2010, Number 5
<< Back Next >>
Rev Mex Neuroci 2010; 11 (5)
Topiramato vs. Amitriptilina en el tratamientoprofiláctico de la migraña: Ensayo clínico controlado
Rodríguez-Leyva I, Sánchez-Aguilar M, Hernández-Sierra JF, Mandeville PB, Rodríguez LMR, Shiguetomi-Medina JM, Tapia-Pérez JH
Language: Spanish
References: 69
Page: 338-342
PDF size: 40.08 Kb.
ABSTRACT
Antecedentes: La cefalea relacionada con la migraña es un problema frecuente en la práctica médica, el tratamiento comienza por la identificación de agentes desencadenantes para evitarlos. La siguiente etapa es el manejo de la cefalea aguda y la tercera, consiste en la elección del mejor tratamiento profiláctico para cada paciente.
Objetivo: Comparar la eficacia y costo de la amitriptilina vs. el topiramato como tratamiento profiláctico para la migraña.
Pacientes y métodos: Ensayo clínico controlado que compara la frecuencia e intensidad de la cefalea migrañosa entre pacientes que recibieron topiramato vs. amitriptilina (18 en cada grupo), utilizando como medición la Evaluación de Discapacidad de la Migraña (MIDAS, por sus siglas en inglés). Estas mediciones fueron realizadas antes y después del tratamiento profiláctico por cuatro meses en ambos grupos. También se compararon los efectos adversos así como la respuesta al ketorolaco en cada grupo para el manejo agudo de la migraña.
Resultados: Se encontró reducción estadísticamente significativa en la frecuencia e intensidad del dolor migrañoso en ambos grupos (p‹0.007), sin diferencias entre ambos grupos. La frecuencia de efectos colaterales fue mayor para el grupo de topiramato (n=69) que para el grupo de amitriptilina (n=43)(p‹0.001). El aumento de peso fue el efecto indeseable más frecuente en el grupo que recibió amitriptilina mientras que la pérdida de peso lo fue para el topiramato.
Conclusión: El topiramato y la amitriptilina son tratamientos profilácticos efectivos en el tratamiento profiláctico para la migraña. La elección del fármaco debe hacer de acuerdo a las características del paciente y posibilidades económicas.
REFERENCES
Löscher W, Hönack D. Profile of UCB L059, a novel anticonvulsant drug, in models of partial and generalized epilepsy in mice and rats. Eur J Pharmacol 1993; 232: 147-58.
Brodie MJ, Schachter S. Fast facts-Epilepsy. Health press ltd Oxford, UK; 1999. ISBN 1-899541-27-6.
Sander WJ, Shorvon S. Epidemiology of the epilepsies Neurol Neruosurg Psych 1996; 61(5): 433-43.
Klitgaard H, Matgane A, Gobert J, Wülfert E. Evidence for a unique profile of levatiracetam in rodent models of seizures and epilepsy. Eur J Pharmacol 1998; 353: 191-206.
Löscher W, Hönack D, Rundfelt C. Antiepileptogenic effects of the novel anticonvulsant levetiracetam in the kindling model of temporal lobe epilepsy. J Pharmacol Ther 1998; 284(2): 474-9.
Noyer M, Gillard M, Matagne A, Hénichart JP, Wülfert E. The novel antiepileptic drug levetiracetam appers to act via specific binding site in CNS membranes. Eur J Pharmacol 1995; 286: 137-46.
Patasalos PN. Pharmacokinetics profile of levetiracetam:towards ideal characteristics. Pharmacol Ther 2000; 85: 77-85.
Perucca E, Gidal BE, Ledent E, Baltes E. Levetiracetam does not interact with other antiepileptic drugs. Epilepsia 2000; 41(Suppl. 7): 254-5.
Shorvon S, Van Rijckevorsel K. Levetiracetam, a pirrolidone drug recently licensed as an antiepileptic. J Neurol Neurosurg Psych 2001; 34: 58-69.
Kasteleijn-Nolst Trénité D, Marescaux C, Stoidieck S, Edelbroek P, Oosting J. Photosensitive epilepsy: a model to study the effect of antiepileptic drugs. Evaluation of piracetam analogue, levetiracetam. Epilepsia Res1996; 25: 225-30.
Betts T, Waegemans T, Crawford P. A multicentre, double blind, randomized, parallel group study to evaluate the tolerability and efficacy of two oral doses of levetiracetam, 2000 and 4000 mg daily, without titritation in patients with refractory epilepsy. Seizures 2000; 9: 80-7.
Smith K, Betts T, Pritchett L. Levetiracetam, a promising for the treatment of Juvenile myoclonic epilepsy. Epilepsia 2000; 41(Suppl- Florence): 39.
Genton P, gelisse P. Antimyoclonic effect of levetiracetam. Neurology 2001; 56: 411-2.
Krauss GL, Bergin MB, Kramer RE, Cho YW, Reich SG. Supression of Post-hipoxic and post-encephalitic myoclonus with levetiracetam. Neurology 2001; 56: 411-2.
