FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2057765414> ?p ?o ?g. }

• W2057765414 endingPage "125" @default.
• W2057765414 startingPage "118" @default.
• W2057765414 abstract "Objective To assess the ability of patients, during an acute migraine attack, to successfully self-inject a single dose of sumatriptan using a novel sumatriptan auto-injector (Alsuma®), and to evaluate the safety, tolerability, and effectiveness of this sumatriptan auto-injector during an acute migraine attack. Background This sumatriptan auto-injector is a single-use system for the rapid subcutaneous delivery of 6 mg of sumatriptan succinate in the acute management of migraine pain. This auto-injector was developed to address the clinical need for an easy-to-use and rapid-to-administer system that did not require any assembly during the time of an ongoing attack. Methods This was an open-label, phase 3 trial conducted at 10 sites in the USA. Male or female adults, ages 18-60 years old, were eligible for study entry if they met International Headache Society criteria for migraine with or without aura, with at least 2 attacks per month, and if they reported use of subcutaneous injectable sumatriptan on at least 2 occasions within the previous 2 months. During the onset of a migraine attack of moderate-to-severe intensity, patients were asked to administer a 6-mg subcutaneous dose of sumatriptan using the auto-injector. Patients returned to the study site within 72 hours of the migraine for the post-treatment assessment visit. Results A total of 63 patients met entry criteria and received a dose of study medication (the intent-to-treat sample). Sixty-one patients (96.8%) reported injection in the thigh, and 2 patients (3.2%) reported injection in the arm. On the patient questionnaire, 100% of patients (95% confidence interval [CI] 94.3-100%) “agreed” or “agreed strongly” that the written instructions for the auto-injector were clear and easy to follow (30.2% “agreed”; 69.8% “agreed strongly”); 95.2% of patients (95% CI 86.7-99.0%) found that the auto-injector was easy to use (36.5% “agreed”; 58.7% “agreed strongly”), and 65.1% of patients (95% CI 52.0-76.7%) stated that they preferred the new auto-injector to the traditional auto-injector that they were using prior to study entry (42.9% “agreed”; 22.2% “agreed strongly”). Headache response rate at 2 hours was 93.7% (95% CI 84.5-98.2%), and pain-free rate at 2 hours was 60.3% (95% CI 47.2-72.4%). Pain-free rates at 2 hours were similarly high (58.3%; 95% CI 36.6-77.9%) in the subgroup of patients reporting severe baseline headache pain. Only 1 patient reported use of rescue medication after use of the auto-injector, a single oral dose of sumatriptan 100 mg on the same day. The most frequent adverse event was injection site bruising, reported by 15.9% of patients, and rated in all instance as mild in intensity. The second most frequent adverse event was injection site pain, reported by 6.3% of patients, and rated as mild by all patients except 1, who rated it as moderate in intensity. Conclusion The majority of injection-experienced patients reported the pre-assembled, single-use sumatriptan auto-injector to be an easy-to-use, preferred treatment for an acute migraine attack. The study found the auto-injector to be safe and well tolerated, with levels of injection site reactions that were mild and infrequent." @default.
• W2057765414 created "2016-06-24" @default.
• W2057765414 creator A5023181172 @default.
• W2057765414 creator A5056972994 @default.
• W2057765414 creator A5064341657 @default.
• W2057765414 creator A5082980079 @default.
• W2057765414 creator A5091485152 @default.
• W2057765414 date "2012-11-13" @default.
• W2057765414 modified "2023-10-05" @default.
• W2057765414 title "An Open-Label Trial of a Sumatriptan Auto-Injector for Migraine in Patients Currently Treated With Subcutaneous Sumatriptan" @default.
• W2057765414 cites W1975689516 @default.
• W2057765414 cites W1981638246 @default.
• W2057765414 cites W1983452443 @default.
• W2057765414 cites W2002685901 @default.
• W2057765414 cites W2003265473 @default.
• W2057765414 cites W2027261838 @default.
• W2057765414 cites W2069237840 @default.
• W2057765414 cites W2114413295 @default.
• W2057765414 cites W2146272590 @default.
• W2057765414 cites W4211249799 @default.
• W2057765414 cites W58525860 @default.
• W2057765414 doi "https://doi.org/10.1111/j.1526-4610.2012.02295.x" @default.
• W2057765414 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/23148799" @default.
• W2057765414 hasPublicationYear "2012" @default.
• W2057765414 type Work @default.
• W2057765414 sameAs 2057765414 @default.
• W2057765414 citedByCount "7" @default.
• W2057765414 countsByYear W20577654142013 @default.
• W2057765414 countsByYear W20577654142014 @default.
• W2057765414 countsByYear W20577654142015 @default.
• W2057765414 countsByYear W20577654142016 @default.
• W2057765414 countsByYear W20577654142021 @default.
• W2057765414 crossrefType "journal-article" @default.
• W2057765414 hasAuthorship W2057765414A5023181172 @default.
• W2057765414 hasAuthorship W2057765414A5056972994 @default.
• W2057765414 hasAuthorship W2057765414A5064341657 @default.
• W2057765414 hasAuthorship W2057765414A5082980079 @default.
• W2057765414 hasAuthorship W2057765414A5091485152 @default.
• W2057765414 hasConcept C126322002 @default.
• W2057765414 hasConcept C170493617 @default.
• W2057765414 hasConcept C197934379 @default.
• W2057765414 hasConcept C2777350023 @default.
• W2057765414 hasConcept C2778375690 @default.
• W2057765414 hasConcept C2778541695 @default.
• W2057765414 hasConcept C2778871607 @default.
• W2057765414 hasConcept C2778938600 @default.
• W2057765414 hasConcept C42219234 @default.
• W2057765414 hasConcept C71924100 @default.
• W2057765414 hasConceptScore W2057765414C126322002 @default.
• W2057765414 hasConceptScore W2057765414C170493617 @default.
• W2057765414 hasConceptScore W2057765414C197934379 @default.
• W2057765414 hasConceptScore W2057765414C2777350023 @default.
• W2057765414 hasConceptScore W2057765414C2778375690 @default.
• W2057765414 hasConceptScore W2057765414C2778541695 @default.
• W2057765414 hasConceptScore W2057765414C2778871607 @default.
• W2057765414 hasConceptScore W2057765414C2778938600 @default.
• W2057765414 hasConceptScore W2057765414C42219234 @default.
• W2057765414 hasConceptScore W2057765414C71924100 @default.
• W2057765414 hasIssue "1" @default.
• W2057765414 hasLocation W20577654141 @default.
• W2057765414 hasLocation W20577654142 @default.
• W2057765414 hasOpenAccess W2057765414 @default.
• W2057765414 hasPrimaryLocation W20577654141 @default.
• W2057765414 hasRelatedWork W1970872264 @default.
• W2057765414 hasRelatedWork W1973349312 @default.
• W2057765414 hasRelatedWork W1988486442 @default.
• W2057765414 hasRelatedWork W2011047754 @default.
• W2057765414 hasRelatedWork W2022293527 @default.
• W2057765414 hasRelatedWork W2083330259 @default.
• W2057765414 hasRelatedWork W2137547383 @default.
• W2057765414 hasRelatedWork W2169042796 @default.
• W2057765414 hasRelatedWork W2592354866 @default.
• W2057765414 hasRelatedWork W2093125501 @default.
• W2057765414 hasVolume "53" @default.
• W2057765414 isParatext "false" @default.
• W2057765414 isRetracted "false" @default.
• W2057765414 magId "2057765414" @default.
• W2057765414 workType "article" @default.