title: Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration.
abstract: Anti-inflammatory and pain therapies have been associated with blood pressure (BP) destabilization. Hence, the effects on BP of sumatriptan/naproxen sodium in fixed-dose combination, sumatriptan 85 mg, and naproxen sodium 500 mg administered intermittently for the acute treatment of migraine attacks were assessed. Patients with migraine with or without aura and no history of hypertension were randomized to sumatriptan/naproxen sodium (n=135), sumatriptan (n=136), or naproxen sodium (n=136) to treat migraine attacks for 6 months in a double-blind, parallel-group trial. Following a treated migraine attack, patients performed 2 consecutive days of self-measured BPs beginning ≥24 hours after the last dose of study medication and transmitted them by a transtelephonic modem. The primary end point was the change from baseline in self-measured BP at 6 months. Changes in self-measured BP from baseline to 6 months for sumatriptan/naproxen sodium were -2.1/-1.5 mm Hg (95% confidence intervals, -3.4 to -0.8 for systolic and -2.6 to -0.3 for diastolic). Mean changes from baseline in self-measured BP did not differ among the 3 treatment groups. Additional categorical analyses did not show increases from baseline with sumatriptan/naproxen sodium relative to either of the monotherapy groups. Intermittent acute migraine treatment with sumatriptan/naproxen sodium for up to 6 months was associated with clinically insignificant decreases in self-measured BP that were similar to those with sumatriptan or naproxen alone in normotensive patients with migraine.
authors.affiliation: Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT 06030-3940, USA.
authors.forename: William B
authors.initials: WB
authors.lastname: White
authors.forename: Frederick J
authors.initials: FJ
authors.lastname: Derosier
authors.forename: April H
authors.initials: AH
authors.lastname: Thompson
authors.forename: Bryan E
authors.initials: BE
authors.lastname: Adams
authors.forename: David K
authors.initials: DK
authors.lastname: Goodman
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects*; D016001:Confidence Intervals; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D006973:Hypertension / Q000139:chemically induced*; D016015:Logistic Models; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy; D009288:Naproxen / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D012307:Risk Factors; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D018170:Sumatriptan / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D017366:Serotonin Receptor Agonists; D009288:Naproxen; D018170:Sumatriptan