Real world effectiveness and tolerability of candesartan in the treatment of migraine: a retrospective cohort study

Abstract

To date, two randomized, controlled studies support the use of candesartan for migraine prophylaxis but with limited external validity. We aim to evaluate the effectiveness and tolerability of candesartan in clinical practice and to explore predictors of patient response. Retrospective cohort study including all patients with migraine who received candesartan between April 2008-February 2019. The primary endpoint was the number of monthly headache days during weeks 8-12 of treatment compared to baseline. Additionally, we evaluated the frequency during weeks 20-24. We analysed the percentage of patients with 50% and 75% response rates and the retention rates after three and 6 months of treatment. 120/4121 patients were eligible, aged 45.9 [11.5]; 100 (83.3%) female. Eighty-four patients (70%) had chronic migraine and 53 (42.7%) had medication-overuse headache. The median number of prior prophylactics was 3 (Inter-quartile range 2-5). At baseline, patients had 20.5 ± 8.5 headache days per month, decreasing 4.3 ± 8.4 days by 3 months (weeks 12-16) and by 4.7 ± 8.7 days by 6 months (paired Student's t-test, p < 0.001). The percentage of patients with a 50% response was 32.5% at 3 months and 31.7% at 6 months, while the retention rate was 85.0% and 58.3%. The number of prior treatments (Odds ratio 0.79, 95% CI 0.64-0.97) and the presence of daily headache (Odds ratio 0.39, 95% CI 0.16-0.97) were associated with a lower probability of response. Candesartan showed beneficial effects in the preventive treatment of migraine in clinical practice, including patients with chronic migraine, medication-overuse headache and resistance to prior prophylactics.

Figure 1

Flow-diagram of screened, included, and excluded patients.

Figure 2

Mean (SD) number of headache days per month in the month prior to candesartan use (baseline) versus weeks 8–12 (p < 0.001) and versus weeks 20–24 (p < 0.001) after candesartan use. Paired Student’s t-test. Analysis was intention-to-treat and used the last observation carried forward imputation method.

Figure 3

Fifty percent and 75% response rates by prophylactic category at weeks 8–12 and 20–24. Analysis was intention-to-treat and used the last observation carried forward imputation method.

Figure 4

Kaplan–Meier survival curve showing the duration of candesartan treatment. X-axis, duration in months; Y-axis, the proportion of patients (n = 114).