Rizatriptan (MAXALT) for the Acute Treatment of Migraine and Migraine Recurrence. A Placebo-Controlled, Outpatient Study

• Published in: Headache Vol. 38; no. 4; pp. 281 - 287
• Main Authors: Teall, Judith, Tuchman, Michael, Cutler, Neal, Gross, Michael, Willoughby, Ernest, Smith, Betty, Jiang, Kai, Reines, Scott, Block, Gilbert
• Format: Journal Article
• Language: English
• Published: USA/Oxford, UK American Association for the Study of Headache/Blackwell Science Ltd 01-04-1998; Blackwell
• Subjects: Biological and medical sciences; Drug toxicity and drugs side effects treatment; headache recurrence; Medical sciences; migraine; Pharmacology. Drug treatments; rizatriptan; Toxicity: nervous system and muscle; Headache; Agonist; Relapse; Toxicity; Multicenter study; Cardiovascular disease; 5-HT1 Serotonine receptor; Dose activity relation; Vascular disease; Randomization; Pain; Secondary effect; Adult; Neurological disorder; Cerebrovascular disease; Human; Nervous system diseases; Antimigrainous agent; Migraine; Oral administration; Cerebral disorder; Crisis; Chemotherapy; Treatment; Central nervous system disease; Rizatriptan
• ISSN: 0017-8748; 1526-4610
• DOI: 10.1046/j.1526-4610.1998.3804281.x

Rizatriptan is a novel 5‐HT1B/1D agonist which is rapidly absorbed after oral administration. The efficacy and tolerability of oral rizatriptan (5 mg and 10 mg) were examined in this multicenter, double‐blind, outpatient study of 1473 migraineurs which featured randomized, placebo‐controlled treatment of migraine recurrences. On experiencing moderate or severe migraine headaches, patients rated headache severity prior to dosing and at 30‐minute intervals for 2 hours after dosing. Onset of effect was seen as early as 30 minutes after dosing with rizatriptan 10 mg. At 2 hours postdose, the percentage of patients with pain relief was significantly higher after rizatriptan 5 mg (62%) or 10 mg (71%) compared with placebo (35%). Complete relief was also significantly higher after rizatriptan 5 mg (33%) and 10 mg (42%) compared with placebo (10%). In patients experiencing headache recurrence after initial benefit, further relief was obtained in 71% with rizatriptan 5 mg (placebo 54%) and in 82% with rizatriptan 10 mg (placebo 44%). Complete relief of recurrent headache was obtained in 36% with rizatriptan 5 mg, 49% with rizatriptan 10 mg, and 15% with placebo (P<0.05). The most common drug‐related adverse experiences were dizziness, somnolence, asthenia/fatigue, and nausea (the incidences of which were low and dose related). There was no increase in the incidence of adverse experiences after use of up to three doses of rizatriptan within 24 hours. We conclude that both doses of rizatriptan are effective and well tolerated in the acute treatment of migraine and migraine recurrence, with the l0‐mg dose preferred as it is more effective with a faster onset of action.