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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by Rick on November 11, 1999, at 0:13:51
Am I missing something here? Has there been ANOTHER Parke-Davis-funded study that showed more impressive Social Phobia response than the report released in August? This study showed response rates that may be statistically significant, yet are less than seen for SSRI's and far, far less than seen in large-scale controlled studies of Nardil and Klonopin which each produced 70-80% improvement vs. 20% for placebo. If there's been a more recent study, could someone let me know where to locate it? Thanks.
Meanwhile, here is an excerpt from the write-up which has me less than impressed with Neurontin (31% improvement vs. 14% for placebo).
-----------Results of a new study, published in the Journal of Clinical Psychopharmacology (JCP), found that patients suffering from social phobia experienced a decrease in symptoms by an average of 31 percent after treatment with Neurontin (gabapentrin), compared to only a 14 percent reduction in patients treated with placebo.
Research for the study was conducted at Duke University in Durham, North Carolina, and the Dean Foundation of Health, Research and Education in Middleton, Wisconsin, and was supported by the Parke-Davis Division of Warner-Lambert Company. The study also showed that the drug was generally well tolerated.
Historically, social phobia has been treated with a number of drugs, most notably selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), and anti-anxiety agents (benzodiazepines)," explained Dr. Greist. "In the study, gabapentin was shown to significantly reduce the symptoms of this disorder."The most common adverse events during the study in social phobia were infection (29 percent vs. 23 percent with placebo); headache (24 percent vs. 26 percent with placebo); dizziness (24 percent vs. 6 percent with placebo); somnolence (21 percent vs. 9 percent with placebo); nervousness (15 percent vs. 11 percent with placebo); weakness (15 percent vs. 9 percent with placebo); dry mouth (12 percent vs. 0 percent with placebo)
Posted by JohnB on November 11, 1999, at 8:53:55
In reply to Neurontin Social Phobia Hype?, posted by Rick on November 11, 1999, at 0:13:51
Rick, yes, I think you are missing the point. The study was conducted with dosages ranging from 1800 mg/day to 3600 mg/day. So, the overall efficacy ratings are an average of patient response at the different dosages. 1800 mg/day is supposed to be sub-therapeutic, as is 2400 mg/day, as far as social phobia is concerned. 3600mg/day to 4800 mg/day are where the results are suppose to kick in. Discounting the patients at dosages under 3600 mg/day, you can easily estimate that the response for the few at the higher dosages was SIGNIFICANTLY higher than a 30% response rate.
Parke-Davis is planning a follow-up study at the higher dosages, as indicated at the end of their study report.
JohnB
Posted by Rick on November 11, 1999, at 15:29:02
In reply to Same Study, But , Yes, You are Missing the Point, posted by JohnB on November 11, 1999, at 8:53:55
John B.
That would make sense. But I'm surprised neither the abstract nor the press release mentioned this key finding nor the planned follow-up.
Since you must have a copy of the full report, I have a few questions: Did the complete study break out response rates by dosage level? Were side effects worse at the higher levels? How long did effects take to kick in at the mega-doses?
Thanks,
Rick
> Rick, yes, I think you are missing the point. The study was conducted with dosages ranging from 1800 mg/day to 3600 mg/day. So, the overall efficacy ratings are an average of patient response at the different dosages. 1800 mg/day is supposed to be sub-therapeutic, as is 2400 mg/day, as far as social phobia is concerned. 3600mg/day to 4800 mg/day are where the results are suppose to kick in. Discounting the patients at dosages under 3600 mg/day, you can easily estimate that the response for the few at the higher dosages was SIGNIFICANTLY higher than a 30% response rate.
>
> Parke-Davis is planning a follow-up study at the higher dosages, as indicated at the end of their study report.
>
> JohnB
Posted by JohnB on November 11, 1999, at 23:14:56
In reply to Re: Same Study, But , Yes, You are Missing the Point, posted by Rick on November 11, 1999, at 15:29:02
The sample size at 3600 mg/day was "insufficient" for the manufacturer to make claims with regards to efficacy at that specific dosage. Parke-Davis does not want to be "burned" by contradicting results from a broader fixed-dose follow-up controlled study, however unlikely that is to happen. The eventual goal is to obtain FDA approval to market Gabapentin for treament of social phobia. Further, there are some indications that slightly higher dosages, sucha as 4800 mg/day, may be even more effective.
JohnB
Posted by Justitia on November 17, 1999, at 10:31:25
In reply to F/up study to increase sample size at 3600 mg/day, posted by JohnB on November 11, 1999, at 23:14:56
After 12 years on 1 mg of klonopin, my presription plan won't cover it. Attempts to withdraw have proved disastrous. My doctor is prescribing neurontin, claiming it is non-adictive. The plan is to use it while I slowly wihdraw from klonopin which is highly adictive. I am super sensitive to drugs (which has its pluses and minuses) but I usually get every side effect reported no matter how small the percentage of the population that gets it. What side effects do you know of?
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