Pauline Anderson

June 28, 2012

June 28, 2012 (Los Angeles, California) — Rizatriptan (Maxalt, Merck Sharp & Dohme Corp) is safe, effective, and well tolerated in teens and children as young as 6 years old, according to new research.

Two studies of the drug in children were presented here during the American Headache Society's 51st Annual Meeting, by study author Eric M. Pearlman, medical director, physician-in-chief, from Children's Administration, Children's Hospital at Memorial University Medical Center, Savannah, Georgia.

Rizatriptan has been indicated for migraine in adults for the past dozen years, but only recently has received approval from the US Food and Drug Administration (FDA) for treatment of migraine in children 6 to 17 years of age. "Since the approval, kids with painful headaches, their parents, and their doctors are feeling some relief," said Dr. Pearlman.

"Some children respond to nonspecific analgesics such as ibuprofen or acetaminophen, but it's important to have a migraine-specific medication such as rizatriptan for those who don't, said Dr. Pearlman. "Migraine clearly is a childhood problem; more than half of migraineurs have their first attack before they’re 15 years of age, and the incidence of migraine in adolescents older than 12 years of age is the same as that in adults."

As well, noted Dr. Pearlman, "there's the feeling that if you intervene at a younger age, you can prevent some of the lifelong problems, the suffering from very frequent or chronic migraines."

Although many clinicians had been using the drug off-label in children, "pediatricians don't feel comfortable doing that, parents don't feel comfortable doing that, and insurers don't feel comfortable doing that," said Dr. Pearlman.

Pain Freedom

"Migraine affects about 2% to 5% of 6-year-olds and about 6% of 12-year-olds, and at these young ages, it affects boys at about the same rate as girls," commented Dr. Pearlman. "But by about the age of 15 years, there starts to be a 'split' between the sexes, with about 15% to 18% of teenage girls versus 6% of teenage boys being affected by migraine," he said.

A poster presentation at this meeting put forth a prespecified analysis of a double-blind, multicenter trial that included children 6 to 17 years of age who had not responded to nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen therapy. Results showed that rizatriptan was statistically significantly more effective than placebo in eliminating pain during a headache attack.

Of 1388 children and adolescents who were randomly assigned for this study, 977 were treated and 770 were evaluated for efficacy. The analysis included patients who had not responded to placebo, who were randomly assigned to a stage 2 phase.

For the study, patients were asked to treat a moderate to severe migraine within 30 minutes of the attack. Rizatriptan dosing was based on weight: 5 mg for those weighing less than 40 kg, and 10 mg for those weighing 40 kg or more.

Pain freedom 2 hours post dose was reported by 33.0% of those taking rizatriptan (using 5 faces on a scale ranging from very bad to no head pain) compared with 24.2% of those taking placebo (odds ratio [OR] for rizatriptan, 1.52; 95% confidence Interval [CI], 1.10-2.10; P = .010).

In younger patients (6 to 11 years of age), the OR for pain freedom in those taking the drug was 1.41 (95% CI, 0.77-2.60; P = .269), and for the 12 to 17-year age group, it was1.55 (95% CI, 1.06-2.26; P = .025).

The drug was generally well tolerated, the authors report. The most common events with rizatriptan treatment were somnolence, nausea, fatigue, and dizziness, but these did not occur more often than with placebo. Children in the 6 to 11-year age group did not report more adverse events than those 12 to 17 years of age.

Long-Term Safety, Tolerability

Dr. Pearlman also presented results of a long-term safety and tolerability trial in older children, which showed that the drug had a consistent treatment effect over time. The open-label study included 606 children from 12 to 17 years of age. Here again, heavier patients got the 10-mg rizatriptan dose (n = 583), and lighter patients (usually the younger children) received the 5-mg dose (n = 23).

Participants could treat up to 8 migraine attacks per month for up to 12 months — with 1 dose allowed in a 24-hour period. They used a diary to record headache severity and adverse events.

The mean study duration was 292 days, and the mean number of drug doses taken was 20.

Results showed that within 14 days of taking any dose, 66.0% had any adverse event, 2.3% discontinued owing to adverse events, 2.6% had a serious adverse event, and 23.4% had a triptan-related adverse event. Use of more than 1 dose within 24 hours was considered an overdose, and an adverse event associated with an overdose was automatically classified as serious.

The mean percentage of patient attacks with pain freedom at 2 hours post dose was 46.3%. This was relatively consistent over 12 months.

Guidance in Dosing

For Heidi K. Blume, MD, assistant professor of pediatric neurology, at the University of Washington, Seattle, this research offers some confirmation of widely held beliefs among child neurologists that triptan drugs are safe for most older children and adolescents. "The studies also offer guidance for appropriate dosing of these medications for children," she said

"Triptans are often effective treatments for children with acute migraine when over-the-counter medications like ibuprofen, acetaminophen, and naproxen are not effective alone," said Dr. Blume. "FDA approval of rizatriptan will also offer more support for insurance coverage for use for acute management of migraine in kids older than 6, and will also offer some peace of mind for patients and families who are advised to use rizatriptan."

The studies were funded by Merck Sharp & Dohme Corp. Dr. Pearlman has received consulting fees from Merck Sharp & Dohme Corp.

American Headache Society 54th Annual Scientific Meeting: Abstract 011. Poster 31.

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