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#367 Oral Calcitonin Gene-related Peptide Antagonists: A painfully long name for the acute treatment of migraines


CLINICAL QUESTION
QUESTION CLINIQUE
 What are the risks and benefits of ubrogepant for the acute treatment of episodic migraines?

BOTTOM LINE
RÉSULTAT FINAL
 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
DONNÉES PROBANTES
  • 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).
    • 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.
  • 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
CONTEXTE
  • 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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Author(s)
Auteur(s)
  • Nicolas Dugré PharmD MSc BCPAC
  • Émélie Braschi MD PhD

1. Yang Y, Chen M, Sun Y, et al. CNS Drugs. 2020 May; 34(5):463-471.

2. Huang T, Xu Y, Chen Y, et al. Brain Behav. 2022 Apr; 12(4):e2542.

3. VanderPluym JH, Halker Singh RB, et al. JAMA. 2021 Jun 15; 325(23):2357-2369.

4. Ha DK, Kim MJ, Han N, et al. Clin Drug Investig. 2021 Feb; 41(2):119-132.

5. Puledda F, Younis S, Huessler EM, et al. Cephalalgia. 2023 Mar; 43(3):3331024231151419.

6. Polavieja P, Belger M, Venkata SK, et al. J Headache Pain. 2022 Jul 6; 23(1):76.

7. Zhang Z, Shu Y, Diao Y, et al. Medicine (Baltimore). 2021 Feb 26; 100(8):e24741.

8. Singh A, Gupta D, Singh A. Neurol India.  2021 Mar-Apr; 69(Supplement):S43-S50.

9. Johnston K, Popoff E, Deighton A, et al. Expert Rev Pharmacoecon Outcomes Res.  2022 Jan; 22(1):155-166.

10. Pak K, Kim J, Lee G, et al. Eur Neurol.  2022; 85(3):195-201.

11. Yang CP, Liang CS, Chang CM, et al. JAMA Netw Open. 2021 Oct 1; 4(10):e2128544.

12. Dodick DW, Lipton RB, Ailani A, et al. N Engl J Med. 2019; 381:2230-2241. 

13. Lipton RB, Dodick DW, Ailani J, et al. JAMA. 2019 Nov 19; 322(19):1887-1898. 

14. Voss T, Lipton RB, Dodick DW, et al. Cephalalgia. 2016 Aug; 36(9):887-98.

15. Ailani J, Lipton RB, Hutchinson S, et al. Headache. 2020 Jan; 60(1):141-152. 

16. AbbVie Corporation. Product monograph : Ubrelvy. November 2022. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/UBRELVY_PM_EN.pdf. Accessed September 21,2023.

17. PharmaClik. McKesson Canada. 2024. https://clients.mckesson.ca/. Accessed February 22, 2024.

18. Ferrari MD, Goadsby PJ, Roon KI, et al. Cephalalgia. 2002 Oct; 22(8):633-58.

19. Blumenfeld AM, Goadsby PJ, Dodick DW, et al. Headache. 2021 Mar; 61(3):422-429. 

20. Lipton RB, Singh RBH, Revicki DA, et al. J Headache Pain. 2022 Apr 25; 23(1):50.

21. Dodick DW, Goadsby PJ, Schwedt TJ, et al. Lancet. 2023; 402:2307-16.

22. Blumenfeld AM, Boinpally R, De Abreu Ferreira R, et al. Headache. 2023 Mar; 63(3):322-332.

23. Jakate A, Blumenfeld AM, Boinpally R, et al. Headache. 2021 Apr; 61(4):642-652.

24. Chiang CC, Arca KN, Dunn RB, et al. Headache. 2021 Apr; 61(4):620-627. 

25. Battini V, Carnovale C, Clementi E, et al. Expert Opin Drug Saf. 2023 Jun 12: 1-8. 

26. Robblee J, Harvey LK. Curr Pain Headache Rep. 2022 Aug; 26(8):647-655.

27. Hutchinson S, Silberstein SD, Blumenfeld AM, et al. Cephalalgia. 2021 Aug; 41(9):979-990. 

Authors do not have any conflicts of interest to declare.