Cardiovascular Diseases, Migraine, Pregnancy
Conditions
Brief summary
Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.
Detailed description
Migraine is a very common condition that can be associated with significant morbidity. For the acute treatment of migraine attacks, the use of triptans, NSAIDs, acetaminophen, dihydroergotamine, calcitonin gene-related peptide antagonists, lasmiditan, and some nonpharmacologic treatments are associated with improved pain and function. The effectiveness of these therapies has been documented in various studies and summarized in systematic reviews. However, systematic reviews have demonstrated evidence gaps in two groups of patients that were excluded from treatment trials. These are patients with cardiovascular disease or at high risk of cardiovascular events, and pregnant women. Triptans, the mainstay treatment for migraine attacks and the one supported by the highest quality evidence, are considered vasoactive and are contraindicated per formulary in individuals who have a history of myocardial infarction, stroke, or uncontrolled vascular risk factors such as hypertension. These individuals are usually excluded from randomized trials. Similarly, pregnant women have been excluded from triptans trials and the observational studies offered low certainty evidence about their safety. Yet, 44% of surveyed members of the American Headache Society reported being somewhat or very comfortable using triptans in pregnancy. Therefore, the investigators intend to evaluate the safety of triptan treatment of migraine in individuals with cardiovascular disease or multiple cardiovascular risk factors, and in pregnant women in two target trial emulations.
Interventions
DRUGAcute migraine treatment with any prescribed triptans
Sumatriptan, treximet (sumatriptan/naproxen combination), zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan. No restriction on dose, frequency, duration, or delivery routes.
DRUGStandard of care management of acute migraine without triptans
Any standard of care management without triptans
Sponsors
Mayo Clinic
Agency for Healthcare Research and Quality (AHRQ)
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: Inclusion: * Aged \>=18 years * At least 1 year history of migraine with or without aura * Confirmed cardiovascular or cerebrovascular disease, including myocardial infarction (MI), coronary artery disease (CAD), cerebrovascular disease, stroke; or at least 2 cardiovascular risk factors, including diabetes, hyperlipidemia, hypertension, obstructive sleep apnea, peripheral vascular disease; * At least 1 year of prior triptan treatment or no previous triptan treatment. Exclusion: • Prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment Treatments of Migraine With Triptans in Pregnant Women Inclusion: * Aged \>=18 years * Pregnant woman * Diagnosis of episodic or chronic migraine with or without aura before pregnancy Exclusion: • Prescription of ergot alkaloids or dihydroergotamine \<= 60 days before pregnancy or during pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: number of subjects to experience major adverse cardiovascular events (MACE) which consists of all-cause death, nonfatal myocardial infarction, nonfatal stroke, heart failure, transient cerebral ischemia, or revascularization |
| Full term birth | 39 0/7 weeks of gestation through 40 6/7 weeks of gestation | Treatments of Migraine With Triptans in Pregnant Women: number of pregnant women to have a full term birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nonfatal stroke | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal stroke |
| Heart failure | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: Heart failure |
| Transient cerebral ischemia | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: transient cerebral ischemia |
| Revascularization | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: revascularization |
| Pre-term delivery | 37 0/7 weeks of gestation through 38 6/7 weeks of gestation | Treatments of Migraine With Triptans in Pregnant Women: Pre-term delivery |
| Cesarean section delivery | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: cesarean section delivery |
| all-cause death | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: all-cause death |
| Fetal death/stillbirth | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: Fetal death/stillbirth |
| Intra-uterine growth restriction | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: Intra-uterine growth restriction |
| Eclampsia/preeclampsia | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: Eclampsia/preeclampsia |
| Tubal or ectopic pregnancy | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: Tubal or ectopic pregnancy |
| Major fetal malformations | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: Major fetal malformations |
| Spontaneous abortions/miscarriage | up to delivery | Treatments of Migraine With Triptans in Pregnant Women: Spontaneous abortions/miscarriage |
| Nonfatal myocardial infarction | 60 days of starting treatment | Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk: nonfatal myocardial infarction |
Countries
United States
Outcome results
None listed