Treatment response and tolerability of frovatriptan in patients reporting short- or long-duration migraines at baseline

Abstract

Objectives:

Compare migraine duration with frovatriptan (versus baseline) in migraineurs reporting long- (24−72 h) or short-duration (<24 h) migraines at baseline.

Methods:

Post hoc analysis of two postmarketing surveillance studies of migraineurs in German primary care clinics using frovatriptan (2.5 mg) to treat a single migraine attack. Using case-report forms, physicians recorded migraine characteristics at baseline (aura, duration, frequency, severity) and with frovatriptan (duration, severity, and recurrence). Patients and physicians rated frovatriptan effectiveness and tolerability versus previous therapy; physicians recorded adverse reactions. The primary analysis was change in migraine duration with frovatriptan versus baseline.

Results:

At baseline, 44.2% (7178/16 253) and 55.8% (9075/16 253) of patients reported short- and long-duration migraines, respectively; long-duration migraines were more often frequent (≥3/months; 55.5% [4893/8811] vs. 30.6% [2132/6973]; p < 0.001; 95% CI, 23.5–26.5%), severe (61.7% [5584/9047] vs. 33.9% [2427/7156]; p < 0.001; 95% CI, 26.3–29.3%), and accompanied by aura (46.8% [4199/8977] vs. 31.3% [2215/7088]; p < 0.001; 95% CI, 14.0–17.0%). Mean (SD) onset of frovatriptan effect was <1 h; 72.3% (11 592/16 040) of patients required only one frovatriptan tablet. With frovatriptan, patients were 26.8-fold more likely to experience decreased versus increased headache duration (p < 0.001; 95% CI, 23.5–30.2) and 76.5% of patients reporting long-duration migraines at baseline experienced short-duration migraines. Most patients (87–90%) and physicians (70–75%) rated frovatriptan more effective and tolerable than previous therapies.

Conclusion:

Patients with more severe migraine characteristics at baseline were more likely to have attacks lasting ≥24 h. When using frovatriptan, patients were 26.8-fold more likely to experience decreased versus increased headache duration. Frovatriptan might be a good option for patients with long-duration or recurrent migraine attacks. The post hoc design and analysis of a single migraine attack are possible study limitations.

Key words::

• Drug therapy
• Frovatriptan
• Migraine
• Migraine duration
• Postmarketing drug surveillance
• Primary care
• Triptans

Transparency

Declaration of funding

Funding for the studies was provided by the Menarini Group, Florence, Italy (the European licensee of frovatriptan), and its affiliate Berlin-Chemie AG, Berlin, Germany. The sponsors were responsible for study design, management, data collection, and initial statistical analyses. Endo Pharmaceuticals Inc. (the North American licensee of frovatriptan) performed the post hoc analysis and initiated collaboration with Dr Kelman for further data interpretation. The authors were responsible for data interpretation and the preparation, review, and final approval of the manuscript before submission. All coauthors contributed scientifically to the manuscript and submitted final approval of the manuscript, but Dr Kelman, as primary author, exercised editorial control, with final responsibility for content decisions and conclusions.

Declaration of financial/other relationships

With the exception of Dr Kelman, all authors have declared that they are employees of Endo Pharmaceuticals Inc. Dr Kelman is an independent clinician and researcher who currently works at the Headache Center of Atlanta. He has declared that he is on the speakers’ bureaus for Endo Pharmaceuticals Inc., GlaxoSmithKline Pharmaceuticals, Merck Pharmaceuticals, and Pfizer/Serono, Inc. Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she is a consultant/advisor to UCB Pharma and GlaxoSmithKline. Peer Reviewer 2 has disclosed no relevant financial relationships.

Acknowledgments

Endo Pharmaceuticals Inc. funded medical writing and editorial support for the article, which was provided by Kristine W. Schuler, MS, and Nicole Strangman, PhD, of Complete Healthcare Communications, Inc. (Chadds Ford, PA, USA).

The data presented herein were presented in part at the 14th Congress of the International Headache Society, Philadelphia, PA, September 10–13, 2009