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Topiramate for Migraine Prevention in a Naturalistic Setting: Results From an Open Label, Flexible Dose Study

Authors

  • Gereon Nelles MD, PhD,

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Anette Delbrück MD,

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Lutz Schulze MD,

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Barbara Kademann MD,

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Karin Bornhoevd MD,

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Susanne Schäfer MSc,

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Barbara Schäuble MD, PhD

    1. From the Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Cologne, Germany (G. Nelles); Private Practice, Celle, Germany (A. Delbrück); Private Practice, Belgersheim, Germany (L. Schulze); Private Practice, Leipzig, Germany (B. Kademann); Janssen-Cilag EMEA, Neuss, Germany (K. Bornhoevd and B. Schäuble); AMS, Mannheim, Germany (S. Schäfer).
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  • Conflict of Interest: None

G. Nelles, Haselnußhof 1, D-50767 Köln, Germany.

Abstract

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.

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