Patient Factors in the Dose Selection of Oral Sumatriptan for Acute Migraine: A Post Hoc Analysis of Two Randomized Controlled Studies.

Introduction: Patients are seeking greater involvement in their healthcare. It therefore may be beneficial to provide guidance on initial oral sumatriptan dose selection for the treatment of acute migraine in nontraditional settings, such as telehealth and other remote forms of medical care. We sought to determine whether clinical or demographic factors are predictive of oral sumatriptan dose preference.

Methods: This was a post hoc analysis of two clinical studies designed to determine preference for 25, 50, or 100 mg oral sumatriptan. Patients were aged 18-65 years with at least a 1 year history of migraine and experienced, on average, between one and six severe or moderately severe migraine attacks per month, with or without aura. Predictive factors were demographic measures, medical history, and migraine characteristics. Possibly predictive factors were identified using three analyses: classification and regression tree analysis, marginal significance (P < 0.1) within a full-model logistic regression, and/or selection within a forward-selection procedure in a logistic regression. A reduced model containing the variables identified in the preliminary analyses was developed. Due to differences in study design, data were not combined.

Results: A dose preference was expressed by 167 patients in Study 1 and 222 patients in Study 2. Gender and medical history of urologic and/or psychological conditions in Study 1 and duration of migraine history, height, and medical history of endocrine or neurologic disease and headache severity in Study 2 were identified as possibly predictive. The predictive model showed low positive predictive value (PPV; 23.8%) and low sensitivity (21.7%) for Study 1. For Study 2, the model showed moderate PPV (60.0%) but low sensitivity (10.9%).

Conclusions: No clinical or demographic characteristics alone or in combination were consistently or strongly associated with preference for oral sumatriptan dose level.

Trial Registration: The studies on which this paper is based were conducted before trial registration indexes were introduced.