The Impact of Topiramate on Health‐Related Quality of Life Indicators in Chronic Migraine

Dodick, David W.; Silberstein, Stephen D.; Saper, Joel R.; Freitag, Fred; Cady, Roger; Rapoport, Alan M.; Mathew, Ninan T.; Hulihan, Joseph; Crivera, Concetta; Rupnow, Marcia F.T.; Mao, Ling‐Feng; Finlayson, Gary; Greenberg, Steven J.

doi:10.1111/j.1526-4610.2007.00950.x

Cited by 64 publications

(53 citation statements)

References 26 publications

(65 reference statements)

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“…There may also be reduced quality of life between attacks related to more general feelings of anxiety, depression, irritability, and sleepiness, which have been observed with greater frequency among migraineurs than corresponding population controls [24][25][26][27] However, the degree to which one or more of these health effects are the result of migraine itself, side effects of medication use (e.g., sleepiness), or independent conditions resulting from some shared risk factor for migraine is not fully understood. Randomized, double-blind, placebo-controlled clinical trials of prophylactic migraine treatments exhibiting efficacy in reducing headache days have produce mixed results, with several studies showing a statistically significant benefit on some quality of life indices [28][29][30][31][32] and others failing to do so [33,34]. However, it is not clear from these studies whether reported quality of life gains derived from patients in the active treatment arms feeling better on days in which they otherwise would have suffered migraine or improved quality of life in general during the between attack period.…”

Section: Discussionmentioning

confidence: 99%

EuroQol (EQ-5D) health utility scores for patients with migraine

Insinga

Golden

et al. 2010

Qual Life Res

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Section: Discussionmentioning

confidence: 99%

EuroQol (EQ-5D) health utility scores for patients with migraine

Insinga

Golden

et al. 2010

Qual Life Res

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“…Health-related quality of life was measured by change from baseline in mean MSQv2.1 score across three domains: role function restrictive (RF), role function preventive (RP), and emotional functioning (EF). MIDs for all domains of the MSQv2.1 have also been established for between-group differences (3.2, 4.6, and 7.5 for RR, RP, and EF, respectively) and within-group changes (+10.9, +8.3, and +12.2 for RR, RP, and EF, respectively) 21,22.…”

Section: Methodsmentioning

confidence: 99%

OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program

Aurora

Dodick

Hc³

et al. 2013

Acta Neurol Scand

151

119

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ObjectiveChronic migraine (CM) is a prevalent and disabling neurological disorder. Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program assessed efficacy and safety of onabotulinumtoxinA (BOTOX®) for prophylaxis of headaches in adults with CM. This secondary analysis assessed patients who received all five treatment cycles and completed the study.Materials and methodsPREEMPT (two phase III studies: 24-week double-blind, placebo-controlled [DBPC], parallel-group phase, followed by 32-week open-label [OL] phase) evaluated the efficacy and safety of onabotulinumtoxinA in CM (≥15 days/month with headache lasting ≥4 h a day). Patients were randomized (1:1) to onabotulinumtoxinA or placebo every 12 weeks for two cycles, followed by onabotulinumtoxinA for three cycles. Multiple headache symptom measures were evaluated. Results for the completer (five cycles) subgroup of patients are reported.ResultsOf 1384 total PREEMPT patients, 1005 received all five treatment cycles (513 received onabotulinumtoxinA only [onabotulinumtoxinA/onabotulinumtoxinA (O/O)] and 492 received two cycles of placebo then three cycles of onabotulinumtoxinA [placebo/onabotulinumtoxinA (P/O)]). Demographics were similar between treatment groups. At Week 56, after all patients were treated with onabotulinumtoxinA, there continued to be significant between-group differences favoring the O/O vs P/O group for the following headache symptom measures: LS mean change from baseline in frequencies of headache days (−12.0 O/O, −11.1 P/O; P = 0.035), migraine days (−11.6 O/O, −10.7 P/O; P = 0.038), and moderate/severe headache days (−11.0 O/O, −10.1 P/O; P = 0.042). For other measures (cumulative hours of headache on headache days, frequency of headache episodes, and percentage with severe Headache Impact Test (HIT)-6 score, and total HIT-6 and Migraine-Specific Quality of Life Questionnaire scores), there were also large mean improvements from baseline. The percent of patients with a ≥50% reduction from baseline in frequency of headache days was significantly greater for the onabotulinumtoxinA-only group at Week 56 (69.6% O/O, 62.8% P/O; P = 0.023). The treatment-related adverse event rate was 28.5% for onabotulinumtoxinA vs 12.4% for placebo in the DBPC phase and 34.8% for patients treated with onabotulinumtoxinA for all five cycles throughout the 56-week trials.ConclusionsThis subgroup analysis demonstrated improvements with onabotulinumtoxinA treatment (five cycles) vs placebo (two cycles)/onabotulinumtoxinA (three cycles) for multiple headache symptom measures and suggests that at Week 56, patients treated earlier with onabotulinumtoxinA had better outcomes. These findings demonstrate the continued need and cumulative benefit over time with continued prophylaxis, an important and clinically pragmatic observation for clinicians and patients.

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“…Topiramate is efficacious across a broad range of migraine frequencies [40][41][42] and has been associated with improvements in the performance of daily activities and QOL in episodic [43][44][45] and chronic migraine, as assessed by the MSQ. [46] The most common adverse effects associated with topiramate treatment include paraesthesia, fatigue, appetite loss and difficulty concentrating. [47] Two divalproex sodium formulations (delayed and extended release) are also effective in migraine prophylaxis.…”

Section: The Role Of Migraine Preventionmentioning

confidence: 99%

Migraine and Functional Impairment

Brandes

2009

CNS Drugs

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Migraine is a leading cause of disability worldwide; approximately half of those affected have such severe attacks that they cannot function normally in routine daily activities. Research is beginning to focus upon the burden of migraine between attacks, referred to as interictal burden. This burden encompasses worry and expectation of future attacks that consequently may be associated with limitations in social and family interactions, as well as work capacity. This review aims to increase physician awareness of the degree and scope of functional impairment associated with migraine. Physicians are in a position to assess the true impact of migraine in their patients using techniques such as open-ended questions during visits, and paper-based migraine assessment tools such as the Migraine Disability Assessment questionnaire. Eliciting such information on interictal burden may help the physician prescribe the most appropriate therapy based on their patients' degree of impairment. This article also describes the instruments most widely used for measuring migraine-related functional impairment, summarizes studies assessing the effects of migraine on indicators of health-related quality of life and presents data on how preventive migraine treatment may beneficially influence migraine-related functional impairment.

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The Impact of Topiramate on Health‐Related Quality of Life Indicators in Chronic Migraine

Cited by 64 publications

References 26 publications

EuroQol (EQ-5D) health utility scores for patients with migraine

EuroQol (EQ-5D) health utility scores for patients with migraine

OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program

Migraine and Functional Impairment

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