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Acute treatment and prevention of menstrually related migraine headache: evidence-based review.
Neurology. 2008 Apr 22; 70(17): 1555-63
Pringsheim T, Davenport WJ, Dodick D
Menstrually related migraine (MRM) headache is common in women and associated with substantial disability. Compared to nonmenstrual migraine, MRM attacks are more severe, longer in duration, and have a poorer response to analgesics. The purpose of this guideline is to provide a systematic review and meta-analysis of the existing therapy trials for MRM and evidence-based recommendations for acute and short-term preventive treatment of MRM headache. Prospective, double-blind, randomized controlled trials of any pharmacologic agent for the symptomatic relief or prevention of MRM headache were included in the guideline. The main outcomes considered were the pain response and pain-free response at 2 hours for acute treatment trials, and the incidence of MRM or the number of days on which MRM attacks occurred for short-term prevention trials. Nineteen trials were included in the analysis. The US Preventive Services Task Force quality criteria were used to assess trial quality and to grade recommendations. Based on the evidence, grade B recommendations can be made for the use of sumatriptan 50 and 100 mg, mefenamic acid 500 mg, and rizatriptan 10 mg for the acute treatment of MRM. For the preventive treatment of MRM, there are grade B recommendations for the perimenstrual use of transcutaneous estrogen 1.5 mg, frovatriptan 2.5 mg twice daily, and naratriptan 1 mg twice daily. Choosing among treatment strategies must be based on clinical considerations.
Rizatriptan Efficacy in ICHD-II Pure Menstrual Migraine and Menstrually Related Migraine.
Headache. 2008 Apr 14;
Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE
Objective.- To examine the efficacy of rizatriptan for the treatment of pure menstrual migraine (PMM). Background.- In 2004, the International Headache Society proposed new research criteria for menstrual migraine (International Classification of Headache Disorders [ICHD-II]). Two subtypes were defined: PMM, in which attacks occur exclusively with menstruation, and menstrually related migraine (MRM), in which attacks may also occur at other times of the cycle. Methods.- The 2 protocols (MM1 and MM2) were identical randomized, double-blind studies. Adult patients with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo (2:1). Patients were to treat a single menstrual migraine attack of moderate or severe pain intensity. This prospectively planned substudy pooled data from patients with a diagnosis of PMM from both studies. The primary substudy endpoint was 2-hour pain relief. Efficacy data were summarized for patients with a diagnosis of MRM. Results.- Of 707 (MM1: 357, MM2: 350) patients treated in the study, 146 patients (MM1: 81, MM2: 65) had a diagnosis of PMM. The percentage of patients reporting 2-hour pain relief was significantly greater for rizatriptan than for placebo for both PMM (73% vs 50%, P = .006) and MRM subgroups (71% vs 52%, P < .001). Most other efficacy endpoints favored rizatriptan compared with placebo in patients with either PMM or MRM. Conclusion.- Rizatriptan 10 mg was superior to placebo for the treatment of PMM, as measured by 2-hour pain relief. Rizatriptan was also effective for the treatment of MRM and for relief of migraine-associated symptoms for both headache subtypes.
[A new therapeutic principle for migraine]
Ugeskr Laeger. 2008 Mar 17; 170(12): 1029
Ashina M, Jensen RH
Expert Opin Pharmacother. 2008 Apr; 9(6): 1001-11
Mannix LK
BACKGROUND: Among the 5-HT(1B/1D) agonists or 'triptans,' which are considered first-line therapy for acute migraine, rizatriptan has emerged as one of the most efficacious. OBJECTIVE: Several comprehensive reviews of rizatriptan are available in the literature; the aim of this paper is to review the most current research with rizatriptan. METHODS: The scope of the review addresses current topics of clinical interest, including studies of time to pain relief, effect of early administration, use in combination with other drugs, and tolerability updates, as well as trials of rizatriptan in certain subpopulations such as patients with menstrual migraine, patients with motion sickness and pediatric patients. CONCLUSION: In the context of these newly available data, the potential for expansion of the role of rizatriptan in the clinic is evaluated.
