TOPLINE:

A daily administration of candesartan, an angiotensin II type 1 receptor blocker, at a dose of 16 mg for 12 weeks was effective and well tolerated in preventing episodic migraine.

METHODOLOGY:

• Researchers conducted a phase 2 trial to evaluate the efficacy, safety, and tolerability of candesartan at doses of 16 and 8 mg in preventing episodic migraine.
• They included 457 patients with a history of episodic migraine (mean age, 38.7 years; 86% women) who were randomly assigned (1:1:1) to receive candesartan 16 or 8 mg or placebo once daily for 12 weeks.
• The primary outcome was changes in the mean number of migraine days per 4 weeks (monthly) from baseline to weeks 9-12 of the treatment period.

TAKEAWAY:

• Participants receiving candesartan 16 mg showed a greater reduction in the mean number of monthly migraine days from baseline to 9-12 weeks than those receiving placebo (between-group difference, -1.22; P < .0001).
• Those who received candesartan 8 mg reported a greater reduction in the mean number of monthly migraine days at 9-12 weeks post-treatment (between-group difference, -1.39; P < .0001); however, the effect was not greater than that seen for the 16-mg dose.
• The mean number of monthly headache days, days with triptan use, and a ≥ 50% reduction in monthly migraine days were higher with both doses of candesartan than with placebo.
• Dizziness was more common in candesartan 16 mg (30%) and 8 mg (28%) groups than in the placebo group (13%). Serious adverse events occurred in 3% of participants in the 16 mg group and 1% of those in the 8 mg group, with 3% of those in the candesartan 16 mg and placebo groups discontinuing the trial due to adverse events.

IN PRACTICE:

"Given its demonstrated efficacy, high tolerability, low toxicity, ease of administration, and affordability, candesartan should be included in migraine prevention guidelines as a first-line treatment," the authors wrote.

"Compared with existing treatment options, candesartan's favourable safety and tolerability profile might encourage better adherence in a condition with substantial unmet need," they added.

SOURCE:

This study was led by Lise Rystad Øie, PhD, Department of Neurology, St Olav's University Hospital, Trondheim, Norway, and was published online on September 17, 2025, in The Lancet Neurology.

LIMITATIONS:

The 12-week treatment duration may have limited the assessment of candesartan's long-term efficacy. The eligibility criteria of two to eight attacks per month may have underrepresented individuals with high-frequency migraines, and the exclusion of those with 15 or more headache days per month limited the generalisability of the findings to populations with chronic migraine.

DISCLOSURES:

This study was funded by the Norwegian Research Council. Several authors reported receiving honoraria from various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.