An academic debate: OnabotulinumtoxinA for chronic migraine: PREEMPT-derived vs "customized" dosing/injection paradigm. (1st June 2018)

• Record Type: Journal Article
• Authors: Green, Mark W.; Rothrock, John F.
• Is Part Of: Toxicon. Volume 147(2018)
• Page Start: 116
• Page End: 119
• Publication Date: 2018-06-01
• Subjects: OnabotulinumtoxinA -- Chronic migraine -- PREEMPT; Toxins -- Periodicals; Venom -- Periodicals; 615.9
• DOI: 10.1016/j.toxicon.2018.03.011
• Languages: English
• ISSNs: 0041-0101

Abstract

Abstract: In 2010 onabotulinumtoxinA (OnabotA) was approved by the United States Food and Drug Administration for the treatment of chronic migraine (CM). Data supporting approval were derived primarily from two parallel placebo-controlled trials, the PREEMPT studies. Many clinicians and research investigators critical of those data have recommended that the dosing/injection paradigm for treating CM be "customized" to the needs of the individual patient rather than administered in a uniform fashion conforming to the methodology utilized in the PREEMPT studies. In this paper the authors debate the issue of whether treatment of CM with OnabotA should be standardized versus customized. Highlights: From the PREEMPT studies emerged a "standardized" dosing and paradigm for administering onabotulinumtoxinA to treat chronic migraine. A number of headache providers argue that a "customized" paradigm specific to the individual patient may be more effective. Supporters of the "standardized" paradigm argue that no other means of administering the toxin has been demonstrated to be superior. In this academic debate Drs. Rothrock and Green offer their rationales for choosing a "standardized" versus "customized" paradigm, respectively.