#367 Oral Calcitonin Gene-related Peptide Antagonists: A painfully long name for the acute treatment of migraines
CLINICAL QUESTION
What are the risks and benefits of ubrogepant for the acute treatment of episodic migraines?
BOTTOM LINE
Ubrogepant is an oral calcitonin gene-related peptide (CGRP) antagonist approved for the acute treatment of episodic migraines. At 2 hours, ubrogepant is more effective than placebo for freedom from pain (21% versus 13%) or pain relief (61% versus 49%). Ubrogepant is well tolerated; safety in people with co-morbidities is unclear.
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EVIDENCE
- Results statistically significant unless stated.
- 11 systematic reviews1-11 of the same 2-3 industry-funded randomized controlled trials (RCTs).12-14 Participants with 2-8 migraines/month (with or without aura) given ubrogepant or placebo for acute moderate-severe migraine.
- Focusing on one systematic review1 of all 3 RCTs (25-100mg) with usable ubrogepant results (3326 participants, ∽24% on prophylaxis (non-CGRP):12,13
- Pain free at 2 hours: 21% versus 13% (placebo).
- No difference between 25, 50 and 100mg doses.
- Relief at 2 hours (from moderate/severe pain to mild/no pain): 61% versus 49% (placebo).
- Absence of the most bothersome symptom at 2 hours: 37% versus 28% (placebo).
- Normal functioning at 2 hours: 42% versus 32% (placebo).
- Sustained pain relief at 24 hours: 37% versus 22% (placebo).
- Pain free at 2 hours: 21% versus 13% (placebo).
- Limitations: Single dose trials, industry funded.
- Other systematic reviews showed similar.2-11
- No difference in adverse events.1-3,7 One systematic review3 found more ear, nose and throat-related adverse events but no absolute numbers reported.
- Focusing on one systematic review1 of all 3 RCTs (25-100mg) with usable ubrogepant results (3326 participants, ∽24% on prophylaxis (non-CGRP):12,13
- A one-year, open-label RCT evaluated safety of ubrogepant versus usual care (1230 participants, 31968 doses).15
- Discontinuation due to adverse events 2-3% with ubrogepant, similar to usual care. No statistical comparison.
CONTEXT
- Ubrogepant (Ubrelvy®) is the only CGRP antagonist approved in Canada for acute migraine treatment.16 Costs ∽$15/dose.17
- No direct comparison available but triptans appear more effective (∽30-40% pain free at 2 hours versus 21% [ubrogepant]).1,3,4,11,18
- Response to ubrogepant independent from response to triptans.19,20
- Based on 1 RCT, ubrogepant likely effective at preventing headache when taken during prodrome (no moderate-severe headache at 24 hours: 46% versus 29% [placebo]).21
- Efficacy in chronic migraines,12,13 role with concomitant prophylactic CGRP antagonists,22,23 long-term safety,24,25 safety in people with cardiovascular disease26,27 unclear.
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I have never heard of this medication! I will have to look into this.