Almotriptan: Meeting today's needs in acute migraine treatment

Expert Review of Neurotherapeutics

Volumn 7, Issue 12, 2007, Pages 1659-1673

  Láinez, Miguel J A ^a  

^a HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

Author keywords

Almotriptan; Early treatment; Efficacy; Migraine; Tolerability; Triptans

Indexed keywords

ALMOTRIPTAN; PLACEBO; SUMATRIPTAN;

ACUTE DISEASE; COST EFFECTIVENESS ANALYSIS; DISEASE SEVERITY; DRUG COST; DRUG EFFICACY; DRUG TOLERABILITY; HUMAN; MENSTRUAL MIGRAINE; MIGRAINE; MORBIDITY; REVIEW; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

CLINICAL TRIALS AS TOPIC; HUMANS; MIGRAINE DISORDERS; SEROTONIN AGONISTS; TRYPTAMINES;

EID: 37149042252     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/14737175.7.12.1659     Document Type: Review

References (84)

1. Lipton RB, Bigal ME, Diamond M et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 68, 343-349 (2007).
2. Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J. Headache Pain 6, 429-440 (2005).
3. Santanello NC, Davies G, Allen C, Kramer M, Lipton R. Determinants of migraine-specific quality of life. Cephalalgia 22, 680-685 (2002). • Interesting study determining the end points of migraine therapy that have the most impact on patients' migraine-related quality of life.
4. Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J. Headache Pain 6, 429-440 (2005).
5. Goldberg LD. The cost of migraine and its treatment. Am. J. Manag. Care 11(Suppl. 2), S62-S67 (2005).
6. Ferrari MD, Goadsby PJ, Roon KI, Lipton RB. Triptans (serotonin 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 22, 633-658 (2002). • Landmark meta-analysis comparing the efficacy and tolerability of oral triptans that underlies the substantial need for further exploration of the relative merits of different triptans.
7. Rapoport AM, Tepper SJ, Bigal ME, Sheftell FD. The triptan formulations. How to match patients and products. CNS Drugs 17, 431-447 (2003).
8. Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 55, 754-762 (2000).
9. Lipton RB. Disability assessment as a basis for stratified care. Cephalalgia 18(Suppl. 22), 40-43 (1998).
10. Lucas C. Strategies to improve migraine treatment results. Drugs 66(Suppl. 3), 9-16 (2006). • Worthwhile consideration of the potential benefits of newer approaches to migraine management with oral triptans.
11. Dowson AJ, Mathew NT, Pascual J. Review of clinical trials using early acute intervention with oral triptans for migraine management. Int. J. Clin. Pract. 6, 698-706 (2006).
12. Burstein R, Jakubowski M. Analgesic triptan action in an animal model of intracranial pain: a race against the development of central sensitization. Ann. Neurol. 55, 27-36 (2004). • Analysis of the pathophysiologic mechanism of migraine and how it relates to early/late triptan therapy.
13. MacGregor EA, Brandes J, Eikermann A. Migraine prevalence and treatment patterns: the global Migraine and Zolmitriptan Evaulation survey. Headache 43, 19-26 (2003).
14. Pascual J, Leira R, Láinez JM et al. Spanish study of quality of life in migraine (II). Profile of medication consumption and subjective efficacy. Neurologia 14, 204-209 (1999).
15. Mateos V, Díaz-Insa SI, Morera J, Porta J, Pascual J, Matías-Guiu J. PALM Program Scientific Commitee. Migraine managing in neurological consults in Spain: PALM program results. Neurologia 3(Suppl.), 7-14 (2007).
16. Gras J, Llenas J, Jansat JM, Jauregui J, Cabarrocas X, Palacios JM. Almotriptan, a new anti-migraine agent: a review. CNS Drugs 8, 217-234 (2002).
17. 1B/1D receptor agonist for the treatment of migraine. Clin. Pharmacokinet. 44, 237-246 (2005). • Useful summary of the pharmacokinetic profile of almotriptan.
18. McEwen J, Salvà M, Jansat JM, Cabarrocas X. Pharmacokinetics and safety of oral almotriptan in healthy male volunteers. Biopharm. Drug Dispos. 25, 303-311 (2004).
19. Pascual J, Munoz P. Correlation between lipophilicity and triptan outcomes. Headache 45, 3-6 (2005).
