Restoring Migraine Sufferers’ Ability to Function Normally: A Comparison of Rizatriptan and Other Triptans in Randomized Trials
Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal functio...
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Published in | European neurology Vol. 48; no. 3; pp. 172 - 177 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
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Basel, Switzerland
Karger
01.01.2002
S. Karger AG |
Subjects | |
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Abstract | Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Methods: Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale (‘normal’, ‘mild impairment’, ‘severe impairment’, ‘requires bedrest’) at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Results: Most patients in each trial and treatment group had some level of disability at baseline (range = 94–100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). Conclusion: In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan. |
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AbstractList | Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Methods: Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale ('normal', 'mild impairment', 'severe impairment', 'requires bedrest') at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Results: Most patients in each trial and treatment group had some level of disability at baseline (range = 94-100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). Conclusion: In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan. Copyright [copy 2002 S. Karger AG, Basel Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Methods: Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale (‘normal’, ‘mild impairment’, ‘severe impairment’, ‘requires bedrest’) at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Results: Most patients in each trial and treatment group had some level of disability at baseline (range = 94–100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). Conclusion: In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan. Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale ('normal', 'mild impairment', 'severe impairment', 'requires bedrest') at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Most patients in each trial and treatment group had some level of disability at baseline (range = 94-100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan. Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers.BACKGROUNDMany migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers.Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale ('normal', 'mild impairment', 'severe impairment', 'requires bedrest') at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline.METHODSRetrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale ('normal', 'mild impairment', 'severe impairment', 'requires bedrest') at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline.Most patients in each trial and treatment group had some level of disability at baseline (range = 94-100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008).RESULTSMost patients in each trial and treatment group had some level of disability at baseline (range = 94-100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008).In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan.CONCLUSIONIn direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan. Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms, rather than looking at functional impact. This study compared the efficacy of different oral triptans for restoring normal function in migraine sufferers. Retrospective subgroup analysis of data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan was directly compared with oral sumatriptan 100 mg (772 attacks), 50 mg (2,227 attacks), and 25 mg (1,182 attacks), naratriptan 2.5 mg (413 attacks), and zolmitriptan 2.5 mg (578 attacks) for the acute treatment of a moderate or severe migraine attack. Functional disability was evaluated by patients on a 4-grade scale ('normal', 'mild impairment', 'severe impairment', 'requires bedrest') at baseline and at 0.5, 1, 1.5, 2, 3 and 4 h after dosing. This analysis looked at the percentage of patients who had normal functional ability at 2 h, the last time point before escape medications were allowed, in the subgroup of patients who had some level of disability at baseline. Most patients in each trial and treatment group had some level of disability at baseline (range = 94-100%). At 2 h, more patients on rizatriptan 10 mg were able to function normally compared with sumatriptan 100 mg (39 vs. 32%, odds ratio = 1.4, p = 0.021), sumatriptan 50 mg (47 vs. 42%, odds ratio = 1.2, p = 0.033), sumatriptan 25 mg (48 vs. 36%, odds ratio = 1.7, p < 0.001), naratriptan 2.5 mg (39 vs. 22%, odds ratio = 2.5, p < 0.001), and zolmitriptan 2.5 mg (45 vs. 36%, odds ratio = 1.6, p = 0.008). In direct head-to-head comparative clinical trials, oral rizatriptan 10 mg enabled more migraine sufferers to function normally at 2 h after dosing than oral sumatriptan, naratriptan, and zolmitriptan. |
