Funding: The study described in this paper was funded by Zogenix Inc.
Satisfaction With and Confidence in Needle-Free Subcutaneous Sumatriptan in Patients Currently Treated with Triptans
Article first published online: 3 AUG 2011
© 2011 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 51, Issue 8, pages 1202–1211, September 2011
How to Cite
Cady, R. K., Aurora, S. K., Brandes, J. L., Rothrock, J. F., Myers, J. A., Fox, A. W. and Farr, S. J. (2011), Satisfaction With and Confidence in Needle-Free Subcutaneous Sumatriptan in Patients Currently Treated with Triptans. Headache: The Journal of Head and Face Pain, 51: 1202–1211. doi: 10.1111/j.1526-4610.2011.01972.x
Clinical trial registration number: NCT01016834 on http://www.clinicaltrials.gov.
Conflict of Interest: Dr. Cady has served as a consultant, served on the advisory board, received honoraria, and received research grants or funds for studies from Zogenix, and has served as a consultant, served on the advisory board, received honoraria, and/or received research grants or funds for studies for the following companies: Advanced Neuromodulation, Allergan, Astellas, AstraZeneca, Boston Scientific, Endo Pharmaceuticals, Inc., GlaxoSmithKline, Johnson & Johnson, KOWA Pharmaceuticals, MAP Pharmaceuticals, Merck & Company, Inc., Minster Pharmaceuticals, Nautilus Neuroscience, NuPathe, Ortho-McNeil Neurologies, Prometheus Labs, Puramed BioScience, and Wyeth. Dr. Aurora has received compensation from Zogenix and other pharmaceutical companies for activities including consulting fees/honoraria and research funds. Dr. Brandes has received speaker fees for activities with Merck, GlaxoSmithKline, Allergan, Endo, Zogenix/Astellas, and Nautilus. Dr. Brandes has received research grants and support from Merck, GlaxoSmithKline, Pfizer, AstraZeneca, Allergan, Zogenix/Astellas, Boston Scientific, Johnson & Johnson, Eli Lilly, MAP Pharmaceuticals, NuPathe, Sanofi-Aventis, Bristol-Myers Squibb, and Novartis. Dr. Brandes serves as a consultant for Merck, Allergan, and Nautilus. Within the past year, Dr. Rothrock has received funding for investigator-initiated or collaborative clinical research from GlaxoSmithKline, Merck, and Zogenix. He actively serves as a consultant to Allergan and within the past year has served on physicians' advisory boards for Allergan, Zogenix, MAP Pharmaceuticals, and Nautilus. He is an active member of the speakers' bureaus for Allergan, Merck, Zogenix, and GlaxoSmithKline. Dr. Fox serves as a consultant to Zogenix. Ms. Myers and Dr. Farr are employed by Zogenix.
- Issue published online: 1 SEP 2011
- Article first published online: 3 AUG 2011
- Accepted for publication June 6, 2011.
Objective.— To evaluate patient satisfaction with and confidence in Sumavel® DosePro® (needle-free subcutaneous sumatriptan) among current triptan users administering Sumavel DosePro for up to 4 migraine attacks.
Background.— Sumavel DosePro is a needle-free, single-use device that facilitates subcutaneous injection of sumatriptan 6 mg and confers relief as early as 10 minutes after dosing.
Design/Methods.— In this open-label, multicenter study, Sumavel DosePro was self-administered for ≤4 migraine attacks (over a ≤60-day period) involving moderate or severe baseline pain by adult migraineurs who currently were using triptans (any form, any dosage) and reported being less than very satisfied with their current therapy (ie, baseline satisfaction ranging from satisfied to very dissatisfied). Treatment satisfaction was measured via the Patient Perception of Migraine Questionnaire, revised (PPMQ-R).
Results.— Among the 212 patients using Sumavel DosePro to treat ≥1 migraine attack, PPMQ-R Overall Satisfaction (primary endpoint) increased significantly from baseline to the end of treatment (mean ± SD 65.7 ± 19.8 vs 73.7 ± 29.1, P = .0007), an improvement that met the criterion for clinical significance. From baseline to the end of treatment, PPMQ-R scores also improved significantly for Efficacy (62.2 ± 17.6 vs 76.2 ± 23.7, P < .0001), Functionality (59.0 ± 22.3 vs 73.8 ± 25.3, P < .0001), and Tolerability (83.9 ± 13.1 vs 86.4 ± 15.0, P = .02), but declined for Ease of Use (82.6 ± 15.3 vs 67.8 ± 27.6, P < .0001). For all global satisfaction domains, the percentage of patients satisfied or very satisfied increased from baseline to the end of treatment (Overall Satisfaction 36.3% vs 64.0%, Satisfaction with Medication Effectiveness 40.1% vs 68.2%, Satisfaction with Side Effects 48.6% vs 67.3%). The percentage of patients who were confident or very confident in treating repeated migraine attacks also increased (baseline: 41.0%, 90% confidence interval [CI] 35.4, 46.9 vs end of treatment: 66.5%, 90% CI 58.9, 70.1). The efficacy results (pain relief, pain-free response, sustained 24-hour pain relief and pain-free response) were consistent with those previously observed with needle-based sumatriptan.
Conclusion.— Patients currently treated with triptans and less than very satisfied with their acute migraine therapy experienced a statistically significant and clinically relevant increase in satisfaction with therapy and enhanced confidence in treatment after use of Sumavel DosePro for up to 4 migraine attacks.