The concomitant use of atogepant for preventive and ubrogepant for acute migraine treatment was found to be safe and well-tolerated over 12 weeks, according to research presented at the American Academy of Neurology annual meeting.

Patients often take atogepant for prevention of migraine plus ubrogepant for acute treatment, Jessica Ailani, MD, director of the MedStar Georgetown Headache Center and a professor in the department of neurology at Georgetown University Medical Center, said in a presentation. Sometimes they are each prescribed by two different providers.

“We thought, ‘What does their liver look like?’” she said. “We wanted to see, if we purposely put people on a combination of these treatments, what would happen to safety and tolerability.”

In the phase 4 TANDEM study, patients with episodic migraines received atogepant 60 mg once daily for 12 weeks. Then ubrogepant 100 mg was added as needed for breakthrough migraines for 12 weeks, according to the study. A second ubrogepant dose or another medication could be taken for unresolved headaches within 24 hours.

A total of 262 participants were treated in the first period of the study (Safety Population 1), and 218 continued into the second period (Safety Population 2).

“There was similar data across the board relative to frequency of use of ubrogepant,” Ailani said.

A treatment-emergent adverse event (TEAE) was seen in 49.6% of participants in Safety Population 1 vs. 43.1% in Safety Population 2. The most common TEAEs included COVID-19, fatigue, nausea, decreased appetite and constipation.

“Percentages are on the low side for atogepant when we add ubrogepant in,” she said. “No hepatic safety issues were seen in the combination group.”

Ailani concluded: “Concomitant use of ubrogepant and atogepant was safe and well-tolerated over a 12-week period. Overall safety results across 24 weeks were consistent with the safety profile of atogepant alone. No new safety issues were identified across the 24-week study.”

During the discussion period, Ailani noted that patients with uncontrolled cardiac disease, meaning those who experienced a myocardial infarction or stroke in the last 6 months, would not have been included in the trial.

“And you wouldn’t see uncontrolled hypertension come up in this short-term trial,” she said.