Headache Prophylaxis With BoNTA: Patient Characteristics

Authors

  • Stephen D. Silberstein MD,

    1. From the Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein and M.J. Marmura); Department of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA (J. Shaw and S. Yu).
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  • Michael J. Marmura MD,

    1. From the Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein and M.J. Marmura); Department of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA (J. Shaw and S. Yu).
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  • James Shaw PhD, PharmD, MPH,

    1. From the Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein and M.J. Marmura); Department of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA (J. Shaw and S. Yu).
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  • Shengsheng Yu MS

    1. From the Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein and M.J. Marmura); Department of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA (J. Shaw and S. Yu).
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  • Conflict of Interest: Dr. Marmura and Mr. Yu have nothing to disclose. Dr. Shaw owns and operates a health outcomes research consulting firm, Shaw Analytics, Inc. He has received grants from Allergan and financial compensation for participating as a journal reviewer. Dr. Silberstein has proprietary interest (Speaker/Advisory Board/Grants) in the following commercial, health care–related businesses: Abbott, AdvancedBionics, Advanced NeurModulation System, AGA, Allergan, AstraZeneca, Endo, GSK, Lilly, Medtronic, Merck, Ortho-McNeil, Pfizer, Pozen, ProEthic, Valeant, Vernalis.

M. Marmura, 8130 Gibbon Building, 111 South 11th Street, Philadelphia, PA 19107, USA.

Abstract

(Headache 2010;50:63-70)

Objective.— To assess the characteristics of patients receiving botulinum toxin type A (BoNTA; BOTOX®) in the treatment of headache (HA) disorders.

Methods.— The following observational epidemiologic data and baseline patient characteristics were prospectively collected from eligible patients treated with BoNTA at 10 US HA specialty centers: demographics; HA diagnoses and characteristics (frequency, severity, and disability); prior and current HA treatments and response; clinical response to BoNTA; Migraine Disability Assessment (MIDAS) questionnaire; and adverse events. Patients maintained a daily HA diary and were evaluated at each follow-up visit.

Results.— Of 703 patients enrolled (mean age 43.1 years, 78.5% females, 95.4% white), nearly 66% had a diagnosis of chronic migraine (CM), with or without medication overuse. Approximately 75% had severe disability (MIDAS grade IV), and the mean pain rating was 6.5 (where 0 = no pain, 10 = pain as bad as it can be). More than 90% of patients had ≥1 prophylactic HA treatment failure; median number of failures was 4. Significant association was observed between HA frequency and MIDAS grade (P < .001). Approximately 80% of patients with CM had severe (grade IV) disability. The median number of monthly medication days was higher in the group with MIDAS grade IV (P < .001). HA frequency and severity, failed prophylactic therapies, and greater number of coexisting medical conditions were all negatively associated with measures of health-related quality of life.

Conclusions.— Majority of patients treated with BoNTA in a specialty HA center presented with a CM diagnosis. HA disability was correlated with measures of frequency and treatment utilization.

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