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Oral Almotriptan vs Oral Sumatriptan in the Abortive Treatment of Migraine
A Double-blind, Randomized, Parallel-Group, Optimum-Dose Comparison
Egilius L. H. Spierings, MD, PhD;
Baltazar Gomez-Mancilla, MD, PhD;
Daniel E. Grosz, MD;
Clayton R. Rowland, PhD;
Fredrick S. Whaley, PhD;
Kathleen J. Jirgens
Arch Neurol. 2001;58:944-950.
Background Almotriptan malate is a novel, selective serotonin1B/D agonist,
or triptan, developed for the abortive treatment of migraine. In double-blind,
placebo-controlled studies, it has been shown to be effective, well tolerated,
and safe.
Objective To compare the efficacy, tolerability, and safety of almotriptan with
that of the "standard triptan," sumatriptan succinate. The power calculation
of the study was based on 24-hour headache recurrence, an efficacy measure
in the abortive treatment of migraine, and on the occurrence of adverse events.
Subjects and Methods Subjects, aged between18 and 65 years, with migraine with or without
aura but otherwise healthy, were randomized to take orally either almotriptan
malate, 12.5 mg, or sumatriptan succinate, 50 mg. The medications were provided
in identical-looking capsules to ensure blinding and were taken for the treatment
of moderate or severe headache. Efficacy was determined in terms of (1) headache
relief—a decrease in pain intensity to mild or no pain; (2) headache
freedom—a decrease to no pain; (3) use of rescue medications, allowed
after 2 hours; and (4) headache recurrence—moderate or severe pain returning
within 24 hours after headache relief at 2 hours. Adverse events were collected
for 96 hours after treatment and for safety evaluation, vital signs, blood
tests, and electrocardiograms were performed at the screening and exit visits.
Results Seventy-five investigators enrolled 1255 subjects of whom 1173 were
treated (591 with almotriptan and 582 with sumatriptan). At 2 hours, almotriptan
treatment provided headache relief in 58.0% of the subjects and sumatriptan
treatment in 57.3%; headache freedom was provided by the medications in 17.9%
and 24.6%, respectively (P = .005). Rescue medications
were taken by 36.7% of the subjects in the almotriptan-treated group and by
33.2% in the sumatriptan-treated group; headaches returned to moderate or
severe intensity in 27.4% and 24.0%, respectively. Treatment-emergent adverse
events occurred in 15.2% of the subjects in the almotriptan-treated group
and in 19.4% in the sumatriptan-treated group (P
= .06); treatment-related adverse events occurred in 9.1% and 15.5% of the
subjects, respectively (P = .001), including chest
pain, which occurred in 0.3% and 2.2%, respectively (P
= .004).
Conclusions Almotriptan and sumatriptan are similarly effective in the abortive
treatment of moderate or severe migraine headache; they are also similarly
well tolerated and safe.
From the Department of Neurology, Brigham and Women's Hospital and
Harvard Medical School, Boston, Mass (Dr Spierings); Departments of Central
Nervous System Development (Dr Gomez-Mancilla), Health Economics (Dr Rowland
and Ms Jirgens), and Biostatistics and Data Management (Dr Whaley), Pharmacia,
Kalamazoo, Mich; and the Pharmacology Research Institute, Northridge, Calif
(Dr Grosz). Dr Spierings received honoraria (advisory board, speakers bureau)
and grants from Pharmacia (almotriptan) and GlaxoSmithKline (sumatriptan);
Drs Gomez-Mancilla, Rowland, and Whaley as well as Ms Jirgens are employees
of Pharmacia.
Corresponding author: Egilius L. H. Spierings, MD, PhD, 25 Walnut
St, Suite 102, Wellesley Hills, MA 02481-2106 (e-mail: Spierings{at}MediaOne.net).
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