Efficacy of eletriptan in triptan-naïve patients: results of a combined analysis.
OBJECTIVE
To compare the efficacy and tolerability of eletriptan 20 mg, 40 mg, and 80 mg in triptan-naïve patients (who have not previously used triptans) versus triptan-experienced patients (who have previously used triptans).


METHODS
Efficacy and tolerability data for eletriptan 20 mg, 40 mg, and 80 mg were pooled from 10 similarly designed, randomized, parallel-group studies, and triptan-naïve and triptan-experienced patients were compared with placebo across the 3 triptan doses. The primary efficacy endpoint was headache response at 2 hours postdose. Secondary efficacy endpoints were 2-hour pain-free response, 2-hour absence of associated symptoms, 2-hour functional response, 24-hour sustained headache response, and 24-hour sustained pain-free response.


RESULTS
For eletriptan 20 mg, 40 mg, and 80 mg versus placebo, respectively, triptan-naïve patients showed significantly higher 2-hour headache response (54%, 61%, 66% vs. 31%; P < .0001), 2-hour pain-free response (20%, 28%, and 31% vs. 8%; P < .0001), and 24-hour sustained headache response (34%, 45%, and 51% vs. 20%; P < .0001). A similarly significant efficacy advantage was also observed in the triptan-experienced subgroup for 2-hour headache response (46%, 63%, 69% vs. 21%; P < .0001), 2-hour pain-free response (13%, 32%, and 38% vs. 4%; P < .0001), and 24-hour sustained headache response (29%, 41%, and 45% vs. 9%; P < .0001). Previous treatment status did not influence tolerability, and all 3 doses of eletriptan were well tolerated.


CONCLUSIONS
These data suggest that eletriptan has comparable efficacy versus placebo among both triptan-naïve and triptan-experienced patients.
Martin
Vincent T
VT
Division of General Internal Medicine, University of Cincinnati, Cincinnati, OH 45267-4217, USA.
Valade
Dominique
D
Almas
Mary
M
Hettiarachchi
Jayasena
J
Sikes
Carolyn
C
Albert
Kenneth S
KS
Parsons
Bruce
B
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014363:Tryptamines / Q000009:adverse effects / Q000627:therapeutic use*
D011759:Pyrrolidines; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C115647:eletriptan