Author | Gerth, William Bussone, Gennaro Lines, Christopher R. D’Amico, Domenico McCarroll, Kathleen A. |
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Cites_doi | 10.1046/j.1526-4610.1998.3810737.x 10.1016/S0140-6736(97)11370-8 10.1159/000008094 10.1046/j.1526-4610.1998.3810748.x |
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Keywords | Triptans Sumatriptan Zolmitriptan Migraine Rizatriptan 5-HT1B/1D receptor agonists Naratriptan Agonist Prognosis Tryptamine derivatives Cardiovascular disease Serotonine receptor Serotonin agonist Functional capacity Dose activity relation Vascular disease Randomization Pain Adult Cerebrovascular disease Human Nervous system diseases Antimigrainous agent Oral administration Cerebral disorder Treatment Central nervous system disease Double blind study Indole derivatives Comparative study |
Language | English |
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References | Lipton RB, Stewart WF: Migraine in the United States: A review of epidemiology and healthcare use. Neurology 1993;43(suppl 3):S6-S10. Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH: Oral rizatriptan versus oral sumatriptan: A direct comparative study in the acute treatment of migraine. Headache 1998;38:748-755.1128446310.1046/j.1526-4610.1998.3810748.x Bomhof M, Paz J, Legg N, Allen C, Vandormael K, Patel K: Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. Eur Neurol 1999;42:173-179.1052954510.1159/000008094 Headache Classification Committee of the International Headache Society: Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988;8(Suppl 7):1-96. Staffa JA, Lipton RB, Stewart WF: The epidemiology of migraine headache. Rev Contemp Pharmacol 1994;5:241-252. Pascual J, Vega P, Diener HC, Allen C, Vrijens F, Patel K: Comparison of rizatriptan 10 mg versus zolmitriptan 2.5 mg in the acute treatment of migraine. Rizatriptan-Zolmitriptan Study Group. Cephalalgia 2000;20:455-461.11037741 Menken M, Munsat TL, Toole JF: The global burden of disease study: Implications for neurology. Arch Neurol 2000;57:418-420.10714674 Fuseau E, Petricoul O, Sabin A, Pereira A, O'Quinn S, Thein S, Leibowitz M, Purdon H, McNeal S, Salonen R, Metz A, Coates P: Effect of encapsulation on absorption of sumatriptan tablets: Data from healthy volunteers and patients during a migraine. Clin Ther 2001;23:242-251.11293557 Goldstein J, Ryan R, Jiang K, Getson A, Norman B, Block GA, Lines C: Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 and 50 mg in migraine. Rizatriptan Protocol 046 Study Group. Headache 1998;38:737-747.1128446210.1046/j.1526-4610.1998.3810737.x Gerth WC, Mannix L, McCarroll KA, Vandormael K, Zhang Q, Santanello NC: Patient satisfaction with rizatriptan 10 mg vs. other triptans: Head-to-head comparisons. Headache 2000;40:408-409. Ferrari MD: Migraine. Lancet 1998;351:1043-1051.954652610.1016/S0140-6736(97)11370-8 Holmes WF, MacGregor A, Sawyer JPC, Lipton RB: Information about migraine disability influences physicians' perception of illness severity and treatment needs. Headache 2000;41:343-350. Adelman JU, Lipton RB, Ferrari MD, Diener H-C, McCarroll KA, Vandormael K, Lines CR: Comparison of rizatriptan and other triptans on stringent measures of efficacy. Neurology 2001;57:1377-1383.11673575 International Headache Society Clinical Trials Subcommittee: Guidelines for controlled trials of drugs in migraine: Second edition. Cephalalgia 2000;20:765-786.11167908 Stewart WF, Shechter A, Rasmussen BK: Migraine prevalence: A review of population-based studies. Neurology 1994;44(suppl 4):S17-S23. Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML: Burden of migraine in the United States. Arch Intern Med 1999;159:813-818.10219926 Senn S: Crossover designs; in Armitage P, Colton T (eds): Encyclopedia of Biostatistics. New York, Wiley , 1998, vol 2, pp 1033-1049. Jones B, Kenward MG: Design and Analysis of Cross-over Trials. Monographs on Statistics and Applied Probability. New York, Chapman and Hall, 1989. Visser WH, Terwindt GM, Reines SA, Jiang K, Lines CR, Ferrari M: Rizatriptan vs sumatriptan in the acute treatment of migraine. Arch Neurol 1996;53:1132-1137.8912486 ref2 ref1 ref4 ref3 |
