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Use of Topiramate in Preventing Pediatric Migraine Marcia L PEDIATRIC PHARMACOTHERAPY Volume 19 Number 7 July 2013 Use of Topiramate in Preventing Pediatric Migraine Marcia L. Buck, Pharm.D., FCCP, FPPAG igraines affect 3-11% of children and Clinical Experience M may impact school performance, social Since 2002, over two dozen studies have been interactions, and family life. Current therapies published describing the use of topiramate in for migraine prophylaxis include tricyclic children with migraines.3,5-13 These include antidepressants, β-blockers, calcium channel observational and retrospective studies, as well blockers, antihistamines, and the antiseizure as randomized, blinded placebo-controlled, dose- medications valproic acid and topiramate. ranging, and comparison trials. A 2008 meta- Topiramate was approved by the Food and Drug analysis of pediatric migraine prophylaxis Administration (FDA) in 1996 as an antiseizure studies identified topiramate as one of only two medication and later found to be an effective drugs with adequate evidence to demonstrate its therapy for the prevention of migraines. Based efficacy in the pediatric population.14 on clinical trials in adults, the FDA approved an indication for migraine prophylaxis in 2004. Three placebo-controlled studies have shown the Although not yet approved for this use in benefit of topiramate in reducing migraine children, topiramate has shown promise as a frequency.3,7,8 In 2005, Winner and colleagues means of preventing migraines in the pediatric randomized 162 children, ages 6-15 years, with population as well.1,2 migraines to receive topiramate or placebo.7 Topiramate was initiated at 15 mg once daily and Mechanism of Action titrated to a final dose of 2-3 mg/kg/day over 8 Topiramate has a number of physiologic effects weeks (maximum dose 200 mg/day). The final that may play a role in migraine prevention, dose was then maintained for another 12 weeks. including dose-dependent inhibition of voltage- Migraine frequency decreased by a similar gated sodium and calcium channels, degree in the two groups, with a mean reduction augmentation of GABA-induced chloride flux, of 2.6 migraines/month in the topiramate group and inhibition of glutamate-related excitatory and 2.0 in the placebo group (p = 0.061). There neurotransmission.1,3 In addition, it produces was a significant difference, however, in the inhibition of carbonic anhydrase.1 percentage of patients experiencing a reduction in migraines of 75% or greater (32% of the Pharmacokinetics topiramate patients versus 14% of controls, p = The pharmacokinetic profile of topiramate has 0.02). There was no difference between the been evaluated in adults and children. groups in the discontinuation rate due to lack of Absorption after oral administration is rapid, efficacy or adverse effects. with a peak serum concentration occurring in 2-4 hours. Bioavailability is approximately 80% and A second placebo-controlled topiramate trial is not altered in the presence of food. Topiramate enrolled 44 children with migraines between the is 15-40% protein bound; the fraction bound ages of 8 and 14 years.3 Children in the decreases as plasma concentrations increase. topiramate group received an initial dose of 25 Approximately 70% of a dose is excreted in the mg, with weekly titration by 25 mg-increments urine as unchanged drug. Six metabolites have as needed to a maximum of 100 mg/day (given been identified, but are present in small as 50 mg twice daily). This was followed by a quantities. The clearance of topiramate is more 12-week maintenance phase. The mean reduction rapid in children than adults.1,4 In a study of 18 in migraine frequency in the topiramate group children 4-17 years of age, mean elimination (from 16.14 + 9.35 events per month at baseline half-life increased from 7.7-8 hours in children to 4.27 + 1.95 at completion) was significantly 4-7 years of age to 11.3-11.7 hours in children 8- greater than that in the placebo group (13.38 + 11 years of age and 12.3-12.8 hours in 7.78 to 7.48 + 5.94, p = 0.025). The number of adolescents (12-17 years of age).4 patients with a 50% or greater reduction in migraine frequency was also significantly higher properties available in other countries but in the treatment group (95.2% compared to classified as an orphan drug in the United 52.4% of controls, p = 0.002). There were no States.11-13 In each of the three comparison differences in migraine severity or duration, or in studies, topiramate was found to produce a the number of rescue medications needed. reduction in headache or migraine frequency equivalent to the comparator. Impact on quality of life, as assessed by the Pediatric Migraine Disability Assessment Scale In 2013, Sezer and colleagues conducted a