ABSTRACT
OBJECTIVE: To examine the safety and efficacy of rizatriptan 10 mg PO in the treatment of multiple migraine attacks. BACKGROUND: Rizatriptan is a potent and rapidly absorbed 5-HT1B/1D receptor agonist. Efficacy and general safety have been examined in controlled trials treating single migraine attacks. In the current placebo-controlled study, we report constancy of safety and efficacy of rizatriptan for patients treating four discrete migraine attacks. METHODS: Patients with moderate or severe migraine (n = 473) were randomized to one of five sequence groups, in which each patient was to treat four migraine attacks. Patients in four groups received rizatriptan 10 mg for three of four attacks and placebo for the remaining attack. Patients in the fifth group received rizatriptan 10 mg for four attacks. Headache severity, functional disability, and migraine symptoms were measured immediately before dosing and at 0.5, 1, 1.5, 2, 3, and 4 hours postdose. RESULTS: After the first attack, response rates were 77% for rizatriptan and 37% for placebo (p < 0.001). Similar efficacy of rizatriptan, ranging from a 75 to 80% response, was observed in each of the subsequent attacks with no evidence of tolerance to therapeutic effects. Most patients (93%) responded to rizatriptan 10 mg during the first or second attack. Adverse experiences were generally mild and transient, the most common being dizziness and somnolence. Incidence of adverse experiences per attack decreased after the first attack. CONCLUSIONS: Rizatriptan 10 mg PO is efficacious and generally well tolerated in acute migraine. Its efficacy is maintained throughout the treatment of multiple, discrete migraine attacks.
Subject(s)
Migraine Disorders/drug therapy , Serotonin Receptor Agonists/therapeutic use , Triazoles/therapeutic use , Administration, Oral , Adolescent , Adult , Aged , Cross-Over Studies , Female , Humans , Male , Middle Aged , Patient Satisfaction , Serotonin Receptor Agonists/administration & dosage , Serotonin Receptor Agonists/adverse effects , Treatment Outcome , Triazoles/administration & dosage , Triazoles/adverse effects , TryptaminesABSTRACT
OBJECTIVE: To evaluate the efficacy and safety of sumatriptan, a 5-HT1 receptor agonist, in patients with menstruation-associated migraine. METHODS: Two double-blind, placebo-controlled, single-attack parallel group studies of subcutaneous sumatriptan were conducted for the acute treatment of migraine. A retrospective analysis of 1104 patients produced 157 women who were treated for a menstruation-associated migraine (defined as a migraine beginning between 1 day before and 4 days after the onset of menstrual flow) and 512 women treated for nonmenstrual migraine. We excluded 435 other patients who were either male (123), women with hysterectomies (260), or women with missing data (52). Patients with moderate or severe pain were treated with 6 mg subcutaneous sumatriptan or placebo. One hour after treatment, response rates of headache severity and associated symptoms were measured. Menstruation-associated migraine patients were compared to female patients with nonmenstrual migraine. Migraine recurrence was analyzed retrospectively for 24 hours. RESULTS: At 1 hour, 80% of the sumatriptan-treated menstrual-migraine patients had pain relief (reduction of severe or moderate pain to mild or no pain), compared to 19% of the placebo patients (P < .001). Sumatriptan also treated nausea and photophobia more effectively in menstrual-migraine patients than did placebo. Response rates for pain and associated symptoms were similar between patients with menstruation-associated and nonmenstrual migraines. Adverse effects were also similar between the groups. CONCLUSION: Sumatriptan was as effective and well tolerated for menstruation-associated migraine as it was for nonmenstrual migraine.
