title: A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience.
abstract: BACKGROUND
  The efficacy and safety of OnabotulinumtoxinA (BOTOX®) in adults with chronic migraine (CM) were demonstrated in the PREEMPT program. However, the dosage used in this study was flexible from 155 U to 195 U at the physician's discretion. Therefore, the objective of this prospective study was to compare the efficacy and safety of OnabotulinumtoxinA 195 U vs. 155 U for the treatment of CM and medication overuse headache (MOH) during a 2-year period.
  
  
  METHODS
  We prospectively evaluated the mean reduction in headache days, migraine days, acute pain medication intake days and Headache Impact Test (HIT)-6 score in 172 patients injected with OnabotulinumtoxinA 195 U. Successively, we compared the efficacy measures with data of 155 patients injected with OnabotulinumtoxinA 155 U and followed up for 2 years. All patients were affected by CM and MOH, and failed one or more previous detoxification and preventative therapies.
  
  
  RESULTS
  Both OnabotulinumtoxinA 195 U and 155 U reduced significantly the number of headache and migraine days, acute pain medication intake days and HIT-6 score, when compared with the baseline measures. Nevertheless, OnabotulinumtoxinA 195 U proved to be superior of 155 U in all efficacy measures since the first injection and for all the 2 years of treatment, with the exception of the reduction in pain medication intake days that resulted significantly larger with 195 U only after the 4th injection. The safety and tolerability of the two doses were similar and treatment related adverse events were transient and mild-moderate.
  
  
  CONCLUSIONS
  This study represents the largest and longest post-marketing studies of doses comparison with OnabotulinumtoxinA in a real-life clinical setting. Here, we demonstrate the superior efficacy of OnabotulinumtoxinA 195 U compared to 155 U in CM patients with MOH during a 2-year treatment period with similar safety and tolerability profile.
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy. andrea.negro@uniroma1.it.|Regional Referral Headache Centre, Sant'Andrea Hospital, Rome, Italy. andrea.negro@uniroma1.it.|Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University, Via di Grottarossa, 1035-1039, Rome, Italy. andrea.negro@uniroma1.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Negro
authors.affiliation: Regional Referral Headache Centre, Sant'Andrea Hospital, Rome, Italy.|Department of Psychiatry, Harvard Medical School, Boston, MA, USA.|Bipolar & Psychotic Disorders Program, McLean Hospital, Belmont, MA, USA.
authors.forename: Martina
authors.initials: M
authors.lastname: Curto
authors.affiliation: Advanced Molecular Diagnostics Unit, IDI Istituto Dermopatico dell'Immacolata-IRCSS, Rome, Italy.
authors.forename: Luana
authors.initials: L
authors.lastname: Lionetto
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.|Regional Referral Headache Centre, Sant'Andrea Hospital, Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Martelletti
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D005260:Female; D051271:Headache Disorders, Secondary / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D000067490:Prescription Drug Overuse; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: Chronic migraine; Medication overuse headache; Migraine abuse; OnabotulinumtoxinA; Preventative therapy