Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs
Abstract Objective: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. Methods: This was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority study...
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| Veröffentlicht in: | Clinical therapeutics 2009-03, Vol.31 (3), p.542-559 |
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| creator | Dodick, David W., MD Freitag, Fred, DO Banks, James, MD Saper, Joel, MD Xiang, Jim, PhD Rupnow, Marcia, PhD Biondi, David, DO Greenberg, Steven J., MD Hulihan, Joseph, MD |
| description | Abstract Objective: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. Methods: This was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority study. Adults with 3 to 12 migraines per month were randomized in a 1:1 ratio to receive an initial dose of 25 mg/d of either topiramate or amitriptyline, subsequently titrated to a maximum of 100 mg/d (or the maximum tolerated dose). The primary efficacy outcome was the change from prospective baseline in the mean monthly number of migraine episodes. Secondary efficacy variables included changes from the prospective baseline phase to the end of the double-blind phase in the mean monthly (28-day) rate of days with migraine, mean monthly rate of days with headache (migraine and nonmigraine), mean monthly rate of acute abortive medication use, mean monthly migraine duration, and mean monthly migraine severity. Additional secondary efficacy variables included changes in the mean monthly severity of migraine-associated symptoms (photophobia, phonophobia, and nausea), change in the mean monthly frequency f migraine-associated vomiting, and response rates (based on monthly migraine days and total headache days). The Migraine-Specific Quality of Life Questionnaire (MSQ) and the Weight Satisfaction Scale Questionnaire, which measures subjective satisfaction with current weight, were administered. Treatment-emergent adverse events (TEAEs) were monitored through the end of double-blind treatment. Results: The intent-to-treat population included 331 subjects (172 topiramate, 159 amitriptyline; 84.9% female; 84.6% white; mean [SD] age, 38.8 [11.0] years; mean weight, 77.1 [20.1] kg) who provided at least 1 efficacy assessment. The least squares mean (LSM) change from baseline in the mean monthly number of migraine episodes was not significantly different between the topiramate and amitriptyline groups (-2.6 and -2.7, respectively; 95% CI, -0.6 to 0.7). There were no significant differences between treatment groups in any of the prespecified secondary outcome measures. Subjects receiving topiramate had a significantly greater improvement in mean functional disability scores during migraine attacks compared with amitriptyline (LSM change: -0.33 vs -0.19; 95% CI, -0.3 to 0.0; P = 0.040) and in the role function-restrictive, role function-preventive, and emotional function domains o |
| doi_str_mv | 10.1016/j.clinthera.2009.03.020 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1033160197</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0149291809000952</els_id><sourcerecordid>2734240791</sourcerecordid><originalsourceid>FETCH-LOGICAL-c482t-e0fccc62476c94135fc23cd9e93f810a4493e079531f97ddf8f5e48f9ef0f0ce3</originalsourceid><addsrcrecordid>eNqNUk2P0zAQtRCILYW_AJYQt6bYsdvEHFaqVnxJK3FgkbhZrj1e3E3iME6Kyq_iJ-KoVStx4mRbfvPezLxHyCvOlpzx9dvd0jahG34AmmXJmFoysWQle0RmvK5Uwbn8_pjMGJeqKBWvr8izlHaMMaFW5VNyxZVQopZyRv7cxT6gac0AdA-YxkRNGwYM_XDICkBDR9twj2a69wh76IYQu3d0Q8t18QvgYUHbsRmCzR-AC4qmc7ENv8EtqIvjtoFim4kuLze27WFBe4OmaaAp7jGOPe1iFzoPGCKG4UBzA6aZtI3L5OcORkzPyRNvmgQvTuecfPvw_u7mU3H75ePnm81tYWVdDgUwb61dl7JaWyW5WHlbCusUKOFrzoyUSgCr1EpwryrnfO1XIGuvwDPPLIg5eX3k7TH-HCENehdH7LKk5kwIvmZcVRlVHVEWY0oIXvcYWoOHDNKTU3qnz07pySnNhM5O5cqXJ_5x24K71J2syYA3J4BJ1jQ-L9aGdMaVXPLVNNmcbI44yNvYB0CdbIDOggsIdtAuhv9o5vofjgkXsuwDHCBdJtep1Ex_nYI15YqpnKkcKfEXg6LPcw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1033160197</pqid></control><display><type>article</type><title>Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><source>ProQuest Central UK/Ireland</source><creator>Dodick, David W., MD ; Freitag, Fred, DO ; Banks, James, MD ; Saper, Joel, MD ; Xiang, Jim, PhD ; Rupnow, Marcia, PhD ; Biondi, David, DO ; Greenberg, Steven