Mental Notes * newsworthy and useful

October 1, 2005

Migraine, Headache, Epilepsy, Vagus nerve stimulation, VNS, Stroke, Insomnia

Positive News on Migraine and Headache

At the 9th annual meeting of the European Federation of Neurological Societies, held in mid-September in Athens, Greece, researchers reported additional evidence of the effectiveness of 2 medications already on the market--topiramate (Topamax, Ortho-McNeil) and zolmitriptan (Zomig, AstraZeneca)--in treating some forms of migraine and headache. Results from 2 large clinical trials indicated that topiramate is effective in preventing migraine long-term (Diener HC et al, poster reference P2138), and results from 3 pivotal 26-week trials showed that it improved health-related quality of life (Dahlof C et al, poster reference P1158).

The 2 prevention trials consisted of a 6-month, randomized, double-blind, placebo-controlled trial followed by an 8-month open-label extension. A separate pooled analysis (Bussone G et al. Int J Clin Pract. 2005;59:961-968) of data from the 3 pivotal trials found that 46.3% of patients taking 100 mg/d of topiramate experienced a 50% reduction in the number of monthly migraine attacks, compared with 22.8% of patients taking placebo.

New data presented by Michael Tuchman, MD, of Palm Beach Neurological Center in Florida, indicated that oral zolmitriptan, 2.5 mg, is effective and tolerable as an acute and prophylactic treatment for menstrual migraine. The research consisted of a 2-phase multicenter, double-blind study. In the first phase, patients received either zolmitriptan or placebo to be used for up to 2 menstrual migraine attacks per menstrual cycle for 3 consecutive cycles. The 2-hour headache response rate and the 2-hour pain-free rate were significantly improved in patients taking zolmitriptan compared with patients taking placebo (66% vs 33% and 28% vs 9%, respectively). Patients who successfully completed the first phase received 2.5 mg 2 or 3 times a day or placebo in the second phase. Both dosing regimens of zolmitriptan showed significant effectiveness over placebo.

Other results from a multicenter study conducted in Germany, Italy, and the United Kingdom demonstrated that zolmitriptan nasal spray is effective in the acute treatment of cluster headache (Cittadini E et al. Eur J Neurol. 2005;12[suppl 2]:202). The primary end point was headache relief at 30 minutes, and the study involved patients taking zolmitriptan, 5 or 10 mg, or placebo. Results showed that the patients taking zolmitriptan experienced reductions from moderate, severe, or very severe headache pain to mild or no pain at all.

--Larry Hand

VNS Safe and Effective in Young Epileptics

A team from the Comprehensive Epilepsy Clinic at Columbus Children's Hospital and Ohio State University demonstrated that vagus nerve stimulation (VNS) was effective and safe in managing intractable epilepsy in children aged 1 to 17 years. The clinic's director, Juliann Paolicchi, MD, reported the findings at the 26th International Epilepsy Congress, which convened August 28 to September 1 in Paris.

VNS was approved in 1997 for use in people 12 years and older who have intractable partial epilepsy. Paolicchi and colleagues studied its use in more than 75 children aged 1 to 17 years and found that it had significant clinical benefit. The incidence of epilepsy-related hospital visits decreased by 41% among children in whom vagus nerve stimulators were implanted (average age at implantation was 9.5 years), and only 4 patients (5%) had to discontinue therapy because of adverse effects, Paolicchi said. She also noted that the majority of patients in the study (59%) had nonfocal epilepsy. Finally, Paolicchi stressed that reduction in hospital visits and morbidity will ultimately bolster VNS therapy as a strategy that provides long-term cost-effectiveness.

In continuing studies, Paolicchi and her team plan to analyze VNS use in different types of childhood epilepsy and investigate whether outcomes differ according to age and duration of epilepsy before stimulator implantation. They also intend to investigate quality-of-life outcomes.

--Dee Rapposelli

Patient Education on Stroke en Español

More than 700,000 Americans experience a stroke each year, according to the CDC, and Hispanics tend to be at greater risk than white persons. Indeed, the CDC notes that Hispanics aged 35 to 64 years are 1.3 times more likely to have a stroke than their white counterparts.

As a public-service, patient-education effort, the National Institute of Neurological Disorders and Stroke (NINDS) recently released a video about the prevention and treatment of stroke for the Spanish-speaking community. NINDS developed the video, titled "Ataque cerebral: Conozca los síntomas y actúe a tiempo" ("Stroke: Know the symptoms and act in time"), in partnership with the National Council of La Raza (NCLR), an Hispanic civil rights and advocacy group.

NINDS and NCLR began distributing the video this summer to a nationwide network of lay health educators who are affiliated with the NCLR. Physicians and patients can order a single free copy of the video by calling toll-free 800-352-9324.

--Dee Rapposelli

Recent FDA Activity

Epilepsy The FDA approved on September 15 diazepam rectal gel (Diastat AcuDial, Valeant Pharmaceuticals International) as an immediate at-home treatment of emergency seizures, the first such treatment approved for use outside a hospital. The Diastat drug delivery system allows a caregiver to dial, set, and lock in doses ranging from 5 to 10 mg in one configuration and 10 to 20 mg in another configuration, depending on the patient's individual needs. It is approved for epilepsy patients (2 years or older) receiving stable regimens of antiepileptic drugs who require the use of diazepam to control intermittent seizures. Valeant said in a statement that the product will be available this month in twin packs of prefilled configurations.

Insomnia The FDA approved on September 7 the extended-release formulation of zolpidem tartrate (Ambien CR, Sanofi Aventis) as a treatment for sleep maintenance and sleep induction, the first extended-release prescription sleep medicine approved. Treatment is delivered in the form of a bilayered tablet, with the first layer dissolving quickly and the second releasing gradually into the body. The medication will be available in a 6.25-mg dose for the elderly and a 12.5-mg dose for other adults.

--Larry Hand

New Clinical Trials Portal

The International Federation of Pharmaceutical Manufacturers & Associations launched a new Internet portal in September as a resource on clinical trials worldwide. The URL is www.ifpma.org/ clinicaltrials. The portal started with about 250,000 links to other Web sites containing information on ongoing and closed clinical trials, including the US National Library of Medicine's, www.clinicaltrials.gov. The portal allows basic searches of trial registries and results of completed trials. Future enhancements could include the ability to search in languages other than English and the addition of dictionary-assisted searches to ensure correct spelling.

--Larry Hand