Time to pain freedom and onset of pain relief with rizatriptan 10 mg and prescription usual-care oral medications in the acute treatment of migraine headaches: A multicenter, prospective, open-label, two-attack, crossover study
ABSTRACT Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy.
This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings.
This was a multicenter, prospective, open-label study. Adult patients treated 2 sequential migraine attacks with rizatriptan 10 mg and a usual-care prescription migraine medication in a crossover manner. Patients chose which medication to take first. They recorded the treatment outcomes using a stopwatch and a treatment diary. End points included time to pain freedom (length of time from dosing to no pain) and time to onset of pain relief (mean time to onset of pain relief and proportion of patients reporting onset of pain relief at 30 minutes), satisfaction with treatment, and medication preference. Information on adverse events was collected through the normal post-marketing reporting mechanism. Comparisons were made using the paired t test and McNemar test for continuous and categorical variables, respectively. A mixed model, accounting for multiple observations per patient, was fitted for the time to pain freedom, controlling for age, sex, treatment period, medication, and headache severity.
Of 2346 enrolled patients, 1489 treated 2 migraines in a crossover manner and were included in the analysis (86.8% women, 13.2% men; mean age, 41.7 years). A majority of patients (80.6%) treated both migraines with oral triptans. The most commonly used nontriptans were NSAIDs (5.4%), butalbital-containing combinations (4.3%), and isometheptene (3.4%). Over-the-counter medications were used by 22.3% of patients during rizatriptan-treated attacks and by 28.9% of patients during attacks treated with usual-care medications. The mean time to pain freedom was significantly shorter when an attack was treated with rizatriptan compared with usual-care medications (222 vs 298 minutes, respectively; P<0.001), and the onset of pain relief was significantly more rapid (85 vs 107 minutes; P=0.003), with significant differences noted as early as 15 minutes after dosing (P<0.001). The findings remained similar after adjustment for potential confounding factors. No significant sequence effect was detected. Significantly more patients reported being very satisfied or satisfied with rizatriptan compared with usual-care medications (65.4% vs 57.7%; P<0.001) and preferred rizatriptan (58.0% vs 42.0%; P<0.001). One female patient reported having hives and itchy skin the day after taking rizatriptan; the symptoms subsided after treatment with methylprednisolone.
In this selected population, treatment of a migraine attack with rizatriptan 10 mg was associated with a faster time to pain freedom and onset of pain relief compared with treatment with usual-care oral migraine medications. Patients reported greater satisfaction with and preference for rizatriptan.
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ABSTRACT: In the clinical trial setting, oral rizatriptan 10 mg has greater efficacy than other oral triptans in freedom from migraine headache pain 2 h after dosing. The study objective is to compare the effectiveness of rizatriptan 10 mg and other oral triptans for acute migraine attack in a naturalistic setting. A total of 673 patients took rizatriptan 10 mg or their usual-care oral triptans for two migraine attacks in a sequential, cross-over manner and recorded outcomes using a diary and a stopwatch. Mean and median times to pain relief (PR) and pain freedom (PF) for rizatriptan and other oral triptans were compared. The effect of rizatriptan on times to PR and PF, adjusting for potential confounding factors (treatment sequence, treatment order and use of rescue medication), was computed via a Cox proportional hazard model. Significantly, more patients taking rizatriptan achieved both PR and PF within 2 h after dosing than other oral triptans. Times to PR and PF were shorter with rizatriptan than with other oral triptans (median time to PR: 45 vs. 52 min, p < 0.0001; median time to PF: 100 vs. 124 min, p < 0.0001). The adjusted proportional hazard ratios (rizatriptan vs. other oral triptans) for times to PR and PF were 1.32 (95% CI: 1.22-1.44) and 1.27 (95% CI: 1.16-1.39) respectively. The times to PR and PF in a 'naturalistic' setting were significantly shorter for patients treating a migraine attack with rizatriptan 10 mg than with other oral triptans.International Journal of Clinical Practice 08/2007; 61(7):1091-111. DOI:10.1111/j.1742-1241.2007.01400.x · 2.54 Impact Factor
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ABSTRACT: 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. Several comprehensive reviews of rizatriptan are available in the literature; the aim of this paper is to review the most current research with rizatriptan. 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. In the context of these newly available data, the potential for expansion of the role of rizatriptan in the clinic is evaluated.Expert Opinion on Pharmacotherapy 05/2008; 9(6):1001-11. DOI:10.1517/14656518.104.22.1681 · 3.09 Impact Factor
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ABSTRACT: Although randomized controlled trials (RCTs) are the gold standard for assessing efficacy of a drug intervention, because they are conducted in a highly selected group of patients, they do not necessarily reflect normal customary or optimized patient care. Accordingly, information from RCTs must be supplemented by outcomes research and by nonexperimental or quasi-experimental study designs. Herein, we discuss information that supplements the rigorous but sometimes rigid nature of RCTs in an effort to better understand the clinical utility of drug treatment for migraine with patient-centered outcomes in mind. We start by discussing several lessons we learned from RCTs on comparative triptan studies, followed by presenting data on outcomes studies for rizatriptan. We then briefly discuss migraine treatment behavior issues, including early treatment and adherence to treatment.Headache The Journal of Head and Face Pain 03/2009; 49 Suppl 1:S34-42. DOI:10.1111/j.1526-4610.2008.01337.x · 3.19 Impact Factor