Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial.

L'autore è ricompreso nel TOPMAT-MIG-303 Investigators Group, il cui elenco è è riportato in calce al paper Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial Hans-Christoph Diener, Reto Agosti, Gianni Allais, Paul Bergmans, Gennaro Bussone, Brendan Davies, Mustafa Ertas, Michel Lanteri-Minet,Uwe Reuter, Margarita Sánchez Del Río, Jean Schoenen, Susanne Schwalen, Joop van Oene, for the TOPMAT-MIG-303 Investigators Group* Lancet Neurol 2007; 6: 1054–62 Summary Background Use of preventive therapy for migraine is often recommended for only 6–9 months, but no randomised, placebo-controlled trials have investigated migraine frequency after the end of prophylaxis. We assessed the eff ects of discontinuation of topiramate after a treatment period of 6 months. Methods 818 patients who have migraines were enrolled from 88 clinics in 21 countries. After a 4–8-week lead-in period, patients received topiramate in a 26-week open-label phase. Daily dose was increased from 25 mg to 100 mg in steps of 25 mg every week; the dose could be adjusted further in the range 50–200 mg/day, but was stable for the final 4 weeks. Patients were randomly assigned to continue this dose or switch to placebo for a 26-week double-blind phase. The primary endpoint was the diff erence in number of days with migraine during the last 4 weeks of the double-blind phase compared with the last 4 weeks of the open-label phase. Analysis was by intention to treat. This trial is registered with EudraCT, number 2005-000321-29. Findings 559 patients (68•3%) completed the open-label phase; 514 entered the double-blind phase and were assigned to topiramate (n=255) or placebo (n=259). The mean increase in number of migraine days was greater in the placebo group (1•19 days in 4 weeks, 95% CI 0•71 to 1•66; p<0•0001) than in the topiramate group (0•10, –0•36 to 0•56; p=0•5756; mean diff erence between groups –1•09, –1•75 to –0•43). Patients in the placebo group had a greater number of days on acute medication than did those in the topiramate group (mean diff erence between groups –0•95, –1•49 to –0•41; p=0•0007). Quality of life, as assessed by the MIDAS questionnaire, fell in the placebo group but remained stable in the topiramate group. Patients were more satisfi ed with the effi cacy of topiramate than with that of placebo, whereas satisfaction with tolerability was similar in both treatment groups. Interpretation Sustained benefi t was reported after discontinuation of topiramate, although number of migraine days did increase. These fi ndings suggest that patients should be treated for 6 months, with the option to continue to 12 months in some patients. * TOPMAT-MIG-303 investigators Austria—C Lampl (Linz); T Berger (Innsbruck). Belgium—J Jacquy (Charleroi); L Herroelen (Leuven); P Louis (Antwerpen); J Schoenen (Luik). Bulgaria—I Milanov (Sofi a); Z Zahariev (Plovdiv); S Bozhinov (Pleven). Czech Republic—P Dočekal, M Grunermelova (Prague); G Waberžinek (Hradec Kralove). Denmark—P Tfelt-Hansen (Glostrup); M Groenbech-Jensen (Copenhagen); I Tsiropoulos (Odense); R Kirkeby (Aabenraa); M-J Rasmussen (Esbjerg). France—D Valade, H Massiou, C Sereni (Paris); A Donnet (Marseille); M Lanteri-Minet (Nice); C Lucas (Lille); G Mick (Voiron); A Pradalier (Colombes); E Guegan Massardier (Rouen). Germany—H-C Diener (Essen); S Evers (Muenster); U Reuter (Berlin); A Straube (Munich). Greece—D Mitsikostas, K Karageorgiou (Athens); I Milonas, G Georgiadis (Thessaloniki). Hungary—G Gyula, A Judit, H Peter (Budapest); V Laszlo (Szeged). Ireland—O Hardiman (Dublin); B Sweeny (Cork). Italy—L Grazzi, B Colombo (Milan); C Ferrarese (Monza); G Bruzzone (Novi Ligure); A Quattrone (Catanzaro); C Benedetto (Torino); G D’Andrea (Vicenza); P Barbanti (Rome); R De Simone (Naples); F Valguarnera (Genova). Saudi Arabia— M A Al-Jumah, A Al Tahan (Riyadh). Norway—I Monstad, O Rosjo (Oslo); R Salvesen (Bodo); LJ Stovner (Trondheim). Poland— H Kwiecinski (Warsaw); W Fryze (Gdansk); D Pruchnik-Wolinska (Mosina); R Motyl (Krakow); W Kozubsk, K Ulatowska-Blaszyk (Poznan); A Prusinski (Lodz). Portugal—L Cunha (Coimbra); J Pereira Monteiro (Porto); P Esperanca (Lisbon). Russia—A Boyko (Moscow); A Skoromets (Saint Petersburg). Slovenia—T Pogačnik (Ljubljana); T Hojs Fabjan (Maribor). Spain—M Sanchez Del Rio (Madrid). Switzerland—R Agosti (Zurich); F Donati (Biel); B Tettenborn (St Gallen); M Siccoli (Zurich). Turkey—A Siva, M Ertaş (Istanbul); M Zarifoğlu (Bursa). UK—B Davies (Stoke-on-Trent); P Davies (Northampton); D Bates (Newcastle-upon- Tyne); M Fontebasso (York); P Cleland (Sunderland); S Lipscombe (Brighton); A Dowson (Guildford); M Lawden (Leicester); S McPhee (Kirkintilloch); B Calder (Helensburgh).