title: A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  EUDRACT (2008-002312-7), ClinicalTrials.gov (NCT00884663).
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway lars.stovner@ntnu.no.
authors: Lars J
authors: LJ
authors: Stovner
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway.
authors: Mattias
authors: M
authors: Linde
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway.
authors: Gøril B
authors: GB
authors: Gravdahl
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway.
authors: Erling
authors: E
authors: Tronvik
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway Department of Neurology, Oslo University Hospital - Rikshospitalet, Norway.
authors: Anne H
authors: AH
authors: Aamodt
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway.
authors: Trond
authors: T
authors: Sand
authors: Norwegian National Headache Centre, Department of Neuroscience, Norwegian University of Science and Technology (NTNU), and St. Olavs Hospital, Norway.
authors: Knut
authors: K
authors: Hagen
mesh_terms: D000328:Adult; D001562:Benzimidazoles / Q000627:therapeutic use*; D001713:Biphenyl Compounds; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000517:prevention & control*; D008959:Models, Neurological; D011433:Propranolol / Q000627:therapeutic use*; D055502:Secondary Prevention; D013777:Tetrazoles / Q000627:therapeutic use*
chemical_list: D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; D011433:Propranolol; C081643:candesartan
keywords: Candesartan; clinical trial; migraine; prophylaxis; propranolol