pilot (PedMIDAS) was reduced by topiramate use. study comparing topiramate to amitriptyline in Children in the treatment group had a mean children with chronic daily headaches.13 The reduction in PedMIDAS score from 50.7 + 32.1 authors randomized 57 children between 9 and to 10.4 + 6.4 by the end of 4 months, while the 16 years of age to receive either amitriptyline 0.5 placebo group decreased from 42.7 + 27.5 to mg/kg/day or topiramate 25 mg/day initially, 23.7 + 19.1 in the controls. School absenteeism with titration up to 100 mg/day. After 4 months, was also significantly improved in the topiramate 55% of the children given amitriptyline and 61% group, falling from 4.04 days/month at baseline of those given topiramate had achieved a 50% or to 0.38 days/month at 4 months, compared to the greater reduction in headache frequency. The placebo group, where the baseline rate of 0.04 number of children who were headache-free days/month had increased slightly to 0.38 (defined as having no events in one month or days/month at 4 months (p = 0.002).3 more) was also similar between the groups: 28% and 31%, respectively. Adverse effects were In 2009, Lewis and colleagues reported the mild, 10% of patients receiving amitriptyline and results of a placebo-controlled topiramate study 7% of those receiving topiramate reported in 103 adolescents (12-17 years of age) with drowsiness, nervousness, or dizziness. No migraines.8 The patients were randomized to patients withdrew because of adverse effects. receive topiramate, at a dose of 50 mg or 100 The mean weight change was +1.8 kg with mg, or placebo for 16 weeks. The number of amitriptyline and –1.1 kg with topiramate. patients achieving a 50% or greater reduction in migraine frequency was 83% in the 100 mg/day A multicenter study is currently underway to group, 46% in the 50 mg/day group, and 45% in compare the effectiveness of topiramate, the placebo group (p = 0.002 for the 100 mg/day amitriptyline, and placebo in children and group and p = 0.957 for the 50 mg/day group). adolescents with migraine. The CHAMP study, The patients receiving 100 mg/day had a sponsored by the National Institute of significantly greater percent reduction in Neurological Disorders and Stroke and National monthly migraine rate compared to placebo Institutes of Health, will enroll 675 children (median 72.2% versus 44.4%, p = 0.016). In between 8 and 17 years of age at 40 centers addition, more than half of patients in the 100 throughout the United States.16 The drugs will be mg/day group were migraine-free during the last titrated over an 8-week period to a target dose of 4 weeks of the study. None of the other outcome 2 mg/kg/day for topiramate and 1 mg/kg/day for measures for the 50 mg/day group were amitriptyline, then continued for a total of 24 significantly different from placebo. Six subjects weeks. The primary outcome measures will be withdrew because of adverse effects, including the percentage of patients with a 50% or greater fatigue in two patients, and nervousness, reduction in migraine frequency between the end emotional lability/depression, renal stones, and of titration and the final 28 days of treatment hypokalemia each in one patient. The mean and the mean change in PedMIDAS scores. weight change from baseline was 1.7 + 3.8%, -0.1 + 3.0%, and -0.6 + 5.2% for the placebo, 50 Warnings and Precautions mg/day, and 100 mg/day groups, respectively. Patients taking topiramate and their families No patient had a weight change of more than should be aware of the risk for oligohidrosis and 10% from baseline. hyperthermia associated with its use. The majority of these cases have been in children In all three trials, one or more outcome receiving topiramate for seizure prophylaxis, but measurements related to migraine frequency it has been reported in a child enrolled in a showed a significant improvement from baseline topiramate migraine study. Elevated in the patients who received a placebo. This high environmental temperatures should be avoided rate of placebo response has also been observed and caution should be used if patients require a in studies of acute migraine treatments, second agent that has the potential to produce particularly in those conducted in children and these effects, such as another carbonic anhydrase adolescents. A meta-analysis of 13 pediatric inhibitor or an anticholinergic.1 acute migraine studies found a pooled placebo response rate of 46%.15 Topiramate has also been associated with the development of a hyperchloremic, non-anion gap Topiramate has been compared to amitriptyline, metabolic acidosis as a result of the bicarbonate sodium valproate, and flunarizine, a calcium loss resulting from carbonic anhydrase channel blocker with histamine (H1) blocking inhibition.
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