PMID- 19804392 OWN - NLM STAT- MEDLINE DCOM- 20110804 LR - 20181201 IS - 1526-4610 (Electronic) IS - 0017-8748 (Linking) VI - 49 IP - 10 DP - 2009 Nov-Dec TI - Topiramate for migraine prevention in a naturalistic setting: results from an open label, flexible dose study. PG - 1454-65 LID - 10.1111/j.1526-4610.2009.01522.x [doi] AB - BACKGROUND: Headaches are one of the most common neurological symptoms and migraines are the most common primary headache disorder. The global prevalence of migraines is around 10% and the condition is associated with a high burden of disease. Despite an abundance of good quality evidence, only 1 in 5 of patients who fulfill the criteria for preventive migraine therapy are appropriately treated. Data on patient outcomes with preventive medication derive mostly from specialized academic centers, which contrasts with normal clinical practice where the majority of patients are treated outside tertiary care centers. OBJECTIVE: To explore tolerability, safety and efficacy outcomes of patients receiving topiramate for migraine prevention in a naturalistic setting. METHODS: After a 4-week prospective baseline, patients with a diagnosis of migraine according to International Headache Society criteria and eligible for migraine prevention were treated with flexible dosing of topiramate for 24 weeks (core phase), and optionally for a total of 48 weeks. The primary safety analysis included adverse events (AEs) during the core phase. For the main efficacy measures, the absolute changes from baseline to end of core phase as well as last follow-up visit were calculated for migraine days per 4 weeks, migraine attacks per 4 weeks, mean maximum visual analogue scale of migraine headache per 4 weeks and mean maximum pain intensity of migraine headache (4-point scale) per 4 weeks. In addition, changes in individual quality of life aspects were captured. RESULTS: The intention-to-treat population (ITT) consisted of 161 patients (90.7% female, mean age 45.7 +/- 11.1 years). Topiramate median dose was 45.7 mg/day at endpoint. Some 74.1% of patients reported treatment emergent AEs, most frequently paresthesias (18.4%) and nausea (12.4%). Some 20.0% of patients withdrew from the study due to AEs. The mean number of migraine days per 4 week decreased from 6.2 +/- 3.9 days at baseline to 3.9 +/- 3.5 days at last core visit (P < .001). Mean maximum pain intensity per 4 week changed from 7.0 +/- 2.3 at baseline to 4.7 +/- 3.2 at last visit core phase (P < .001). Consumption of triptans and analgesics reduced during the course of the core phase (P < .005). Fifty-one percent of all patients experienced at least a 50% reduction in migraine days during the core phase. CONCLUSION: Topiramate used for migraine prevention in non-academic institutions is generally safe, well tolerated and results in good control of migraine headaches and improvement in several aspects of quality of life. FAU - Nelles, Gereon AU - Nelles G AD - Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Koln, Haselnusshof 1, Cologne, Germany. FAU - Delbruck, Anette AU - Delbruck A FAU - Schulze, Lutz AU - Schulze L FAU - Kademann, Barbara AU - Kademann B FAU - Bornhoevd, Karin AU - Bornhoevd K FAU - Schafer, Susanne AU - Schafer S FAU - Schauble, Barbara