PMID- 11385257 OWN - NLM STAT- MEDLINE DCOM- 20010726 LR - 20171101 IS - 0014-3022 (Print) IS - 0014-3022 (Linking) VI - 45 IP - 4 DP - 2001 TI - Tolerability and efficacy of almotriptan in the long-term treatment of migraine. PG - 206-13 AB - BACKGROUND: Almotriptan is a highly specific 5-HT(1B/1D) receptor agonist, which acts selectively on blood vessels of the brain. Short-term studies have demonstrated that almotriptan provides rapid, effective and reliable relief of migraine attacks, while offering excellent tolerability. PURPOSE: To assess the long-term tolerability and efficacy of oral almotriptan 12.5 mg administered for every migraine attack over a 1-year period. METHODS: A total of 762 patients treated 13,751 attacks (1-97 per patient); 61.5% of attacks were treated with one 12.5-mg dose, while for 38.5% of attacks, patients took a second dose within 24 h. RESULTS: Three hundred and ninety-one patients (51.3%) experienced a total of 1,617 adverse events (AEs). The majority (88.6%) of AEs were of mild-to-moderate intensity, and only 28.8% of AEs were considered to be related to the study drug. Only 2 patients experienced serious AEs possibly related to almotriptan, syncope and chest pain; both recovered without any sequelae. Patients reported at least 1 AE in 11% of attacks treated. The incidence of AEs decreased during the study. Only 6 (0.8%) study withdrawals were due to AEs considered to be related to almotriptan. Tolerability was not compromised in patients taking 2 doses of almotriptan or in those using migraine prophylactics. Patient age or sex did not influence the incidence of AEs. There was no evidence of tachyphylaxis in those patients completing the study. Pain relief at 2 h after the initial dose was achieved in 84.2% of moderate/severe attacks. Patients were pain free at 2 h after dose in 58.2% of all attacks. Older patients (> 40 years) tended to respond better than younger ones (< 40 years). Efficacy was not modified by use of migraine prophylactics or hormonal contraceptives. Efficacy measurements were consistent on treating repeated moderate/severe migraine attacks. CONCLUSION: This large, open study indicates that the new, specific 5-HT(1B/1D) agonist almotriptan, at a dose of 12.5 mg, is a well tolerated and effective treatment for migraine pain when used over a period of up to 1 year. CI - Copyright 2001 S. Karger AG, Basel FAU - Pascual, J AU - Pascual J AD - Servicio de Neurologia, University Hospital, Santander, Spain. pascualj@medi.unican.es FAU - Falk, R AU - Falk R FAU - Docekal, R AU - Docekal R FAU - Prusinski, A AU - Prusinski A FAU - Jelencsik, J AU - Jelencsik J FAU - Cabarrocas, X AU - Cabarrocas X FAU - Segarra, X AU - Segarra X FAU - Luria, X AU - Luria X FAU - Ferrer, P AU - Ferrer P LA - eng PT - Clinical Trial PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PL - Switzerland TA - Eur Neurol JT - European neurology JID - 0150760 RN - 0 (Indoles) RN - 0 (Serotonin Receptor Agonists) RN - 0 (Tablets) RN - 0 (Tryptamines) RN - 1O4XL5SN61 (almotriptan) SB - IM MH - Administration, Oral MH - Adolescent MH - Adult MH - Aged MH - Female MH - Humans MH - Indoles/*pharmacology/*therapeutic use MH - Male MH - Middle Aged MH - Migraine Disorders/*drug therapy MH - Pain Measurement MH - Self Administration MH - Serotonin Receptor Agonists/*pharmacology/*therapeutic use MH - Tablets MH - *Time MH - Treatment Outcome MH - Tryptamines EDAT- 2001/06/01 10:00 MHDA- 2001/07/28 10:01 CRDT- 2001/06/01 10:00 PHST- 2001/06/01 10:00 [pubmed] PHST- 2001/07/28 10:01 [medline] PHST- 2001/06/01 10:00 [entrez] AID - 52131 [pii] AID - 10.1159/000052131 [doi] PST - ppublish SO - Eur Neurol. 2001;45(4):206-13. doi: 10.1159/000052131.