, as were product information extracts. Clinical trials of naratriptan were critically reviewed and compared with pertinent clinical trials of other oral triptans. DATA SYNTHESIS: The treatment of migraine has been dramatically improved with the use of sumatriptan, other triptans, and serotonin-receptor subtype 1B and 1D agonists. Drawbacks to these medications, however, have included poorly tolerated adverse effects and the recurrence of the migraine. Naratriptan has been recently approved for acute oral migraine therapy. In two Phase III trials of naratriptan compared with placebo, relief at four hours was obtained in 60% and 68% of patients using the 2.5-mg dose, with recurrence of headache in 24 hours in 27% and 28% of patients. The data on migraine recurrence were similar to those of other oral triptans; the efficacy of naratriptan at two hours was not specifically analyzed. Adverse effects of naratriptan were similar to placebo, and its tolerability seemed superior compared with studies of other oral triptans. CONCLUSIONS: Naratriptan is a promising new oral therapy for acute migraine; it may successfully treat patients who poorly tolerate other triptan therapies or have longer duration migraine headaches.     

PATIENT SATISFACTION WITH RIZATRIPTAN VERSUS OTHER TRIPTANS: DIRECT HEAD-TO-HEAD COMPARISONS

This study summarises the impact of treatment with rizatriptan 10 mg versus other 5-HT_1B/1D receptor agonists (triptans) on patient satisfaction with medication. Rizatriptan is a potent, selective 5-HT_1B/1D receptor agonist shown to be fast, effective and well tolerated in the acute treatment of migraine. We investigated patients' overall satisfaction with treatment in studies in which direct comparisons with other triptans were made. Data from five double-blind, placebo-controlled trials in which rizatriptan 10 mg was compared with another triptan were included in the analysis. Rizatriptan 10 mg was compared with sumatriptan 100 mg in one parallel study (n=916), sumatriptan 50 mg in two crossover studies (n=1599), naratriptan 2.5 mg in one parallel study (n=502), and zolmitriptan 2.5 mg in one parallel study (n=701). Satisfaction was reported by patients on a seven-point scale ranging from ‘completely satisfied, couldn't be better’ to ‘completely dissatisfied, couldn't be worse’ at 2 hours after dosing. The percent of patients in the top two ‘satisfied’ categories (completely or very satisfied) were analysed. More patients on rizatriptan 10 mg were completely or very satisfied compared with sumatriptan 100 mg (33% vs 26%, p<0.05), sumatriptan 50 mg (40% vs 35%, p<0.05), naratriptan 2.5 mg (33% vs 19%, p<0.01), and zolmitriptan 2.5 mg (38% vs 30%, p<0.05). In all five studies more patients treated with rizatriptan 10 mg or other triptans were completely or very satisfied with treatment than patients receiving placebo (p<0.001, except naratriptan vs placebo p=0.004). The results, combined with the superior efficacy profile (fast, effective, well tolerated) of rizatriptan 10 mg, should enhance the treatment of migraine headache and lead to improved therapeutic intervention in clinical practice.     

Triptans and CNS side-effects: pharmacokinetic and metabolic mechanisms

Triptans are the treatment of choice for acute migraine. While seemingly a homogenous group of drugs, results from a meta-analysis reveal significant differences in efficacy and tolerability among oral triptans. The incidence of drug-related central nervous system (CNS) side-effects with some triptans is as high as 15% and may be associated with functional impairment and reduced productivity. The occurrence of adverse events associated with triptans in general, and CNS side-effects in particular, may lead to a delay in initiating or even avoidance of an otherwise effective treatment. Potential explanations for differences among triptans in the incidence of CNS side-effects may relate to pharmacological and pharmacokinetic differences, including receptor binding, lipophilicity, and the presence of active metabolites. Of the triptans reviewed, at clinically relevant doses, almotriptan 12.5 mg, naratriptan 2.5 mg and sumatriptan 50 mg had the lowest incidence of CNS side-effects, while eletriptan 40 and 80 mg, rizatriptan 10 mg and zolmitriptan 2.5 and 5 mg had the highest incidence. The most likely explanations for the differences in CNS side-effects among triptans are the presence of active metabolites and high lipophilicity of the parent compound and active metabolites. Eletriptan, rizatriptan and zolmitriptan have active metabolites, while lipophilicity is lowest for almotriptan and sumatriptan. If CNS side-effects are a clinically relevant concern in the individual patient, use of a triptan with a low incidence of CNS side-effects may offer the potential for earlier initiation of treatment and more effective outcomes.     

Naratriptan in the prophylaxis of transformed migraine

We report three patients with transformed migraine, previously refractory to a wide variety of traditional preventive pharmacologic and nonpharmacologic interventions. Naratriptan 2.5 mg given each morning, with a second tablet allowed for breakthrough headache, at least 4 hours later, demonstrated a remarkable reduction in frequency and intensity of daily headache. In addition, a subjective improvement in quality of life and restoration of functioning including a decrease in missed workdays was noted. All three patients had previously experienced good responses to sumatriptan or zolmitriptan, but were limited in frequency of use by the authors. The patients were not experiencing rebound phenomena at the onset of treatment with naratriptan. Clinical responses were noted within 3 to 7 days of initiation of treatment. Traditional risk factor analysis and screening were performed. Naratriptan was extremely well tolerated, with no cardiovascular adverse events reported or observed. Possible mechanisms of action are discussed.     