Use of 5-HT1 agonists in pregnancy.
Ann Pharmacother. 2008 Apr; 42(4): 543-9
Evans EW, Lorber KC
OBJECTIVE: To report and evaluate available data on the use of serotonin 5-HT(1) agonists (triptans) during pregnancy. DATA SOURCES: A PubMed search, limited to English-language articles on human subjects, was conducted (1990-December 2007) using the search terms pregnancy, migraine, and the individual triptan drug names. In addition, the manufacturers of all 7 available triptans were contacted regarding the existence of a pregnancy registry for their drug(s) and the availability of registry reports. STUDY SELECTION AND DATA EXTRACTION: All retrospective and prospective studies reporting on pregnancy outcomes after the use of a triptan were included and critically evaluated. Data from all available manufacturer-sponsored pregnancy registries were also included. DATA SYNTHESIS: Safe and effective treatment of migraine during pregnancy is imperative. Data involving sumatriptan and, to a lesser extent, naratriptan and rizatriptan, exist primarily regarding exposure in the first trimester. These data show no significant differences in congenital malformations or poor pregnancy outcomes when compared with expected rates in the general population or with the observed rates in control subjects. There is very little information regarding exposure in middle and late pregnancy. CONCLUSIONS: Sumatriptan appears to be a safe treatment alternative for pregnant women who experience new-onset or worsened migraines in the first trimester. Further observation is needed prior to recommending its use in later trimesters. Based upon available data, the other agents in this class cannot be recommended for use during pregnancy at this time.
Identification of Aquaporin 4 inhibitors using in vitro and in silico methods.
Bioorg Med Chem. 2008 Jan 5;
Huber VJ, Tsujita M, Nakada T
The in vitro inhibitory effects and in silico docking energies of 18 compounds with respect to Aquaporin 4 (AQP4) were investigated. More than half of the compounds tested showed inhibitory activity in the in vitro functional assay and included the 5-HT(1B/1D) agonists sumatriptan, and rizatriptan. Moreover, the observed inhibitory activity of the compounds used in this study at 20muM showed a strong correlation with their in silico docking energies, r(2)=0.64, which was consistent with that found in previous studies. The AQP4 inhibitory IC(50) values of three compounds, 2-(nicotinamido)-1,3,4-thiadiazole, sumatriptan and rizatriptan, were subsequently found to be 3, 11, and 2muM, respectively.
Meta-analysis of the efficacy and safety of zolmitriptan in the acute treatment of migraine.
Headache. 2008 Feb; 48(2): 236-47
Chen LC, Ashcroft DM
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.
Headache. 2008 Mar; 48(3): 368-77
Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F
OBJECTIVE: To confirm the efficacy of rizatriptan 10 mg orally disintegrating tablet (ODT) for the elimination of migraine-associated nausea. BACKGROUND: Pooled studies of rizatriptan analyzing elimination of nausea as a secondary endpoint showed that 65% of rizatriptan patients reported elimination of nausea at 2 hours compared with 41% of patients taking placebo. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled single-attack trial enrolling adult patients with at least a 6-month history of migraine who typically experience migraine-associated nausea. Patients treated a moderate or severe migraine headache at the earliest sign of nausea with either rizatriptan 10 mg ODT or placebo (2 : 1). The primary endpoint was elimination of nausea at 2 hours postdose, and the secondary endpoint was pain relief at 2 hours postdose. RESULTS: Although not statistically significant, a greater percentage of patients had elimination of nausea at 2 hours with rizatriptan compared with placebo (70.3% vs 62.0%, P = .165, odds ratio [95% CI] = 1.45 [0.86, 2.46]). When patients were grouped by baseline headache severity, rizatriptan showed a greater advantage than placebo for patients with moderate pain (rizatriptan 72.8% vs placebo 57.4%), but no difference for patients with severe pain (rizatriptan 67.7% vs placebo 66.7%). There were significantly more patients who achieved 2-hour pain relief with rizatriptan (69.7% vs 54.3%, P = .012, odds ratio [95% CI] = 1.94 [1.16, 3.25]). CONCLUSION: Although the efficacy of rizatriptan 10 mg ODT for the elimination of migraine-associated nausea was comparable to that seen in previous rizatriptan trials, the higher-than-usual placebo response prevented a finding of a statistically significant difference. There was a sizable difference in placebo response between patients who treated moderate vs severe migraine. Rizatriptan was effective for 2-hour pain relief.