J., MD ; Hulihan, Joseph, MD</creator><creatorcontrib>Dodick, David W., MD ; Freitag, Fred, DO ; Banks, James, MD ; Saper, Joel, MD ; Xiang, Jim, PhD ; Rupnow, Marcia, PhD ; Biondi, David, DO ; Greenberg, Steven J., MD ; Hulihan, Joseph, MD ; for the CAPSS-277 Investigator Group ; CAPSS-277 Investigator Group</creatorcontrib><description>Abstract Objective: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. Methods: This was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority study. Adults with 3 to 12 migraines per month were randomized in a 1:1 ratio to receive an initial dose of 25 mg/d of either topiramate or amitriptyline, subsequently titrated to a maximum of 100 mg/d (or the maximum tolerated dose). The primary efficacy outcome was the change from prospective baseline in the mean monthly number of migraine episodes. Secondary efficacy variables included changes from the prospective baseline phase to the end of the double-blind phase in the mean monthly (28-day) rate of days with migraine, mean monthly rate of days with headache (migraine and nonmigraine), mean monthly rate of acute abortive medication use, mean monthly migraine duration, and mean monthly migraine severity. Additional secondary efficacy variables included changes in the mean monthly severity of migraine-associated symptoms (photophobia, phonophobia, and nausea), change in the mean monthly frequency f migraine-associated vomiting, and response rates (based on monthly migraine days and total headache days). The Migraine-Specific Quality of Life Questionnaire (MSQ) and the Weight Satisfaction Scale Questionnaire, which measures subjective satisfaction with current weight, were administered. Treatment-emergent adverse events (TEAEs) were monitored through the end of double-blind treatment. Results: The intent-to-treat population included 331 subjects (172 topiramate, 159 amitriptyline; 84.9% female; 84.6% white; mean [SD] age, 38.8 [11.0] years; mean weight, 77.1 [20.1] kg) who provided at least 1 efficacy assessment. The least squares mean (LSM) change from baseline in the mean monthly number of migraine episodes was not significantly different between the topiramate and amitriptyline groups (-2.6 and -2.7, respectively; 95% CI, -0.6 to 0.7). There were no significant differences between treatment groups in any of the prespecified secondary outcome measures. Subjects receiving topiramate had a significantly greater improvement in mean functional disability scores during migraine attacks compared with amitriptyline (LSM change: -0.33 vs -0.19; 95% CI, -0.3 to 0.0; P = 0.040) and in the role function-restrictive, role function-preventive, and emotional function domains of the MSQ ( P = 0.012, P = 0.014, and P = 0.029, respectively). Subjects receiving topiramate had a mean weight loss of 2.4 kg, compared with a mean weight gain of 2.4 kg in subjects receiving amitriptyline. Subjects in the topiramate group reported an overall improvement from baseline in weight satisfaction, whereas the amitriptyline group reported an overall deterioration in weight satisfaction ( P < 0.001, topiramate vs amitriptyline). TEAEs of mild or moderate severity were reported in 118 subjects (66.7%) in the topiramate group and 112 subjects (66.3%) in the amitriptyline group. Among the most common TEAEs (reported in ±5% of subjects during the double-blind phase) in the topiramate group were paresthesia (29.9%), fatigue (16.9%), somnolence (11.9%), hypoesthesia (10.7%), and nausea (10.2%). The most commonly reported TEAEs in the amitriptyline group were dry mouth (35.5%), fatigue (24.3%), somnolence (17.8%), weight increase (13.6%), dizziness (10.7%), and sinusitis (10.7%). Conclusions: In this noninferiority study, topiramate was at least as effective as amitriptyline in terms of reducing the rate of mean monthly migraine episodes and all prespecified secondary efficacy end points. Topiramate was associated with improvement in some quality-of-life indicators compared with amitriptyline and was associated with weight loss and improved weight satisfaction.