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Safety, tolerability, and effectiveness of repetitive intravenous dihydroergotamine for refractory chronic migraine with cardiovascular risk factors: A retrospective study
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Design
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Single-center, retrospective, observational cohort study
N= 347
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Objective
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To assess the safety, tolerability, and effectiveness of repetitive intravenous (IV) dihydroergotamine (DHE) in patients with cardiovascular (CV) risk factors
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Study Groups
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Low atherosclerotic cardiovascular disease (ASCVD; n= 163)
Elevated ASCVD (n= 64)
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Inclusion Criteria
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Adult patients with refractory chronic migraine (rCM) admitted to the Jefferson Headache Center (JHC) and administered IV DHE
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Exclusion Criteria
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Not described
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Methods
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Data was collected from electronic medical records of patients receiving IV DHE. Patients with ASCVD risk score <5% were considered low-risk, while those with scores of ≥5.0% were considered elevated risk. The JHC inpatient headache protocol was utilized and consisted of repetitive IV DHE in addition to other IV medications. Medications were adjusted based on pain intensity and adverse events (AEs), which were self-reported or noted by providers. DHE was titrated to a maximum tolerable dose or to 1 mg q8h. Electrocardiogram (EKG) was obtained daily to monitor for cardiac complaints, telemetry, and QTc monitoring.
DHE treatment continuation was determined by patient input and provider recommendations. In patients with a history of moderate to severe ischemic heart disease, coronary vasospasm, peripheral artery disease, Raynaud's phenomenon, or ischemic stroke, IV DHE was not usually offered. While inpatient, IV DHE was usually withheld from patients with complaints of chest pain, severe nausea, blood pressure elevation (>150/90 mmHg), or diarrhea, despite the use of additional anti-emetics, anti-hypertensive, or antidiarrheal medications.
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Duration
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January 2019 to October 2019
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Outcome Measures
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Treatment efficacy, pain reduction, tolerability, vital signs and additional medication use
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Baseline Characteristics
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Low ASCVD (n= 163)
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Elevated ASCVD (n= 64)
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Age, years
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49 |
62.5 |
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Male
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10% |
42% |
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White
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91% |
88% |
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Body mass index, kg/m2
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28.7 |
39.7 |
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ASCVD score
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1.6 |
9.4 |
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Comorbidities
Diabetes
Hyperlipidemia
Hypertension
Psychiatric history
Stroke
Tobacco use
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3%
16%
22%
77.9%
3.7%
12.3%
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23%
42%
63%
68.8%
9.4%
17.2%
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Notably, patients with elevated ASCVD were older, male, and an increased number of diabetes, hyperlipidemia, and hypertension compared to patients with low ASCVD.
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Results
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Endpoint
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Low ASCVD (n= 163)
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Elevated ASCVD (n= 64)
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p-value
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Change in NRS from admission*
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-5
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-3.8
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0.037
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DHE Usage
Initial dose of DHE, mg
Final dose of DHE, mg
Time on DHE, days
≤2 days on DHE
On max dose of DHE
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0.5
1
6
6 (3.7%)
105 (64.4%)
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0.5
0.75
5
6 (9.4%)
27 (42.2%)
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0.009
<0.001
0.273
0.102
0.002
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Cardiac consultation
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7%
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27%
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<0.001 |
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Adverse events^
Nausea
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31%
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14%
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0.008
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Vital signs
MAP upon admission
MAP maximum
MAP at discharge
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89.5 ± 12.6
100.6 ± 12.3
86.9 ± 11.8
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95.6 ± 11.4
113.5 ± 10.4
92.4 ± 11.8
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0.001
<0.001
0.002
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Additional medications
Anti-emetic
Anti-hypertensive
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77%
14%
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64%
42%
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0.045
<0.001
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Abbreviations: MAP= mean arterial pressure
* Negative value indicates reduction in pain
^ Chest pain, non-sustained supraventricular tachycardia, deep vein thrombosis, visual symptoms, akathisia, anxiety, dizziness, emotional lability, extremity pain, and vivid dreams were not significantly different between groups.
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Adverse Events
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See Results
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Study Author Conclusions
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Patients receiving intravenous DHE by the Jefferson Headache Centerinpatient headache protocol had significantly reduced pain severity at discharge. No clinically significant cardiac or electrocardiogram abnormalities were detected in pa-tients with elevated (or low) atherosclerotic cardiovascular disease risk. Repetitive intravenous DHE used by our protocol was safe in refractory chronic migraine patients.
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InpharmD Researcher Critique
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Notably, the retrospective and observational nature of this study may confound findings, as data may be missing or inaccurate, and patients were not compared to a cohort that utilized a placebo or active control. Additionally, all data came from a single center servicing patients with rCM, making the results less applicable to a larger patient population. Patients were not barred from using other medications concomitantly, further limiting the ability to discern whether IV DHE had an impact on pain response.
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