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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.
Clin Ther. 2006 Jun; 28(6):872-80.CT

Abstract

BACKGROUND

Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy.

OBJECTIVE

This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Outcomes Research and Management, Merck & Co., Inc., West Point, Pennsylvania 19486, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

16860170

Citation

Bell, Christopher F., et al. "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." Clinical Therapeutics, vol. 28, no. 6, 2006, pp. 872-80.
Bell CF, Foley KA, Barlas S, et al. 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. Clin Ther. 2006;28(6):872-80.
Bell, C. F., Foley, K. A., Barlas, S., Solomon, G., & Hu, X. H. (2006). 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. Clinical Therapeutics, 28(6), 872-80.
Bell CF, et al. 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. Clin Ther. 2006;28(6):872-80. PubMed PMID: 16860170.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Bell,Christopher F, AU - Foley,Kathleen A, AU - Barlas,Suna, AU - Solomon,Glen, AU - Hu,X Henry, PY - 2006/04/11/accepted PY - 2006/7/25/pubmed PY - 2006/11/15/medline PY - 2006/7/25/entrez SP - 872 EP - 80 JF - Clinical therapeutics JO - Clin Ther VL - 28 IS - 6 N2 - BACKGROUND: Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE: This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16860170/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(06)00142-1 DB - PRIME DP - Unbound Medicine ER -