Shown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by jlbl2l on March 1, 2004, at 10:01:21
Pfizer Inc’s novel medicine pregabalin was shown to work quickly and be effective in treating a broad range of symptoms in patients with generalized anxiety disorder (GAD), according to data presented today at the annual meeting of the American Psychiatric Association.
Data from a combination of five placebo-controlled studies—including Phase II and pivotal Phase III trials—suggest that pregabalin may offer broad and rapid efficacy for the acute treatment of GAD. Pregabalin was shown to be significantly effective in each individual study in providing relief of both psychic and somatic anxiety symptoms as early as the first week of treatment.In one of the pivotal studies, the antidepressant venlafaxine was a comparator drug. In this study, pregabalin achieved significantly faster improvement than placebo of psychic and somatic symptoms within the first week. Venlafaxine did not show improvement by week one for either psychic or somatic symptoms. In another pivotal study using the benzodiazepine alprazolam as a comparator drug, data once again showed that pregabalin achieved significantly faster relief of psychic and somatic symptoms than placebo as early as week one. Alprazolam demonstrated significant improvement of only psychic symptoms by week one.
“Psychic and somatic symptoms represent a significant burden of disease experienced by patients with GAD,” said Dr. Stuart Montgomery, Professor of Psychiatry, Imperial College School of Medicine, University of London. “Pregabalin represents a new class of drug for the treatment of GAD that works quickly and appears to offer the strengths of both the benzodiazepines and the antidepressants by providing effective control of somatic symptoms, at least as fast as the benzodiazepines, and more rapid control of psychic symptoms than antidepressants.”
GAD is a chronic condition characterized by excessive worry—considered a psychic symptom—and fatigue and muscle tension—referred to as somatic symptoms. GAD also is characterized by other symptoms such as poor sleep, difficulty concentrating and restlessness that can worsen during times of stress. Approximately five percent of people are affected by GAD at some point in their lives, though it is estimated that only one-third seek treatment.
“When treating GAD, physicians frequently prescribe benzodiazepines to provide fast relief of anxiety during the first few weeks before the anti-anxiety effects of antidepressants take hold,” said Dr. Mark Pollack, study investigator and Director of the Center for Anxiety and Traumatic Stress Related Disorders, at Massachusetts General Hospital and Associate Professor of Psychiatry, Harvard Medical School. “Pregabalin appears to work at least as quickly as benzodiazepines in treating anxiety, and with less risk for dependence. Pregabalin also appears to work significantly faster than antidepressants, which can take up to two or three weeks to begin working.”
The five combined studies represent data from 1,282 patients who received either pregabalin or placebo. All treatment groups had similar baseline clinical and demographic characteristics. Psychic and somatic symptoms as well as speed of onset were assessed using the standard measurement tool, the Hamilton Rating Scale for Anxiety (HAM-A).
Dizziness and drowsiness were the most common adverse events reported by pregabalin-treated patients. However, the majority did not result in discontinuation and most cases were resolved during the trial.
Pregabalin has a novel mechanism of action for potential treatment of anxiety disorders. Developed by Pfizer, pregabalin has been studied in an extensive clinical program involving over 8,000 patients worldwide. Pfizer plans to submit a New Drug Application to the U.S. Food and Drug Administration this year for pregabalin in the treatment of GAD, neuropathic pain and as an add-on therapy for epilepsy.
Pfizer is committed to pioneering targeted, innovative therapies for psychiatric and neurological disorders. The company's knowledge and expertise in the areas of anxiety, depression, schizophrenia, Alzheimer's disease and epilepsy have helped bring effective treatments to market.
Psychiatric and neurologic disorders represent one of the highest research priorities at Pfizer. Of the company's total R&D investment of $5.2 billion, the largest of any healthcare research company in the world, more than $1 billion is allocated to the development of more effective neuroscience compounds.
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer products.
Posted by NotAddicted on March 1, 2004, at 10:44:05
In reply to Pregabalin Excitement!!! better than Xanax/Effexor, posted by jlbl2l on March 1, 2004, at 10:01:21
I must say I am intrigued by the findings and may end up being interested. I'm not trying to be a "wet blanket", but I think a healthy dose of common sense and looking to the past needs to be incorporated. I have found that each new addition in the fight for these problems we have, generally comes in as the latest, greatest and far superior (or at least as good). It is only after a test drive in the "real world" that the hype gets a little clouded by real life difficulties that arise. This may not be the case here, but I, have to look at it objectively.
One only needs to read the numerous threads here to see the "great" clinical results dim a bit in the daylight of real users. Of course, one person's poison is yet another's nirvana.
I do hope for some this is the "be all - end all" greatest thing. But for me, I'll wait until it's been on the market for a while to decide if I would like to test drive it.
Time will certainly tell the tale as it evolves.
I am glad to see increased work in this area and that is certainly a plus....
Posted by jlo820 on March 1, 2004, at 15:11:35
In reply to Re: Pregabalin Excitement!!! better than Xanax/Effexor, posted by NotAddicted on March 1, 2004, at 10:44:05
When this drug comes out, it will be interesting to see the results/responses on this board.
Mark my words - within 6 mos. to a year, many people here will be telling us how this is the worst drug ever and how it ruined their lives because of the SE's, etc.
I am very excited about pregab, but let's just wait and see...
Posted by NotAddicted on March 1, 2004, at 15:31:14
In reply to Re: Pregabalin Excitement!!! better than Xanax/Effexor, posted by jlo820 on March 1, 2004, at 15:11:35
"Mark my words - within 6 mos. to a year, many people here will be telling us how this is the worst drug ever and how it ruined their lives because of the SE's, etc.
I am very excited about pregab, but let's just wait and see... "
~~~That was my point and as you say, we will have to wait and see.
Posted by Viridis on March 2, 2004, at 0:52:53
In reply to Pregabalin Excitement!!! better than Xanax/Effexor, posted by jlbl2l on March 1, 2004, at 10:01:21
This really is just an extension of the previous posters' comments, but I'll add my prediction. If Pregabalin is as effective as they say it is, then it's bound to have discontinuation issues etc., just like benzos, SSRIs, etc. After all, if the effect is so dramatic re: anxiety, then people will become dependent on it and quitting likely will be very difficult, whether due to true withdrawal or simply a return to previous anxiety levels.
It's great to have another med in the arsenal of anti-anxiety drugs, but by the very nature of the condition it seems unlikely that anything that's truly effective will be free of dependency issues. In a broader sense, any med that changes brain chemistry in a major way (even if very positively) is not likely to be something you can go on and off of easily.
None of this is a criticism of Pregabalin (which I know little about), or anti-anxiety meds in general. Anxiety reduction is extremely important for one's mental and physical health, and I'm a big supporter of benzos. I just don't see how anyone with long-term anxiety issues could take a med that works, get results, and not feel compelled to take it continuously. The same goes for depression and antidepressants that work. Psychologically, and probably physically too, one is bound to become dependent.
Tolerance, abuse, etc. are separate concerns, and who knows how these will play out with Pregabalin, but if the pre-release "advertising" is true, some people probably will have to accept that this will be a long-term necessity, just as Klonopin, various SSRIs etc. are for many people.
If the meds work and improve your life, then that's what's important. I'd just hate to see Pregabalin give doctors yet another excuse to avoid the proven meds. Valium, Xanax, Prozac, Paxil, Zoloft, Effexor etc. were all marketed as the new "addiction" (really dependency) free alternatives for anxiety and/or depression, and all have proven to have dependency/withdrawal issues for some people, while at the same time being life-changing meds for many. I expect Pregabalin will be the same.
Of course, I'll probably try it!
Posted by scott-d-o on March 2, 2004, at 9:23:05
In reply to Re: Pregabalin Excitement!!! better than Xanax/Eff » jlbl2l, posted by Viridis on March 2, 2004, at 0:52:53
I agree, anything that alters brain chemistry in a significant way is going to cause dependency when used on a regular basis. I truly hope that this medication is not another buspar and actually does provide relief for the majority of patients, but I think I will stick to benzos regardless. The mechanisms of action are really just causing the same overall effect thru different means, benzo's act selectively (although indirectly) on GABA and it's truely astounding they have been around for as long as they have. I think it's likely benzo's may never be replaced although I'm sure the pharmaceutical companies will be successful in curbing their use though the marketing of their inferior, patented, product. There's a reason benzo's have been around for thirty years, and I think some people need a reality check when it comes to this utopian vision of future medications; where you will be able to treat any psychiatric disorder, without any side effects or dependency.. I wouldn't count on it.
Posted by johnray on March 2, 2004, at 20:30:47
In reply to Re: Pregabalin Excitement!!! better than Xanax/Eff, posted by scott-d-o on March 2, 2004, at 9:23:05
Is there anyone out there who wouldn't rather replace their SSRI with something equally effective that doesen't ruin their sex lives?
I would love to never take another AD again which I believe only allows one to barely brake even.
Posted by jack smith on March 3, 2004, at 1:06:21
In reply to Re: Pregabalin Excitement!!! better than Xanax/Effexor, posted by NotAddicted on March 1, 2004, at 15:31:14
This is the end of the thread.
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