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2009.03.020</identifier><identifier>PMID: 19393844</identifier><language>eng</language><publisher>Bridgewater, NJ: EM Inc USA</publisher><subject>Adult ; amitriptyline ; Amitriptyline - adverse effects ; Amitriptyline - therapeutic use ; Anniversaries ; Biological and medical sciences ; Body Weight - drug effects ; Central Nervous System Agents - adverse effects ; Central Nervous System Agents - therapeutic use ; Clinical trials ; Disability Evaluation ; Disease prevention ; Double-Blind Method ; Female ; Fructose - adverse effects ; Fructose - analogs & derivatives ; Fructose - therapeutic use ; headache ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Headaches ; Humans ; Internal Medicine ; Male ; Medical Education ; Medical sciences ; Middle Aged ; Migraine ; Migraine Disorders - prevention & control ; migraine prophylaxis ; Nervous system (semeiology, syndromes) ; Neurology ; Patient Satisfaction ; Pharmacology. Drug treatments ; Quality of Life ; Questionnaires ; Severity of Illness Index ; Surveys and Questionnaires ; Time Factors ; topiramate ; Treatment Outcome ; United States ; Vascular diseases and vascular malformations of the nervous system ; weight loss</subject><ispartof>Clinical therapeutics, 2009-03, Vol.31 (3), p.542-559</ispartof><rights>Excerpta Medica Inc. All rights reserved.</rights><rights>2009 Excerpta Medica Inc. All rights reserved.</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c482t-e0fccc62476c94135fc23cd9e93f810a4493e079531f97ddf8f5e48f9ef0f0ce3</citedby><cites>FETCH-LOGICAL-c482t-e0fccc62476c94135fc23cd9e93f810a4493e079531f97ddf8f5e48f9ef0f0ce3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1033160197?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000,64390,64394,72474</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21415941$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19393844$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dodick, David W., MD</creatorcontrib><creatorcontrib>Freitag, Fred, DO</creatorcontrib><creatorcontrib>Banks, James, MD</creatorcontrib><creatorcontrib>Saper, Joel, MD</creatorcontrib><creatorcontrib>Xiang, Jim, PhD</creatorcontrib><creatorcontrib>Rupnow, Marcia, PhD</creatorcontrib><creatorcontrib>Biondi, David, DO</creatorcontrib><creatorcontrib>Greenberg, Steven J., MD</creatorcontrib><creatorcontrib>Hulihan, Joseph, MD</creatorcontrib><creatorcontrib>for the CAPSS-277 Investigator Group</creatorcontrib><creatorcontrib>CAPSS-277 Investigator Group</creatorcontrib><title>Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Abstract Objective: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. Methods: This was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority study. Adults with 3 to 12 migraines per month were randomized in a 1:1 ratio to receive an initial dose of 25 mg/d of either topiramate or amitriptyline, subsequently titrated to a maximum of 100 mg/d (or the maximum tolerated dose). The primary efficacy outcome was the change from prospective baseline in the mean monthly number of migraine episodes. Secondary efficacy variables included changes from the prospective baseline phase to the end of the double-blind phase in the mean monthly (28-day) rate of days with migraine, mean monthly rate of days with headache (migraine and nonmigraine), mean monthly rate of acute abortive medication use, mean monthly migraine duration, and mean monthly migraine severity. Additional secondary efficacy variables included changes in the mean monthly severity of migraine-associated symptoms (photophobia, phonophobia, and nausea), change in the mean monthly frequency f migraine-associated vomiting, and response rates (based on monthly migraine days and total headache days). The Migraine-Specific Quality of Life Questionnaire (MSQ) and the Weight Satisfaction Scale Questionnaire, which measures subjective satisfaction with current weight, were administered. Treatment-emergent adverse events (TEAEs) were monitored through the end of double-blind treatment. Results: The intent-to-treat population included 331 subjects (172 topiramate, 159 amitriptyline; 84.9% female; 84.6% white; mean [SD] age, 38.8 [11.0] years; mean weight, 77.1 [20.1] kg) who provided at least 1 efficacy assessment. The least squares mean (LSM) change from baseline in the mean monthly number of migraine episodes was not significantly different between the topiramate and amitriptyline groups (-2.6 and -2.7, respectively; 