Abstracts

To examine our center[apos]s experience with the off-label use of progesterone for refractory seizures in selected women. Our center developed a protocol for progesterone supplementation and patient education materials. A commercially available dosage form of progesterone (Prometrium[reg]) was used for patient convenience and for possible prescription insurance coverage.
In Oct 2003, female patients with medically intractable seizures that increased in frequency around or during menses were offered progesterone therapy in addition to their current antiepileptic medications. Each patient received extensive education from our center[apos]s clinical pharmacist including therapy rationale and expectations, instructions, and side effects. Each patient received standard follow-up care at our center.
In Apr 2004, the charts of patients offered progesterone therapy were retrospectively reviewed for efficacy, side effects, and reason for discontinuation of progesterone if applicable. Patients were contacted via telephone or interviewed at a clinic appointment if necessary. Between Oct 2003 and Apr 2004, 6 patients were offered progesterone therapy. By April 30, 2004, 33% (2/6) of the patients remained on progesterone, 50% (3/6) of the patients discontinued progesterone due to lack of efficacy (1 of these patients also experienced an intolerable side effect), and 17% (1/6) of the patients chose not to start therapy. All patients were maintained on individualized regimens of therapeutic antiepileptic medications.
The majority of patients who started on progesterone later discontinued it due to lack of effect on seizure frequency. Of the five patients who started progesterone therapy, four patients continued it for an adequate (at least 3 month) trial period, and one patient discontinued it after 1.5 months due to a noticeable increase in seizure frequency. Of note, all patients offered progesterone have been difficult to treat. Of the 5 patients who started progesterone, each failed an average of 9 medications (range: 5-17) prior to progesterone therapy. All patients had also been treated with non-medication interventions including surgery, vagus nerve stimulation, or both.
Of the five patients who started progesterone, four patients reported side effects. One patient reported improvement in mood (favorable). One patient reported tolerable dizziness and continued therapy. One patient with a history of sleep difficulties reported insomnia, and one patient reported excessive fatigue that contributed to progesterone discontinuation. Overall, our center experienced limited success using a regimen containing progesterone (as Prometrium[reg]) in female patients with medically intractable seizures that increased in frequency around or during menses. In patients refractory to other therapies, a regimen containing progesterone may be an option with a low risk of intolerable side effects.