eLetters to:

ARTICLES: Donald Lewis, Paul Winner, Joel Saper, Seth Ness, Elena Polverejan, Steven Wang, Caryn L. Kurland, Jeff Nye, Eric Yuen, Marielle Eerdekens, and Lisa Ford Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for Migraine Prevention in Pediatric Subjects 12 to 17 Years of Age Pediatrics 2009; 123: 924-934 [Abstract] [Full text] [PDF]

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eLetters published:

? Gender Bias

Michael D. Schwartz   (12 March 2009)

Safety considerations in prescribing topiramate in adolescents

Ram Kumar, Stephen Ray   (10 June 2009)

? Gender Bias 12 March 2009
Michael D. Schwartz, Pediatrician Lehigh Valley Health Network Send letter to journal: Re: ? Gender Bias Michael.Schwartz{at}lvh.com Michael D. Schwartz	This much needed study on migraine prophylaxis in 12-17 year old patients, reported an improvement of monthly migraine day rate of 83% for Topirimate 100mg/day versus 45% for placebo. There was no significant improvement for topiramate at 50mg/day. However, a review of the patient population reveals that 64% of the pacebo group was female , 71% of the 50mg/day group was female but there was a 51% male preponderance in the 100mg/day group. Is it possible that the increased response rate in the 100mg/day group was caused by that male preponderance? Does the beneficial effect of 100mg/day persist if only female patients are considered ? Conflict of Interest: None declared
Safety considerations in prescribing topiramate in adolescents 10 June 2009
Ram Kumar, Consultant Paediatric Neurologist Alder Hey Children's NHS oundation Trust, Stephen Ray Send letter to journal: Re: Safety considerations in prescribing topiramate in adolescents ram.kumar{at}alderhey.nhs.uk Ram Kumar, et al.	The study by Lewis and colleagues demonstrates the significant efficacy of topiramate compared to placebo in appropriately selected adolescents with migraine (1). The study findings are in line with our own emerging experience of the effectiveness of topiramate for adolescents and younger children with migraine in real-life clinical practice. In real-life practice however, patients with frequent and severe migraine may have considerably more co-morbidities (e.g. clinical or subthreshold psychiatric disorders) than patients entered into clinical trials (2,3). Other deviations of routine practice from that in clinical trials are likely to include less frequent contact between patient and prescriber and loss of the patient to follow-up (with prescriptions continued by an alternative provider). Thus pharmacovigilance studies are required to confirm the long-term safety of topiramate prescribed to children with migraine in routine practice. We would like to highlight one particular pattern of prevalent comorbidity in adolescents (particularly female) that we feel impacts on the safety of topiramate - obesity, and associated body image and eating disorders. Our discussions with a number of adolescent female migraineurs suggests the adverse effect of topiramate on reducing appetite and inducing weight loss (4) is seen rather as a beneficial effect. Weight loss for overweight and obese migraineurs is promoted as a means to reduce migraine severity (5). The treating clinician may thus be tempted to prescribe topiramate to achieve this secondary goal of weight loss, in concordance with the patient's goal. This leaves topiramate open to abuse by the patient to achieve excessive weight loss, particularly in girls with an unrecognised eating disorder. Intentional overuse of topiramate by an adult (prescribed for a manic syndrome) to achieve excessive weight loss has been reported previously (6). Prescribers should exercise some caution in promoting the effect of topiramate on appetite and weight as beneficial in adolescents with migraine. (1) Lewis D, Winner P, Saper J, et al. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate for migraine prevention in pediatric subjects 12 to 17 years of age. Pediatrics. 2009;123(3):924-34. (2) Seshia SS, Phillips DF, von Baeyer CL. Childhood chronic daily headache: a biopsychosocial perspective. Dev Med Child Neurol 2008; 50(7): 541-5. (3) Pakalnis A, Gibson J, Colvin A. Comorbidity of psychiatric and behavioral disorders in pediatric migraine. Headache. 2005; 45(5): 590-6. (4) Young WB. Preventive treatment of migraine: effect on weight. Curr Pain Headache Rep. 2008;12(3):201-6. (5) Hershey AD, Powers SW, Nelson TD, et al. Obesity in the pediatric headache population: a multicenter study. Headache. 2009;49(2):170-7. (6) Colom F, Vieta E, Benabarre A, et al. Topiramate abuse in a bipolar patient with an eating disorder. J Clin Psychiatry 2001; 62:6. Conflict of Interest: None declared