Mayo Clinic proceedings · 2025
Safety of Triptans in Treating Migraines in Pregnant Women: A Target Trial Emulation.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Wang Zhen, VanderPluym Juliana H, Halker Singh Rashmi B, Alsibai Reem A, Roellinger Daniel L, Murad Mohammad Hassan
Аннотация
OBJECTIVE: To evaluate the safety of triptans in pregnant women with migraine.
PATIENTS AND METHODS: We emulated a randomized clinical trial that hypothetically assigned patients to triptans or no triptan treatments. Data were retrieved from a multistate US-based health system from 2000 to 2022 on pregnant women with a diagnosis of migraine. We compared the effect of triptans to no-triptan treatments on patient-important pregnancy outcomes.
RESULTS: One hundred eighty-three patients in the triptan group and 3674 patients in the no-triptan group were included in the analysis. Of the patients in the triptan group, 43.74% reported full-term delivery, compared with 53.09% in the no-triptan group. There was no statistically significant difference between the groups on full-term delivery (relative risk [RR], 0.84; 95% CI, 0.71 to 1.01; absolute risk difference [RD], -0.08; 95% CI, -0.16 to 0.00), pre-term delivery (RR, 1.35; 95% CI, 0.96 to 1.91; RD, 0.05; 95% CI, -0.01 to 0.11), and cesarean delivery (RR, 1.15; 95% CI, 0.91 to 1.44; RD, 0.04; 95% CI: -0.03 to 0.12). We found no significant differences in intrauterine growth restriction, fetal death/stillbirth, and major fetal malformations. Patients in the triptan group had no events of miscarriage and spontaneous abortions, eclampsia/pre-eclampsia, or tubal or ectopic pregnancy.
CONCLUSION: This target trial emulation shows that after balancing patients' characteristics and potential confounders, triptan use during pregnancy was not associated with major birth defects or other adverse birth outcomes. These data add to the accumulating body of evidence suggesting that triptans can be offered to well-informed pregnant women in need of pharmacologic therapy to abort acute attacks.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05854992. (https://clinicaltrials.gov/ct2/show/NCT05854992?id=NCT05854992&cntry=US&draw=2&rank=1).
PATIENTS AND METHODS: We emulated a randomized clinical trial that hypothetically assigned patients to triptans or no triptan treatments. Data were retrieved from a multistate US-based health system from 2000 to 2022 on pregnant women with a diagnosis of migraine. We compared the effect of triptans to no-triptan treatments on patient-important pregnancy outcomes.
RESULTS: One hundred eighty-three patients in the triptan group and 3674 patients in the no-triptan group were included in the analysis. Of the patients in the triptan group, 43.74% reported full-term delivery, compared with 53.09% in the no-triptan group. There was no statistically significant difference between the groups on full-term delivery (relative risk [RR], 0.84; 95% CI, 0.71 to 1.01; absolute risk difference [RD], -0.08; 95% CI, -0.16 to 0.00), pre-term delivery (RR, 1.35; 95% CI, 0.96 to 1.91; RD, 0.05; 95% CI, -0.01 to 0.11), and cesarean delivery (RR, 1.15; 95% CI, 0.91 to 1.44; RD, 0.04; 95% CI: -0.03 to 0.12). We found no significant differences in intrauterine growth restriction, fetal death/stillbirth, and major fetal malformations. Patients in the triptan group had no events of miscarriage and spontaneous abortions, eclampsia/pre-eclampsia, or tubal or ectopic pregnancy.
CONCLUSION: This target trial emulation shows that after balancing patients' characteristics and potential confounders, triptan use during pregnancy was not associated with major birth defects or other adverse birth outcomes. These data add to the accumulating body of evidence suggesting that triptans can be offered to well-informed pregnant women in need of pharmacologic therapy to abort acute attacks.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05854992. (https://clinicaltrials.gov/ct2/show/NCT05854992?id=NCT05854992&cntry=US&draw=2&rank=1).