Löscher W, Honack D. Development of tolerance during chronic treatment of kindled rats with the novel AED levetiracetam. Epilepsia 2000; 41(12): 1499-506.
Ben-Menachen E. Sustained efficacy during long-term treatment with levetiracetam. J Neurol Sc. 2001; 187(Suppl. 1).
Lynch BA, Lambeng N, Nocka K, Kensel-Hammes P, Bajjalieh S, Matagne A, et al. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. PNAS 2004; 101(26): 9861-6.
Ben-Menachem E. Efficacy and Tolerability of Levetiracetam 3000 mg/ d in patients with refractroy partial seizures: a multicenter, doubleblind, responder-selected study evaluating monotherapy. Epilepsia 2000; 41(10): 1276-83.
Ben-Menachem E. Preliminary efficacy of levetiracetam in monotherapy. Epileptic Disord 2003; 5(Suppl. 1): S51-S55.
Pellock JM, Glauser TA, Martina BE, Fountain NB, Ritter FJ, Ocupes RM, Donald SW. Pharmacokinetic study of levetiracetam in children Epilepsia 2001; 42(12): 1574-9.
Lagae L, Byse G, Deconinck A, Ceulemans B. Effect of levetiracetam in refractory childhood epilepsy syndromes. Eur J Paed Neurol 2003; 7: 123-8.
Glauser TA, Pellock JM, Bebin EM, Fountain NB, Ritter FJ, Jensen ChM, Donald SW. Efficacy and safety of levetiracetam in children with partial seizures: An open-label trial. Epilepsia 2002; 43(5): 518-24.
Perucca E. Clinical pharmacology and therapeutic use of the new antiepileptic drugs. Fund Clin Pharmacol 2001; 15: 405-17.
Verdru P. Epilepsy in children: the evidence for new antiepileptic drugs. Acta Neurol Scand 2005; 112(Suppl. 181): 17-20.
Kerlinger FN. Muestreo y aleatorización. En: Investigación del comportamiento. 2a. Ed. México: McGraw-Hill; 1988: 135.
McGuigan FJ. Diseño experimental. El diseño factorial. En: Psicología experimental. Enfoque metodológico. 2a. Ed. México: Trillas; 1972, p. 291-340.
Sarramona LJ. Diseños factoriales. En: Investigación y estadística aplicadas a la educación. Barcelona: CEAC; 1980, p. 209-18.
Williams F. Análisis multifactorial de variancia. En: Razonamiento estadístico. 2a. Ed. México: Interamericana; 1982, p. 82-96.
Krakow K, Walker M, Otoul C, Sander JWAS. Continuación a largo plazo de levetiracetam en pacientes con epilepsia refractaria. Neurology 2001; 56: 1772-4.
Shorvon S D, LöwenHl A, Janz D, Bielen E. Estudio multicéntrico doble ciego, aleatorio, controlado con placebo. Levetiracetam como terapia de adición en pacientes con crisis parciales refractarias. Epilepsia 2000; 41(9): 1179-86.
Vicrey BG, Perrine KR, Hyas RD, Hermann BP, Cramer JA, Gordon J, Meador KJ, Devinsky O. Quality of life in epilepsy QOLIE-89. Scoring manual. Santa Monica Ca.: Edit Rand; 1993.
Cramer JA, Arrigo C, Van Hammer G, Gaujer LJ, Cereghino JJ. Effect of levetiracetam on epilepsy-related quality of life. N132 Study Group Epilepsia 2000; 41: 868-74.
Coppola G, Franzoni E, VerrotiA, Garone C, Sarajlija J. Levetiracetam or oxcarbazepine as monotherapy for children and adolescents with benign rolandic seizures. Seizure 2007; 16: 271-5.
Headache Classification Committee of the International Headache Society. Classification and Diagnostic Criteria for Headache Disorders, Cranial Neuralgia, and Facial Pain. Cephalalgia 1988; 8(7): 1-96.
The International Classification of Headache Disorders. 2nd Ed. Headache Classification Subcommittee of the International Headache Society. Cephalalgia 2004; 24(Suppl. 1): 8-152.
Silberstein S, Lipton R, Dalessio D. Overview, Diagnosis, and Classification of Headache in Wolff’s Headache and Other Head Pain. 7th Ed. Oxford University Press; 2001: 22-58.
Silberstein SD, Goadsby PJ. Migraine: preventive treatment. Cephalalgia 2002; 22(7): 491-512.
McCrory DC, Matchar DB, Rosenberg JH, Silberstein SD. Evidencebased guidelines for migraine headache: overview of program description and methodology. Neurology. [Serial online] URL: http://www.neurology.org Accessed April 25, 2000.
Matchar DB, Young WB, Rosenberg JA, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. Available from the American Academy of Neurology. Accessed April 25, 2000.
Topiramate (Topamax) for prevention of migraine. Med Lett Drugs Ther 2005; 47(1201): 9-10.
McCrory DC, Matchar DB, Rosenberg JH, Silberstein SD. Evidencebased guidelines for migraine headache: overview of program description and methodology. Neurology. [Serial online] URL: http://www.neurology.org Accessed April 25, 2000.