曲坦类药物对偏头痛疗效及副作用的Meta分析

目的:评估七种曲坦药物治疗偏头痛的效能及副作用。方法:检索Medline,PubMed,Cochrane图书馆、CALIS外文期刊网、SAGE外文期刊网,中国知网,维普全文数据库。检索年限为1995年1月~2010年6月。纳入曲坦类药物治疗的随机安慰剂对照试验。采用Cochrane协作网提供的RevMan 5.0软件对纳入文献进行Meta分析。结果:共检索到127篇文献,纳入符合标准的56篇进行分析。利扎曲坦10 mg的2小时及24小时持续疗效、5 mg的2小时头痛缓解率与安慰剂对比具有统计学差异;依来曲坦20 mg、40 mg、80 mg治疗效能均优于安慰剂;舒马曲坦50 mg、100 mg速崩片及50 mg片剂所有治疗效果均优于安慰剂,100 mg片剂除24小时持续疼痛缓解率外,其他治疗效能优于安慰剂组;阿莫曲坦12.5 mg所有效能、6.25 mg、25 mg 2小时疼痛缓解率与安慰剂对比有显著差异;佐米曲坦2.5 mg、5 mg治疗效能均优于安慰剂;夫罗曲坦2.5 mg、那拉曲坦2.5 mg 2小时治疗效能优于安慰剂。阿莫曲坦、依来曲坦、那拉曲坦、佐米曲坦2.5 mg、10 mg口服片剂,舒马曲坦5 mg、10 mg喷剂的副作用发生率与安慰剂相当。结论:7种曲坦类药物均有一定的有效性和耐受性。     

A comparative trial of zolmitriptan and sumatriptan for the acute oral treatment of migraine

OBJECTIVE: This randomized, double-blind, parallel group multicenter study compared response rates and tolerability of zolmitriptan with sumatriptan in the acute treatment of migraine. METHODS: A sample consisting of 1445 outpatients with an established diagnosis of migraine was randomized to zolmitriptan, 2.5 mg or 5 mg, or sumatriptan, 25 mg or 50 mg. Patients took 1 tablet for moderate/severe migraine and a second identical tablet, if necessary, for recurrent headache of moderate/severe intensity 4 to 24 hours after the initial dose. Up to six attacks were treated during a 6-month period. The primary outcome measure was headache response 2 hours after the initial dose. Secondary end points included 1-hour and 4-hour headache response and pain relief over 24 hours. RESULTS: A headache response at 2 hours was noted in 67.1% of patients taking zolmitriptan, 2.5 mg, and 64.8% of those taking zolmitriptan, 5 mg, versus 59.6% of patients taking sumatriptan, 25 mg, and 63.8% of those taking sumatriptan, 50 mg. At 2 and 4 hours, the differences between zolmitriptan, 2.5 mg, and sumatriptan, 25 mg, were statistically significant (odds ratio=1.49 and 1.67, respectively; both P<.001). Statistically significant differences between zolmitriptan, 2.5 mg, and sumatriptan, 50 mg, were seen at 2 and 4 hours post dose (odds ratio=1.21 and 1.23, respectively; both P<.05). At 1 hour post dose, the headache response rate for zolmitriptan, 2. 5 mg, was numerically higher than response rates for sumatriptan, 25 mg and 50mg (odds ratio=1.16, odds ratio=1.06, though they failed to reach statistical significance; P=.061, P=.461 respectively). Differences between zolmitriptan, 5 mg, and sumatriptan, 25 mg, were statistically significant at 1, 2, and 4 hours (odds ratio=1.43, 1. 46, and 1.78, respectively; all P<.001) and at 1 and 4 hours versus sumatriptan, 50 mg (odds ratio=1.28, P=.002; odds ratio=1.29, P=.012, respectively). Although not statistically significant at 2 hours, more patients responded to zolmitriptan, 5 mg, than to sumatriptan, 50 mg (odds ratio=1.16, P=.064). Patients receiving zolmitriptan, 2. 5 mg or 5 mg, achieved more pain relief over 24 hours than patients receiving sumatriptan, 25 mg (odds ratio=1.47, and 1.54 respectively, both P<.001) or sumatriptan, 50 mg (odds ratio=1.17, P=.021; odds ratio=1.22, P=.005, respectively). All treatments were well tolerated. CONCLUSIONS: Zolmitriptan, 2.5 mg and 5 mg, was at least as effective as sumatriptan, 25 mg or 50 mg, for all parameters studied. Zolmitriptan, 2.5 mg, was significantly more effective than sumatriptan, 50 mg, in terms of headache response at 2 and 4 hours. Patients taking zolmitriptan were significantly more likely to have pain relief over 24 hours than those taking sumatriptan.