95% CI, -0.6 to 0.7). There were no significant differences between treatment groups in any of the prespecified secondary outcome measures. Subjects receiving topiramate had a significantly greater improvement in mean functional disability scores during migraine attacks compared with amitriptyline (LSM change: -0.33 vs -0.19; 95% CI, -0.3 to 0.0; P = 0.040) and in the role function-restrictive, role function-preventive, and emotional function domains of the MSQ ( P = 0.012, P = 0.014, and P = 0.029, respectively). Subjects receiving topiramate had a mean weight loss of 2.4 kg, compared with a mean weight gain of 2.4 kg in subjects receiving amitriptyline. Subjects in the topiramate group reported an overall improvement from baseline in weight satisfaction, whereas the amitriptyline group reported an overall deterioration in weight satisfaction ( P < 0.001, topiramate vs amitriptyline). TEAEs of mild or moderate severity were reported in 118 subjects (66.7%) in the topiramate group and 112 subjects (66.3%) in the amitriptyline group. Among the most common TEAEs (reported in ±5% of subjects during the double-blind phase) in the topiramate group were paresthesia (29.9%), fatigue (16.9%), somnolence (11.9%), hypoesthesia (10.7%), and nausea (10.2%). The most commonly reported TEAEs in the amitriptyline group were dry mouth (35.5%), fatigue (24.3%), somnolence (17.8%), weight increase (13.6%), dizziness (10.7%), and sinusitis (10.7%). Conclusions: In this noninferiority study, topiramate was at least as effective as amitriptyline in terms of reducing the rate of mean monthly migraine episodes and all prespecified secondary efficacy end points. Topiramate was associated with improvement in some quality-of-life indicators compared with amitriptyline and was associated with weight loss and improved weight satisfaction.</description><subject>Adult</subject><subject>amitriptyline</subject><subject>Amitriptyline - adverse effects</subject><subject>Amitriptyline - therapeutic use</subject><subject>Anniversaries</subject><subject>Biological and medical sciences</subject><subject>Body Weight - drug effects</subject><subject>Central Nervous System Agents - adverse effects</subject><subject>Central Nervous System Agents - therapeutic use</subject><subject>Clinical trials</subject><subject>Disability Evaluation</subject><subject>Disease prevention</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fructose - adverse effects</subject><subject>Fructose - analogs & derivatives</subject><subject>Fructose - therapeutic use</subject><subject>headache</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Headaches</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medical Education</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Migraine</subject><subject>Migraine Disorders - prevention & control</subject><subject>migraine prophylaxis</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Patient Satisfaction</subject><subject>Pharmacology. Drug treatments</subject><subject>Quality of Life</subject><subject>Questionnaires</subject><subject>Severity of Illness Index</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>topiramate</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Vascular diseases and vascular malformations of the nervous system</subject><subject>weight loss</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNUk2P0zAQtRCILYW_AJYQt6bYsdvEHFaqVnxJK3FgkbhZrj1e3E3iME6Kyq_iJ-KoVStx4mRbfvPezLxHyCvOlpzx9dvd0jahG34AmmXJmFoysWQle0RmvK5Uwbn8_pjMGJeqKBWvr8izlHaMMaFW5VNyxZVQopZyRv7cxT6gac0AdA-YxkRNGwYM_XDICkBDR9twj2a69wh76IYQu3d0Q8t18QvgYUHbsRmCzR-AC4qmc7ENv8EtqIvjtoFim4kuLze27WFBe4OmaaAp7jGOPe1iFzoPGCKG4UBzA6aZtI3L5OcORkzPyRNvmgQvTuecfPvw_u7mU3H75ePnm81tYWVdDgUwb61dl7JaWyW5WHlbCusUKOFrzoyUSgCr1EpwryrnfO1XIGuvwDPPLIg5eX3k7TH-HCENehdH7LKk5kwIvmZcVRlVHVEWY0oIXvcYWoOHDNKTU3qnz07pySnNhM5O5cqXJ_5x24K71J2syYA3J4BJ1jQ-L9aGdMaVXPLVNNmcbI44yNvYB0CdbIDOggsIdtAuhv9o5vofjgkXsuwDHCBdJtep1Ex_nYI15YqpnKkcKfEXg6LPcw</recordid><startdate>20090301</startdate><enddate>20090301</enddate><creator>Dodick, David W., MD</creator><creator>Freitag, Fred, DO</creator><creator>Banks, James, MD</creator><creator>Saper, Joel, MD</creator><creator>Xiang, Jim, PhD</creator><creator>Rupnow, Marcia, PhD</creator><creator>Biondi, David, DO</creator><creator>Greenberg, Steven