Effect of high-dose intravenous eletriptan on coronary artery diameter.
The goal of this study was to evaluate the coronary vasoconstrictive effects of high doses of eletriptan compared with a standard dose of sumatriptan. Patients with no clinically significant coronary artery disease were randomized to receive high-dose intravenous eletriptan (n = 24) vs a standard dose of sumatriptan (n = 18; 6 mg subcutaneously) vs placebo (n = 18). Serial angiograms were obtained. The primary non-inferiority analysis found equivalence between the mean maximum change in left anterior descending coronary artery diameter for eletriptan, -22%[95% confidence interval (CI) -26, -19], and sumatriptan, -19% (95% CI -22, -16). The change due to placebo was -16% (95% CI -20, -12). No individual cases of clinically significant vasoconstriction were observed. The results confirm that eletriptan has a broad cardiovascular safety margin, with plasma concentrations comparable to three to five times the Cmax of an oral 80-mg dose associated with modest vasoconstriction equivalent to standard therapeutic doses of sumatriptan.
Goldstein
J A
JA
William Beaumont Hospital, Royal Oak, MI 48073, USA. jgoldstein@beaumont.edu
Massey
K D
KD
Kirby
S
S
Gibson
M
M
Hettiarachchi
J
J
Rankin
A J
AJ
Jackson
N C
NC
D000328:Adult; D016001:Confidence Intervals; D003331:Coronary Vessels / Q000187:drug effects* / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines / Q000008:administration & dosage*; D018170:Sumatriptan / Q000008:administration & dosage; D014363:Tryptamines; D014661:Vasoconstriction / Q000187:drug effects* / Q000502:physiology
D007211:Indoles; D011759:Pyrrolidines; D014363:Tryptamines; C115647:eletriptan; D018170:Sumatriptan