20. Salvà M, Jansat JM, Martinez-Tobed A, Palacios JM. Identification of the human liver enzymes involved in the metabolism of the antimigraine agent almotriptan. Drug Metab. Dispos. 31, 404-411 (2003).
21. Dahlöf C, Tfelt-Hansen P, Massiou H, Fazekas A. Dose finding, placebo-controlled study of oral almotriptan in the acute treatment of migraine. Neurology 57, 1811-1817 (2001).
22. Cabarrocas X, Salvà M, Pavesi M, Costa J. Ethanol does not significantly affect the bioavailability of almotriptan: an open, randomized, crossover, single-dose, Phase I clinical trial in healthy volunteers. Int. J. Clin. Pharmacol. Ther. 44, 443-448 (2006).
23. Eichelbaum M, Ingelman-Sundberg M, Evans WE. Pharmacogenomics and individualized drug therapy. Annu. Rev. Med. 57, 119-137 (2006).
24. 1F receptor gene: no evidence for involvement in response to sumatriptan in migraine. Am. J. Med. Genet. 5, 415-420 (1998).
25. 1B receptor polymorphism and clinical response to sumatriptan. Headache 38, 288-291 (1998).
26. Boyce M, Dunn K, Warrington S. Hemodynamic and electrocardiographic effects of almotriptan in healthy volunteers. J. Cardiovasc. Pharmacol. 37, 280-289 (2001).
27. Fleishaker JC, McEnroe JD, Azie NE, Francom SF, Carel BJ. Cardiovascular effect of almotriptan in treated hypertensive patients. Clin. Pharmacol. Ther. 71, 169-175 (2002).
28. Dodick DW. Oral almotriptan in the treatment of migraine: safety and tolerability. Headache 41, 449-455 (2001).
29. Pascual J, Falk RM, Piessens F et al. Consistent efficacy and tolerability of almotriptan in the acute treatment of multiple migraine attacks: results of a large, randomized, double-blind, placebo-controlled study. Cephalalgia 20, 588-596 (2000).
30. Spierings EL, Gomez-Mancilla B, Grosz DE, Rowland CR, Whaley FS, Jirgens KJ. Oral almotriptan vs. oral sumatriptan in the abortive treatment of migraine: a double-blind, randomized, parallel-group, optimum dose comparison. Arch. Neurol. 58, 944-950 (2001).
31. Dowson AJ, Massiou H, Lainez JM, Cabarrocas X. Almotriptan is an effective and well-tolerated treatment for migraine pain: results of a randomized, double-blind, placebo-controlled clinical trial. Cephalalgia 22, 453-461 (2002).
32. Dahlöf CG, Pascual J, Dodick DW, Dowson AJ. Efficacy, speed of action and tolerability of almotriptan in the acute treatment of migraine: pooled individual patient data from four randomized, double-blind, placebo-controlled clinical trials. Cephalalgia 26, 400-408 (2006). •• Useful review of the essential efficacy measures and tolerability of almotriptan in clinical trials.
33. Tfelt-Hansen P, Block G, Dahlöf C et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 20, 765-786 (2000).
34. Gallagher RM, Kunkel R. Migraine medication attributes important for patient compliance: concerns about side effects may delay treatment. Headache 43, 36-43 (2003).
35. Dodick DW. Almotriptan increases sustained pain-free outcomes in acute migraine: results from three controlled clinical trials. Headache 42, 21-27 (2002).
36. Mathew NT. Use of rescue medication in trials of almotriptan versus placebo in the treatment of acute migraine. Clin. Ther. 24, 520-529 (2002). • Interesting survey of patient attitudes, revealing that concerns about adverse events cause patients to delay medication, with consequent worsening of the attack.
37. Dodick DW, Sandrini G, Williams P. Use of the sustained pain-free plus no adverse events end point in clinical trials of triptans in acute migraine. CNS Drugs 21, 73-82 (2007). • Exploration of the relative performance of triptans on an end point that incorporates the attributes of therapy most important to patients.
38. Mathew NT. A long-term open-label study of oral almotriptan 12.5 mg for the treatment of acute migraine. Headache 42, 32-40 (2002).
39. Pascual J, Falk R, Docekal R et al. Tolerability and efficacy of almotriptan in the long-term treatment of migraine. Eur. Neurol. 45, 206-213 (2001).
40. Dodick DW, Martin V. Triptans and CNS side-effects: pharmacokinetic and metabolic mechanisms. Cephalalgia 24, 417-424 (2004).
41. Dodick DW. Triptans and chest symptoms: the role of pulmonary vasoconstriction. Cephalalgia 24, 298-304 (2004).
42. Pascual J, Lainez JM, Leria R et al. Almotriptan in the treatment of migraine attacks in clinical practice: results of the TEA 2000 observational study. Neurologia 18, 7-17 (2003).
43. Láinez MJA, Pascual J, Mateos V, Galván J. Real world experience comparing neurologist and primary care physician management of acute migraine with almotriptan in Spain. Presented at: the 56th Annual Meeting of the American Academy of Neurology. San Francisco, CA, USA, 24 April-1 May 2004.
44. Pascual J. Efficacy and tolerability of almotriptan in postmarketing surveillance studies. Eur. Neurol. 53(Suppl. 1), 34-40 (2005).
45. Diener H-C. Consistent efficacy, tolerability, and high levels of satisfaction with almotriptan 12.5 mg when used to treat multiple migraine attacks in routine clinical practice. Headache 45, 624-631 (2005). • Interesting study of almotriptan in real clinical practice incorporating patient and physician opinions.
46. Massiou H, Pradalier A, Donnet A, Lanteri-Minet M, Allaf B. Evaluation of efficacy, tolerability, and treatment satisfaction with almotriptan in 3 consecutive migraine attacks. Eur. Neurol. 55, 198-203 (2006).
47. Goadsby PJ, Massiou H, Pascual J et al. Almotriptan and zolmitriptan in the acute treatment of migraine. Acta Neurol. Scand. 115, 34-40 (2007).
48. Iglesias Díez F, Straube A, Zanchin G. Patient preference in migraine therapy: a randomized, open-label, crossover clinical trial of acute treatment of migraine with oral almotriptan and rizatriptan. J. Neurol. 254, 242-249 (2007).
49. Láinez MJA, Galván J, Heras J, Vila C. Crossover, double-blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy. Eur. J. Neurol. 14, 269-275 (2007).
50. Dodick DW. Triptan nonresponder studies: implications for clinical practice. Headache 45, 156-162 (2005). •• Concise review of trial data supporting the clinical benefits of triptan switching in poor responders.
51. Dahlöf CGH. Infrequent or non-response to oral sumatriptan does not predict response to other triptans - review of four trials. Cephalalgia 26, 98-106 (2005).
52. Diener HC, Gendolla A, Gebert I, Beneke M. Almotriptan in migraine patients who respond poorly to oral sumatriptan: a double-blind, randomized trial. Headache 45, 874-882 (2005).
53. Allais G, Acuto G, Cabarrocas X, Esbri R, Benedetto C, Busssone G. Efficacy and tolerability of almotriptan versus zolmitriptan for the acute treatment of menstrual migraine. Neurol. Sci. 27(Suppl. 2), S193-S197 (2006).
54. Mannix LK, Files JA. The use of triptans in the management of menstrual migraine. CNS Drugs 19, 951-972 (2005).
55. Tuchman M, Hee A, Emeribe U, Silberstein S. Efficacy and tolerability of zolmitriptan oral tablet in the acute treatment of menstrual migraine. CNS Drugs 20, 1019-1026 (2006).
56. Winner P, Landy S, Richardson M, Ames M. Early intervention in migraine with sumatriptan tablets 50 mg versus 100 mg: a pooled analysis of data from six clinical trials. Clin. Ther. 27, 1785-1794 (2005).
57. Mannix LK, Loder E, Nett R et al. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomizes, placebo-controlled, double-blind studies. Cephalalgia 27, 414-421 (2007).
58. Massiou H, Jamin C, Hinzelin G et al. Efficacy of oral naratriptan in the treatment of menstrually related migraine. Eur. J. Neurol. 12, 774-781 (2005).
59. Solomon S, Frishberg B, Hu XH, Markson L, Berger M. Migraine treatment outcomes with rizatriptan in triptan-naive patients: a naturalistic study. Clin. Ther. 23, 886-900 (2001).
60. Martin VT, Valade D, Almas M et al. Efficacy of eletriptan in triptan-naive patients: results of a combined analysis. Headache 47, 181-118 (2007).
61. Goadsby PJ, Vila C. 'ACT' when mild: early versus non-early almotriptan intervention in migraine. Cephalalgia 26, 1393-1394 (2006) (Abstract).
62. Pascual J. Clinical benefits of early triptan therapy for migraine. Headache 42(Suppl. 1), S10-S17 (2002).
63. Dodick D, Silberstein S. Central sensitization theory of migraine: clinical implications. Headache 46(Suppl. 4), S182-S191 (2006).
64. Pascual J, Cabarrocas X. Within-patient early versus delayed treatment of migraine attacks with almotriptan: the sooner the better. Headache 42, 28-31 (2002).
65. Mathew NT. Early intervention with almotriptan improves pain-free response in acute migraine. Headache 43, 1075-1079 (2003).
66. Dowson AJ, Massiou H, Lainez JM, Cabarrocas X. Almotriptan improves response rates with treatment is within 1 h of migraine onset. Headache 44, 318-322 (2004).
67. Láinez MJA. Clinical benefits of early triptan therapy for migraine. Cephalalgia 24(Suppl. 2), 24-30 (2004).
68. Freitag FG, Finlayson G, Rapoport AM et al. Effect of pain intensity and time to administration on responsiveness to almotriptan: results from AXERT® 12.5 mg time versus intensity migraine study (AIMS). Headache 47, 519-530 (2007).
69. Mathew NT, Finlayson G, Smith TR et al. Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). Headache 47, 189-198 (2007). • First published double-blind, placebo-controlled, prospective trial of almotriptan as an early intervention therapy.
70. Lofland JH, Nash DB. Oral serotonin receptor agonists: a review of their cost-effectiveness in migraine. Pharmacoeconomics 23, 259-274 (2005). • Useful consideration of triptan cost-effectiveness.
71. Williams P, Reeder CE. Cost-effectiveness of almotriptan and rizatriptan in the treatment of acute migraine. Clin. Ther. 25, 2903-2919 (2003).
72. Williams P, Reeder CE. A comparison of the cost-effectiveness of almotriptan and sumatriptan in the treatment of acute migraine using a composite efficacy/tolerability end point. J. Manag. Care Pharm. 10, 259-265 (2003).
73. Adelman JU, Belsey J. Meta-analysis of oral triptan therapy for migraine: number needed to treat and relative cost to achieve relief within 2 hours. J. Manag. Care Pharm. 9, 45-52 (2003).
74. Gori S, Morelli N, Acuto G, Caiola F, Iudice A, Muri L. A pharmacoeconomic evaluation of oral triptans in the treatment of migraine in Italy. Minerva Med. 97, 467-477 (2006).
75. Kelman L, von Seggern RL. Using patient-centered end points to determine cost-effectiveness of triptans for acute migraine therapy. Am. J. Ther. 13, 411-417 (2006).
76. Slof J, Badia X, Lainez-Andres JM, Galvan J, Heras J. Management costs of chest and CNS-related adverse events associated with the treatment of acute migraine attacks with oral triptans. Neurologia 20, 290-298 (2005).
77. Lipton RB, Cutrer FM, Goadsby PJ et al. How treatment priorities influence triptan preferences in clinical practice: perspectives of migraine sufferers, neurologists, and primary care physicians. Curr. Med. Res. Opin. 3, 413-424 (2005). ••Overview of the TRIPSTAR project and how it provides guidance in selection of a triptan most likely to yield a successful therapeutic outcome.
78. Dodick DW, Lipton RB, Ferrari AD et al. Prioritizing treatment attributes and their impact on selecting an oral triptan: results from the TRIPSTAR project. Curr. Pain Headache Rep. 8, 435-442 (2004).
79. Cutrer FM, Goadsby PJ, Ferrari AD et al. Priorities for triptan treatment attributes and the implications for selecting an oral triptan for acute migraine: a study of US primary care physicians (the TRIPSTAR project). Clin. Ther. 26, 1533-1545 (2004).
80. Lipton RB, Liberman J, Cutrer FM et al. Treatment preferences and the selection of acute migraine medications: results from a population-based survey. J. Headache Pain 5, 123-130 (2004).
81. Ferrari MD, Goadsby PJ, Lipton RB et al. The use of multiattribute decision models in evaluating triptan treatment options. J. Neurol. 252, 1026-1032 (2005).
82. Loder E. Fixed drug combinations for the acute treatment of migraine: place in therapy. CNS Drugs 19, 769-784 (2005).
83. Bigal ME, Krymchantowski AV. Emerging drugs for migraine prophylaxis and treatment. MedGenMed 8, 31 (2006).
84. Unger J, Cady RK, Farmer-Cady K. Understanding migraine: pathophysiology and presentation (Accessed July 2007) www.emedmag.com/html/pre/cov/covers/ 081503.asp