TY - JOUR
T1 - Blood pressure lowering for prevention of episodic migraine
T2 - results of a pilot randomized, placebo-controlled trial of combination blood pressure lowering medication with propranolol
AU - Carcel, Cheryl
AU - Haghdoost, Faraidoon
AU - Davies, Leo
AU - Cordato, Dennis
AU - Griffiths, Lyn
AU - Balicki, Grace
AU - Li, Qiang
AU - Freed, Ruth
AU - Anderson, Craig S.
AU - Zagami, Alessandro S.
AU - Delcourt, Candice
AU - Rodgers, Anthony
N1 - Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2025/9/16
Y1 - 2025/9/16
N2 - Background: Beta blockers are effective in migraine prevention. Low-dose combination therapy of blood pressure lowering is likely to lower blood pressure more than a beta-blocker, but there are no data on comparative efficacy of these treatments in migraine prophylaxis.Methods: A double-blind, randomized, pilot trial in participants with episodic migraine to assess feasibility and tolerability of low-dose triple combination BP lowering (telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg) vs. propranolol 160 mg daily vs. matching placebos. The primary outcome was monthly headache days.Results: Between March 2017 and June 2018, 378 participants were screened and 30 were randomized (8%). The key reasons for ineligibility among screen failures were low blood pressure (86, 26%), unwilling to participate in a drug trial (76, 23%) and not meeting episodic migraine criteria (54, 16%). Among those randomized, mean age was 49 years, 83% female, baseline migraine frequency was 67 h, aura present in 47%, mean baseline BP was 131/87 mmHg. As expected from a small pilot, the confidence intervals for treatment effect estimates were wide: reduction in monthly headache days for the low-dose triple were -0.6 (95% confidence interval [CI] -2.9, 1.8) and for propranolol -1.1 (95% CI -3.8, 1.6) compared to placebo. Tolerability was good, there were no dropouts from adverse events.Conclusion: As a pilot study, the trial was not powered to detect efficacy; larger trials are required to determine the effect of low-dose triple combination blood pressure lowering on migraine. The medication was safe and well tolerated by participants with migraine; it is likely that study co-design with people with lived experience of migraine will benefit recruitment into the trial.Clinical trial registration: ACTRN12616000937415, https://anzctr.org.au/.
AB - Background: Beta blockers are effective in migraine prevention. Low-dose combination therapy of blood pressure lowering is likely to lower blood pressure more than a beta-blocker, but there are no data on comparative efficacy of these treatments in migraine prophylaxis.Methods: A double-blind, randomized, pilot trial in participants with episodic migraine to assess feasibility and tolerability of low-dose triple combination BP lowering (telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg) vs. propranolol 160 mg daily vs. matching placebos. The primary outcome was monthly headache days.Results: Between March 2017 and June 2018, 378 participants were screened and 30 were randomized (8%). The key reasons for ineligibility among screen failures were low blood pressure (86, 26%), unwilling to participate in a drug trial (76, 23%) and not meeting episodic migraine criteria (54, 16%). Among those randomized, mean age was 49 years, 83% female, baseline migraine frequency was 67 h, aura present in 47%, mean baseline BP was 131/87 mmHg. As expected from a small pilot, the confidence intervals for treatment effect estimates were wide: reduction in monthly headache days for the low-dose triple were -0.6 (95% confidence interval [CI] -2.9, 1.8) and for propranolol -1.1 (95% CI -3.8, 1.6) compared to placebo. Tolerability was good, there were no dropouts from adverse events.Conclusion: As a pilot study, the trial was not powered to detect efficacy; larger trials are required to determine the effect of low-dose triple combination blood pressure lowering on migraine. The medication was safe and well tolerated by participants with migraine; it is likely that study co-design with people with lived experience of migraine will benefit recruitment into the trial.Clinical trial registration: ACTRN12616000937415, https://anzctr.org.au/.
KW - migraine
KW - antihypertensive treatment
KW - randomized trials
KW - feasibility
KW - tolerability
UR - http://purl.org/au-research/grants/nhmrc/1122387
UR - http://www.scopus.com/inward/record.url?scp=105018217877&partnerID=8YFLogxK
U2 - 10.3389/fneur.2025.1630732
DO - 10.3389/fneur.2025.1630732
M3 - Article
C2 - 41036277
SN - 1664-2295
VL - 16
SP - 1
EP - 7
JO - Frontiers in Neurology
JF - Frontiers in Neurology
M1 - 1630732
ER -