English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Zendy Plus

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Zendy Tools

Zendy Open

Background and purpose  Onabotulinumtoxin A  was effective and well tolerated for prophylaxis of headache in patients with chronic migraine ( CM ) in two randomized, double‐blind, placebo‐controlled, phase 3 trials. To further assess the safety and tolerability of onabotulinumtoxin A  in  CM  prophylaxis in adults, the pooled safety data from four double‐blind, placebo‐controlled trials were analyzed.    Methods  The pooled analysis included two phase 2 and two phase 3 double‐blind, placebo‐controlled trials. The safety population was 2436 patients, 1997 of whom received ≥1 dose of onabotulinumtoxinA. The studies shared similar dosing intervals (approximately 12 weeks) with doses between 75 and 260 U. Safety assessments included adverse events ( AE s), physical examination and clinical laboratory tests.    Results  Onabotulinumtoxin A  was safe and well tolerated, with a low discontinuation rate (3.4%) due to  AE s. The majority of patients in this pooled analysis received doses between 150 and 200 U, with an average of 163 U per treatment cycle. Of the 1997 patients who received any onabotulinumtoxin A  injections, 1455 patients (72.9%) reported at least one  AE . Neck pain (12.6%) was the most common onabotulinumtoxin A ‐associated  AE , followed by muscle weakness (8.0%), musculoskeletal stiffness (6.1%) and eyelid ptosis (4.6%). Serious  AE s were infrequent, occurring in 5.4% of patients who received any onabotulinumtoxin A  treatment and 3.0% of patients receiving placebo.  AE s were consistent with the known tolerability profile of onabotulinumtoxin A .    Conclusions  Multiple treatments with onabotulinumtoxinA at doses of 75–260 U administered every 12 weeks, and up to five treatment cycles, were well tolerated for the prophylaxis of headache in adults with  CM .

Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine