American Neurological Association: Early Frovatriptan Treatment for Migraine
Speaker: Arthur H. Elkind, MD, Director, Elkind Headache Center, Mount Vernon, New York, and Clinical Assistant Professor of Medicine, New York Medical College, Valhalla, New York.
The use of frovatriptan (Frova®, Elan) during the initial mild phase of a migraine attack promotes more rapid pain relief while preventing the progression of migraine pain intensity from mild to severe, thus offering a beneficial option.
In a randomized, controlled trial, 241 patients with acute migraine treated two migraine headaches with frovatriptan 2.5 mg or placebo when the headache pain was mild. If the pain progressed to moderate or severe, the patients took an alternate medication as the second dose. The order of treatment was revised for the second attack.
Treating mild pain with frovatriptan improved two-hour and four-hour pain-free responses, compared with placebo, and patients achieved pain-free responses more quickly with frova-triptan. Fifty-one percent of these patients achieved this goal in 3.1 hours, compared with 4.5 hours in the placebo group. Furthermore, 69% to 78% of patients reported mild or no headache two to four hours after taking frovatriptan in the early phase of headache compared with 51% to 64% of patients using placebo early on.
Mean pain scores during the first four hours were lower in patients taking frovatriptan during the mild headache phase, whereas patients receiving placebo experienced increases in pain scores. From two to four hours after the dose was given, a statistical difference was observed between the treatment and placebo groups, indicating that the early use of frovatriptan impeded the progression of migraine pain intensity.
Finally, among patients who obtained a pain-free response after four hours, the rate of headache recurrence was low in all patients receiving frovatriptan. In patients treated with frova-triptan for the early headache phase, the recurrence rate was 4%. For patients who used frovatriptan for the later headache phase, the recurrence rate was 6%.
A related open-label trial was also reported in conjunction with the randomized study. Early intervention with frovatriptan appeared to be effective and well tolerated during long-term use in more than 13,000 migraine attacks treated. The likelihood of achieving meaningful relief was greatest when treatment was begun while the migraine was still mild.
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The use of frovatriptan provided a consistent effect for 12 months. Only 10% of treated attacks required rescue medication within 24 hours of dosing with frovatriptan, and 57% of patients rated the drug’s effectiveness as “good” or “excellent.”
Intravenous Tramadol for Intractable Migraine
Speaker: John Claud Krusz, MD, PhD, Medical Director, Anodyne Headache and Pain Center, Dallas, Texas.
An open-label study using intravenous (IV) tramadol (Ultram®, Ortho-McNeil) demonstrates a new pharmacological approach to the clinical treatment of intractable migraine.
IV treatment of acute intractable migraine, especially in the headache clinic, can be very gratifying, because patients like their physicians to be able to short-circuit an ongoing migraine attack. Oral tramadol has been available in the U.S. and Europe for years, but the IV form has been available only in Europe.
To test the efficacy and safety of this approach for acute intractable headaches, the investigators prepared an injectable, 50-mg/ml formulation of tramadol in a sterile neutral pH solution. The IV formulation was given to clinic patients with severe migrainous or migraine attacks refractory to their usual medications (e.g., triptans, opiates, and even oral tramadol). In this open-label series, 12 patients were treated 17 times with IV tramadol; one patient was treated three times, and four patients were treated twice. Nine of these 12 patients had already tried oral tramadol.
The average percentage of decrease in headache severity was 75.6% after administration of IV tramadol, as rated by the patients on a numeric rating scale from 0 to 10. This represents a headache severity rating of 8.1 at the start of treatment in contrast to 1.54 after IV tramadol. Seven of 17 headaches (41%) were rated as totally eliminated after tramadol treatment.
Adverse effects during treatment included transient nausea in two patients and drowsiness in two other patients.
Rasagiline Appears Promising in Parkinson’s Disease
Speaker: Lawrence W. Elmer, MD, PhD, Assistant Professor, Department of Neurology, and Director of the Center for Neurologic Disorders, Medical College of Ohio, Toledo, Ohio.
Once-daily rasagiline mesylate (Agilect™, Azilect®, Teva Neuroscience), a selective reversible monoamine oxidase-B (MAO-B)-inhibitor, is effective and well tolerated by patients with Parkinson’s disease (PD). Patients with levodopa-related motor fluctuations who were already receiving concomitant dopamine agonist (DA) therapy experienced additional symptomatic relief.
Initially, in the Parkinson’s Rasagiline Efficacy and Safety in the Treatment of “Off” (PRESTO) study, rasagiline was effective for PD patients with motor fluctuations. (“Off” refers to when the effects of medication wear off and symptoms return; “on” refers to when the medication is working.) silagra
All of the patients were taking an optimal levodopa-decarboxylase inhibitor (LD-DDI); many were also receiving DA therapy. The study enrolled 472 PD patients who were randomly assigned to rasagiline 1 mg or 0.5 mg once daily or to placebo for 26 weeks. In this analysis of PRESTO data, the efficacy and tolerability of adjunctive rasagiline were compared in PD patients with or without concomitant DA therapy.
A total of 106 patients (71%) receiving rasagiline 1 mg/day and 111 patients (70%) receiving placebo had concomitant treatment with DA therapy. Consequently, 43 patients (29%) receiving rasagiline 1 mg/day and 48 patients (30%) receiving placebo formed the “without DA” subgroup. Baseline characteristics (e.g., age, sex, disease duration, daily levodopa dosage, mean daily “off” time) were comparable in both patient groups with and without DA therapy.
As shown previously, rasagiline 1 mg/day produced additional significant symptomatic benefits, compared with placebo, when administered to patients already receiving optimized and stable therapy with LD-DDIs. The clinical benefits of rasagiline are in addition to and unaffected by concomitant treatment with DAs, as determined by the current subgroup analysis.
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This study showed that rasagiline reduced daily “off” time, and produced improvements in Clinical Global Impression (CGI) scores, as measured by the examiner; in the Unified Parkinson’s Disease Rating Scale-Activities of Daily Living (UPDRS-ADL) scores while “off”; and in UPDRS-ADL scores while “on.” Similar magnitudes were observed in patients treated both with and without DAs.