AHS Conference Coverage

Atogepant Reduces Blood Pressure in Participants With Migraine, Overweight or Obesity, and Baseline Hypertension

Anthony Calabro, MA

Key Highlights

  • Atogepant treatment was associated with reductions in sitting systolic blood pressure and diastolic blood pressure over 52 weeks among participants with overweight or obesity.
  • In participants with overweight or obesity and baseline hypertension, mean systolic blood pressure reductions ranged from −3.5 to −5.0 mmHg through week 52.
  • Hypertension-related treatment-emergent adverse events were uncommon and were not serious.

A 1-year interim analysis of Study 312 found that atogepant treatment was associated with overall blood pressure reductions over 52 weeks in participants with migraine and overweight or obesity, including those with baseline hypertension. The study findings were presented his findings at the American Headache Society 68th Annual Scientific Meeting in Orlando, FL.

Atogepant, a calcitonin gene–related peptide receptor antagonist indicated for preventive treatment of migraine, is associated with weight loss in people with migraine, including individuals with overweight or obesity. The analysis focused on blood pressure changes among individuals with overweight or obesity and baseline hypertension.

Researchers evaluated blood pressure changes in participants with overweight or obesity, defined as BMI ≥25 kg/m², who had hypertension at baseline and had previously participated in 1 of 2 phase 3, 12-week, double-blind lead-in studies. These were PROGRESS, which enrolled participants with chronic migraine, and ELEVATE, which enrolled participants with episodic migraine who had failed 2 to 4 conventional oral preventive treatments.

All Study 312 participants received atogepant 60 mg once daily for preventive treatment of migraine. Outcomes in the interim analysis included change from baseline in sitting systolic blood pressure and sitting diastolic blood pressure through week 52, as well as hypertension-related treatment-emergent adverse events.

Study Findings

The safety population included 595 participants, of whom 279 (46.9%) had overweight or obesity at baseline. Among participants with overweight or obesity, 153 (54.8%) also had hypertension. In the overweight/obesity group overall, mean (SD) baseline blood pressure was 124.7 (13.1)/80.5 (8.5) mmHg for systolic/diastolic blood pressure.

Across 52 weeks, mean blood pressure changes in participants with overweight or obesity ranged from −1.0 to −2.9 mmHg for systolic blood pressure and from −0.3 to −1.7 mmHg for diastolic blood pressure. Among those with overweight or obesity and hypertension at baseline, mean (SD) baseline blood pressure was 131.1 (11.1)/84.8 (6.9) mmHg. In this subgroup, mean changes through 52 weeks ranged from −3.5 to −5.0 mmHg for systolic blood pressure and from −1.3 to −3.3 mmHg for diastolic blood pressure.

Hypertension-related treatment-emergent adverse events occurred in 6 participants with overweight or obesity. These events were described as uncommon, nonserious, and mild or moderate in severity. None of these events, according to the researchers, were considered to have a causal relationship with atogepant treatment.

Clinical Implications

According to the study authors, the findings suggest that atogepant treatment was associated with overall blood pressure reduction over 52 weeks in participants with overweight or obesity, with greater magnitude of reduction observed among those with hypertension at baseline. The researchers also noted that atogepant was associated with weight loss over 52 weeks among participants with overweight or obesity, including those with baseline hypertension.

Expert Commentary

“Atogepant treatment was associated with overall BP reduction over 52 weeks in participants with overweight or obesity, including those with baseline hypertension. Hypertension-related treatment-emergent adverse events were uncommon,” the researchers concluded.

Reference
Ailani J, Peterlin BL, Chiang C-C, Monteith TS, Liu Y, Cohen E, et al. Blood pressure changes with atogepant in overweight and obese persons with migraine and baseline hypertension: interim analysis of a phase 3, multicenter, open-label, 156-week extension study. Abstract T13. https://americanheadachesociety.org/events/68th-annual-scientific-meeting/agenda