Migraine Treatment 2014

Practical Tips

  1. Cefaly: The first FDA approved migraine prevention device - For patients who are willing to use an electrical stimulation device 20 minutes daily, Cefaly may be worth trying. If you are using Cefaly, please participate in the DIRW? Cefaly study to verify the effectiveness and safety of Cefaly.
  2. Petadolex: Highest recommendation by AHS/AAN based on scientific data - Petadolex 75 mg twice daily helps 70% of patients reduce migraine attacks by 50% or more. Petadolex causes fewer bothersome side effects compared to other migraine prevention medications such as topiramate (Topamax). For patients who are considering taking migraine prevention medication, Petadolex should be at the top of the list. If you are taking Petadolex, please participate in the DIRW? Petadolex study to verify the effectiveness and safety of Petadolex.
  3. Topamax: Newly approved by FDA for use in adolescents. About 1 out of 3 adult patients were not be able to stay on Topamax because of intolerable side effects. For patients who do not experience bothersome side effects, Topamax can be a helpful treatment. Read more about Topamax: Topamax Migraine Prevention Summary

New in 2014

  1. In 2014, the Cefaly became the first treatment device that is FDA approved for migraine prevention. Compared to other treatment options, there are less data available on Cefaly. Unlike medications, patients must wear Cefaly for 20 minutes daily. With its unique therapeutic approach, Cefaly has the potential to become an important option for migraine suffers. The FDA approval is based on study results that suggest Cefaly may reduce migraine attacks and the assessment that electrical stimulation is unlikely to cause significant safety consequences. For more information about the Cefaly, please refer to the DIRW? Cefaly report.
  2. Cefaly device photo
  3. Petadolex is a plant extract with Level A recommendation for migraine prevention. Unlike other Level A treatment options, Petadolex is available over-the-counter and has less severe side effects. Unfortunately, Petdolex is not widely known outside a small group of neurologists who specialize in migraine headaches. Due to this, Petadolex may be under-utilized despite the highest level classification by the American Academy of Neurology (AAN) and the American Headache Society (AHS). For more information about Petadolex, please see the 2014 DIRW? Petadolex report.
  4. Topamax is a migraine prevention medication, initially marketed for the treatment of seizures in 1996. In 2004 Topamax became FDA-approved for prevention of migraine attacks in adults. In 2014, FDA additionally approved Topamax for migraine prevention in adolescents age 12-17.

Why Prevent Migraine?

The exact causes of migraine headaches remain unclear. Despite incomplete understanding of the disease, many treatment options are currently available.

A substantial number of migraine suffers can benefit from migraine prevention treatment, but do not receive it. From the American Migraine Prevalence and Prevention (AMPP) study, we learned that only 13% of the migraine suffers take medication to prevent migraine.   43% never tried migraine preventive treatment, 26% tried in the past but did not continue. Of those who never tried migraine prevention treatment, one-third met guideline recommendation for physicians to ask patients to consider or for physicians to offer prevention treatment. [Lipton et al, 2007]

Many migraine suffers start out with over-the-counter anti-inflammatory medications. Tylenol (acetaminophen) or ibuprofen are popular choices. Those who take Tylenol should be aware of possible liver damage, when taking more than 3000 mg a day (as few as 5 pills of Tylenol arthritis 650 mg). In addition, frequent use of anti-inflammatory medications (more than 10 days per month) may cause worsening of headaches, called medication overuse headaches. [reference: Tepper et al, 2010]

Taking a dose of migraine medication only after the start of a migraine attack means suffering migraine symptoms will be unavoidable even if the treatment work. Relief is almost always delayed and incomplete. Headache, nausea, sensitivity to sound/light, fatigue, and other symptoms all have to be endured. Even after medication starts to work, "postdrome" symptoms often persist for many hours after the headache is gone. A vivid description of the postdrome can be found here: [reference: The postdrome: migraine's silent sister]

Because of these limitations, preventive treatment should be considered when migraine is severe enough or frequent enough to interfere with work or home life. Ultimately, each individual must decide after assessing the pro's and con's of the treatment options whether to try migraine prevention.

Historical Perspective: Topamax

Key Points

  • Like Petadolex, Topamax is one of the medications recommended by the American Academy of Neurology (AAN) at Level A (highest level).
  • In randomized clinical trials, Topamax reduced the average number of migraine headaches from 5 per month to 3 per month. Most patients still experienced migraine headaches but at a lower frequency. About half of Topamax group reported a reduction of migraine attacks by 50% or more.
  • Depending on dose, about 1 out of 3 patients were not able to stay on Topamax because of bothersome side effects.
  • In adolescents with migraine, Topamax reduced migraine headaches with effectiveness similar to adults. Bothersome side effects that led to stopping Topamax were less common in adolescents (7% of patients). In addition to anorexia (12% of patients) and weight loss (10%), mental/physical slowing and reduction in verbal fluency were associated with Topamax, as measured by computerized testing.[FDA Review 2014] Long term consequences of these cognitive effects are unknown.

