Detaillierte Beitrags-Information
| Beitragstitel | Efficacy, tolerability, and safety of onabotulinumtoxinA treatment for chronic migraine in patients with acute medication overuse: Analysis of the PREEMPT and COMPEL trials |
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| Beitragscode | P14 |
| Autor:innen | |
| Präsentationsform | Poster |
| Themengebiete |
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| Abstract-Text |
Background: To evaluate the efficacy, tolerability, and safety of onabotulinumtoxinA (onabotA) [BOTOX®] in patients treated for chronic migraine (CM) with or without acute medication overuse (MO). Material and Methods: Data analyzed from patients with CM treated with onabotA with or without MO across COMPEL, a phase 4, single-arm trial (NCT01516892) and PREEMPT, a phase 3, placebo (PBO)-controlled trial (NCT00156910, NCT00168428). Per ICHD, MO was defined as taking acute medication ≥ 2 times per week in any week (depending on the medication category) during screening. Patients received onabotA every 12wks for 108wks (COMPEL) or 56wks (PREEMPT). In PREEMPT, PBO patients received onabotA starting at week 24. Efficacy was reported as mean headache days (MHD), 6-item Headache Impact Test (6-HIT) score, and MSQ (Role Function Restrictive) score. Tolerability and safety were reported as adverse events (AEs). Results: MO criteria was met by 65% (n=904/1384) of patients in PREEMPT (onabotulinumtoxinA: n=445, PBO: 459) and 64% (n=456/715) of patients in COMPEL (MO: n=456, no MO: n=259). In PREEMPT, onabotA reduced MHD vs PBO at 24wks in patients with MO (mean: -8.2 vs. -6.2, P < 0.001) and without (-8.8 vs. –7.3, P=0.019). OnabotA reduced moderate/severe MHD with MO (P < 0.001) and without (P=0.008). Severe impact via HIT-6 was reported by fewer patients with MO vs PBO at 24wks (P < 0.001) and without MO (P=0.027). MSQ score was improved vs PBO at 24wks (P < 0.001) and without (P < 0.001). In COMPEL, the improvements were no different between patients with or without MO: MHD (mean: -10.6 vs -11.0, P=0.397), moderate/severe MHD (P=0.573) and HIT-6 score (P=0.644) at 108wks. Treatment related AEs were of similar frequencies in patients with MO (27%) or without (26%) and were consistent with onabotA safety profile for CM. Conclusions: In this post-hoc-analysis, patients with CM and MO treated with onabotA responded in similar frequency to patients with CM without MO and displayed a similar safety profile. |