Ashoke K. Mitra, Country Leader Pain
Country Leader Medical Affairs and Innovation - Pain
Haleon
Morris Plains, New Jersey
Oral over-the-counter (OTC) analgesics such as acetaminophen-aspirin-caffeine (AAC) and ibuprofen (IBU) are widely used as first-line treatments for episodic migraine. Recently approved oral prescription (Rx) agents including gepants (ubrogepant [UBR], rimegepant [RIM]) and a selective 5-HT1F agonist lasmiditan (LAS), offer alternative options. A comprehensive evaluation of their relative efficacy is needed to guide evidence-based treatment selection.
Purpose/Objectives:
To compare the efficacy of OTC and oral Rx medications for the acute treatment of episodic migraine using a network meta-analysis (NMA) of randomized controlled trials (RCTs).
Methods:
A systematic literature search was conducted in MEDLINE (via ProQuest) and Embase for RCTs published between January 1990 and May 2024. Studies evaluating AAC, ibuprofen, lasmiditan, ubrogepant, and rimegepant for acute treatment of episodic migraine were included. Placebo served as the reference comparator. The primary outcomes were pain relief and pain freedom at 2 hours post-dose. Secondary outcomes included reduction in photophobia, phonophobia, and nausea. Network meta-analysis was performed using relative risk (RR) estimates. Non-RCTs, preventive therapies, intravenous formulations, and studies on chronic migraine were excluded.
Results:
Thirty two studies evaluating OTC and Rx oral treatments for episodic migraine were included in the meta-analysis. All active treatments were superior to placebo across pain and associated symptom endpoints. For two-hour pain relief, the highest efficacy was observed with ibuprofen 400–600 mg (RR: up to 2.21) and AAC (RR: 1.77). Two-hour pain freedom was highest with lasmiditan 200–400 mg (RR: up to 3.36), followed by ibuprofen 400–600 mg (RR: up to 2.20) and AAC (RR: 2.21). Freedom from photophobia and phonophobia was consistently achieved by AAC, with RRs up to 2.00 and 1.57, respectively. Relief from nausea was modest across treatments, with no significant differences observed. All primary endpoints were statistically significant (p< 0.0017 for pain relief; p< 0.0023 for pain freedom).
Conclusions/Implications for future research and/or clinical care:
OTC products, specifically AAC and ibuprofen (7.5–10 mg/kg; 200–600 mg), demonstrated comparable or superior efficacy to newer oral Rx agents to treat episodic migraine. Given their accessibility and lower cost, OTC options remain a valuable first-line treatment choice.