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Migraine News for April 2001 DIVALPROEX SODIUM DELAYED-RELEASE TABLETS FOUND EFFECTIVE IN LONG-TERM TREATMENT OF CHRONIC DAILY HEADACHE |
| MAGNUM would like to bring attention
to a newly published study appearing in the March 2001 issue of Headache:
The Journal of Head and Face Pain, shows that divalproex
sodium delayed-release tablets (a time released form of Depakoteš
marketed under the name Depakote ERš) can be used for a prolonged period
(up to three years) as a sole agent for the successful treatment of chronic
daily headache.
As many Migraineurs have a chronic daily headache component, or for those who suffer chronic daily headaches with a Migraine component, this study may hold up some hope. In this study, nearly 75 percent of the 138 participants had at least a 50 percent reduction in overall headache frequency, and average improvement of chronic daily headache was 47 percent. "Previous short-term studies have suggested that divalproex sodium is a safe and effective drug for chronic daily headache," said Frederick G. Freitag, D.O., lead author of the study and associate director of the Diamond Headache Clinic. "Our research shows long-term effectiveness for divalproex sodium for chronic daily headaches with a Migraine component." | |
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Adverse effects occurred in approximately one third of the patients, though none were severe, according to the study. The researchers point out that weight gain has been noted in the past as a side effect of divalproex sodium treatment; however, in the current study, weight gain occurred in less than one half of the patients and, in fact, nearly one half of the patients experienced weight loss. Chronic daily headache is a widespread clinical problem and comprises almost 40 percent of patients seen in specialty headache clinics. Chronic daily headaches are those that occur every day or nearly every day. Most of these are a combination of "transformed Migraine" and tension-type headaches. Transformed Migraine consists of a daily headache lasting at least four hours. Patients with chronic daily headache report a prior history of Migraine or a history of increasing frequency, but decreasing severity of Migraine-associated features. In the current study, chronic daily headache encompasses four major diagnostic categories: chronic tension-type headache, new daily persistent headache, hemicrania continua, and transformed Migraine. Hemicrania continua is a chronic, continuous, fluctuating headache on one side of the head. The study was a retrospective analysis of 642 patients at the Diamond Headache Clinic who were treated with divalproex sodium. Data on headache frequency, characteristics and diagnosis were determined from patient diaries and concurrent case histories. Of the 642 patients, 138 were receiving divalproex sodium as the only preventive treatment for chronic daily headache. Of the 138 patients included in the analysis, 37 were men and 101 were women. Mean patient age was 41.5 years. Study subjects received treatment for an average of 13.2 months, with a range of 3 to 71 months. Ninety-three of the 138 patients receiving only divalproex sodium had at least a 50 percent reduction in overall headache frequency. The mean decrease in headache frequency was 47 percent. About one-third of study participants experienced adverse effects. Weight gain occurred in less than one half of the patients; weight gained averaged 2.9 lbs. and was greater in men than women. Weight loss occurred in 42 percent of the patients. No correlation between weight gain and sex, age, duration of treatment, dose of divalproex sodium, baseline weight, or response to treatment was demonstrated. Previously reported side effects, as well as concerns about hepatotoxicity and weight gain, have been a cause of concern to many doctors in regard to divalproex sodium, according to the researchers. However, results from this study show weight gain was negligible and hepatotoxicity did not occur during treatment periods of up to six years. "In our study, the incidence of adverse effects were less than those seen in controlled trials," Freitag said. "Although a copharmaceutical approach to the treatment of migraine and tension-type headache may be required in some patients, this study demonstrates that divalproex sodium may be the only agent needed for successful management of chronic daily headache." In addition to migraine prevention, divalproex sodium is indicated for epilepsy and bipolar disorder. Founded in 1972 and located in Chicago, the Diamond Headache Clinic is the oldest private clinic in the United States devoted solely to the management of headache pain. In 1983, it expanded to include an inpatient unit specializing in care of recidivist patients. For More Information Please Contact: Judy O’Malley, Diamond Headache Clinic, |
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