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

This comprehensive analysis of migraine- and non-migraine-related clinical factors, as well as demographic characteristics, in two clinical studies failed to identify predictors of oral sumatriptan dose preference. Although sex, urologic history, and psychological history were identified in Study 1 as possibly predictive of dose preference, they did not reach statistical significance. While sex as a predictive factor is plausible, there is no rationale for urologic and psychological history impacting dose preference; thus, these findings are likely anomalous. In Study 2, duration of migraine history, headache severity, height, and medical history of endocrine or neurologic disease were identified as possibly predictive, with history of endocrine disease being statistically significant. A relationship between some of the factors identified in Study 2 and migraine is possible. However, the lack of overlap between factors identified as possibly predictive between the two studies suggests that none are clinically important.

Previous analyses have found that only features of migraine itself, including headache severity at baseline, nausea, and photophobia/phonophobia, are predictive of 2 h response to triptans; numerous demographic and clinical variables have been found to be nonpredictive [28, 29]. Here, migraine-related baseline characteristics were not strongly associated with dose preference. Only duration of migraine history and headache severity were identified as possibly predictive of dose preference, but only in Study 2, and neither reached statistical significance. Consistent with studies of response to triptans [28, 29], no other clinical or demographic characteristics seem to have any impact on oral sumatriptan dose preference.

Overall, patients preferred a higher dose of oral sumatriptan of 50 or 100 mg rather than a lower 25 mg dose. In the original studies on which this analysis was based, better pain relief and faster pain relief were the primary reasons for preferring the higher doses, and poor tolerability was the main reason for decreasing the dose [24, 25]. In clinical trials, higher doses of sumatriptan have proven more effective than a lower 25 mg dose [30], but a 100 mg dose has not been shown to be more effective than the 50 mg dose [19]. However, sumatriptan 50 mg is associated with fewer adverse events than the 100 mg dose [30]. Altogether, these findings suggest that it would be difficult to offer specific guidance on initial sumatriptan dose selection. However, an initial trial of a moderate sumatriptan dose of 50 mg would be an appropriate starting point.

A strength of this analysis is that it was based on prospective, albeit historical, clinical studies designed to ascertain patient preference for sumatriptan dose [24, 25]. Because of the prospective nature of these studies, it was conceivable to test for a wide range of possible predictive factors using several statistical and machine-learning techniques. Importantly, the analysis has identified dose level as a potential key factor in treatment selection; this factor was omitted in previous analyses [23].

Several limitations of the study should be noted. Patients in Study 1 did not explicitly express a dose preference per se but, rather, elected to change or not change their dose to a lower or higher one. In addition, this was a post hoc analysis with limited statistical power. The sample size of patients who expressed a preference for the lower 25 mg dose of oral sumatriptan was small, limiting the ability to identify potential factors predictive of a preference for this lower dose. Populations in some patient groups, including male and non-White participants, were small, which could produce spurious findings. Furthermore, since the analysis was based on older studies, assessments of modern migraine metrics (e.g., Migraine Disability Assessment Test) were not captured. Although some of the predictive candidate factors derived from the original studies may have differed if the studies were conducted more recently, many of the factors remain relevant today (e.g., migraine characteristics and physical characteristics). Finally, the analysis did not differentiate between the 50 and 100 mg doses of oral sumatriptan, as their effectiveness may not be different [19, 30].

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