Objective: The objective of this article is to see whether the effect of candesartan for migraine prevention, shown in one previous study, could be confirmed in a new study, and if so, whether the effect was comparable to that of propranolol (non-inferiority analysis), and whether adverse events were different.
Methods: In a randomised, triple-blind, double cross-over study, 72 adult patients with episodic or chronic migraine went through three 12-week treatment periods on either candesartan 16 mg, propranolol slow-release 160 mg, or placebo. The main outcome measures were days with migraine headache per four weeks (primary outcome), days with headache, hours with headache, proportion of responders (>50% reduction of migraine days from baseline), and adverse events.
Results: In the modified intention-to treat-analysis, candesartan and propranolol were both superior to placebo: 2.95 (95% confidence interval: 2.35-3.55%) and 2.91 (2.36-3.45%), versus 3.53 (2.98-4.08%) for migraine days per month (p = 0.02 for both comparisons, Wilcoxon's paired signed rank test, blinded statistical analysis). Candesartan was non-inferior to propranolol (and vice versa). The proportion of responders was significantly higher on candesartan (43%) and propranolol (40%) than on placebo (23%) (p = 0.025 and <0.050, respectively). There were more adverse events on candesartan (n = 133%) and propranolol (n = 143%) than on placebo (n = 90%), and the adverse event profiles of the active substances differed somewhat.
Conclusion: It is confirmed that candesartan 16 mg is effective for migraine prevention, with an effect size similar to propranolol 160 mg, and with somewhat different adverse events.
Trial registration: EUDRACT (2008-002312-7), ClinicalTrials.gov (NCT00884663).
Keywords: Candesartan; clinical trial; migraine; prophylaxis; propranolol.
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