High-Dose Neuromodulators: A Roundtable on Making Sense of the Data in Real-World Clinical Practice.

Background: For aesthetic treatment with botulinum neurotoxin type A (BoNTA), interest in maximizing treatment duration and efficacy has prompted study of doses higher than those used in registration studies. As data emerge, it is important that physicians understand how to apply study findings to their own practice so that patient demand is satisfied.

Objectives: To bring together leading experts in neuromodulators for a roundtable discussion on the implications of high-dose BoNTA studies for patient care.

Methods: The authors reviewed and discussed recent data from high-dose BoNTA studies for abobotulinum toxin A, incobotulinum toxin A, and Oonobotulinumtoxin A.

Results: Discussion focused on the challenges of data interpretation and extrapolation of study findings for real-world patient care. The authors participated in a candid discussion of whether the observed improvements in treatment duration and patient satisfaction warrant treatment with high-dose regimens delivered as high-concentration injections. Safety was also discussed, as well as economic considerations for both practices and patients. Of note, for BoNTA products, the registration dose, when administered in a smaller total volume, appears to give rise to more durable results than those observed in pivotal trials, implicating product concentration as an important consideration. Importantly, at higher doses, extended duration of effect does not appear to be at the expense of natural-looking results.

Conclusions: While the authors provide considerations for the development of individual clinical practice, there is no one-size-fits-all recommendation. It may be that "high-dose" BoNTA is in reality the optimal dose; however, important economic considerations may prevent rapid uptake for all patients.