Topamax (generic name: topiramate) is manufactured by Ortho McNeil Janssen and received FDA approval in 2004 for migraine prevention. Results from two randomized controlled studies support the efficacy of Topamax in migraine prevention. [reference: FDA Label 2004]

After 26 weeks of treatment, the patients who were randomized to receive up to 100 mg and 200 mg per day had greater reduction in migraine attacks compared to the placebo group. The patients received Topamax twice daily and reported number of migraine attacks reduced by 2 per month, from average of 5.5 per month down to 3.5 per month. In contrast, the placebo group experienced reduction of 1 migraine per month: FDA Label 2004 Reviewing the TOPMAT-MIGR-002 study [Silberstein et al, 2004] in greater detail: All Topamax groups experienced improvement during the first month, although the 200 mg group appears to have the largest improvement. After the second month, the 100 mg group continued to improve, nearly catching up to the 200 mg group by the end of 26 weeks. Silberstein et al 2004 TOPMAT MIGR-002 Greater proportion of patients on 50 mg, 100 mg and 200 mg Topamax (36%, 54%, 52% respectively) were responders, defined as patients with number of migraine attacks reduced by 50% or more by the end of the study, compared to the placebo group (23% were responders). Silberstein et al 2004 TOPMAT MIGR-002

Side Effects

34% of patients in the 200 mg group did not complete the 26-week study due to side effects, compared to 18% and 19% for those in the 50 mg and 100 mg groups respectively.

The three most common side effects were numbness and tingling in nearly half of the patients (47% in 100 mg group), nausea in about 15% of patients (16% in 100 mg group), and fatigue in about 10% of patients (11% in 100 mg group) .

Use of Topamax during the first trimester of pregnancy increases birth defect in the unborn child. Women who may become pregnant need to be aware of this risk.[reference: FDA Press Release 2011]

Comparison of Treatment Options

Individual medical history and response to medication can be different. Before making a decision about your treatment, please consult a physician who can offer medical advice based on your individual situation.

No reliable method of matching migraine prevention treatment to individual patients has been validated. Thus, the selection of migraine treatment is partly based on patient preference and partly based on physician factors.

Scientific research that compare the effectiveness of migraine treatment options to date have not identified clear superiority of any one treatment approach over the others.

While similar number of patients may experience similar reductions in migraine attacks, big differences in side effects have been documented. For example, a substantial proportion of patients were not able to continue Topamax due to side effects (34% in the 200 mg group). In contrast, very few Petadolex and Cefaly patients (2%) stopped treatment due to side effects.

Treatment Strategy

When it comes to finding the most appropriate treatment for individual migraine sufferers, a reasonable approach is to begin with treatment that is least likely to cause bothersome side effects. Then, sequentially, different treatments can be tried to discover the best choice considering both effectiveness and side effects.

Petadolex has one of the most favorable side effect profiles and ability to prevent migraine headaches. Even with the highest recommendation from the leading headache and neurology professional associations (AHS, AAN), Petadolex is not widely known outside a small circle of neurologists who supervise specialized headache clinics. This unfortunate under-utilization may be due to lack of marketing by the manufacturer and the classification of Petadolex as a herbal supplement in the U.S..

For patients who have already tried other migraine prevention medication but have not been treated with Petadolex and Cefaly, these two new options are worth considering in 2014.

For patients who are newly considering migraine prevention, Petadolex is worthy of consideration as a first option due to its low incidence of bothersome side effects, especially compared to Topamax. Scientific data from Cefaly is more limited at this time but if wearing the Cefaly for 20 minutes daily is a possibility, then Cefaly is also worthy of consideration. A randomized sham-controlled study of Cefaly showed response rate of 38% (defined as percent of patients with as at least 50% reduction in migraine attacks). This compares favorably to Petadoex and Topamax, especially considering only 12% of the sham group were responders. [PREMICE: Schoenen et al, 2013] Schoenen et al 2013 % responder at 3 month Both Cefaly and Petadolex are not yet widely known by doctors in general practice. If you decide to try them, we invite you to share your experience via the DIRW? studies. Our goal is to help patients and doctors make informed decisions. We can do that only with your help.

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