References_xml | – reference: Staffa JA, Lipton RB, Stewart WF: The epidemiology of migraine headache. Rev Contemp Pharmacol 1994;5:241-252. – reference: Pascual J, Vega P, Diener HC, Allen C, Vrijens F, Patel K: Comparison of rizatriptan 10 mg versus zolmitriptan 2.5 mg in the acute treatment of migraine. Rizatriptan-Zolmitriptan Study Group. Cephalalgia 2000;20:455-461.11037741 – reference: Goldstein J, Ryan R, Jiang K, Getson A, Norman B, Block GA, Lines C: Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 and 50 mg in migraine. Rizatriptan Protocol 046 Study Group. Headache 1998;38:737-747.1128446210.1046/j.1526-4610.1998.3810737.x – reference: Senn S: Crossover designs; in Armitage P, Colton T (eds): Encyclopedia of Biostatistics. New York, Wiley , 1998, vol 2, pp 1033-1049. – reference: Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML: Burden of migraine in the United States. Arch Intern Med 1999;159:813-818.10219926 – reference: Lipton RB, Stewart WF: Migraine in the United States: A review of epidemiology and healthcare use. Neurology 1993;43(suppl 3):S6-S10. – reference: Stewart WF, Shechter A, Rasmussen BK: Migraine prevalence: A review of population-based studies. Neurology 1994;44(suppl 4):S17-S23. – reference: International Headache Society Clinical Trials Subcommittee: Guidelines for controlled trials of drugs in migraine: Second edition. Cephalalgia 2000;20:765-786.11167908 – reference: Jones B, Kenward MG: Design and Analysis of Cross-over Trials. Monographs on Statistics and Applied Probability. New York, Chapman and Hall, 1989. – reference: Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH: Oral rizatriptan versus oral sumatriptan: A direct comparative study in the acute treatment of migraine. Headache 1998;38:748-755.1128446310.1046/j.1526-4610.1998.3810748.x – reference: Visser WH, Terwindt GM, Reines SA, Jiang K, Lines CR, Ferrari M: Rizatriptan vs sumatriptan in the acute treatment of migraine. Arch Neurol 1996;53:1132-1137.8912486 – reference: Fuseau E, Petricoul O, Sabin A, Pereira A, O'Quinn S, Thein S, Leibowitz M, Purdon H, McNeal S, Salonen R, Metz A, Coates P: Effect of encapsulation on absorption of sumatriptan tablets: Data from healthy volunteers and patients during a migraine. Clin Ther 2001;23:242-251.11293557 – reference: Headache Classification Committee of the International Headache Society: Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988;8(Suppl 7):1-96. – reference: Holmes WF, MacGregor A, Sawyer JPC, Lipton RB: Information about migraine disability influences physicians' perception of illness severity and treatment needs. Headache 2000;41:343-350. – reference: Adelman JU, Lipton RB, Ferrari MD, Diener H-C, McCarroll KA, Vandormael K, Lines CR: Comparison of rizatriptan and other triptans on stringent measures of efficacy. Neurology 2001;57:1377-1383.11673575 – reference: Bomhof M, Paz J, Legg N, Allen C, Vandormael K, Patel K: Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. Eur Neurol 1999;42:173-179.1052954510.1159/000008094 – reference: Gerth WC, Mannix L, McCarroll KA, Vandormael K, Zhang Q, Santanello NC: Patient satisfaction with rizatriptan 10 mg vs. other triptans: Head-to-head comparisons. Headache 2000;40:408-409. – reference: Menken M, Munsat TL, Toole JF: The global burden of disease study: Implications for neurology. Arch Neurol 2000;57:418-420.10714674 – reference: Ferrari MD: Migraine. Lancet 1998;351:1043-1051.954652610.1016/S0140-6736(97)11370-8 – ident: ref2 doi: 10.1046/j.1526-4610.1998.3810737.x – ident: ref4 doi: 10.1016/S0140-6736(97)11370-8 – ident: ref3 doi: 10.1159/000008094 – ident: ref1 doi: 10.1046/j.1526-4610.1998.3810748.x |
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Snippet | Background: Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine... Many migraine patients are unable to function normally during a migraine attack. Assessments of treatment efficacy have tended to focus on migraine symptoms,... |
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SubjectTerms | Administration, Oral Adolescent Adult Aged Biological and medical sciences Cardiovascular system Female Humans Indoles - administration & dosage Male Medical sciences Middle Aged Migraine Disorders - drug therapy Original Paper Oxazolidinones - administration & dosage Pharmacology. Drug treatments Piperidines - administration & dosage Randomized Controlled Trials as Topic Retrospective Studies Serotonin Receptor Agonists - administration & dosage Sumatriptan - administration & dosage Treatment Outcome Triazoles - administration & dosage Tryptamines Vasodilator agents. Cerebral vasodilators |
Title | Restoring Migraine Sufferers’ Ability to Function Normally: A Comparison of Rizatriptan and Other Triptans in Randomized Trials |
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