Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain.

BACKGROUND AND OBJECTIVES: To examine the efficacy of ubrogepant in the treatment of migraine with mild vs moderate or severe pain. METHODS: This was a phase 3, open-label, dose-blinded, 52-week extension trial. Adults with migraine were randomized 1:1:1 (usual care, ubrogepant 50 mg, or ubrogepant 100 mg). Participants treated up to 8 migraine attacks of any pain intensity every 4 weeks. Efficacy outcomes (only collected for ubrogepant) included 2-hour pain freedom (2hPF), freedom from associated symptoms, and from disability. A generalized linear mixed model with binomial distribution and logit link function was used to assess the influence of baseline pain intensity on treatment outcomes in this post hoc analysis. RESULTS: Data for 19,291 attacks from 808 participants were included. 2hPF rates were higher for attacks treated when pain was mild vs moderate or severe: ubrogepant 50 mg (47.1% vs 23.6%; odds ratio [95% CI] 2.89 [2.57-3.24]) and ubrogepant 100 mg (55.2% vs 26.1%; 3.50 [3.12-3.92]; p < 0.0001 both doses). Rates of freedom from photophobia, phonophobia, and nausea 2 hours after treatment were also significantly higher following the treatment of mild vs moderate or severe pain (p < 0.001 all symptoms, both doses). At 2 hours, the proportion of attacks with normal function was more than double for both doses of ubrogepant (p < 0.001). The most common adverse event was upper respiratory tract infection (∼11% both doses). Serious adverse events were reported by 2% in ubrogepant 50 mg and 3% in ubrogepant 100 mg. DISCUSSION: Relative to treatment of attacks with moderate or severe pain, treatment with ubrogepant during mild pain resulted in significantly higher rates of freedom from pain, freedom from associated symptoms, and achieving normal function 2 hours after administration. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov, NCT02873221. CLASSIFICATION OF EVIDENCE: This trial provides Class III evidence that treatment of migraine with ubrogepant when pain is mild vs moderate or severe increases the likelihood of achieving pain freedom, absence of symptoms, and normal function within 2 hours postdose.

Assessing Physician-Patient Dialogues About Chronic Migraine During Routine Office Visits.

OBJECTIVE: To assess physician-patient communication and identify the frequency of use of specific communication techniques by analyzing recordings of routinely scheduled medical encounters for patients with clinician-identified chronic migraine. BACKGROUND: Chronic migraine is an under-diagnosed, under-treated, and highly burdensome disease. Effective medical communication is integral to optimal medical care, including providing accurate diagnoses, creating effective treatment plans, and enhancing patient adherence. Communication patterns during office visits may be a target for intervention to improve outcomes for people with chronic migraine. DESIGN: This was a prospective, observational study based on analysis of audio recordings collected during neurologist-patient chronic migraine dialogues. METHODS: Twenty neurologists from a US neurology panel maintained by Verilogue, Inc., a research organization specializing in healthcare dialogues, were invited to identify patients with chronic migraine and record clinical encounters with their patients. Both new patient visits and follow-up visits were included in this analysis. Neurologist-patient dialogues were audio-recorded, anonymized, transcribed, and analyzed by a sociolinguist for the presence of prespecified communication parameters, strategies, and specific language indicative of optimal migraine-related medical care. RESULTS: Fourteen out of the 20 invited neurologists (70.0%) accepted the study invitation and recorded 35 encounters with patients eligible for the study. The patient sample was 91.4% female (n = 32/35), with a mean age of 46 years. On average, there were 17 headache-related questions per visit; 82.0% of questions were closed-ended (n = 369/450). Headache/migraine frequency was elicited in 77.1% of the dialogues (n = 27/35), but headache days per month was assessed in only a single dialogue. Only one neurologist utilized the ask-tell-ask technique. Headache-related disability was discussed in 22.9%of the dialogues (n = 8/35), with only one using open-ended questions. None of the dialogues discussed ictal vs interictal headache-related disability. Chronic migraine was mentioned in 8.6% of dialogues (n = 3/35) and treatment plans were discussed in 37.1% of the dialogues (n = 13/35). CONCLUSIONS: Results from this preliminary study showed that the majority of the neurologist-chronic migraine patient dialogues did not assess elements crucial for diagnosis and treatment (eg, headache days per month and headache related disability) or use standard communication techniques (eg, open-ended questions, ask-tell-ask). We recommend intervention studies designed to assess the benefits of improved communication on diagnostic accuracy, treatment decisions, and patient reported outcomes.

Clinical Pharmacokinetics of Oxymetazoline Cream Following Topical Facial Administration for the Treatment of Erythema Associated With Rosacea.

BACKGROUND: Oxymetazoline cream 1.0% is FDA-approved for the topical treatment of persistent facial erythema associated with rosacea in adults. This phase 2, multicenter, randomized, double-blind, parallel-group study assessed the pharmacokinetics, safety, and tolerability of oxymetazoline in patients with moderate to severe erythema associated with rosacea. METHODS: Eligible patients were randomized to 1 of 8 treatment groups (oxymetazoline cream 0.5%, 1.0%, or 1.5% or vehicle applied topically either once or twice daily for 28 days). Pharmacokinetic analyses were conducted in patients receiving oxymetazoline. Plasma samples for pharmacokinetic assessments were collected prior to dosing and 6 times postdose on days 1 and 28. RESULTS: A total of 356 patients were included in the safety population (oxymetazoline, n=268; vehicle, n=88). Thirty patients (11.2%) in the oxymetazoline group reported treatment-related treatment-emergent adverse events, most of which were mild to moderate application-site reactions. Oxymetazoline, at all concentrations, was generally safe and well tolerated. Mean maximum observed plasma concentrations were ≤115 pg/mL across all groups; the highest mean values for area under the plasma concentration-time curve from time 0 to 24 hours following once- and twice-daily administration of oxymetazoline 1.5% were 1680 pg•h/mL and 2660 pg•h/mL, respectively. Systemic exposure to oxymetazoline increased dose proportionally with once- and twice-daily administration. CONCLUSION: These findings support the use of oxymetazoline for the treatment of persistent facial erythema associated with rosacea. J Drugs Dermatol. 2018;17(2):213-220.