Matchar DB, Young WB, Rosenberg JA, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. Available from the American Academy of Neurology. Accessed April 25, 2000.
Ramadan NM, Silberstein SD, Freitag FG, Gilbert TT, Frishberg BM. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management for prevention of migraine. Neurology. [Serial online] URL: http://www.neurology.org Accessed April 25, 2000.
Guidelines for controlled trials of drugs in migraine. The IHS Member’s Handbook 1997/1998. 1sr Ed. 111-133.
Stewart WF, Lipton RB, Kolodner K. Migraine Disability Assessment (MIDAS) Score: Relation to Headache Frequency, Pain Intensity, and Headache Symptoms. Headache 2003; 43(3): 258-65.
Chatterton ML, Lofland JH, Schechter A, Curtice WS, Hu XH, Lenow J, Smullens SN, Nash DB, Silberstein SD. Reliability and validity of the migraine therapy assessment questionnaire. Headache 2002; 42(10): 1006-15.
Fragoso VD. MIDAS (Migraine Disability Assessment): a valuable tool for work-site identification of migraine in workers in Brazil. Sao Paulo Med J 2002; 120(4): 118-21.
Stewart W, Lipton R. Need for care and perceptions of MIDAS among headache sufferers study. CNS Drugs 2002; 16(Suppl. 1): 5-11.
Damico D, Mosconi P, Genco S, Usai S, Prudenzano AM, Grazzi L, Leone M, Puca FM, Bussone G. The Migraine Disability Assessment (MIDAS) questionnaire: translation and reliability of the Italian version. Cephalalgia 2001; 21(10): 947-52.
Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache 2001; 41(9): 854-61.
Lipton RB, Silberstein SD. The role of headache-related disability in migraine management: implications for headache treatment guidelines. Neurology 2001; 56(6 Suppl. 1): 35-42.
Edmeads J, Lainez JM, Brandes JL, Schoenen J, Freitag F. Potential of the Migraine Disability Assessment (MIDAS) Questionnaire as a public health initiative and in clinical practice. Neurology 2001; 56(6 Suppl. 1): S29-34.
Santos Zambrano JA, Rodríguez Leyva I, Salinas Estebané R, Fernández Alvarado B, Nuñez Orozco L. Estudio multicéntrico abierto para evaluar la eficacia y seguridad del tratamiento profiláctico de migraña con topiramato. Rev Mex Neuroci 2005; 6(1): 38-41.
Browne RH. On the use of a pilot simple for sample size determination. Stat Med 1995; 14: 1933-40.
R: Copyright 2004. The R Foundation for Statistical Computing Version 2.0.1 (2004-11-15). ISBN 3-900051-07-0.
Stang PE, Von Korff M. The diagnosis of headache in primary care: factors in the agreement of clinical and standardized diagnoses. Headache 1994; 34(3): 138-42.
Lyngberg AC, Rasmussen BK, Jorgensen T, Jensen R. Has the prevalence of migraine and tension-type headache changed over a 12-year period? A Danish population survey. Eur J Epidemiol 2005; 20(3): 243-9.
Rasmussen BK. Epidemiology of headache. Cephalalgia 1995; 15(1): 45-68.
Goldberg LD. The cost of migraine and its treatment. Am J Manag Care 2005; 11(2): 62-7.
Lipton RB, Bigal ME. Migraine: epidemiology, impact, and risk factors for progression. Headache 2005; 45(Suppl. 1): S3-S13.
Garnett WR. Clinical pharmacology of topiramate: a review. Epilepsia 2000; 41(Suppl. 1): 61-5.
Kirov G, Tredget J. Add-on Topiramate reduces weight in overweight patients with affective disorders: a clinical case series. BMC Psychiatry 2005; 5(1): 19.
Krymchantowski A, Tavares C. Weight variations in patients receiving topiramate migraine prophylaxis in a tertiary care setting. Med Gen Med 2004; 6(3): 48.
Sahli Ch, Bryois Ch. Psychotropics and weight gain. Schweiz Rundsch Med Prax 2004; 93(35): 1393-401.
Van Ameringen M, Mancini C, Pipe B, Campbell M, Oakman J. Topiramate treatment for SSRI-induced weight gain in anxiety disorders. J Clin Psychiatry 2002; 63(11): 981-4.
Brown JS, Papadopoulos G, Neumann PJ, Friedman M, Miller JD, Menzin J. Cost-effectiveness of topiramate in migraine prevention: results from a pharmacoeconomic model of topiramate treatment. Headache 2005; 45(8): 1012-22.
Instituto Mexicano del Seguro Social (IMSS). Comparativo de Precios de Adquisición de Medicamentos. March, 2005.
Diener HC, Tfelt-Hansen P, Dahlof C, Lainez MJ, Sandrini G, Wang SJ, et al. Topiramate in migraine prophylaxis—results from a placebocontrolled trial with propranolol as an active control. J Neurol 2004; 251(8): 943-50.
Ramadan NM, Schultz LL, Gilkey SJ. Migraine prophylactic drugs: proof of efficacy, utilization and cost. Cephalalgia 1997; 17(2): 73-80.