Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: A retrospective claims analysis

Hepp, Zsolt; Dodick, David W.; Varon, Sepideh F.; Chia, Jenny; Matthew, Nitya; Gillard, Patrick; Hansen, Ryan N.; Devine, Emily Beth

doi:10.1177/0333102416678382

Cited by 284 publications

(292 citation statements)

References 20 publications

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“…One was the possible bias introduced by awareness among patients who were randomized to topiramate that they could cross over to onabotulinumtoxinA, potentially inflating topiramate discontinuation rates. 15 It should be noted that the discontinuation rate for onabotulinumtoxinA in this trial was also higher than that in prior RCTs. While such biases cannot be excluded, topiramate patients could not cross over to onabotuli-numtoxinA until week 12 (16 weeks after enrollment).…”

Section: Discussionmentioning

confidence: 56%

“…15,16 Efficacy, addressing the benefit of a treatment under ideal conditions, is best measured in RCTs, 17 which already have been undertaken for onabotulinumtoxinA and topiramate. 15,16 Efficacy, addressing the benefit of a treatment under ideal conditions, is best measured in RCTs, 17 which already have been undertaken for onabotulinumtoxinA and topiramate.…”

Section: Introductionmentioning

confidence: 99%

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FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

et al. 2019

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Objective To compare effectiveness of onabotulinumtoxinA and topiramate for chronic migraine (CM) prevention. Background The efficacy* of onabotulinumtoxinA and topiramate has been established in placebo‐controlled randomized clinical trials (*defined as the benefit of treatment under ideal conditions). The effectiveness* of the 2 preventive treatments, however, has not been established (*the benefit of treatment under real‐world conditions, representing a blend of efficacy and tolerability). Methods In this multicenter, randomized, parallel‐group, post‐authorization, open‐label prospective study (FORWARD; http://ClinicalTrials.gov, NCT02191579), we randomized adults with CM (1:1) to onabotulinumtoxinA 155 U every 12 weeks for 3 cycles or topiramate “immediate release” 50‐100 mg/day to week 36. Primary outcome measure was proportion of patients achieving ≥50% reduction in headache days (weeks 29‐32). Missing values were imputed using baseline observation carried forward (BOCF) methodology. After 12 weeks, patients initially randomized to topiramate could cross over to onabotulinumtoxinA treatment. We monitored and recorded all adverse events (AEs). Results We enrolled 282 patients (onabotulinumtoxinA, n = 140; topiramate, n = 142) and 148 patients completed randomized treatment (onabotulinumtoxinA, n = 120 [86%]; topiramate, n = 28 [20%]). Primary reasons for withdrawal were ineffective treatment (onabotulinumtoxinA, n = 7 [5%]; topiramate, n = 27 [19%]) and AEs (onabotulinumtoxinA, n = 5 [4%]; topiramate, n = 72 [51%]). Eighty topiramate patients crossed over to onabotulinumtoxinA. In the BOCF analysis, a significantly higher proportion of patients randomized to onabotulinumtoxinA experienced ≥50% reduction in headache frequency compared with those randomized to topiramate (40% [56/140] vs 12% [17/142], respectively; adjusted OR, 4.9 [95% CI, 2.7‐9.1]; P < .001). OnabotulinumtoxinA was superior to topiramate in meeting secondary endpoints. In a post hoc analysis using observed data, the 50% responder rates at week 12 were 45.6% for onabotulinumtoxinA (n = 125) and 29.4% for topiramate (n = 109) (P = .015). AEs were reported by 48% (105/220) of onabotulinumtoxinA and 79% (112/142) of topiramate patients. Results were similar in those who crossed over to onabotulinumtoxinA. Conclusions While using imputation methods of accounting for differences in discontinuation rates, we found onabotulinumtoxinA to have greater clinical utility than topiramate, largely because of tolerability issues associated with the latter and a relatively higher number of onabotulinumtoxinA patients remaining on treatment.

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Section: Discussionmentioning

confidence: 56%

Section: Introductionmentioning

confidence: 99%

FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

et al. 2019

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“…Treatment guidelines suggest that patients who have 4 or more migraine headache days (MHDs) per month or who have significant impairment due to migraine should be offered preventive therapy. 7 There appears to be a limited window of time during which a patient will make a decision on whether to remain on their current migraine preventive medication. 4 Among those who do receive preventive therapy, adherence is poor, with most discontinuing the therapy within 6-12 months.…”

Section: Introductionmentioning

confidence: 99%

Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies

et al. 2019

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Objective.-To evaluate onset of effect of galcanezumab in patients with episodic migraine. Background.-Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. Design/Methods.-Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs. Results.-For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P < .001) and each subsequent week compared with placebo-treated patients (P ≤ .004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P < .001], and for EVOLVE-2, 59.4% vs 38.0% [P < .001]). Conclusion.-Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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“…Serotonin (5-hydroxytryptamine ) has multiple receptors: 5-HT [1][2][3][4][5][6][7] . The 5-HT 1 subfamily consists of 5-HT 1A,1B,1D, and-1F .…”

Section: -Ht 1f Receptor Agonists (Ditans)mentioning

confidence: 99%

“…1 The health-related financial burden of migraine in the U.S. has been estimated to be $11 billion. 4 Most treatment options available have been nonspecific to migraine and limited by adverse events (AEs) and patients' medical comorbidities. 3 Adherence to preventive medications, however, is often poor, with only 25% adherence at 6 months.…”

Section: Introductionmentioning

confidence: 99%

Novel Medications for the Treatment of Migraine

2019

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Objective To describe the new classes of medication for headache management and their roles in clinical practice. Background Calcitonin gene‐related peptide (CGRP) is a key component in the underlying pathophysiology of migraine. Research focused on targeting CGRP for headache treatment has led to the development of entirely new classes of medications – the gepants and the CGRP monoclonal antibodies (mAbs) – for both acute and preventive treatment. A third class, the ditans, is being developed to target the 5‐HT1F receptor to provide acute treatment without vasoconstrictive effects. Methods This article reviews the pathophysiology of migraine that has led to these new pharmacologic developments. Available information from randomized controlled trials, abstracts, press releases, and relevant preclinical studies is summarized for each class of medications. Results At the time of this writing, one ditan has been submitted to the U.S. Food and Drug Administration (FDA) for approval. One gepant is anticipated to be submitted within the first quarter of 2019, and others are in clinical trials. Three CGRP mAbs have been FDA approved and are now available in clinical practice, and a fourth was submitted in the first quarter of 2019. Conclusions The development of new migraine‐specific classes of medications provides more treatment options for both acute and preventive treatment of migraine.

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Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: A retrospective claims analysis

Cited by 284 publications

References 20 publications

FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies

Novel Medications for the Treatment of Migraine

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