J., MD</creator><creator>Hulihan, Joseph, MD</creator><general>EM Inc USA</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>20090301</creationdate><title>Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs</title><author>Dodick, David W., MD ; Freitag, Fred, DO ; Banks, James, MD ; Saper, Joel, MD ; Xiang, Jim, PhD ; Rupnow, Marcia, PhD ; Biondi, David, DO ; Greenberg, Steven J., MD ; Hulihan, Joseph, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c482t-e0fccc62476c94135fc23cd9e93f810a4493e079531f97ddf8f5e48f9ef0f0ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>amitriptyline</topic><topic>Amitriptyline - adverse effects</topic><topic>Amitriptyline - therapeutic use</topic><topic>Anniversaries</topic><topic>Biological and medical sciences</topic><topic>Body Weight - drug effects</topic><topic>Central Nervous System Agents - adverse effects</topic><topic>Central Nervous System Agents - therapeutic use</topic><topic>Clinical trials</topic><topic>Disability Evaluation</topic><topic>Disease prevention</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fructose - adverse effects</topic><topic>Fructose - analogs & derivatives</topic><topic>Fructose - therapeutic use</topic><topic>headache</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Headaches</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Medical Education</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Migraine</topic><topic>Migraine Disorders - prevention & control</topic><topic>migraine prophylaxis</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurology</topic><topic>Patient Satisfaction</topic><topic>Pharmacology. Drug treatments</topic><topic>Quality of Life</topic><topic>Questionnaires</topic><topic>Severity of Illness Index</topic><topic>Surveys and Questionnaires</topic><topic>Time Factors</topic><topic>topiramate</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Vascular diseases and vascular malformations of the nervous system</topic><topic>weight loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dodick, David W., MD</creatorcontrib><creatorcontrib>Freitag, Fred, DO</creatorcontrib><creatorcontrib>Banks, James, MD</creatorcontrib><creatorcontrib>Saper, Joel, MD</creatorcontrib><creatorcontrib>Xiang, Jim, PhD</creatorcontrib><creatorcontrib>Rupnow, Marcia, PhD</creatorcontrib><creatorcontrib>Biondi, David, DO</creatorcontrib><creatorcontrib>Greenberg, Steven J., MD</creatorcontrib><creatorcontrib>Hulihan, Joseph, MD</creatorcontrib><creatorcontrib>for the CAPSS-277 Investigator Group</creatorcontrib><creatorcontrib>CAPSS-277 Investigator Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Proquest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dodick, David W., MD</au><au>Freitag, Fred, DO</au><au>Banks, James, MD</au><au>Saper, Joel, MD</au><au>Xiang, Jim, PhD</au><au>Rupnow, Marcia, PhD</au><au>Biondi, David, DO</au><au>Greenberg, Steven J., MD</au><au>Hulihan, Joseph, MD</au><aucorp>for the CAPSS-277 Investigator Group</aucorp><aucorp>CAPSS-277 Investigator Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2009-03-01</date><risdate>2009</risdate><volume>31</volume><issue>3</issue><spage>542</spage><epage>559</epage><pages>542-559</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Abstract Objective: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. Methods: This was a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority study. Adults with 3 to 12 migraines per month were randomized in a 1:1 ratio to receive an initial dose of 25 mg/d of either topiramate or amitriptyline, subsequently titrated to a maximum of 100 mg/d (or the maximum tolerated dose). The primary efficacy outcome was the change from prospective baseline in the mean monthly number of migraine episodes. Secondary efficacy variables included changes from the prospective baseline phase to the end of the double-blind phase in the mean monthly (28-day) rate of days with migraine, mean monthly rate of days with headache (migraine and nonmigraine), mean monthly rate of acute abortive medication use, mean monthly migraine duration, and mean monthly migraine severity. Additional secondary efficacy variables included changes in the mean monthly severity of migraine-associated symptoms (photophobia, phonophobia, and