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

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

Author Carvalho, Deusvenir de Souza Autor UNIFESP Google Scholar
Barea, Liselotte Menke Google Scholar
Kowacs, Pedro Andre Google Scholar
Fragoso, Yara Dadalti Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Fed Univ Hlth Sci Porto Alegre UFCSPA RS
Fed Sch Med Sci Porto Alegre
Univ Fed Parana
Univ Metropolitana Santos
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.
Keywords attack treatment
headache
migraine
mild-to-moderate headache
primary headache
tension-type headache
Language English
Sponsor Nycomed Pharma
Nycomed Pharma, Brazil
Date 2012-02-01
Published in Expert Review of Neurotherapeutics. London: Expert Reviews, v. 12, n. 2, p. 159-167, 2012.
ISSN 1473-7175 (Sherpa/Romeo, impact factor)
Publisher Expert Reviews
Extent 159-167
Origin http://dx.doi.org/10.1586/ERN.11.193
Access rights Closed access
Type Review
Web of Science ID WOS:000300860900012
URI http://repositorio.unifesp.br/handle/11600/34618

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