Headache. 2008 Feb; 48(2): 226-35
Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F
OBJECTIVE: A prospective subgroup analysis of the TAME (Treat A Migraine Early) studies examined the efficacy of rizatriptan in patients treating a menstrual migraine attack. METHODS: Both TAME studies were randomized, placebo-controlled, and double-blind. Adults with migraine were assigned (2:1) to either rizatriptan 10-mg tablet or placebo. Patients were instructed to treat within 1 hour of migraine onset and when the pain was mild. The primary endpoint was 2-hour pain freedom. The diagnosis of menstrual migraine was established according to the revised 2004 International Headache Society (IHS) diagnostic criteria. Data from both studies were pooled for logistic regression analyses. A test for interaction was performed to compare rates of 2-hour pain freedom between patients treating a menstrual and non-menstrual attack. RESULTS: A total of 94 patients (63 in the rizatriptan group and 31 in the placebo group) met IHS criteria for menstrual migraine and treated a menstrual attack. The percentage of patients reporting 2-hour pain freedom was significantly greater for rizatriptan than for placebo (63.5% vs 29.0%; odds ratio = 4.5; 95% confidence interval: 1.7, 11.9; P = .002) in those treating a menstrual attack. In those treating with rizatriptan, the percentage of patients with 2-hour pain freedom did not statistically differ between those treating a menstrual or non-menstrual migraine attack (63.5% vs 57.5%; P = .454). CONCLUSION: Rizatriptan 10 mg was effective for the treatment of menstrual migraine in an early intervention model, as measured by 2-hour pain freedom. Rates of 2-hour pain freedom were comparable for patients treating menstrual and non-menstrual migraine attacks with rizatriptan.
BMC Clin Pharmacol. 2007; 7: 12
Edward C, Himmelmann A, Wallerstedt SM
BACKGROUND: To provide doctors with producer-independent information to facilitate choice of treatment is an important task. The objective of the present study was to evaluate if an e-mail with a drug information attachment has effects on sales of prescribed drugs and if the design of the attachment is of importance. METHODS: The Swedish pharmaceutical benefit board found rizatriptan (Maxalt) 10 mg to be the most cost-effective triptan. All 119 heads of primary care units in western Sweden were randomized to receive information concerning this conclusion via (i) e-mail with attachment I, (ii) e-mail with attachment II or (iii) no information (control). Attachment I was a short one (heading plus three lines text), whereas attachment II was a long one (heading plus one page text and one page with tables). The change in percentage rizatriptan of total triptans sold before and after the intervention (May - July 2004 and May - July 2005, respectively) was compared between the groups. RESULTS: Totally 48,229 (2004) and 50,674 (2005) defined daily doses of triptans were prescribed and sold during May - July in primary care units in the western part of Sweden. The absolute change in percentage rizatriptan was greater in the intervention groups compared with the control group 2 (25th - 75th percentile: -3 - 7) vs 0 (-7 - 5), P = 0.031). The absolute change in percentage rizatriptan did not differ between the two attachment groups (P = 0.93). CONCLUSION: An e-mail with a drug information attachment may influence sales of prescribed drugs. No difference between different designs of the attachment could be detected.