Efficacy and tolerability of combined dipyrone, isometheptene and caffeine in the treatment of mild-to-moderate primary headache episodes

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dc.contributor.author Carvalho, Deusvenir de Souza [UNIFESP]
dc.contributor.author Barea, Liselotte Menke
dc.contributor.author Kowacs, Pedro Andre
dc.contributor.author Fragoso, Yara Dadalti
dc.date.accessioned 2016-01-24T14:17:55Z
dc.date.available 2016-01-24T14:17:55Z
dc.date.issued 2012-02-01
dc.identifier http://dx.doi.org/10.1586/ERN.11.193
dc.identifier.citation Expert Review of Neurotherapeutics. London: Expert Reviews, v. 12, n. 2, p. 159-167, 2012.
dc.identifier.issn 1473-7175
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/34618
dc.description.abstract The efficacy and tolerability of a combination of dipyrone 600 mg, isometheptene 60 mg and caffeine 60 mg for the acute treatment of mild-to-moderate episodic primary headaches were evaluated against paracetamol 1000 mg and placebo. A total of 84 adult patients with two to six primary headache episodes (mild or moderate severity) per month were enrolled in this prospective, multicenter, randomized, two-period crossover study. Patients had a mean of 4.4 headache episodes/month (mean duration: 13 h; mean severity: 50.5 mm; assessed by visual analog scale (VAS). in patients with no improvement, rescue medications were allowed after 2 h. the primary outcome parameter was sustained pain-free rate. Secondary outcomes were evolution of pain severity (at 30, 60, 90, 120 and 240 min after treatment), presence of associated symptoms, and recurrence of episodes. Analyses included 243 headache episodes (81 patients). Sustained pain-free rates were 57.1% for combination therapy, 46.8% for paracetamol and 46.8% for placebo (not statistically significant). Pain improvement (assessed by VAS) occurred in 72.5, 54.5 and 49.2% of patients, respectively, after 120 min. the mean reduction in pain severity (assessed by VAS) was significantly lower in those receiving placebo and paracetamol compared with combination therapy (p < 0.001 at 90 and 120 min). Fewer patients required rescue medication after receiving combination therapy (18.4%), compared with paracetamol (37.7%; p = 0.008) or placebo (43.8%; p = 0.0007). Adverse events were infrequent and mild. We conclude that, despite failing to meet the primary outcome, the combination of dipyrone, isometheptene and caffeine is effective for the acute treatment of mild-to-moderate primary headache episodes, with excellent tolerability. en
dc.description.sponsorship Nycomed Pharma
dc.description.sponsorship Nycomed Pharma, Brazil
dc.format.extent 159-167
dc.language.iso eng
dc.publisher Expert Reviews
dc.relation.ispartof Expert Review of Neurotherapeutics
dc.rights Acesso restrito
dc.subject attack treatment en
dc.subject headache en
dc.subject migraine en
dc.subject mild-to-moderate headache en
dc.subject primary headache en
dc.subject tension-type headache en
dc.title Efficacy and tolerability of combined dipyrone, isometheptene and caffeine in the treatment of mild-to-moderate primary headache episodes en
dc.type Resenha
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution Fed Univ Hlth Sci Porto Alegre UFCSPA RS
dc.contributor.institution Fed Sch Med Sci Porto Alegre
dc.contributor.institution Univ Fed Parana
dc.contributor.institution Univ Metropolitana Santos
dc.description.affiliation Hosp São Paulo, Div Invest & Treatment Headaches, São Paulo, Brazil
dc.description.affiliation Fed Univ São Paulo UNIFESP, Escola Paulista Med EPM, Dept Clin Neurol & Neurosurg, São Paulo, Brazil
dc.description.affiliation Fed Univ Hlth Sci Porto Alegre UFCSPA RS, Dept Neurol, Porto Alegre, Brazil
dc.description.affiliation Fed Sch Med Sci Porto Alegre, Dept Neurol, Porto Alegre, RS, Brazil
dc.description.affiliation Univ Fed Parana, Div Headaches, Neurol Inst, Neurol Sect, BR-80060000 Curitiba, Parana, Brazil
dc.description.affiliation Univ Metropolitana Santos, Sch Med, São Paulo, Brazil
dc.description.affiliationUnifesp Hosp São Paulo, Div Invest & Treatment Headaches, São Paulo, Brazil
dc.description.affiliationUnifesp Fed Univ São Paulo UNIFESP, Escola Paulista Med EPM, Dept Clin Neurol & Neurosurg, São Paulo, Brazil
dc.identifier.doi 10.1586/ERN.11.193
dc.description.source Web of Science
dc.identifier.wos WOS:000300860900012



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