| Автор | Steiner, TJ |
| Автор | Ahmed, F |
| Автор | Findley, LJ |
| Автор | MacGregor, EA |
| Автор | Wilkinson, M |
| Дата выпуска | 1998 |
| dc.description | S-fluoxetine is the long-acting enantiomer of the racemic antidepressant serotonin reuptake inhibitor. Sixty-five patients needing migraine prophylaxis were recruited into a phase II, double-blind, placebo-controlled trial. After a 1-month placebo run-in, 53 patients met entry criteria with regard to attack frequency and were randomized, 27 to S-fluoxetine and 26 to matching placebo. Three failed to start treatment and mere were 17 early discontinuations, 9 from S-fluoxetine, 8 from placebo, at similar times and for similar reasons. The primary efficacy variable was attack frequency and analysis compared decline-from-baseline in the two groups. This was earlier and greater (1.7 attacks/28 days, or 52%) on active therapy than on placebo (1.1 attacks/28 days, or 27%), and statistically significant in month 2 (F=4.93; p=0.033) and month 4 (F=4.55; p=0.041). As secondary measures of efficacy, migraine-days per month and Patient's Global Impression of Disease Severity coherently reflected the changes in attack frequency. Mean attack severity and acute medication use (doses per attack) were unaltered by either treatment. There were no serious adverse events. Withdrawals for adverse events were four from each group but none was considered causally related. The finding of greater efficacy of S-fluoxetine than of placebo should be interpreted conservatively, since the analysis in the final month was made on only half of the entered patients. It supports progression to phase III evaluation, which was the purpose of the study. |
| Издатель | SAGE Publications |
| Тема | Enantiomer |
| Тема | fluoxetine |
| Тема | migraine |
| Тема | placebo |
| Тема | randomized controlled trial |
| Название | S-Fluoxetine in the Prophylaxis of Migraine: A Phase Ii Double-Blind Randomized Placebo-Controlled Study |
| Тип | Journal Article |
| DOI | 10.1111/j.1468-2982.1998.1805283.x |
| Electronic ISSN | 1468-2982 |
| Print ISSN | 0333-1024 |
| Журнал | Cephalalgia |
| Том | 18 |
| Первая страница | 283 |
| Последняя страница | 286 |
| Аффилиация | Steiner, TJ, 1 Division of Neuroscience and Psychological Medicine, Imperial College School of Medicine, London, U |
| Аффилиация | Ahmed, F, 1 Division of Neuroscience and Psychological Medicine, Imperial College School of Medicine, London, U |
| Аффилиация | Findley, LJ, 2 Essex Centre for Neurological Sciences, Oldchurch Hospital, Romford, U |
| Аффилиация | MacGregor, EA, 3 The City of London Migraine Clinic, London, UK |
| Аффилиация | Wilkinson, M, 3 The City of London Migraine Clinic, London, UK |
| Выпуск | 5 |
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