Daily candesartan well tolerated and effective prophylaxis for episodic migraine: Study

A new study published in the journal of The Lancet Neurology showed that candesartan 16 mg used daily is a well-tolerated and effective preventive therapy for episodic migraine.

The angiotensin receptor blocker candesartan has showed promise in modest studies, but there are still few effective and well-tolerated migraine preventative therapies. Thus, this study assessed the safety, tolerability, and effectiveness of candesartan as a preventative measure for episodic migraine.

9 hospitals in Norway and one sizable hospital in Estonia participated in this study. For 12 weeks, adults between the ages of 18 and 64 who experienced 2 to 8 migraine attacks (with or without aura) each month were randomized (1:1:1) to receive oral candesartan 16 mg, candesartan 8 mg, or a placebo every day.

During the experiment, acute migraine medicine was allowed, but other preventative measures were not. In the intention-to-treat group (those who had at least one post-baseline assessment throughout the masked treatment period), the main outcome was the change in the mean number of migraine days per 4 weeks from baseline to weeks 9–12.

A total of 1340 people were evaluated for eligibility between April 9, 2021, and April 12, 2024, 806 were found to be ineligible, and 534 were added to the experiment. 457 individuals were randomly allocated to receive candesartan 16 mg (n = 156), candesartan 8 mg (n = 150), or a placebo (n = 151) after 77 were eliminated.

The study population had a mean age of 38·7 years (SD 10·0), with 391 (86%) female participants and 66 (14%) male individuals. At baseline, the average number of migraine days was 5·7 (SD 2·5). By weeks 9–12, the candesartan 16 mg group saw a reduction in migraine days of 2·04 days (95% CI 1·65–2·41 p<0·0001) when compared to 0·82 days (0·38–1·23; p=0·0003) in the placebo group (difference between groups –1·22 [95% CI –1·75 to –0·70]; p<0·0001).

The most common adverse event with candesartan 16 mg was dizziness, reported in 46 (30%) of 156 participants, compared with 19 (13%) of 151 in the placebo group. Serious adverse events were reported in 4 (3%) participants in the candesartan 16 mg group and one (1%) participant in the placebo group. Adverse events leading to discontinuation occurred in four (3%) participants in both the candesartan 16 mg and placebo groups. Overall, these results validate candesartan and its function as an evidence-based, clinically significant migraine preventive strategy.

Source:

Øie, L. R., Wergeland, T., Salvesen, Ø., Gravdahl, G. R. B., Aschehoug, I., Gulati, S., Bj Rk, M.-H., Lundqvist, C., Alstadhaug, K. B. R., Winsvold, B. S., Aamodt, A. H., Larsen, I. C., B E, M. G., Braschinsky, M., Müller, B., Vetvik, K. G. T., Müller, K. I., Aaseth, K., Khanevski, A. N., … Tronvik, E. (2025). Candesartan versus placebo for migraine prevention in patients with episodic migraine: a randomised, triple-blind, placebo-controlled, phase 2 trial. Lancet Neurology, 24(10), 817–827. https://doi.org/10.1016/S1474-4422(25)00269-8