Tolerability of Acute Migraine Medications: Influence of Methods of Assessment and Relationship With Headache Attributes

Abstract

Tolerability is an important attribute of patient satisfaction with, and consequence adherence to, migraine acute treatment. Nevertheless, the determinants of tolerability are poorly explored. Accordingly, our objectives were: (i) in subjects receiving triptans, to contrast two methods of assessing adverse events (AEs); and (ii) to explore the relationship between migraine features and treatment attributes with tolerability. We surveyed 365 migraineurs who had been using the same triptan for at least 3 months. After prospectively treating an attack, headache characteristics and treatment response were assessed using headache calendars. Subjects also completed a standardized questionnaire, first asking about any AE and then prompting patients with a list of possible AEs. We contrasted both sets of answers and conducted logistic regression to assess if headache attributes or response to therapy influenced tolerability. Using the unprompted method, AEs occurred in 11.5-36.4% of patients, depending on the triptan used. Using the prompted method, they ranged from 26.9 to 64.3%. Chest and neck tightness were spontaneously reported by 3.5% of the sample, vs. 7.4% when prompted (P < 0.05). Chest pain was not spontaneously reported and was elicited in nine patients (2.5%, P = 0.002). Feeling groggy occurred in 5.7 and 17.5% (P < 0.001). AEs were not a function of headache severity, disability, efficacy of the drug, time to meaningful relief with the drug or recurrence of pain. The report of AEs varies dramatically with the methods of assessment. However, tolerability is not influenced by the severity of the attacks or by medication efficacy.

Barriers to Satisfactory Migraine Outcomes. What Have We Learned, Where Do We Stand?

“…However, when presented with a list of potential side effects, most of them (US = 62.9%, Italy = 54.1%) reported at least 1 triptan side effect 69 . Interestingly, 31 (7.5%) subjects graded their adverse events as severe in the prompted questionnaire, but had not self‐reported them 70 …”

“…69 Interestingly, 31 (7.5%) subjects graded their adverse events as severe in the prompted questionnaire, but had not self-reported them. 70 Several potential explanations help to explain the low rate of persistent use of therapy, and many were discussed above. Two others deserve highlighting.…”

Early Onset of Efficacy and Consistency of Response Across Multiple Migraine Attacks From the Randomized COMPASS Study: AVP‐825 Breath Powered®Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral Sumatriptan

“…Total migraine freedom is a rigorous composite measure of pain freedom with absence of migraine‐associated symptoms, and provides a more comprehensive understanding of treatment impact than evaluation of these items individually . AVP‐825 produced higher rates of total migraine freedom than 100 mg oral sumatriptan, which were statistically significant at all measured time points from 15 through 90 minutes postdose in a post hoc analysis, demonstrating that AVP‐825 provides clinical results that matter to patients, namely, the complete absence of all major migraine symptoms (headache, photophobia, phonophobia, nausea, and vomiting) . Achievement of total migraine freedom at earlier time points is important because both migraine pain and migraine‐associated symptoms can contribute to disability and direct healthcare costs .…”

“…The exhalation delivery system enables, on average, more sumatriptan to reach the systemic circulation within the first 15 minutes relative to 100 mg oral sumatriptan, despite the considerably lower overall total systemic exposure with AVP‐825 . Collectively, the efficacy results from the COMPASS clinical trial are relevant to patients because a treatment effect that is achieved within 30 minutes for migraine pain or associated symptoms is generally deemed a highly desirable clinical outcome …”

Self-medication of migraine and tension-type headache: summary of the evidence-based recommendations of the Deutsche Migräne und Kopfschmerzgesellschaft (DMKG), the Deutsche Gesellschaft für Neurologie (DGN), the Österreichische Kopfschmerzgesellschaft (ÖKSG) and the Schweizerische Kopfwehgesellschaft (SKG)

“…Paracetamol and ibuprofen showed a comparable safety and tolerability, which was significantly superior to that of ASA. Further interesting approaches for a comparative evaluation of the safety and tolerability of non-narcotic analgesics [90] and triptans [91], respectively, should be referred to at this point.…”