Patient Satisfaction With MAP0004: Results of an Optional Survey During a Long-Term Open-Label Safety Study (I9-1.001)

Neurology(2014)

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摘要
OBJECTIVE: To assess satisfaction with the TEMPO ® inhaler delivery system and with MAP0004 (orally inhaled dihydroergotamine [DHE]) compared with previous migraine medications (eg, triptans) . BACKGROUND: MAP0004, an investigational orally inhaled DHE administered through the TEMPO ® inhaler, has demonstrated efficacy in treating migraine. Subjects completed a voluntary survey to assess satisfaction with the use of the inhaler and perceived efficacy of the investigational drug. DESIGN/METHODS: Subjects who were still participating at week 24 in an open-label, long-term, phase 3 study were invited to complete a nonvalidated survey consisting of 16 questions categorized into comparison with previous medications (n=8), convenience of use (n=4), medication aftertaste (n=3), and overall satisfaction (n=1). Surveys were completed voluntarily at 24 or 54 weeks. Response options ranged from strongly agree to strongly disagree (5-point scale). No formal statistical inferences were made and responses are presented as a normalized percentage of the respondents agreeing or disagreeing with the statements. RESULTS: 197 subjects completed 蠅1 survey question. Compared with their previous medications, subjects reported that MAP0004 works more consistently (68%), works faster (63%), provides better pain relief (53%), longer pain relief (54%), faster return to normal activity (63%), works even when taken late (57%), prevents recurrence (62%), and works better when taken early (83%). 58% preferred MAP0004 over their previous medications; 88% felt it was easy and 83% convenient to use. 58% reported medication aftertaste, but 77% said that aftertaste was tolerable and 69% indicated that they would ask for a MAP0004 prescription if the product was available. CONCLUSIONS: In this nonvalidated survey, most respondents preferred MAP0004 over their previous migraine medication and most reported that the inhaler was easy and convenient to use. Aftertaste was associated with the drug, but would not prevent participants from requesting a MAP0004 prescription. Study Supported by: Allergan, Inc., Irvine, CA. Disclosure: Dr. Aurora has received personal compensation for activities with Merck & Co., Inc., Allergan, Inc., and eNeura. Dr. Aurora has received research support from Merck & Co., Inc., Allergan, Inc., and eNeura. Dr. Buse has received personal compensation for activities with Allergan Inc., and Zogenix. Dr. Buse has received research support from Allergan Inc., Merck & Co. Inc., and Zogenix. Dr. Lu has received personal compensation for activities with Allergan, Inc. Dr. Lu holds stock and/or stock options in MAP Pharmaceuticals, which sponsored research in which Dr. Lu was involved as an investigator. Dr. Lu has received research support from Allergan, Inc. Dr. Kellerman has received personal compensation for activities with Allergan Inc. as an employee, and Ockham as a member of the board of directors. Dr. Kellerman holds stock and/or stock options in MAP Pharmaceuticals which sponsored research in which Dr. Kellerman was involved as an investigator. Dr. Cooper has received personal compensation for activities with Zogenix. Dr. Kori has received personal compensation for activities with Allergan Inc. as an employee. Dr. Kori holds stock and/or stock options in MAP Pharmaceuticals. Dr. Kori has received research support from Allergan Inc.
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