AU - Schauble B CN - TOPMAT-MIG-4009 investigators LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study DEP - 20091005 PL - United States TA - Headache JT - Headache JID - 2985091R RN - 0H73WJJ391 (Topiramate) RN - 30237-26-4 (Fructose) SB - IM MH - Adult MH - Aged MH - Dose-Response Relationship, Drug MH - Female MH - Follow-Up Studies MH - Fructose/administration & dosage/*analogs & derivatives MH - Humans MH - Male MH - Middle Aged MH - Migraine Disorders/drug therapy/epidemiology/*prevention & control MH - Prospective Studies MH - Topiramate MH - Treatment Outcome MH - Young Adult FIR - Beer, C IR - Beer C FIR - Berger, H J IR - Berger HJ FIR - Berling, J IR - Berling J FIR - Braetsch, M IR - Braetsch M FIR - Breidung, R IR - Breidung R FIR - Burow, M IR - Burow M FIR - Buttner, E IR - Buttner E FIR - Dahmen, G P IR - Dahmen GP FIR - Dekant, H IR - Dekant H FIR - Dellbruck, A IR - Dellbruck A FIR - Dorn, W IR - Dorn W FIR - Drescher, T IR - Drescher T FIR - Dworschak, R IR - Dworschak R FIR - Eissfeller, E F IR - Eissfeller EF FIR - Emden, J C IR - Emden JC FIR - Ernst, B IR - Ernst B FIR - Esser, M IR - Esser M FIR - Frieling, A IR - Frieling A FIR - Friesacher, I IR - Friesacher I FIR - Gann, H IR - Gann H FIR - Gessler, M IR - Gessler M FIR - Glienke, Y IR - Glienke Y FIR - Grunert, S IR - Grunert S FIR - Gurge, C B IR - Gurge CB FIR - Hafer, J IR - Hafer J FIR - Heintze, A IR - Heintze A FIR - Hesselbarth, S IR - Hesselbarth S FIR - Himpel-Bonninghoff, A IR - Himpel-Bonninghoff A FIR - Hollenbach, P IR - Hollenbach P FIR - Huenten, M A IR - Huenten MA FIR - Huttner, W IR - Huttner W FIR - Imbach, U IR - Imbach U FIR - Kademann, B IR - Kademann B FIR - Klasen, H IR - Klasen H FIR - Kosak, A IR - Kosak A FIR - Krempien, P IR - Krempien P FIR - Krohn, T IR - Krohn T FIR - Langler, K IR - Langler K FIR - Lapp, M IR - Lapp M FIR - Larisch, S IR - Larisch S FIR - Lehmann, M A IR - Lehmann MA FIR - Lowenstein, O IR - Lowenstein O FIR - Maack, B IR - Maack B FIR - Mager, B IR - Mager B FIR - Mahler, A IR - Mahler A FIR - Mattern, R J IR - Mattern RJ FIR - Menke, H IR - Menke H FIR - Metzger, B IR - Metzger B FIR - Monke, B IR - Monke B FIR - Moser, C IR - Moser C FIR - Muhlbauer, M IR - Muhlbauer M FIR - Muhlmann, U IR - Muhlmann U FIR - Muller-Schwefe, G IR - Muller-Schwefe G FIR - Nelles, G IR - Nelles G FIR - Ost, S IR - Ost S FIR - Rauchmaul, G IR - Rauchmaul G FIR - Reng, S IR - Reng S FIR - Ribbschlaeger, J IR - Ribbschlaeger J FIR - Rucker, C IR - Rucker C FIR - Schmickaly IR - Schmickaly FIR - Schmidt, H J IR - Schmidt HJ FIR - Schulze, L IR - Schulze L FIR - Schwittay, A IR - Schwittay A FIR - Seyer, H IR - Seyer H FIR - Sonntag, T IR - Sonntag T FIR - Speier, U IR - Speier U FIR - Staudenmayer, H IR - Staudenmayer H FIR - Steinbach, K IR - Steinbach K FIR - Trommer, S IR - Trommer S FIR - Tusker, T IR - Tusker T FIR - Weber, E IR - Weber E FIR - Wey, M IR - Wey M EDAT- 2009/10/07 06:00 MHDA- 2011/08/05 06:00 CRDT- 2009/10/07 06:00 PHST- 2009/10/07 06:00 [entrez] PHST- 2009/10/07 06:00 [pubmed] PHST- 2011/08/05 06:00 [medline] AID - HED1522 [pii] AID - 10.1111/j.1526-4610.2009.01522.x [doi] PST - ppublish SO - Headache. 2009 Nov-Dec;49(10):1454-65. doi: 10.1111/j.1526-4610.2009.01522.x. Epub 2009 Oct 5.