Context There is a paucity of effective, well-tolerated drugs available for
Objective To determine whether treatment with the angiotensin II receptor blocker
candesartan is effective as a migraine-prophylactic drug.
Design and Setting Randomized, double-blind, placebo-controlled crossover study performed
in a Norwegian neurological outpatient clinic from January 2001 to February
Patients Sixty patients aged 18 to 65 years with 2 to 6 migraine attacks per
month were recruited mainly from newspaper advertisements.
Interventions A placebo run-in period of 4 weeks was followed by two 12-week treatment
periods separated by 4 weeks of placebo washout. Thirty patients were randomly
assigned to receive one 16-mg candesartan cilexetil tablet daily in the first
treatment period followed by 1 placebo tablet daily in the second period.
The remaining 30 received placebo followed by candesartan.
Main Outcome Measures The primary end point was number of days with headache; secondary end
points included hours with headache, days with migraine, hours with migraine,
headache severity index, level of disability, doses of triptans, doses of
analgesics, acceptability of treatment, days of sick leave, and quality-of-life
variables on the Short Form 36 questionnaire.
Results In a period of 12 weeks, the mean number of days with headache was 18.5
with placebo vs 13.6 with candesartan (P = .001)
in the intention-to-treat analysis (n = 57). Some secondary end points also
favored candesartan, including hours with headache (139 vs 95; P<.001), days with migraine (12.6 vs 9.0; P<.001),
hours with migraine (92.2 vs 59.4; P<.001), headache
severity index (293 vs 191; P<.001), level of
disability (20.6 vs 14.1; P<.001) and days of
sick leave (3.9 vs 1.4; P = .01), although there
were no significant differences in health-related quality of life. The number
of candesartan responders (reduction of ≥50% compared with placebo) was
18 (31.6%) of 57 for days with headache and 23 (40.4%) of 57 for days with
migraine. Adverse events were similar in the 2 periods.
Conclusion In this study, the angiotensin II receptor blocker candesartan provided
effective migraine prophylaxis, with a tolerability profile comparable with
that of placebo.