Objective.-To evaluate clinical parameters that may affect the incidence of
headache recurrence or the time to headache recurrence, or both, in migrai
neurs treated with naratriptan, 2.5-mg tablets.
Background.-The incidence of headache recurrence within 24 hours of treatme
nt with naratriptan, 2.5-mg tablets (17%-28%), is lower than that reported
for other currently available selective serotonin agonists. Identifying cli
nical parameters that influence headache recurrence may further reduce the
incidence of headache recurrence or prolong the time to recurrence, or both
, for naratriptan-treated patients.
Methods.-We examined the effects of three clinical parameters (predose pain
severity, headache duration prior to treatment, and relief status 4 hours
post dose) on the incidence of and time to headache recurrence across four
placebo-controlled naratriptan clinical trials. The impact of these paramet
ers on headache recurrence was examined individually and in combination.
Results.-Predose pain severity had no effect on the incidence of headache r
ecurrence (overall 23%; moderate 22%, severe 23%). The median time to recur
rence was longer for patients with moderate pain before treatment compared
with patients with severe pain before treatment (14.5 hours versus 9.3 hour
s, respectively). Overall time to headache recurrence was 11.8 hours. Patie
nts with headache recurrence reported a longer time until they treated the
headache compared with patients without headache recurrence (median, 145 mi
nutes versus 97.5 minutes). Patients who treated headache pain within 3 hou
rs of onset had a lower incidence of headache recurrence (20%) than patient
s who treated their headache more than 3 hours after onset (28%). Patients
with no pain 4 hours post dose had a lower incidence of and a longer time t
o headache recurrence compared with patients with mild pain 4 hours post do
se (17% versus 32%; median, 17.8 hours versus 8.1 hours, respectively). The
interaction of all three clinical parameters was significant in predicting
headache recurrence.
Conclusions.-The overall incidence of headache recurrence is low after nara
triptan, 2.5 mg, compared with other currently available selective serotoni
n agonists. Predose pain severity, time to treatment, and 4-hour relief sta
tus appear related to the incidence of or time to headache recurrence, or b
oth. Treating less severe migraine attacks, treating earlier within an atta
ck, and obtaining complete relief post dose may enhance the low incidence o
f headache recurrence and achieve longer times to recurrence with naratript
an, 2.5 mg.