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Topic: Topiramate: safety & interesting effect (Read 277 times) |
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Bob_Johnson
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Topiramate: safety & interesting effect
« on: Sep 11th, 2007, 11:36am » |
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While I regularly caution against using info on meds for migraine and apply it to CH, this is an interesting report. If you use topiramate you might keep notes about effect and post your response: Like that reported here?
A non-statistical comment about long term safety also noted.
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"Topiramate Prophylaxis Effectiveness for Migraines Maintained for Up to 6 Months After Termination"
"August 30, 2007 -- Topiramate, an anticonvulsant, provides prophylactic efficacy along with the expected safety profile for subjects who meet the International Headache Society (IHC) criteria as migraine sufferers, say researchers. Furthermore, the effective migraine prophylaxis achieved is largely maintained after termination of 6 months of prophylaxis. The findings of this combination open-phase and randomised, double-blind trial were presented here on August 28 at the 11th Congress of the European Federation of Neurological Societies (EFNS) on behalf of the Prolonged Migraine Prevention with Topiramate (PROMPT) Study Group by Hans Christoph Diener, MD, PhD, Principal Investigator, Professor and Head, Department of Neurology, University Hospital of Essen, Essen, Germany. Dr. Diener said, "Topiramate is approved for the prevention of migraine in most of the European countries, and as with all the preventive therapies, the label does not limit the duration of therapy of any of these preventive drugs." However, most of these countries have guidelines to limit topiramate use to 4 to 6 months. As there is no evidence from clinical studies to support the validity of this restriction, Dr. Diener explained that this was "why we set-up PROMPT, to address the issue of what happens when you terminate long-term preventive therapy."
"For the primary efficacy parameter from the double-blind phase, the mean changes in number of migraine days in 4 weeks indicated significantly greater increments for topiramate withdrawal (from open-label topiramate to placebo) over continued topiramate treatment at most of the assessments. Also, there was no rebound effect seen on subjects randomised to placebo, whereby the number of migraine days in 4 weeks did not returned to baseline and remained similar to, and not significantly different from, those with continued active treatment.
At the primary endpoint for the last 4 weeks of the double-blind phase, the placebo group showed a continuing increase in the number of migraine days, which was not seen for those on active treatment (1.2 vs 0.1; P <.01). Of note, a "worry effect" was seen under continued topiramate use after randomisation, whereby there was a small increase in migraine days over the first assessments, probably provoked by patients' knowledge of the possibility of having their medication removed.
Dr. Diener pointed out that progressive weight loss for all observed cases in the open-label phase that continued into the double-blind phase remained only for those on active treatment. The placebo group rapidly recovered lost weight, although they did not return to baseline within the duration of the trial.
Of note, Dr. Diener stressed that this first randomised trial investigating the effect of terminating migraine-preventive therapy has shown that "the bad news is, when you terminate prophylactic therapy, you get an increase in migraine frequency; the good news is, migraine frequency does not return to the original level, so you have a sustained treatment effect if you stop after 6 months."
(Edited for length.)
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Bob Johnson
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luveemom
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Re: Topiramate: safety & interesting effect
« Reply #1 on: Sep 11th, 2007, 11:50am » |
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Thanks Bob,
I am on it, and found your post very interesting. I appreciate the info. So far, so good.
Alicia
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