Migraine Prophylaxis and Acute Treatment Patterns Among Commercially Insured Patients in the United States

Woolley, J. Michael; Bonafede, Machaon; Maiese, B.A.; Lenz, Robert

doi:10.1111/head.13157

Cited by 65 publications

(81 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Another potential limitation was the substantially larger proportion of male participants vs. female participants (63.1% vs 36.9%), given the greater prevalence of migraine in females than males: males represented 17% of the study population in a large ( N = 107,122), retrospective study of commercial and Medicare Supplemental–insured adults who had a prescription claim for a migraine medication from 2008 through 2011 . Because the PK characteristics of ubrogepant are similar in males and females, however, the impact of this limitation is likely to be minimal.…”

Section: Discussionmentioning

confidence: 99%

“…25 Another potential limitation was the substantially larger proportion of male participants vs. female participants (63.1% vs 36.9%), given the greater prevalence of migraine in females than males: males represented 17% of the study population in a large (N = 107,122), retrospective study of commercial and Medicare Supplemental-insured adults who had a prescription claim for a migraine medication from 2008 through 2011. 31 Because the PK characteristics of ubrogepant are similar in males and females, however, the impact of this limitation is likely to be minimal. Furthermore, the E14 guidance from the FDA and the ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use regarding clinical evaluation of QT/QTc prolongation encourages including both genders in a thorough QT study, and states that gender-based analysis is not expected when the primary analysis is negative and there is no evidence suggesting gender differences.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial

Jakate

Boinpally

Butler

et al. 2019

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

Ubrogepant is a novel, oral calcitonin gene–related peptide receptor antagonist currently under US Food and Drug Administration (FDA) review for the acute treatment of migraine attacks. This double‐blind, four‐period crossover study compared the cardiac repolarization effect of therapeutic (100 mg) and supratherapeutic (400 mg) ubrogepant doses vs. placebo in healthy adults. Moxifloxacin 400 mg was used as an open‐label active control, and the primary end point was change from baseline in Fridericia‐corrected QT intervals (ΔQTcF). Assay sensitivity was demonstrated via statistically significant QTcF prolongation with moxifloxacin vs. placebo. After single oral doses of ubrogepant, the least squares mean placebo‐corrected ΔQTcF (ΔΔQTcF) and 90% confidence intervals (CIs) did not exceed the 10‐millisecond regulatory threshold at any timepoint. The 90% CI upper bounds were 2.46 milliseconds and 2.69 milliseconds for ubrogepant 100 and 400 mg, respectively. Categorical and concentration‐based analyses were consistent with the primary result, showing no significant impact of ubrogepant on cardiac repolarization.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial

Jakate

Boinpally

Butler

et al. 2019

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

show abstract

“… 19 – 22 In the US, nearly 50% and 80% of people with migraine who are prescribed a preventive medication discontinue it 60–90 days after initiation and are no longer on therapy 12 months after initiation, respectively. 20 , 23 , 24 A large proportion of preventive medication users often have a history either of prior medication failures or of switching treatments. 17 , 21 As a result, there is a high risk of patients not achieving meaningful reductions in headache with currently available preventives.…”

Section: Introductionmentioning

confidence: 99%

Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine

Ford¹,

Foster²,

Stauffer³

et al. 2018

PPA

View full text Add to dashboard Cite

BackgroundEffects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine.MethodsPatients with episodic (78.9%) or chronic migraine (21.1%) were evaluated in the CGAJ study, an open-label study with 12-month treatment period. Galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg was administered subcutaneously once a month during treatment period. A self-rated scale, Patient Satisfaction with Medication Questionnaire–Modified (PSMQ-M), was used to measure satisfaction levels. Participants reported HCRU for the previous 6 months at baseline and that which occurred since the patient’s last study visit during treatment period. Acute headache medication use for migraine or headache for the past month was self-reported by participants at baseline and at each monthly visit during treatment period.ResultsAt Months 1, 6, and 12, at least 69% of patients treated with galcanezumab responded positively for overall satisfaction, preference over prior treatments, and less impact from side effects. There were within-group reductions from baseline in migraine-specific HCRU (per 100 person-years) with galcanezumab for health care professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), and hospital admissions (3.7 to 0.4) during treatment period. Statistically significant reductions in HCRU were observed for some events. There were significant within-group reductions from baseline in mean number of days/month with acute headache medication use for migraine or headache at each monthly visit during treatment period (overall change: −5.1 for galcanezumab 120 mg/240 mg; p<0.001).ConclusionResults from this long-term, open-label study suggest that treatment with galcanezumab is likely to lead to high patient satisfaction with treatment as well as meaningful reductions in migraine-specific HCRU and acute headache medication use in people with migraine.

show abstract

“…Based on experience with orals, less frequent dosing improves adherence as do improved side effect profile, increased efficacy and a variety of other variables . However, migraineurs tend to show poor long‐term adherence to preventives, even when they are effective .…”

Section: How Good Are the Cgrp‐based Agents?mentioning

confidence: 99%

“…Based on experience with orals, less frequent dosing improves adherence as do improved side effect profile, increased efficacy and a variety of other variables. 9 However, migraineurs tend to show poor long-term adherence to preventives, even when they are effective. 10 Compliance (the concordance between the provider and the patient with respect to diagnosis and treatment plan) will be a critical factor in how well patients adhere to regimens with long intervals between treatments, particularly if the medications are effective in decreasing headache days and other migraine symptoms.…”

Section: Introductionmentioning

confidence: 99%

The Future of Migraine Prevention

Cowan

2018

Headache

View full text Add to dashboard Cite

Barring unforeseen circumstances, we anticipate the arrival of the first mechanism‐specific class of molecules for migraine prevention in 2018. Despite many ground‐breaking advances in the field over the last several years, these agents, broadly identified as calcitonin gene‐related peptide‐based pharmaceuticals, have captured the imagination and attention of the lay press and much of the headache community. This paper will address the factors, both class‐specific and systems‐based, that are likely to affect the launch, access, compliance, and adherence related to this new class, as well as attempt to place these novel medications in context of the current state and anticipated changes in headache medicine.

show abstract

Migraine Prophylaxis and Acute Treatment Patterns Among Commercially Insured Patients in the United States

Abstract: Patients with migraine who initiated prophylactic therapy had poor persistence with early gaps in therapy, were unlikely to switch prophylactic treatments, and most discontinued prophylaxis by the end of the first year.

Cited by 65 publications

References 15 publications

Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial

Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial

Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine

The Future of Migraine Prevention

Contact Info

Product

Resources

About