nausea), change in the mean monthly frequency f migraine-associated vomiting, and response rates (based on monthly migraine days and total headache days). The Migraine-Specific Quality of Life Questionnaire (MSQ) and the Weight Satisfaction Scale Questionnaire, which measures subjective satisfaction with current weight, were administered. Treatment-emergent adverse events (TEAEs) were monitored through the end of double-blind treatment. Results: The intent-to-treat population included 331 subjects (172 topiramate, 159 amitriptyline; 84.9% female; 84.6% white; mean [SD] age, 38.8 [11.0] years; mean weight, 77.1 [20.1] kg) who provided at least 1 efficacy assessment. The least squares mean (LSM) change from baseline in the mean monthly number of migraine episodes was not significantly different between the topiramate and amitriptyline groups (-2.6 and -2.7, respectively; 95% CI, -0.6 to 0.7). There were no significant differences between treatment groups in any of the prespecified secondary outcome measures. Subjects receiving topiramate had a significantly greater improvement in mean functional disability scores during migraine attacks compared with amitriptyline (LSM change: -0.33 vs -0.19; 95% CI, -0.3 to 0.0; P = 0.040) and in the role function-restrictive, role function-preventive, and emotional function domains of the MSQ ( P = 0.012, P = 0.014, and P = 0.029, respectively). Subjects receiving topiramate had a mean weight loss of 2.4 kg, compared with a mean weight gain of 2.4 kg in subjects receiving amitriptyline. Subjects in the topiramate group reported an overall improvement from baseline in weight satisfaction, whereas the amitriptyline group reported an overall deterioration in weight satisfaction ( P < 0.001, topiramate vs amitriptyline). TEAEs of mild or moderate severity were reported in 118 subjects (66.7%) in the topiramate group and 112 subjects (66.3%) in the amitriptyline group. Among the most common TEAEs (reported in ±5% of subjects during the double-blind phase) in the topiramate group were paresthesia (29.9%), fatigue (16.9%), somnolence (11.9%), hypoesthesia (10.7%), and nausea (10.2%). The most commonly reported TEAEs in the amitriptyline group were dry mouth (35.5%), fatigue (24.3%), somnolence (17.8%), weight increase (13.6%), dizziness (10.7%), and sinusitis (10.7%). Conclusions: In this noninferiority study, topiramate was at least as effective as amitriptyline in terms of reducing the rate of mean monthly migraine episodes and all prespecified secondary efficacy end points. Topiramate was associated with improvement in some quality-of-life indicators compared with amitriptyline and was associated with weight loss and improved weight satisfaction.</abstract><cop>Bridgewater, NJ</cop><pub>EM Inc USA</pub><pmid>19393844</pmid><doi>10.1016/j.clinthera.2009.03.020</doi><tpages>18</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-2918 |
| ispartof | Clinical therapeutics, 2009-03, Vol.31 (3), p.542-559 |
| issn | 0149-2918 1879-114X |
| language | eng |
| recordid | cdi_proquest_journals_1033160197 |
| source | MEDLINE; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Adult amitriptyline Amitriptyline - adverse effects Amitriptyline - therapeutic use Anniversaries Biological and medical sciences Body Weight - drug effects Central Nervous System Agents - adverse effects Central Nervous System Agents - therapeutic use Clinical trials Disability Evaluation Disease prevention Double-Blind Method Female Fructose - adverse effects Fructose - analogs & derivatives Fructose - therapeutic use headache Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Headaches Humans Internal Medicine Male Medical Education Medical sciences Middle Aged Migraine Migraine Disorders - prevention & control migraine prophylaxis Nervous system (semeiology, syndromes) Neurology Patient Satisfaction Pharmacology. Drug treatments Quality of Life Questionnaires Severity of Illness Index Surveys and Questionnaires Time Factors topiramate Treatment Outcome United States Vascular diseases and vascular malformations of the nervous system weight loss |
| title | Topiramate versus amitriptyline in migraine prevention: A 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs |
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