Drug Class Review Triptans Final Report Update 4 June 2009 Update 3: November 2005 Update 2: September 2004 Update 1: December 2003 Original Report: March 2003 The literature on this topic is scanned periodically. The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Mark Helfand, MD, MPH Kim Peterson, MS Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Oregon Health & Science University Copyright © 2009 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Report Update 4 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION .......................................................................................................................... 5 Purpose and Limitations of Systematic Reviews..................................................................................... 8 Scope and Key Questions..................................................................................................................... 10 Inclusion Criteria.................................................................................................................................... 11 METHODS.................................................................................................................................. 12 Literature Search................................................................................................................................... 12 Study Selection ..................................................................................................................................... 12 Data Abstraction.................................................................................................................................... 12 Validity Assessment .............................................................................................................................. 12 Data Synthesis ...................................................................................................................................... 13 RESULTS ................................................................................................................................... 14 Overview ............................................................................................................................................... 14 Summary of Findings ............................................................................................................................ 16 Detailed Assessment............................................................................................................................. 21 Key Question 1. How do effectiveness and efficacy outcomes (reduced severity and duration of symptoms, functional outcomes, quality of life, etc) differ for adult patients with migraine? ............. 21 Key Question 1a. Monotherapy compared with monotherapy .......................................................... 21 Overview....................................................................................................................................... 21 Eletriptan....................................................................................................................................... 22 Direct comparisons................................................................................................................... 22 Placebo-controlled trials: Eletriptan.......................................................................................... 26 Rizatriptan..................................................................................................................................... 26 Direct comparisons................................................................................................................... 26 Placebo-controlled trials: Rizatriptan........................................................................................ 29 Rizatriptan orally disintegrating tablets ......................................................................................... 30 Direct comparisons................................................................................................................... 30 Placebo-controlled trials: Rizatriptan orally disintegrating tablet .............................................. 30 Zolmitriptan: Oral tablet, orally disintegrating tablet, nasal spray ................................................. 31 Direct comparisons: Oral tablet ................................................................................................ 31 Direct comparisons: Zolmitriptan orally disintegrating tablets and nasal spray........................ 32 Placebo-controlled trials: Zolmitriptan ...................................................................................... 33 Almotriptan.................................................................................................................................... 33 Direct comparisons................................................................................................................... 33 Placebo-controlled trials: Almotriptan....................................................................................... 34 Naratriptan .................................................................................................................................... 35 Direct comparisons................................................................................................................... 35 Placebo-controlled trials: Naratriptan ....................................................................................... 36 Reformulated (rapid-release) oral sumatriptan ............................................................................. 36 Direct comparisons................................................................................................................... 36 Placebo-controlled trials: Reformulated oral sumatriptan......................................................... 36 Sumatriptan injection and nasal spray.......................................................................................... 37 Direct comparisons................................................................................................................... 37 Placebo-controlled trials: Sumatriptan injection ....................................................................... 37 Frovatriptan................................................................................................................................... 38 Direct comparisons................................................................................................................... 38 Placebo-controlled trials: Frovatriptan...................................................................................... 38 Key Question 1b. Fixed-dose combination tablets containing a triptan compared with triptan monotherapy ..................................................................................................................................... 38 Direct comparisons ....................................................................................................................... 38 Placebo-controlled trials: Treximet® ......................................................................................... 39 Open-label studies: Treximet®.................................................................................................. 40 Triptans Page 2 of 80 Final Report Update 4 Drug Effectiveness Review Project Key Question 1c. Fixed-dose tablets containing a triptan compared with co-administration of its individual triptan and analgesic component agents........................................................................... 40 Key Question 2. What are the comparative incidence and nature of complications (serious or life- threatening or those that may adversely effect compliance) of different triptans in adult patients being treated for migraine? ............................................................................................................... 40 Key Question 2a. Monotherapy compared with monotherapy .......................................................... 40 Chest pain/tightness ..................................................................................................................... 41 Central nervous system symptoms............................................................................................... 41 Key Question 2b. Fixed-dose combination tablets containing a triptan compared with triptan monotherapy ..................................................................................................................................... 41 Key Question 2c. Fixed-dose tablets containing a triptan compared with co-administration of its individual triptan and analgesic components .................................................................................... 41 Key Question 3. Are there subgroups of patients based on demographics, other medications, or comorbidities for which one medication or preparation