Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 10 mg, 30 mg, 60 mg) |
Drug Class | Calcitonin gene-related peptide receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the preventive treatment of migraine in adults.
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Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Atogepant significantly reduced monthly migraine days compared to placebo, with a mean difference (MD) of -1.16 (95% confidence interval (CI) -1.60 to -0.73) for 10 mg/day, -1.15 (95% CI -1.54 to -0.76) for 30 mg/day, and -1.20 (95% CI -2.18 to -0.22) for 60 mg/day. The 50% responder rate was significantly higher for atogepant compared to placebo (relative risk (RR) 1.66, 95% CI 1.46 to 1.89).
- Atogepant reduced monthly headache days (standardized mean difference (SMD) -0.39, 95% CI -0.46 to -0.33) and decreased the number of acute medication use days (SMD -0.45, 95% CI -0.51 to -0.39) compared to placebo.
- No significant differences in effectiveness were observed between different dosage groups of atogepant, and the efficacy was consistent across both episodic and chronic migraine populations.
- Atogepant was associated with a significantly higher risk of treatment-emergent adverse events (TEAEs) compared to placebo (RR 1.10, 95% CI 1.02-1.21), with the most common TEAEs being constipation (RR 2.55, 95% CI 1.91-3.41), nausea (RR 2.19, 95% CI 1.67-2.87), and urinary tract infection (RR 1.49, 95% CI 1.05-2.11). A higher risk of treatment-related TEAEs was observed with high doses of atogepant, including fatigue (RR 3.07, 95% CI 1.13-8.35).
- There were no significant differences between atogepant and placebo in adverse events leading to treatment discontinuation.
- The studies on atogepant included adult patients with episodic and chronic migraines, with a predominant representation of women (87.7% in one study). No significant differences in effectiveness outcomes were observed across different dosage groups or between episodic and chronic migraine populations, and no subgroup analyses based on age, gender, or comorbid conditions were reported.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Qulipta (atogepant) Prescribing Information. | 2023 | AbbVie Inc., North Chicago, IL |