Sustained pain freedom and no adverse events as an endpoint in clinical trials of acute migraine treatments: Application to patient-level data from a trial of the CGRP receptor antagonist, telcagepant, and zolmitriptan

Cephalalgia

Volumn 31, Issue 3, 2011, Pages 296-300

  Dodick, David W ^a   Kost, James ^b   Assaid, Christopher ^b   Lines, Christopher ^b   Ho, Tony W ^b  

^a MAYO CLINIC   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

adverse events; CGRP receptor; SNAE; sustained pain free; Telcagepant; triptans

Indexed keywords

NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; TELCAGEPANT; TRIPTAN DERIVATIVE; ZOLMITRIPTAN;

ADULT; ANALGESIA; ARTICLE; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MIGRAINE; PAIN ASSESSMENT; POST HOC ANALYSIS; TREATMENT OUTCOME;

ADULT; ANALGESICS; AZEPINES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMIDAZOLES; MALE; MIGRAINE DISORDERS; OXAZOLIDINONES; PAIN; RECEPTORS, CALCITONIN GENE-RELATED PEPTIDE; RESEARCH DESIGN; SEROTONIN 5-HT1 RECEPTOR ANTAGONISTS; TRYPTAMINES;

EID: 79953179720     PISSN: 03331024     EISSN: 14682982     Source Type: Journal    
DOI: 10.1177/0333102410385585     Document Type: Article

References (18)

1. Tfelt-Hansen P., Block G., Dahlof C., et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000 ; 20: 765-786. (Pubitemid 32154559)
2. Lipton RB and Stewart WF Acute migraine therapy: do doctors understand what patients with migraine want from therapy ? Headache 1999 ; 39 (Suppl 2). S20 - S26.
3. Davies GM, Santanello N. and Lipton R. Determinants of patient satisfaction with migraine therapy. Cephalalgia 2000 ; 20: 554-560. (Pubitemid 32269473)
4. Gallagher RM and Kunkel R. Migraine medication attributes important for patient compliance: concerns about side effects may delay treatment. Headache 2003 ; 43: 36-44.
5. Ferrari MD, Goadsby PJ, Roon KI, et al. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 2002 ; 22: 633-658. (Pubitemid 36609333)
6. Ferrari MD Migraine. Lancet 1998 ; 351: 1043-1051. (Pubitemid 28155822)
7. Santanello NC, Davies G., Allen C., et al. Determinants of migraine-specific quality of life. Cephalalgia 2002 ; 22: 680-685. (Pubitemid 36609338)
8. Dodick DW, Sandrini G. and Williams P. Use of the sustained pain-free plus no adverse events endpoint in clinical trials of triptans in acute migraine. CNS Drugs 2007 ; 21: 73-82. (Pubitemid 46072351)
9. Riley RD, Lambert PC and Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. J BMJ 2010 ; 340 (5). c221.
10. Ho TW, Mannix LK, Fan X., et al. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology 2008 ; 70: 1304-1312. (Pubitemid 351550355)
11. Ho TW, Ferrari MD, Dodick DW, et al. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet 2008 ; 372: 2115-2123.
12. Headache Classification Committee of the International Headache Society. The international classification of headache disorders. 2nd ed. Cephalalgia 2004 ; 24 (Suppl 1): 9-160.
13. Burstein R., Collins B. and Jakubowski M. Defeating migraine pain with triptans: a race against the development of cutaneous allodynia. Ann Neurol 2004 ; 55: 19-26. (Pubitemid 38067357)
14. Goadsby PJ, Zanchin G., Geraud G., et al. Early vs. non-early intervention in acute migraine-'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan. Cephalalgia 2008 ; 28: 383-391. (Pubitemid 351341454)
15. Pascual J. and Cabarrocas X. Within-patient early versus delayed treatment of migraine attacks with almotriptan: the sooner the better. Headache 2002 ; 42: 28-31. (Pubitemid 34136608)
16. Cady R., Martin V., Mauskop A., et al. Efficacy of rizatriptan 10 mg administered early in a migraine attack. Headache 2006 ; 46: 914-924. (Pubitemid 43794743)
17. Cady RK, Sheftell F., Lipton RB, et al. Effect of early intervention with sumatriptan on migraine pain: retrospective analyses of data from three clinical trials. Clin Ther 2000 ; 22: 1035-1048.
18. Klapper J., Lucas C., Rosjo O. and Charlesworth B. Benefits of treating highly disabled migraine patients with zolmitriptan while pain is mild. Cephalalgia 2004 ; 24: 918-924. (Pubitemid 39471916)